American Association of Diabetes Educators – 40th Annual Meeting

August 7-10, 2013; Philadelphia, PA; Full Report - Draft

Executive Highlights

In this report, we provide our big picture themes of the 40th Annual Meeting of the American Association of Diabetes Educators, held in Philadelphia’s Pennsylvania Convention Center from August 7-10, 2013. This year’s conference attracted approximately 5,000 attendees and exhibitors, on par with last year’s total of 5,144 in Indianapolis, IN. Of those 5,000, about 3,000 were registered as attendees and 1,950 were registered as exhibitors –similar to last year’s 2,934 attendees and 2,210 exhibitors. The exhibitors at this year’s conference represented 233 companies and organizations, down 11% from the 262 groups at AADE 2012; however, this year the conference boasted 50 first-time exhibitors, including the Centers for Medicare & Medicaid Services (which is particularly significant as competitive bidding is implemented). Over the course of the conference, there were 112 breakout sessions, workshops, and general sessions, as well as three corporate symposia, and seven product theaters. This year, we attended several sessions on mobile health and social media, including one full-day pre-conference workshop aimed at examining how social media could be used to better manage diabetes care. Last year’s AADE had a similar focus on mobile health and social media – an indicator of how quickly these technologies are continually becoming a greater part of diabetes management. At this year’s AADE, we also noticed a focus on the cost of diabetes – perhaps not surprising considering intensifying price pressures, particularly CMS’ implementation of competitive bidding for diabetes testing supplies this spring and plans to implement it for pumps in January 2014. However, the discussion of cost was not limited to diabetes’ testing supplies. Cost was also raised in discussions about diabetes drugs, especially regarding treatment options. While many sessions stressed the importance of individualizing treatment, some speakers also highlighted the importance of low cost and encouraged the use of sulfonylureas. Looking at overall patient treatment, we saw a continued emphasis from last year on patient-centered care, with many presentations highlighting the uses of the ADA/EASD and AACE treatment algorithms.

Below, we discuss major themes of the conference. For ease of navigation, we have organized our coverage into eight topic areas: 1) Diabetes Technology; 2) Diabetes Drugs; 3) Obesity Management; 4) Education, Diabetes Prevention, and Self-Management; 5) Mobile Health and Social Media; 6) Health Policy, Reimbursement, and Healthcare Models; 7) Additional Topics; and 8) Exhibit Hall. Talks highlighted in light blue are newly published in the full report. Talks with a title highlighted in yellow were identified by the Close Concerns team as among the most valuable at the conference – we couldn’t include all of the incredible talks, but we wanted to indicate our top 10 favorites. You can also see our AADE 2013 Top Ten report at http://close.cx/AADE2013TopTen.

With all of the intelligence and enthusiasm we saw in Philadelphia, we are already getting excited for the 2014 AADE conference in Orlando, FL from August 6-9, 2014.  

 

AADE Themes

DIABETES TECHNOLOGY

  • On the technology side, CMS’ competitive bidding program for diabetes supplies was a focus of discussion in a couple of talks – neither speaker favored the program, reinforcing our view that it is not in the best interests of patients or the healthcare system in the long run. Dr. David Klonoff (Mills-Peninsula Health Services, San Mateo, CA) expressed concerns that the program will result in small companies producing strips without the appropriate quality systems. CMS’s point of view, according to Dr. Klonoff, is that these meters/strips are perfectly fine if they have the FDA’s seal of approval. Consequently, it is incumbent upon the FDA to take action if something is wrong with the products’ quality. This brought up Diabetes Technology Society’s upcoming September 9 meeting, which has lots of FDA engagement and will focus on post-market surveillance of SMBG supplies – oversight the agency does not currently have. Ms. Patty Telgener (Emerson Consultants, Excelsior, MN) also discussed competitive bidding in her talk on reimbursement. While Ms. Telgener was quite wary of the impact that competitive bidding will have on patients, especially because many patients will have to change where they buy supplies and many might feel pressed to change brands. She also warned that CMS may begin implementing competitive bidding for insulin pumps in January 2014. Our understanding is that the specifics are under discussion with CMS (per industry panelist comments at Insulindependence’s recent North American conference [item number three in our top 10 report at http://close.cx/InsulindependenceConference]), though we see even less rationale for competitive bidding in the pump arena, mainly because the products are not as commoditized as strips and meters.
    • Competitive bidding was certainly a focus in the AADE 2013 Exhibit Hall. Abbott’s booth included a focus on educating attendees about the impact competitive bidding could have on patient choice. This was not surprising given the company’s recent (very well done, in our view) television advertisements on the issue (visit www.myfreestyle.com and click on the triangular play button next to the “Medicare Part B” sign). On the other side of the hall and the pricing issues, was Walmart’s booth dedicated to its ReliOn line of diabetes care products. When we first approached the booth, the two representatives warmly underscored the affordability of ReliOn products (a 50-count box of ReliOn Prime strips costs $9). We asked the reps about the strips’ accuracy, and one boldly remarked that various theories on accuracy are “put forth by industry” whose products are more expensive. Reps in the Nipro Diagnostics booth also expressed confidence that the company should fare well in the aftermath of competitive bidding. Arguments and divisiveness aside, we would prefer to let the data speak for itself – we hope to see a day where an independent authority tests and verifies strip accuracy. Ideally, this would be the FDA – especially in a post-market setting – and we’ll be interested to hear more nuance on this issue at DTS’ September 9 meeting. For more information on the conference, please see our August 6 letter at http://close.cx/6Aug2013Letter.
  • The AADE 2013 program offered limited content on CGM compared to other recent meetings where there has been more – Dexcom’s product theater was the only session fully devoted to the technology. In a standing-room-only session, Dr. Gregg Gerety (The Endocrine Group, Albany, NY – an extremely highly regarded practice on diabetes technology) and Ms. Keri Weindel made a compelling case for the benefits of Dexcom’s G4 Platinum. In particular, one slide that presented data from ADA 2013 drew murmurs from the audience – one-year after purchase, 76% of patients wore their Dexcom Seven Plus CGM almost daily, compared to just 19% of Medtronic MiniLink users (see page 73 of our report at http://www.closeconcerns.com/knowledgebase/r/94f937d8) – we imagine with the G4 Platinum’s improvements over the Seven Plus, the 76% could now be an underestimate. [While not directly comparable, at Keystone 2013, Dexcom CEO Terry Gregg discussed a recent Kaiser study looking at utilization rates of CGM, and over 90% of patients that started on the G4 Platinum have continued to use it (timeframe not specified)]. Educators in Dexcom’s AADE product theater participated quite actively in what was an extremely interactive session, making it easy for us to see that CGM is becoming more widely accepted in this influential audience. Still, we hope future AADE conferences include whole breakout sessions and symposia devoted to optimizing use of CGM in patients with type 1 and type 2 diabetes – there’s a long way to go to make this technology standard of care and this is a key area in which patients can benefit significantly, especially in helping HCPs personalize their diabetes management.

 

DIABETES DRUGS

  • On the type 2 diabetes drug front, we noticed some cautious optimism for the new SGLT-2 inhibitor class and more broad reassurance about incretins’ pancreatic safety (with one notable exception that didn’t receive much visibility). LifeScan and Animas representatives at the J&J booth generated a great deal of enthusiasm about J&J’s SGLT-2 inhibitor Invokana (canagliflozin), touting the potential for combination with virtually any other agent. This certainly bodes well down the road for fixed dose combinations, depending on J&J partnerships – one co-pay, one pill to take, very attractive to patients, and presumably to payors given likely improved adherence vs. taking two pills. The Invokana Product Theater focused on its superiority over Merck’s DPP-4 inhibitor Januvia (sitagliptin). In a session on new diabetes drug updates, Dr. Joshua Neumiller (Washington State University, Spokane, WA) provided a detailed and balanced overview of Invokana, which some audience members had not yet heard of. By contrast, in a session on using the ADA/EASD 2012 Position Statement to select second-line drug options, pharmacists Drs. Julie Sease and Kayce Shealy (both of the Presbyterian College School of Pharmacy, Clinton, SC) said they purposely did not discuss SGLT-2 inhibitors in detail, as they felt they did not have sufficient experience with this class yet. They were fairly conservative in recommending it, characterizing the A1c reduction as "quite modest" (which was surprisingly incorrect) and worrying about safety in people with renal impairment (where it is contra-indicated). They did note that the potential for weight loss and blood-pressure-lowering is quite attractive. In both of the aforementioned sessions, speakers reviewed evidence about incretins and pancreatic safety and urged CDEs to make no changes to their incretin-prescribing practices. Ms. Caroline Trapp (Premier Internists, Southfield, MI), on the other hand, did not mention the increasing consensus that current data is insufficient to support the association between incretins and pancreatic harm; instead, she appeared to accept the fears as fact. She also expressed particular misgivings about SGLT-2 inhibitors and recommended against prescribing any agent that has been on the market for less than a year.
  • While AADE does not traditionally have a strong focus on novel drugs or new basic science or clinical data, we were excited to hear about glucagon’s therapeutic potential in a Lilly supported CME event. Dr. Carol Wysham (Washington State University, Spokane, WA) and particularly Ms. Geralyn Spollett (Yale School of Medicine, New Haven, CT) voiced strong support for micro-dosing glucagon. Ms. Spollett emphasized her view that micro-dosing is "a great idea" and something providers "should start thinking about more." This symposium also highlighted the pioneering research of Dr. Roger Unger, the role of hyperglucagonemia in diabetes, and reviewed the data on Lilly's glucagon receptor antagonist. All in all, it reminded us of the promising value that addressing glucagon could have as a therapeutic target. As a reminder, we have heard in the past that hyperglucagonemia in type 2 diabetes is responsible for about 50% of the excess postprandial increase in glucose levels (with lack of sufficient insulin accounting for the other 50%; Shah et al., J Clin Endocrin Metab 2000).  At ADA this year, we saw 24-week phase 2 data for Lilly’s glucagon receptor antagonist LY2409021 where the 20 mg and 10 mg doses provided significantly greater A1c reductions (0.92% and 0.78%, respectively) compared to placebo (0.15%; p<0.001 for both comparisons).
  • We also noticed a great deal of cost-conscious discussion about drugs, especially around insulin initiation and the optimal use of sulfonylureas. Dr. Evan Sisson (VCU School of Pharmacy, Richmond, VA) was one of multiple speakers to recommend the combination of basal insulin with sulfonylureas to cover prandial glucose spikes. Although his overall message was valuable in that he offered many creative examples and solutions for individualizing treatment, the presentation was fairly cost-focused, whereas we felt aspects of the conversation like efficacy and adherence were somewhat overlooked. It is a reality that many patients must rely on SFUs and NPH insulin for cost reasons, but for the sake of patients who do have insurance coverage or who can get access through fee assistance programs, we thought he could have elaborated on other options as well. Compared to Dr. Sisson, Dr. Laura Shane-McWhorter (University of Utah, Salt Lake City, UT) spoke far more critically of SFUs, noting their association with hypoglycemia and cardiovascular adverse events (she did not mention weight gain) during a session on medication safety issues. As an example of why better drug options for both patients and prescribers are necessary, one breakout session examined the adequacy of insulin knowledge among staff nurses at UT Southwestern and found that participating nurses had an average score of 67% on a basic insulin knowledge tests. This underscores the need for easier-to-prescribe options so that these over-burdened healthcare professionals can provide better care. Innovation is still sorely needed, but won’t be encouraged if everyone were to stick to only generic options. As well, innovative products will all be generic one day, as long as they are supported while branded drugs.
  • As with last year’s ADA, patient-centered care was a prominent issue, with a focus on treatment algorithms. The highest-profile talk on the topic was a presentation on the ADA/EASD’s patient-centered position statement, co-led by none other than document lead author Dr. Silvio Inzucchi (Yale University, New Haven, CT). Amidst the discussion of a controversial series of issues (including the choice between initial combination therapy or a step-wise escalation approach), Dr. Inzucchi presented a very comprehensive table of patient factors that would favor or not favor the use of a given drug class (the table is included in its entirety later in this report – see page 42). Later in the conference, Drs. Julie Sease and Kayce Shealy (Presbyterian College School of Pharmacy, Clinton, SC) used a series of cases to illustrate the best drug for a given set of patient priorities — for example, they recommended GLP-1 agonists for a patient with hypertension, dyslipidemia, a high BMI, and severe hyperglycemia, and noted that TZDs could have utility in younger, newly diagnosed patients due to their (theorized) capacity to preserve beta cell function. Overall, it seemed this year that educators are more comfortable with the document than ever before. In addition to the talks on algorithms, we enjoyed an exceptional presentation by Drs. James Gavin (Emory University School of Medicine, Atlanta, GA) and Lenore Coleman (Healing Our Village, Inc., Washington, DC) on the importance of cultural competency in diabetes care, as well as a breakout session on patient-centered outcomes research.

 

OBESITY MANAGEMENT

  • The discussion of obesity treatment and prevention at AADE centered on lifestyle intervention with surprisingly sparse discussion of either pharmaceutical or surgical options. Dr. Arya Sharma (University of Alberta, Alberta, Canada) delivered a stirring keynote address in which he provided a practical way forward for aligning obesity management techniques with the growing consensus that obesity is a disease. In a notable moment, he declared, "I'm a healthcare professional. I don't care how big you are. I care how sick you are." Dr. Eva Vivian’s (University of Wisconsin-Madison School of Pharmacy, Madison, WI) answer to her title’s question “The Obesity Epidemic – Is There a Solution?” appeared to be medical nutrition therapy (MNT). In contrast to the strong support she voiced for MNT she described surgical and pharmaceutical options in a cautionary tone. She painted herself as “not a big advocate of pharmacotherapy for weight loss” and seemed to be particularly concerned about the long-term safety and of anti-obesity drugs. She was even more negative on the use of bariatric surgery, noting that people (particularly if they “drink their calories”) can still gain weight following surgery, if their behaviors are not addressed.

 

MOBILE HEALTH AND SOCIAL MEDIA

  • With mobile health (mHealth) rapidly growing, and new healthcare technologies becoming slightly more common, attendees were eager to hear how new technology could be easily integrated into both patient and HCP everyday life. We heard many speakers discuss the importance of improving the ease of use of healthcare technology. In his standout session on advances in blood glucose monitors, CGMs, and pumps, Dr. David Klonoff (Mills-Peninsula Health Services, San Mateo, CA) called attention to barriers of mHealth adoption, emphasizing that mHealth will only become widely implemented if both patients and clinicians find the technologies easy to use. In a session focused on the “e-patient revolution”, Ms. Deborah Greenwood (American Association of Diabetes Educators, Sacramento, CA) and Mr. Perry Gee (University of California Davis, Redding, CA) also touched on barriers to the adoption of personal health records (PHR), noting that difficulties signing up for online records or syncing with other programs could slow down the process of PHR adoption. As audience members asked how all of the information from various sources might be synthesized, Ms. Greenwood turned to WellDoc and hoped that next year they will have a better method of integrating information (see next bullet for more detail). We hope that this increased focus on reducing barriers within health care technology is an indication that HCPs are becoming more comfortable conceptually and in practice that technology will play an influential role in the future of healthcare.
  • Turning specifically to mobile apps, Ms. Molly McElwee (UVA, Charlottesville, VA) and Ms. Marisa Moore (Marisa Moore Nutrition Communications, Atlanta, GA) dedicated an entire (most valuable and very well attended) session to outlining the best apps on the market for diabetes and weight loss management. The audience learned about the best components of dLife, My Fitness Pal, and My Glucose Buddy, to name a few. We were intrigued to see the variation in audience members’ exposure to apps – while most HCPS in the audience seemed to have tried at least one or two apps, there were a few self-identified novices who had never downloaded apps before. During a Q&A session, Ms. Malinda Peeples (WellDoc, Baltimore, MD) announced that WellDoc has just soft-launched a mobile prescription therapy for type 2 diabetes that will be more broadly available nationwide next year (see our report at http://www.closeconcerns.com/knowledgebase/r/ffa40f47). This was great to hear! Ms. Peeples also touched on another issue that will presumably become increasingly important in upcoming years: the FDA’s role in app development. Currently, any apps involved in treatment and mitigation of a disease must be cleared by the FDA, and we believe as technology and healthcare continue to merge (such as CGM readings being sent directly to phones), that line may become even blurrier.
  • AADE appears to be getting ready to be a much more public-facing advocacy group, and it seems keen on alerting the general public about the important role of diabetes educators. We first thought this at the pre-conference session on social media, where Ms. Hope Warshaw (Hope Warshaw Associates, Alexandria, VA) mentioned that the AADE will be unveiling a major public awareness campaign promoting the roles and importance of CDEs. And indeed, just a couple feet away a room full of diabetes educators were being trained in traditional media by former sports broadcaster Gerry Sandusky (Sandusky Group, Baltimore, ML). Certainly, diabetes educators have a lot of valuable insight to share with the public on how they are patients’ strongest allies for staying in control of their diabetes. In addition, a more prominent diabetes educator presence in the mainstream could aid in their efforts to secure reimbursement for prevention and self-management support services. Reimbursement-expert Ms. Patty Telgener (Emerson Consultants, Excelsior, MN) argued in her breakdown of reimbursement changes under healthcare reform that an “important initiative for AADE” should be persuading Medicare to cover prediabetes. As diabetes educators seek the spotlight, it will also be critical for them to come to consensus on what they want to communicate with the public.
  • AADE is growing a greater consciousness for social media. The excellent preconference session on social media, led by Manny Hernandez (Diabetes Hands Foundation, Berkeley, CA), Amy Tenderich (Diabetes Mine, San Francisco, CA), David Edelman (Diabetes Daily, Cleveland, OH), and Hope Warshaw (Hope Warshaw LLC, Alexandria, VA) took a tremendously engaged and curious group of educators through a series of trainings and breakout sessions on how to engage with patients in the diabetes online community. While the attendees were absorbing the information on social media ethics and where to connect with the diabetes online community, many of them still have a ways to go to reach full competency with social media (one of the self-described "power users" called a Facebook profile, "a Facepage"). Of course, the reason educators were keen on this training is because patients are increasingly turning to social media as a way to seek and give support, share their experience, supplement their education, and better their diabetes self-management. Unfortunately, we have to agree with Ms. Warshaw that studies on social media in the diabetes online community are few and far between. Therefore, we took special note of a poster led by Dr. Emily Shaffer-Hudkins (University of South Florida College of Public Health, Tampa, FL) titled “Social Media Use Among Individuals With Diabetes.” When their survey respondents were presented with the statement "I am typically more motivated to maintain a healthy lifestyle after reading or sharing online," 21% of respondents strongly agreed, 49% agreed, and 28% were neutral. Moving forward, we hope to see more expansive studies on the topic, perhaps even trials!

 

HEALTH POLICY, REIMBURSEMENT, AND HEALTHCARE MODELS

  • Attendees and speakers at this year’s AADE appeared to have more optimistic perspective on the potential benefit of the Affordable Care Act on CDEs, though serious concerns certainly still exist. A recurring topic was the impact of healthcare reforms on reimbursement for diabetes care, an area that Ms. Patty Telgener (Emerson Consultants, Excelsior, MN) discussed in “Reimbursement and Diabetes.” Ms. Telgener painted herself a "glass half-full person" on healthcare reform and encouraged attendees that it would increase CDE’s job security by better aligning financial incentives with the work CDEs perform. Still, as noted above, she was wary of the impact that competitive bidding will have on patients in the SMBG domain, and potentially, insulin pumps starting in January 2014. In a symposium sponsored by Dexcom, a talk titled “CGM Reimbursement for Your Practice and Patients”, also led by Ms. Telgener, discussed strategies for providing reimbursement for devices in light of increasing device taxes. At the hospital level, there was much discussion surrounding the streamlining of hospital policy. Dr. Jane Seley (Cornell Medical Center, New York, NY) spoke at multiple sessions, emphasizing the need to ensure that hospital policies coincide with the best outcomes for patients. One such session, “Inpatient Glycemic Management: From Culture Shock to Culture Change,” outlined the necessity of clear guidelines for transitions of care in order to prevent adverse events in patients with diabetes.

 

EDUCATION AND SELF-MANAGEMENT

  • Stanford-star behavioralist Dr. BJ Fogg (Stanford University, Palo Alto, CA) addressed how to change lifestyle habits through behavior modification. Dr. Fogg emphasized that “what works is helping people do what they already want to do.” He outlined several valuable prescriptions for success in motivating behavior change using the Fogg Behavior Model (behavior = motivation + ability + a trigger); the Fogg Behavior Grid (a matrix of the 15 different types of behavior change); the concept of “success momentum” (small wins that build confidence over time); and tips for building new habits (e.g., performing a tiny behavior after an existing routine). Success momentum, Dr. Fogg noted, is especially critical in the health arena since patients will inevitably experience roadblocks. We also appreciated that Dr. Fogg outlined specific areas for the AADE to improve, including teaching behavior that works, providing guidance for environment change, and curating innovations. This talk had the entire room riveted for an hour and was among the most valuable we saw at AADE. Certainly, the long lines to grab Dr. Fogg’s business card/behavior cheat sheet at the back of the hall were a testament to how much educators like it too!
  • Similarly, many other presenters discussed tactics to promote lifestyle change and encourage patients to eat well and exercise. Ms. Marion Franz (Nutrition Concepts By Franz, Inc., Minneapolis, MN) stood at odds with the two other speakers in her session, asserting that macronutrient content in diets did not have a significant effect on A1c reduction. In her mind, there was no single diet that provided an advantage to glycemic control. We were very surprised to hear this, another reminder to us that the interpreting nutritional science is indeed a murky and subjective endeavor. There's no doubt this type of research is incredibly challenging to conduct in a controlled manner, but we find the arguments of Mr. Gary Taubes and Dr. Robert Lustig quite persuasive - that macronutrient composition DOES matter and not all calories are created equal. As briefly mentioned above, Ms. Caroline Trapp (Physician’s Committee for Responsible Medicine, Detroit, MI) remarked on the “pharmacocentrism” of diabetes treatment in lieu of a focus on lifestyle intervention. In particular, we were surprised that she mentioned the incretins/pancreatitis controversy without addressing that the association is far from proven. Relaxation and stress reduction – mindfulness approaches to better diabetes self-management – were underscored by Ms. Monica DiNardo (University of Pittsburgh, Pittsburgh, PA). We think it’s important that patient psychological and social barriers are being acknowledged as significant components of diabetes management. Finally, Ms. Joanne Gallivan (National Institute of Health, Bethesda, MD) and Dr. Linda Siminerio (University of Pittsburgh, Pittsburgh, PA) highlighted the importance of continuing to improve the quality of and access to diabetes education with results of the National Diabetes Education Program’s National Diabetes Survey . In particular, personal acknowledgement of perceived risk for diabetes was startlingly low – only 25% of high-risk individuals (BMI >25 kg/m2 or history of gestational diabetes) reported feeling at risk for diabetes.

 

EXHIBIT HALL

  • AADE 2013 allowed several companies to show educators their newest products in the exhibit hall for the first time. On the drug side, this was the first AADE for the SGLT-2 inhibitor Invokana (J&J Janssen’s canagliflozin) and weight management drugs Qsymia (Vivus’ phentermine/topiramate ER) and Belviq (Arena/Eisai’s lorcaserin). On the device side, Dexcom showed the G4 Platinum CGM for the first time at an AADE (and Dexcom Share under a not-yet-FDA-approved glass case), while Insulet proudly displayed its recently launched second-generation OmniPod. There was also a handful of device news on products awaiting FDA approval: Glooko announced FDA submission of an Android version of its mobile app and universal MeterSync cable, and Philosys attracted a crowd with its Gmate Smart headphone jack-compatible blood glucose meter (awaiting FDA approval). Unsurprisingly, competitive bidding came up in the hall as well – Abbott reps informed attendees how the new CMS program would affect patients’ choice, highlighting that Abbott test strips would still be covered by Medicare Part B. Meanwhile, our conversations at the Nipro Diagnostics and Walmart ReliOn booths leaned more in favor of the program. We were glad to see first-timer CMS in the AADE exhibit hall, though disappointingly, the reps could not answer any of our questions on competitive bidding, test strip quality, CGM, or diabetes technology in general.

 

Table of Contents 

 

1. Diabetes Devices

Breakout Session: Advances in Technology for BG Monitors, CG Monitors and Insulin Pumps

ADVANCES IN TECHNOLOGY FOR BG MONITORS, CG MONITORS AND INSULIN PUMPS

David Klonoff, MD (Mills-Peninsula Health Services, San Mateo, CA)

Dr. David Klonoff’s early morning talk on technology was very well organized and well-paced and included sections on blood glucose monitoring, CGMs, insulin pumps, the artificial pancreas, and mHealth – a lot to cover! His remarks had discussion of hot topics as well as more general background material from presentations he has given at recent conferences (Clinical DTM [http://close.cx/ClinicalDTM2013], NIH/JDRF/FDA AP Workshop [http://close.cx/APInnovationWorkshop], and ENDO 2013 [http://close.cx/ENDO2013]). He spent the most time on blood glucose monitoring, billing the just-announced September 9 DTS meeting as “solutions” focused (vs. the May 21 BGM meeting was centered on identifying problems). Dr. Klonoff also spoke frankly about competitive bidding and counterfeit strips, highlighting significant safety concerns with both. His talk also touched on a variety of other interesting issues: hacking of insulin pumps, use of control solution, MannKind’s Afrezza (“I believe this product is going to get approved…Our patients in clinical trials really like it…I expect this will be a popular product”), the Medtronic MiniMed 530G (FDA approval “in the near future” in his view), and trends/barriers in mHealth. His reviews of the AP and insulin pumps were very brief.

  • The upcoming September 9 DTS meeting in Bethesda, Maryland will be focused on identifying solutions to BGM inaccuracy, particularly regarding post-marketing surveillance of BGMs (see item #1 at http://close.cx/6Aug2013Letter). We were glad to hear Dr. Klonoff say that the FDA “is very engaged” and look forward to learning much more in a few weeks.
  • Dr. Klonoff briefly highlighted the May 21 meeting, “Do Currently Available Blood Glucose Meters Meet Regulatory Standards?” and emphasized its key takeaway: there is a problem. Read our full report at http://www.closeconcerns.com/knowledgebase/r/2e03af3f or the Meeting Proceedings paper in the July 2013 issue of JDST  (Klonoff and Reyes; subscription required). Dr. Klonoff informed the audience of one of the meeting’s key insights: close to 30% of blood glucose meter brands don’t perform according to FDA standards (ISO 15197: 2003), and close to 50% don’t perform according to the new ISO 15197: 2013 standards. We hope FDA becomes both more aware and more focused on this issue.
  • Both the Endocrine Society and ADA have responded to the BGM accuracy issue with formal statements. The July 29 Endocrine Society statement (https://www.endocrine.org/membership/email-newsletters/endocrine-insider/2013/july-26-2013/physicians-urged-to-monitor-accuracy-of-bgm-systems) urges physicians to monitor the accuracy of BGM systems. The ADA’s July 31 statement (http://www.diabetes.org/for-media/2013/fda-reg-blood-glucose-strips.html) is stronger, noting, “It is critical that FDA oversight extend beyond the initial pre-marketing approval to continual monitoring of the post-marketing product to assure that accuracy remains within established standards.” Dr. Klonoff also mentioned the grassroots StripSafely advocacy campaign (www.stripsafely.com) and Dr. Richard Kahn’s valuable recent commentary in RollCall (http://www.rollcall.com/news/competitive_bidding_puts_diabetes_patients_at_risk_commentary-226154-1.html) - we urge readers to look at both.
  • Dr. Klonoff expressed concern that competitive bidding will result in small companies producing strips without the appropriate quality systems. He briefly described some of his conversations with big companies, who have told him that many of the small companies have “zero quality self-reports” with the FDA. It’s unlikely this means they are producing strips with perfect quality (large companies with lots of expertise cannot even do this, Dr. Klonoff said), but rather, that these companies have no quality departments in the first place. CMS argues that these meters are approved by the FDA, and if something is wrong with the products, it is on FDA to take action. This comes back to the September 9 meeting, which will focus on post-market surveillance and how FDA is currently, could, and should be involved.
  • Dr. Klonoff called generic strips “a real problem” from a variety of perspectives: regulatory, patient safety, and business. He discussed Shasta, maker of the GenStrip that fits into J&J OneTouch Ultra, Ultra 2, and UltraMini meters ($19.95 for 50-ct strip on Amazon; http://www.shastagenstrip.com). On May 22, Shasta was barred from using J&J’s logo in their ads, though the company is still able to sell strips.
    • Said Dr. Klonoff, “There is a fallacy here. FDA looks at glucose monitors as a system.” In other words, if there is a problem with the accuracy, who is responsible? The generic company will say the strips are good and something is wrong with the J&J meter, while J&J will say the opposite. Dr. Klonoff rightly pointed out that it’s “a real problem when you start mixing and matching one brand of strips with another brand of meter.” He believes that if generic strips are established, it will kill innovation at larger companies and potentially put them out of business.
  • The Diabetes Technology Society has been working on a new clinical accuracy error grid based on a survey of clinicians; a paper will be published “around the end of the year.” Notably, six people from the FDA have been part of this process. While the FDA is not a fan of error grids as a basis for approving products, the idea is to use the new error grid for post-approval surveillance. If a blood glucose monitor is not working correctly, FDA will look at the abnormal reading and use the error grid to plot out how grave the error is. Larger clinical errors might require the company to fix the problem, while a very large error might require a recall.
  • On July 29, Dr. Klonoff published a paper in Diabetes Educator: “SMBG Out of Control: The Need for Educating Patients About Control Solution.” He highlighted that it is the only article in PubMed focused on control solution for blood glucose monitors. He characterized the results as “appalling though not surprising.” A survey of 18 patients at Mills-Peninsula Health Services found that although 82% of respondents claimed to know what control solution is, 58% claimed to never use this product. This was not surprising to us. The researchers also did a geographic survey of pharmacies in the Bay Area, finding that control solution was stocked by only 15% of pharmacies that sold BGM equipment. The article concludes that SMBG is frequently being practiced not per manufacturer’s instructions, and improper testing without control solution can lead to erroneous blood glucose results. We commend Dr. Klonoff for studying this issue, though are not convinced that it is a critical safety issue for patients or believe that if it is, patients should be advised differently.
  • Dr. Klonoff also discussed malicious hacking of insulin pumps, an issue that has been coming up in the news since the 2011 BlackHat conference. Notably, on June 13, the Department of Homeland Security issued a report on password vulnerability, which noted that 300 medical devices, including insulin pumps, are at risk. The FDA released a statement that same day encouraging manufacturers and healthcare facilities to “assure that appropriate safeguards are in place to reduce the risk of failure due to cyber attack.” We view this issue as an interesting news story, though one that is louder in the media than it deserves to be. We would emphasize the FDA’s conclusion: “The FDA is not aware of any patient injuries or deaths associated with these incidents nor do we have any indication that any specific devices or systems in clinical use have been purposely targeted at this time.”
  • Dr. Klonoff identified five trends feeding into mHealth: 1) the Quantified Self movement (“self knowledge through numbers”); 2) wearable sensors; 3) smartphones; 4) cloud computing; and 5) clinical decision support software. He specifically mentioned two diabetes devices: Telcare’s cellular-enabled blood glucose meter and Sanofi’s iBGStar (we were surprised not to hear any mention of WellDoc or its new BlueStar product; see our report on the launch at http://close.cx/WellDocBlueStar).
  • He also outlined in most valuable fashion four barriers to the adoption of mHealth: 1) adoption by patients (it must be simple and make life easier); 2 adoption by clinicians (it must bring improved outcomes by making life easier; “No doctor wants to see reams of information” for the sake of information only); 3) approval by regulators (safety, effectiveness, and privacy); and 4) reimbursement by payers (it must save money and outcomes are no worse).

Questions and Answers

Q: My biggest problem is getting coverage for strips for people on pumps. We’re having these patients check their sugar more than five times per day. But I work in a poverty setting where patients cannot afford strips. What are ways of getting around strip coverage?

A: You have to keep after insurance companies and show them the data from the literature. You must show them that pumps help people and strips are necessary. You won’t find articles that strips are useful in type 1, because it’s just a basic part of treatment. It’s like breathing keeps you alive. You need to show them information from the literature that it’s standard of care.

Q: We have a big problem – insurance companies. They dictate which meter we give to which patient. If a meter is deemed not as accurate as another, what do we do about having to give a certain meter?

A: It’s a real problem and a problem that affects the entire country. Anybody who uses a meter might be forced into one. There has to be some minimum level of performance. I would love to fly on a private plane, but I fly on FAA approved airlines. At minimum, a blood glucose meter approved by FDA should have these standards. And it should be one that’s been verified after it’s been approved. It’s like a car. It has no emissions the day you buy it, and no emissions when you get it tested later. The movement to post market surveillance of blood glucose meters will lead to better quality of meters. At least you can say Brand X meets certain criteria. We’re going to see what comes out of that meeting on September 9. Many major organizations will be there, including AADE. At the initial meeting in May, the only organization that was interested in speaking was AADE. Later, other organizations realized that this is a problem. We’ll have the ADA, Endocrine Society, and several other organizations. I expect every one of them will say they are aware of the problem.

Q: When inhaled insulin launched in the UK, there was an impact on lung function. Have those issues been overcome?

A: I don’t know what happened in the UK, but in the US, the product from Pfizer was taken off the market. It was not taken off the market because of lung function. It was a reversible change in lung function, and the decline was a couple percent. Safety was not an issue; it was strictly a marketing issue. Pfizer was not able to sell enough drug. That’s why MannKind feels there could be a market. Their product is easier to use and safe and they think there is an opportunity. It remains to be seen how well they’ll do. I think they will get on the market. It will be a popular product for some people. 

Q: I have a comment first. With control solution, it’s really great, but with the Accu-Chek Ultra and Mini, it’s not even in the packaging. [Sic; it was unclear whether the speaker meant Accu-Chek meters or the J&J LifeScan Mini/UltraMini meters]. A question – what about using CGM on multiple patients? Is there possibility of infection? Has the CDC looked into this?

A: To the extent that it's a monitor, the guidelines say the monitor should ideally not be shared. They don’t say it cannot be shared. It should be disinfected according to the manufacturer’s recommendations. Don’t assume bleach will work; it could damage the device.

Q: Should patients only use lancets once?

A: For the slide I showed, it was an assisted monitoring of blood glucose (AMBG) slide. If a person is doing it on themselves, they can use lancets as much as they choose to, but they will eventually stop working from overuse. But there is no risk of transmitting a virus to yourself. It’s perfectly fine to reuse a lancet for SMBG.

Q: Patients come in saying they’ve seen something about testing their blood glucose without a fingerstick. Is this some kind of light technology?

A: You must listen really carefully. They say you don’t have to stick the fingertip. Those are alternate site testing devices.

Q: I thank you for being at the helm of this Diabetes Technology Society.

[Applause]

Q: We see frequently that patients share lancet devices with family members or friends. There is a potential spread of infection. I have a fear of when I run into these patients. There are also partners that both have diabetes and are sharing a meter. You have to be careful about that.

A: As far as sharing for AMBG, any device that is used in lancing cannot be shared. That’s on the CDC and FDA websites. The shared meter is an interesting idea with the husband and wife that both have diabetes. One funny story about this: there was a husband and wife that both had diabetes. They were both using the same meter, and it turns out they were only checking half as often. They were sharing numbers! Only the husband would check his blood sugar, but both would use the same dose of insulin. Then the wife would check later and they would both use that number. [Laughter]

 

Breakout Session: Diabetes Management Among Adults with Excellent Glycemic Control in T1D Exchange Clinic Registry

DIABETES MANAGEMENT AMONG ADULTS WITH EXCELLENT GLYCEMIC CONTROL IN T1D EXCHANGE CLINIC REGISTRY

Elaine Massaro, MS, RN, CDE (Northwestern University Feinberg School of Medicine, Chicago, IL)

Ms. Elaine Massaro, the 2010 AADE Educator of the Year, presented an analysis of T1D Exchange data comparing type 1s in “excellent control” (A1c <6.5%; n=714) to those in poor control (A1c >8.5%; n=1343). Disappointingly, patients using real-time CGM were excluded – it wasn’t clear why this was the case. Demographic and diabetes management factors came out as one might expect, though the results were still instructive. The largest difference was seen in SMBG test frequency – 58% of those in excellent control tested >5 times per day, compared to just 23% of those in poor control (p<0.001). Those in excellent control were also more likely to be on an insulin pump, test their blood glucose before a meal bolus (88% vs. 68%), download their blood glucose meter to a home computer “at least sometimes” (29% vs. 18% - still not very high!), have more basal rate changes per day, and have more than one insulin to carb ratio per day (p<0.001 for each factor). Notably, 12% of those in poor control had a DKA episode in the prior 12 months, compared to just 3% in the excellent control group. However, the rate of severe hypoglycemia in the prior 12 months was dead even in the two groups: a striking 13%! To use, this strongly supports the need for automated insulin delivery technologies that reduce or mitigate hypoglycemia.

  • Those in the excellent control group were also more likely to: give a bolus for daytime snacks most of time or always (43% vs. 33%), never miss an insulin dose (68% vs. 32%), have a lower total daily insulin dose (<0.6 units per kg per day; 64% vs. 49%), have a higher ratio of bolus to basal insulin (ratio >1.2; 45% vs. 31%), exercise three or more days per week (72% vs. 61%), less likely to have bedtime snack (not routinely eaten; 53% vs. 44%).
  • On the demographic side, those in the excellent control group were more likely to be/have: older, married, non-Hispanic white (94% vs. 85%), higher income (>$75,000; 59% vs. 36%), higher education level (Bachelor’s or greater; 68% vs. 39%), private insurance, normal BMI (overweight/obese; 53% vs. 67%), self-reported very good/excellent health (59% vs. 20%), and rarely/never stressed about diabetes (50% vs. 28%) (p<0.001 for each factor).

 

Poster

EXPERIENCES IN CGM USE IN ELDERLY PATIENTS WITH DIABETES: ADDRESSING BARRIERS AND RECOGNIZING OPPORTUNITIES

Nancy Lelle-Michel, Janet Nicollerat, Ellen Davis (Duke University Health System, Durham, NC)

This study, conducted in the Department of Advanced Clinical Practice at Duke University Health System, identified and evaluated the current issues in CGM use in elderly patients with diabetes. We found the discussion of benefits and barriers to using CGM to be the most valuable part of the poster (see specifics below) – in terms of the barriers, we think many can be overcome with targeted product design that directly addresses the challenges of living with diabetes t an advanced age. The authors also had several recommendations to improve outcomes when using CGM in the elderly: 1) CGM therapy in elderly patients with diabetes should be carefully evaluated on an individual and per-case basis, only after analyzing the cognitive and motor functions, co-morbidities, long-term complications, and duration of diabetes and other diseases; 2) those who use CGM should be advised to continue use once they reach age eligible for Medicare, and should do so by partaking in the appeal process (this strikes us as easier said then done!); and 3) for those who are not advised to use CGM, it may be better to increase targets related to hypoglycemia. 

  • The benefits of using CGM in the elderly: 1) a decrease in glucose variability; 2) lessening of epithelial tissue damage; 3) earlier detection of and reduced time in hypoglycemic and/or hyperglycemic states; 4) facilitation of behavioral changes based on receiving feedback from real-time data; and 5) reduction in A1c without an increase in hypoglycemia.
  • The barriers to using CGM in the elderly: 1) difficulty understanding the device; 2) resistance to using the device; 3) decreased visual, auditory, and/or cognitive abilities; 4) decreased muscle strength; 5) anti-coagulation; 6) dehydration; and 7) not being able to afford the device.
  • The authors listed several eligibility criteria for using personal CGM in the elderly population with type 1 diabetes: 1) profound hypoglycemia requiring assistance; 2) fear and/or unawareness of hypoglycemia; 3) gastroparesis; 4) desire for better control and less hypoglycemia (pretty much everyone with type 1 diabetes!); and 5) the ability to use CGM and understand its functionalities.
  • The authors of this study reviewed the literature on cognitive decline and aging in elderly patients with diabetes. They concluded that normal physiology of aging complicates self-management through an earlier onset and increased risk of dementia, heightened risk of falling due to hypoglycemic events, and hypoglycemia unawareness. To us, this speaks even more persuasively to the value of using CGM in the elderly population with type 1 diabetes.

 

Product Theater: Real-Time, Continuous Glucose Monitoring: Technology to Help Your Practice and Patients (Sponsored by Dexcom)

INTRODUCTION

Keri Weindel, MS, RD, CDE (Director, Professional Education, Dexcom, San Diego, CA)

Walking into Dexcom’s corporate symposium, attendees encountered Dexcom representatives stranding in front of their G4 Platinum poster with samples of the sensor. The poster, around which attendees were soon crowded, highlighted the CGM’s smaller profile, the twenty-foot range, the more highly customizable alarms, and the easy-access glucose profile. Highly regarded head of professional education Ms. Keri Weindel opened the presentation with questions to “get to know the audience” to tailor the rest of the product theater, an excellent touch with such a large audience. Educators answered questions about when they are currently prescribing a CGM, if they prescribe it to patients on multiple daily injections (MDI), and if they and patients receive reimbursed for CGM use. We found it inspiring how Ms. Weindel led this session – it was not so many years ago when CGM was an entirely new concept, and when Ms. Weindel herself was introducing the now-much-improved technology. Throughout the introduction the completely full audience was engaged, and it isn’t an exaggeration to say that some in the audience (such as the educator one seat over from us) were completely enthralled. Before turning the stage over, Ms. Weindel pointed to the slim, credit card sized card on our seats, noting that each card contained an USB with all the slides (and, as it turns out, also a summary page and an information page for healthcare professionals for CGM), and she also noted that the speakers, Dr. Gregg Gerety and Ms. Patty Telgener, would be available at Dexcom’s booth after the presentation to discuss any questions the audience had. This was an incredibly instructive session and we believe should serve as a model for Product Theatres. If readers would like a copy of the slides, please let us know at info@closeconcerns.com.

 

PRACTICAL APPLICATION OF CGM IN CLINICAL PRACTICE

Gregg Gerety, MD (The Endocrine Group, Albany, NY)

Dr. Gregg Gerety thanked all the educators in the room, remarking ever so aptly that it is the educators that will carry the “torch for diabetes in the next millennium.” Dr. Gregg Gerety announced that he believes that Dexcom does not get enough attention for the approval of the professional Dexcom 7, which allows the sensor to be worn seven days and lets the patient act on the trends that they see throughout the week; more often than not, Dr. Gerety noted, patients come back wanting to wear it more or get a Dexcom CGM for themselves. Dr. Gerety presented data from a study published in July 2013 demonstrating evidence of a strong association between frequency of self-monitoring of blood glucose and hemoglobin A1c levels in T1D Exchange clinic registry participants (Miller et al., Diabetes Care 2013), emphasizing that knowing blood glucose values is critical to prevent highs and lows. Dr. Gerety then proceeded to review landmark studies of the CGM. Specifically, Dr. Gerety noted JDRF’s Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes (NEJM 2008) as a landmark study. He highlighted the (now) commonly acknowledged fact that only patients consistently using a CGM, regardless of age or initial A1c levels, are able to lower A1c levels and reduce time in hypoglycemia (Dr. Gerety showed the now popular slide of JDRF A1c data overlaid on the DCCT graph). Turning to Dexcom, one slide that presented data from ADA 2013 drew murmurs; one-year after purchase, 76% of patients wore their Dexcom Seven Plus CGM device almost daily, compared to 19% of Medtronic MiniLink users (for more information on this poster, see page 73 of our ADA 2013 coverage at http://close.cx/ADA2013FullReport). After this clinical data, Dr. Gerety presented charts in Dexcom Studio of his own patients. Although Dr. Gerety spend time identifying patterns from CGM readouts, he spent almost as much time reading testimonials from patients who were ecstatic with the results from their CGM. To finish his comprehensive and passionate talk, Dr. Gerety turned to the future. He highlighted the work on the MGH/BU bionic pancreas, a combination of the Dexcom G4 Platinum receiver and insulin control algorithms tagged to the back of a cell phone. The device has controllers for basal, bolus, and pre-meal priming and the one glucagon controller, as well as the prediction of insulin action based on models and the initial calculations based on weight alone. He highlighted initial results from the Beacon Hill Adult Bionic Pancreas Study, and also noted that there is also an ongoing Diabetes Camp study of the Bionic Pancreas (diaTribe and Close Concerns visited the camp earlier this week and we will be reporting on this after AADE). He highlighted the CGM average for in the Beacon Hill study of 124 mg/dl (for more information on the preliminary results on the Beacon Hill study, please see page 35 of our ADA report at http://close.cx/ADA2013FullReport, or read our 7th annual diabetes forum on page 433 of our ADA report at http://close.cx/ADA2013FullReport). Dr. Gerety exclaimed that the initial results are remarkable, with sensing and delivery of both insulin and glucagon.

  • Dr. Gerety emphasized that the professional Dexcom Seven Plus allows patients to see trends in their blood sugars. He said he saw a huge difference in patients using the iPro for three days when the user is blind to the number versus patients using the Dexcom SEVEN PLUS with real time readings that patients can review, respond to and learn from. Using the iPro, Dr. Gerety emphasized, patients are unable to see their trends and patterns and use the values to change their habits. Although this may not be “news” to those familiar with professional CGM, there are clearly educators less familiar with the technology who were very eager to learn! Dr. Gerety conveyed throughout his talk that once patients (particularly type 2 patients who are more likely to be using a professional CGM) realize the power of the CGM, they recognize how their diabetes management can improve and what is missing, and they become excited (or, presumably, more excited) to turn to the CGM. He did not discuss reimbursement, but we assume that enters into patient interest – as we understand it, reimbursement of professional CGM continues to improve and unlike personal CGM, Medicare has coverage for professional CGM.
  • Increased finger stick glucose testing correlates with lower A1c levels. While, again, this was not “news” for those who know the technology well, many educators less familiar with the technology listened intently to the data. Dr. Gerety reviewed a new study published in Diabetes Care in July 2013 (Miller et al.) evaluating the association between the frequency of self- monitoring of blood glucose and A1c levels. The study focused on patients from the T1D exchange clinic registry participants. The study was a crossover design, with one group testing more frequently than the other. The group that tested four or more times a day had lower A1c levels. Dr. Gerety emphasized his discussion of the study on knowing a number is important to preventing dangerous highs or lows that may impact a patient’s well-being in the short run.
  • Dr. Gerety recommended CGMs for that patients with type 1 or type 2 diabetes on insulin, and patients with elevated or normal A1c levels. He also remarked that CGMs are helpful for patients that gained a level of security shortly after diagnosis.
  • Dr. Gerety shared data showing that in a study shown at ADA, 44% of Medtronic users said they would by the same system again, compared to 92% of Dexcom Seven Plus users. Additionally, one year after starting the CGM system, 65% of Medtronic MiniLink wearers only wore their pumps one week or less per month, compared to only 3% of Dexcom Seven Plus. This data was presented at ADA 2013, and our coverage of the poster can be found on page 73 of our ADA full report, which can be found at http://close.cx/ADA2013FullReport.
  • “It [CGM] went off quite a few times at 80, especially in the morning before I woke up... will at some point save my life as I have no feelings of high or lows, especially lows!” This testimony was one of many that Dr. Gerety shared as evidence that his patients loved the CGM when put on the professional Dexcom Seven Plus trial. He found this patient to be particularly successful because she no longer found hypoglycemia so fearful.

 

CGM REIMBURSEMENT FOR YOUR PRACTICE AND PATIENTS

Patty Telgener, RN, MBA (VP of Reimbursement, Emerson Consultants, Excelsior, MN)

Highly regarded reimbursement expert Ms. Patty Telgener provided an overview of the reimbursement process for continuous glucose monitoring and introduced CGM as having mature reimbursement – meaning the 3 primary drivers of reimbursement – coverage, coding and payment are all available for CGM. We have heard similar talks at ADA 2013 and AACE 2013 and we were very glad educators who didn’t attend these meetings could also benefit, since educators are the front line and definitely will benefit from understanding and then relaying to other HCPs (especially doctors) how reimbursement can be optimized. She also remarked on the availability of coverage for both professional and personal use CGMs, and highlighted the reimbursement rates codes 95250 (sensor placement and training or the technical component) and 95251 (interpretation). She reviewed the current 2013 national Medicare payment under the Physician Fee Schedule - $166 for 95250 and $43 for 95251 (noting these payments amounts are regionally adjusted). Ms. Telgener provided information on who could perform and bill for the each code in the hopes that this information would help the educators in the audience gain more reimbursement; 50% of the audience said that they were not getting reimbursed, which seemed low. While some of the audience members may not have been “qualified” to file for reimbursement as CDEs, others likely didn’t fully understand the process – at least we hope this is true for the sake of patients so that more will have access. Ms. Telgener also noted that charging these codes provide more reimbursement than other codes, such as the “G-codes” (which are Diabetes Self-management Training (DSMT) codes) and evaluation and management codes. For more information how coding should be used for reimbursement of CGM, please see page 56 of our AACE 2013 full report at http://close.cx/AACE2013Notably, Dexcom management recently highlighted that the company had recently approached Medicare to understand the required process for obtaining CGM benefits for Medicare patients – this is a major gap that needs filling and we were very glad to hear about greater focus here. Ms. Telgener also informed the audience of the new widening criteria for CGM coverage for patients with Type 2 diabetes, on insulin (specifically Humana just released their new CGM coverage policy with the expanded policy to insulin-requiring T2s).

Questions and Answers

Q: I have heard that if you are providing a CGM service at the same time as you are doing a G-code or evaluation and management codes (E/M) you have to use modifier to show reduced service. That will reduce your benefits. Is this still true or has that changed?

A: If an E/M code is billed on the same day as CGM, a modifier -25 should be attached to E/M code to allow payment for both services. Typically G-codes and 95250 would not be paid separately if billed on same day.

 

Corporate Symposium: Hot Topics in Blood Glucose Monitoring (Sponsored by Bayer Healthcare, LLC)

INTRODUCTION

Solveig Halldorsdottir, PhD (Director of Scientific Affairs, Bayer HealthCare, LCC)

Attendees seemed eager to learn about blood glucose monitoring, with an early morning Bayer product theater filled almost completely. Every seat was equipped with a communication device that allowed attendees to send in answers to questions asked throughout the session. Dr. Solveig Halldorsdottir, Bayer’s Director of Scientific Affairs, outlined the Contour Next portfolio, consisting of the Contour Next EZ, the Contour Next, the Contour Next USB, and the Contour Next Link. We think that is a great name for the new platform. She spent the majority of her presentation focusing on the accuracy and precision of the Contour Next line. Specifically, she emphasized that the Next meters were insensitive to substances that commonly interfered with meters, such uric acid, bilirubin, acetaminophen, and ascorbic acid, as well as the insensitivity to non-glucose sugars, such as maltose and galactose. Ms. Halldorsdottir also showed multiple impressive studies demonstrating the accuracy of the Next models as well as additional unpublished data demonstrating the accuracy of the Next meters. She also pointed out that, impressively, the Contour Next EZ meets all of the new 2013 ISO 15197 requirements (95% within 15 mg/dl when blood sugar is below 100 mg/dl, and within 15% of value when blood sugar is above 100 mg/dl).

  • Dr. Halldorsdottir presented data from the unpublished NACT, NCT, and LMCT studies that all demonstrate the accuracy of the Next meter line. The NACT study compares the accuracies of the Next EZ, Accu-Chek Aviva, OneTouch Ultra 2, and the FreeStyle Freedom Lite. The Next pump had a MARD of 4.7%. Similarly, in the NCT study, the Next meter, Accu-Chek Aviva Nano, Ultra 2, TrueTrack, and Verio Pro meters were compared. The MARD of the Next pump was 3.1%. The LMCT study compares the OneTouch, Nova Max Link, and Contour Next Link. The Contour Next Link has a MARD of 2.7%.
  • There was also a slide announcing that Medicare Part B covers Bayer, and Dr. Halldorsdottir remarked that there are online resources, such as copay cards, to help patients get what they need.

 

MAKING EVERY TEST STRIP COUNT

Jane Seley, DNP, MPH, BC-ADM, CDE (New York-Presbyterian/Weill Cornell, New York, NY)

Dr. Jane Seley started off her talk by emphasizing that, currently, not enough focus is put on the patients’ capacity to use the results from their BGM to make the ‘right’ treatment changes. She then gave a detailed overview of the four models of meters in Bayer’s Next line and what types of patients they might be work especially well for:

  • The Contour Next EZ is good for patients just getting started and who do not want to overwhelm themselves;
  • the Contour Next is when the patient is ready to move on a little and tag meals or add a prompt;
  • the Contour Next USB allows patients to use logs and to upload their meter using a common USB cord; and
  • the Contour Next Link is made for patients using a pump and is communicates with the Medtronic pump.

Dr. Seley also noted how worrisome it is that up to 50% of patients in the US do not receive any formal education for self-managing diabetes, and she remarked that there should be standard advice for what CMEs and other professionals tell their patients so that all diabetes patients are receiving the same information. She acknowledged that patients have a limited number of tests strips, and it is critical to strategically use these tests to give an accurate view of patients’ blood glucose levels (we believe this conversation may not only be informative but also a nod toward CMS’ competitive bidding). Throughout her presentation, Dr. Seley engaged the audience by urging them to vote on what meter a certain patient should take based on their lifestyle, and what regiment of testing should she encourage the patient to perform. She emphasized that paired testing (pre- and post-prandial) give a good idea of how the patient reacts to the meals. Further, for patients taking basal insulin alone, Dr. Seley encouraged taking three fasting tests a week while for patients with bolus insulin alone, they need to check before and after meals in pairs. For patients using either basal and bolus or pre-mixed insulin, there needs to be a combination of both fasting tests and pre- and post- meal checks. She also highlighted that it is important to ask the patient how many times a day checking blood glucose levels is reasonable – we were glad to see this advice about monitoring patient attitudes. One astute attendee chimed in and noted that she encourages her patients to take their glucose between one and two hours after eating because if the blood glucose level after two hours is useless – we know adherence to post-prandial blood glucose measurement is challenging, and we assume some or many patients are unwilling to do this. Dr. Seley also noted that if patients do not know what to do with glucose information, they will not be motivated to change their behavior. It is the responsibility of diabetes educators and HCPs to engage the patient and ensure they understand their blood glucose values. While A1c levels are valuable for long-term glycemic control, Dr. Seley highlighted that the daily monitoring gives information that the patient can use on a daily basis. To close, Dr. Seley called on diabetes educators to help patients choose the right meter for the needs of the patient to ensure improved diabetes control.

 

WHEN A1C AND SMBG RESULTS DON'T MATCH

Bruce Bode, MD (Emory University, Atlanta, GA)

Dr. Bruce Bode started his talk off by discussing the Medtronic/Bayer partnership, noting that Medtronic opted for a global alliance with Bayer because Bayer’s mere is so accurate, which is extremely critical in his view when working with sensor augmented pump therapy. The meter reading has to be very accurate, he emphasized, and Dr. Bode expressed how impressed he was with the Bayer accuracy and, also, how easy it is that the strips work in all of the Next meters. He then discussed what happens when A1c levels do not match the glucose levels. He explained that such mismatches can stem from many factors, including alcohol use, pregnancy, protein turnover, and race. However, this difference is extremely important to consider since many physicians rely on A1c levels as an indication of how well diabetes is being controlled. Dr. Bode introduced the term “Glycation gap (G-gap)”, or the difference between the measured A1c and the regression of A1c on the mean blood glucose or fructosamine (if the value is positive, it means the A1c reading is higher than expected with the glucose levels, while if it is negative, it means that the A1c reading is lower than expected with the current glucose levels). He emphasized that A1c levels do not detect glycemic variability and do not do a good job distinguishing between fasting and postprandial hyperglycemia since A1c gives only the mean. Echoing Dr. Seley highlighted, he urged educators to use multiple blood glucose samples for at least some period of time to see patterns throughout the day. BEAM (bed time and AM blood sugar), for example, provides patients with a good idea of how their blood sugars are being controlled overnight. In conclusion, Dr. Bode highlighted that it is crucial for HCPs to look at patients’ mean blood glucose sugar. If it does not match the A1c levels, always look more closely at the discrepancy.

Questions and Answers

Q: Is there any way to know which indicators you presented would show a positive or negative G-gap?

Dr. Bode: With the example I gave, it is easy to determine if the patient had a hemoglobin variant because there are simple genetic tests you can run. For most patients, you have to look at the data and try to find patterns that just don’t make sense. Sometimes people are just slow or fast glycators. If someone glycates slowly, I usually am more aggressive when that person has an A1c level of 7% since their glucose is still up.

Q: For 2.5 million patients on Medicare, they now have a choice of 18 providers. Can Bayer give us a hint of which providers their patients will have a choice between?

Dr. Halldorsdottir: We have contracted 12 of 18 provider contracted. The patients certainly have the choice of mail-order if they choose to go that route. For our Next portfolio, patients have to go to retail, but that is still covered by Medicare. I hope there is no confusion about that.

Dr. Bode: I would suggest that the HCPs write brand name subscriptions. If the HCPs just write ‘blood glucose strips,’ patients are going to be given the cheapest blood glucose strip so that the suppliers have the greatest chance of making a profit. 

Q: Have you seen any development of complications with high or low glycators?

Dr. Bode: We do not know the complications associated with being a high or low glycator. That is an important point, however. Our best data comes from DCCT, which is not an A1c driven study, and does not evaluate complications associated with high or low glycators. The ACCORD study was based on A1c, however, the results were poor. So at this point we do not know the complications. It may be that being a slow glycator does not really matter, but we do not know that. We are currently looking at doing a great amount of data collection. We have several thousand blood specimen that look at complications associated with A1c levels. 

Comment: I think what you mentioned about Bayer’s test strip program is really important. Would you mind emphasizing what you said before?

Dr. Halldorsdottir: If you go to retail, patients will get branded scripts filled and have their same copay. Mail order is open for Bayer, but not the Next profile. We have brochures about this at our booth. It is a myth that you cannot get the Bayer product while on Medicare. It is important that patients go to retail and get branded script.

Q: My husbands on Medicare and we were just informed by providers that we have to switch to the Nova Max link meter. Do you have a list of your 12 mail-order providers?

Dr. Halldorsdottir: We currently have many sales representatives in the audience, and I would be happy to put you in touch with one of them.

Dr. Seley: Also, all of the providers are listed on Medicare.gov, and you can find a list of providers who offer the meters that you like.

 

Corporate Events

MEDTRONIC AND BAYER 2013 CERTIFIED PRODUCT TRAINER APPRECIATION EVENT (SPONSORED BY MEDTRONIC AND BAYER)

We attended Medtronic and Bayer’s 2013 Certified Product Trainer Appreciation Event at the National Constitution Center. With incredible views of Independence Hall, the upbeat event was a celebration of educator’s hard work, which too often goes unnoticed. The event included a speech (and poem) of appreciation by Dr. Fran Kaufman (Chief Medical Officer, Medtronic Diabetes, Northridge, California) who called the educator’s the night’s stars. She was followed by a performance by singer Amanda Lamb who has had type 1 diabetes, since she was 15 months old. Ms. Lamb explained the importance of the education and support diabetes educators provided her parents and eventually herself, and sang her song “Silver Lining,” which describes her positive outlook on having type 1 diabetes (http://www.youtube.com/watch?v=7_p_hjyTZcg). Additionally, Medtronic and Bayer assembled an inspiring video, called “United in Education”, on the importance of diabetes educators. Later in the evening, a live band performed as attendees danced, explored, the museum, interacted with (reenactors) of the founding fathers, and had their pictures taken in Signers’ Hall with life-size statues of the signers of the declaration of independence.

 

TANDEM'S DANCING AMONG THE STARS (SPONSORED BY TANDEM)

Tandem’s “Dancing Among the Stars” event in the evening featured an appearance by Dancing with the Stars cast members Mr. Toni Dovolani and Ms. Cheryl Burke. The bar promoted their specialty cocktail, a “Cucumber Basal”, which signs proclaimed had only 5 grams of carbohydrate. While attendees got food and drinks, had their pictures taken, and networked with each other, sales representatives from Tandem were available to discuss both the company and the t:slim pump, which they were able to demonstrate and allowed guests to handle themselves. Though it’s unclear how many people attended, a Tandem Sales Representative said that over 400 had registered, and we estimate there were easily at least 300 people when we were there. Around eight o’clock the presentation began, which included introductory remarks from Tandem CEO Kim Blickenstaff. Mr. Blickenstaff noted he had joined the company almost exactly seven years ago, and took a moment to thank a couple audience members for their support of Tandem, including Dr. Steve Edelman. After these introductory remarks Mr. Dovolani and Ms. Burke came out onto the dance floor and began their show. After several numbers, the two finished with a tango, which audience members had enthusiastically requested.

 

2. Diabetes Drugs

Breakout Session: Choosing the Right Drug at the Right Time: Utilization of the 2012 ADA/EASD Position Statement

CHOOSING THE RIGHT DRUG AT THE RIGHT TIME: UTILIZATION OF THE 2012 ADA/EASD POSITION STATEMENT

Julie Sease, PharmD, CDE (Presbyterian College School of Pharmacy, Clinton, SC) and Kayce Shealy, PharmD (Presbyterian College School of Pharmacy, Clinton, SC)

This case-study-based session focused on how to choose second-line agents after patients have failed metformin. Drs. Julie Sease and Kayce Shealy presented a case study of five different patients, each corresponding to one of the five second-line options highlighted in the ADA/EASD 2012 position statement (sulfonylureas, thiazolidinediones, GLP-1 agonists, DPP-4 inhibitors, and basal insulin). The case studies were fairly straightforward, and Drs. Sease and Shealy provided very detailed descriptions of each class’ advantages, disadvantages, and differentiating features of specific agents within the class. Dr. Sease called GLP-1 agonists the “big guns” in the arsenal, given their powerful A1c-lowering effects. She advised educators to counsel patients to “eat slower than they have ever eaten in their lives” to prevent nausea. She also told the audience (a bit surprisingly) that pancreatic and thyroid safety were likely only concerns in people already at high risk anyway. Both Drs. Sease and Shealy were fairly conservative in recommending SGLT-2 inhibitors, characterizing the A1c reduction as rather modest with the added potential for harm in people with renal impairment – there is potential harm in most medicines for those taking it who are contra-indicated, so we were surprised by this. Dr. Sease presented a fairly balanced view of SFUs’ risks and benefits, mentioning the significant hypoglycemia concerns and weight gain, and acknowledging their utility in relatively young, newly diagnosed, uninsured patients. Moving on to TZDs, Dr. Shealy recommended against prescribing rosiglitazone (GSK’s Avandia) due to the cardiovascular safety concerns associated with the drug. Dr. Shealy also said the class’ suspected ability to preserve beta cell function make the class a good option for newly diagnosed patients – not all would agree with this characterization since it has not been shown definitively. While TZDs are quite durable, they were never proven to preserve beta cell function and since they usually cause weight gain (though not as much in low doses), there are still questions about prescribing TZDs broadly. They do, of course, address insulin resistance, which is another valuable reason HCPs cite about taking them.

  • Dr. Sease discussed the choice of GLP-1 agonists for someone who has an A1c of 8.5%, hypertension, dyslipidemia, and a BMI of 48.5 kg/m2. She remarked on a few differentiating factors for agents in the class: 1) she relayed that Byetta (exenatide twice-daily) has a prandial short-term action requiring twice-daily administration while Victoza (liraglutide once-daily) and Bydureon (exenatide once-weekly) are “basal” and longer-acting and require once-daily and once-weekly administration, respectively; 2) she noted that the need for reconstitution with Bydureon may make it unsuitable for people with dexterity issues; and 3) exenatide should not be used in people with creatinine clearance under 30 ml/min.
    • Dr. Sease reviewed the advantages of the GLP-1 agonist class as a whole, citing robust 1-1.5% A1c reduction, no hypoglycemia, weight reduction, potential CV benefit (with demonstrated systolic blood pressure reduction), and potential improvement in beta cell function.
    • She also reviewed disadvantages of GLP-1 agonists and offered qualifying statements for most of them: with regards to nausea/vomiting, she relayed that counseling patients to “eat slower than they have ever eaten in their life” makes a big difference for tolerability. While she said pancreatitis risk is something that prescribers should be aware of, that she only worries about it in people who are already at risk for pancreatitis (past history, heavy drinker, or extremely elevated triglycerides). She dismissed C-cell/medullary thyroid tumor risk saying that it has never been demonstrated in humans. Finally, she also noted that the high cost and need for injection are additional barriers.
  • Dr. Shealy characterized DPP-4 inhibitors as the ideal choice for someone that has an A1c that is not too far from goal. She highlighted Nesina (Takeda’s alogliptin) as the newest DPP-4 inhibitor to the US market and noted that members of the class are highly similar. She did note that the only agent that does not need dose adjustment for renal impairment is Tradjenta (Lilly/BI’s linagliptin).
  • Dr. Sease identified basal insulin as an ideal second-line candidate for a 52-year-old male who was diagnosed six months ago, had a heart attack at 50, has hypertension, a BMI of 28.7 kg/m2, well-controlled lipids and blood pressure; slightly elevated serum creatinine, and an A1c of 10.2%. She stated that, with such a relatively young patient with a history of heart disease, she would want to get his A1c down as quickly as possible. In discussing the difference between NPH and analog insulin, she noted that many patients require a dose that would need twice-a-day dosing – evening dosing of NPH often leads to nocturnal lows and morning highs due to its PK peak. She stated that she did not find major differences between Lantus (glargine) and Levemir (detemir).
  • Dr. Shealy began her discussion of TZDs by noting that she would only consider prescribing pioglitazone, given the major safety concerns associated with rosiglitazone. She noted that generic options are making this drug class far more affordable than in the past. She highlighted their efficacy (0.5-1.5% reductions in A1c) and the possibility that they preserve beta cells. However, they are also associated with weight gain, edema, bone fractures, cardiovascular risks (rosiglitazone), and bladder cancer (pioglitazone). Dr. Shealy stated that TZDs can be a good option for younger, newly diagnosed patients, for whom beta cell preservation is an important goal.
  • Dr. Shealy ended with a discussion of other therapeutic classes, including SGLT-2 inhibitors. Drs. Sease and Shealy purposely did not discuss SGLT-2 inhibitors in detail, as they felt they did not have sufficient experience with this class yet. They were fairly conservative in recommending it, characterizing the A1c reduction as quite modest and worrying about safety in people with renal impairment. She noted that the diabetes care community is still figuring out how to best handle the emergence of this new drug class, and stated that she is somewhat hesitant to jump on the bandwagon. She did note that SGLT-2 inhibitors have an attractive potential for weight loss and blood pressure lowering. She also mentioned colesevelam (a good option in patients who also need cholesterol help) and meglitinides (compatible with unpredictable lifestyles).

 

PANEL DISCUSSION

Julie Sease, PharmD, CDE (Presbyterian College School of Pharmacy, Clinton, SC) and Kayce Shealy, PharmD (Presbyterian College School of Pharmacy, Clinton, SC)

Q: In a patient with longstanding diabetes, would it be appropriate to consider DPP-4 inhibitors or GLP-1 agonists. How much is left to kick in the pancreas at that point?

A:I think it’s still worth a shot and here’s why: they don’t just work on creating more insulin – there are other effects on the liver, GI tract, and brain. Incretins may not be that effective very far out in the treatment process, but I’d say it’s worth the cost.

Q: We haven’t discussed the new class of drugs, Invokana.

A: SGLT-2s don’t appear on the guidelines, so we’re not talking about it in depth today. There is a relatively low A1c reduction in the addition of a SGLT-2 as a third-line agent. Also there is a likelihood of genitourinary issues, so I’m not sold.

Q: What are your thoughts on a patient that is well-controlled, 74 years old, on metformin 1000 mg BID plus an SFU, and not a lot of hypoglycemia? We want to preserve her pancreas and avoid future lows as she ages. Would you pull her off the SFU and try a DPP-4 inhibitor, or would you say if it isn’t broken don’t fix it and just let her go?

Dr. Shealy: My first instinct would be to pull the SFU knowing her age. Even if she has a hypoglycemic event once a month, that may be one too many. Knowing how the drug works and knowing some evidence we have that may or may not be 100% accurate, I think there are other options available. If she’s been well-controlled, then you can try without it and see. I tend to want to pull SFUs because there are other options that wouldn’t be quite as harmful.

Q: In our practice, when we see a patient on metformin who is adding Lantus, we recommend that they need something for mealtimes, either a secretagogue or a mealtime insulin. What are your thoughts?

Dr. Sease: I tend to see what the basal insulin does first, because in a type 2 patient the pancreas may still be able to respond to mealtime needs. I would tend, in a type 2 patient, to give the basal a shot and see the results, with the understanding that we may need to add a prandial. I’ve had plenty of people who I have progressed forward towards prandial insulin, so I do agree with you there.

Q: As a second question, when you are starting a patient on basal, do you ever add that to a SFU or do you stop the SFU when you start basal?

Dr. Sease: I tend to leave the SFU on. I knew a provider who used to always take the SFU off, and the results were an increase in postprandial spikes. However, in someone who has had diabetes for a while, it may make sense to remove the SFU.

Q: What do you think about pharmacologic intervention early on in prediabetes, especially if the patient is already doing lifestyle very actively?

Dr. Sease: Drugs have proven effective, but nothing is better than lifestyle. If lifestyle is already there then I think we have data for metformin for sure. That’s probably the thing I’d think of first. There are also data out there for rosiglitazone, orlistat, pioglitazone, and even acarbose. So you’ve got these to go to. I’d go to metformin.

Dr. Shealy: It depends on their risk. If they have a strong family history, if they’re obese, then that’s where a lot of the good evidence lies for pharmacotherapy. So I would look at the other risk factors to make that determination.

Q: My question is about metformin. I noticed that with most of the case studies you showed, almost everyone had an elevated morning glucose reading. I was wondering if taking a dose of metformin closer to bedtime would help.

Dr. Sease: We assume that metformin has a 24-hour duration. I guess there could be a theoretical benefit to taking it at bedtime, but I’m a bigger fan of taking it twice a day for the tolerability. I know a patient now who takes all his metformin before bedtime, and he has nighttime hypoglycemia on a fairly regular basis. I don’t think the evidence is clear on which way to go with that.

Dr. Shealy: I’ve had a couple patients who take it all at night and tolerate it seemingly well, but I’m not sure they are better controlled than if they took it twice a day.

Q: How much alcohol is too much on metformin?

Dr. Sease: The concern there is lactic acidosis. There’s also the theoretical concern for someone with severe COPD or heart failure that is not stable. Basically anything that will raise the amount of lactic acid increases chance of lactic acidosis. Acute binges of alcohol can do that as well. To me that’s a determining factor. I don’t have a specific test for that – I think you have to insert clinical judgment. If you have someone being hospitalized for alcohol toxicity, they may not be a very good candidate for metformin. If you have someone who is a moderate drinker (two drinks/day for a man, and one drink/day for a woman), they should do fine.

Q: We have someone admitting to nine drinks Fridays and Saturdays and three on weekdays.

Dr. Sease: I think I have had patients in that boat taking metformin. From personal experience, I haven’t had lactic acidosis in those cases before.

 

Breakout Session: Pharmacology & Patient-Centered Care: A Critical Analysis of Prescription Medication Choices

PHARMACOLOGY & PATIENT-CENTERED CARE: A CRITICAL ANALYSIS OF PRESCRIPTION MEDICATION CHOICES

Caroline Trapp, MSN, CDE (Premier Internists, Southfield, MI)

Early in her presentation, Ms. Caroline Trapp acknowledged that she is a major proponent of utilizing lifestyle intervention over pharmacotherapy whenever possible. Consequently, her discussion of the major classes of antihyperglycemic drugs focused largely on safety concerns and cost challenges. As a result, her presentation presented what we perceived as an imbalanced view of some of these medications’ risk-benefit profiles. Ms. Trapp highlighted the high costs associated with insulin pens, fear of lactic acidosis and vitamin B-12 deficiencies linked with metformin use, and the high hypoglycemia risk seen with SFUs and TZDs. She spoke of the association between incretins and pancreatitis without mentioning specifics, specifically the growing consensus that current data do not support the link. She had a very conservative viewpoint on the use of new drug classes such as SGLT-2 inhibitors, generally dissuading use of agents that have been on the market for a limited amount of time. Although her presentation was certainly informative, it would have more aptly labeled as a drug safety concerns seminar rather than an analysis of patient-centered care. Ms. Trapp’s final slides did list a wealth of resources for providers and educators seeking more information on drug safety, as well as a series of websites that can help patients adopt healthier lifestyles.

  • The presentation began with a brief discussion of patient-centered medical principles. Ms. Trapp used an analogy in which the provider is a waiter or waitress: they have a menu of options and a wealth of experience that consumers can gain from, but ultimately the diner (patient) orders what they want. In a patient-centered framework, the social determinants of health are just as important to consider as more standard metrics such as A1c values.
  • Ms. Trapp was up-front about her belief that the overall diabetes care landscape places too much focus on medication and not enough emphasis on lifestyle intervention. This “diabetes pharmacocentricism,” as she termed it, can be attributed to limited patient office visit times, clinical practice guidelines, and providers’ belief that patients are unlikely to change their behavior (among other factors). She underscored the large amount of money that pharmaceutical companies put into marketing and promotion, sometimes through means that appear more innocuous than they are – she noted that medication samples are not charity, but another form of promotion. She noted that over-utilization of pharmacological therapies involves an opportunity cost: for example, if a parent with type 2 diabetes is placed on drugs instead of being told to change their cooking habits, then the opportunity to improve the dietary habits of their children (for whom the parents prepare food as well) is lost. She concluded this section by stating in no uncertain terms that intensive therapy with medication is less safe than intensive lifestyle therapy.
  • Ms. Trapp moved on to a discussion of each of the major antihyperglycemic drug classes, focusing mainly on safety and costs concerns rather than the drugs’ efficacy. As a result, although this section of the presentation was certainly informative, it may have painted a one-sided picture of these agents’ risk-benefit profiles. In what we thought was a very creative approach that facilitated audience participation, Ms. Trapp presented a haiku about a drug class, from which the audience had to guess the class.
    • Sulfonylureas: “Oldest class of drugs; Low blood sugar and weight gain; Cheap but fails over time.” Ms. Trapp emphasized that hypoglycemia unawareness is a major concern for providers and diabetes educators alike.
    • Metformin: “Fear lactic acidosis; Titrate dose — less belly aches; Watch B-12 levels.” Ms. Trapp shared the symptoms of lactic acidosis (trouble breathing, vomiting, weakness), which she noted was rare but life threatening.
    • Insulin: “Start low, go up slow; Match type to patient’s routine; Expensive in pens.” Ms. Trapp was especially concerned (and shocked) with the high price of the drug class.
    • DPP-4 inhibitors: “Pricey but weak pills; Hello pancreatitis?; Watch kidney function.” GLP-1 agonists: “Thyroid cancer risk; Pancreatitis risk; Really lizard spit?” This section of the presentation was less nuanced than we would have liked – Ms. Trapp spoke of the association between incretins and pancreatitis as established fact, when the diabetes care community is increasingly recognizing that current data on the issue is far from conclusive. She also treated the issue of GLP-1 agonists and thyroid cancer risk in the same way.
    • SGLT-2 inhibitors: “Risk hypotension; Risk of vaginal yeast infections; But only in women.” Regarding this relatively new class of drugs, Ms. Trapp recommended against prescribing any agent that has been on the market for less than one year — we understand the roots of this concern, although we think the approach was too conservative. Speaking more generally later in the presentation, she recommended favoring generic medications because they have been on the market for an extensive period of time. As a final note, a low rate of genital mycotic infections also occurs in men.
    • Other notable drug class haikus included: TZDs: “Black box warning: heart; Wait 3 months to raise dose; Bladder cancer risk;” and Pramlintide: “Seven shots a day?; Adjunct to insulin at meals; Black box: hypo risk.”  
  • Ms. Trapp spent a great deal of time discussing specific resources and strategies for facilitating successful lifestyle intervention. She shared her own 5-A algorithm, which utilizes either a “Powerful Diet” or “Extra-Powerful Diet.” In particular, she highlighted the role that a plant-based diet can play in improving patient outcomes, and mentioned the 21-Day Vegan Kickstart program (21DayKickstart.org)

Questions and Answers

Q: How do you handle people like my brother who wouldn’t know a vegetable if it snuck up behind him?

A: If you know someone who really doesn’t like vegetables, if you dig a little bit there are usually one or two that they like. Start with that and get them going. Here’s a pearl: when you are eating a meat-based diet, vegetables don’t taste that good, but it is possible to change your taste by setting those animal based foods aside. Also, something that helps if you have the opportunity is to cook for people. Finally, use people who have had success to inspire other people.

 

Breakout Session: Monitoring Medication Safely: Key Issues

MONITORING MEDICATION SAFETY: KEY ISSUES

Laura Shane-McWhorter, PharmD, BCPS, CDE (University of Utah, Salt Lake City, UT)

In this session, Dr. Laura Shane-McWhorter provided a comprehensive and accessible overview of current safety issues in diabetes pharmacotherapy. Along the way, she underscored the issues and recommendations most relevant to diabetes educators. To begin, she provided a broad overview of key medication safety concepts, including safety information resources (MedWatch) and the primary challenges for ensuring drug safety. Moving on to specific diabetes pharmacotherapies, she discussed the increased risk of hypoglycemia seen with insulin secretagogues such as SFUs. We were also glad that she acknowledged ischemic preconditioning (or the inhibition of cardioprotective mechanisms) as another safety concern facing SFUs. Dr. Shane-McWhorter discussed a number of safety concerns regarding TZD therapies. She noted that current data on pioglitazone, rosiglitazone, and bladder cancer are inconclusive, and that more information is needed. Regarding the potential connection between TZDs and diabetic macular edema, early studies indicate that aspirin and ACE inhibitors may protect against this (suspected) phenomenon. Finally, she elucidated evidence that TZDs increase the incidence of bone fractures. Regarding the hot topic issue of pancreatitis, Dr. Shane-McWhorter encouraged attendees to stay tuned for future results, and (in the meantime) to read the point-counterpoint debate on the issue published in Diabetes Care in July (see our coverage at http://www.closeconcerns.com/knowledgebase/r/6d3e6d53). 

  • Dr. Shane-McWhorter began with a broad overview of medication safety vocabulary, concepts, and regulatory bodies. She outlined the FDA’s five primary means of identifying and communicating safety issues: pharmacovigilance, the MedWatch website, data mining, signal rate detection, and Risk Evaluation Mitigation Strategies (REMS) programs. The primary problems compromising drug safety, in her mind, include insufficient information being made available about drugs, ineffective communication about potential issues, and process issues.
  • Moving on to specific diabetes safety concerns, Dr. Shane-McWhorter began with a discussion of insulin secretagogues. She shared clinical evidence that sulfonylureas (SFUs) and glinides both significantly increase the incidence of hypoglycemia compared to other therapies, sometimes by as much as much as 500%. The implication of these results for educators, she stated, is that hypoglycemia awareness and readiness is a high priority. Patients should understand the signs and symptoms of hypoglycemia, understand glucagon pens, and ideally should have a family member or other individual who can administer glucagon. Dr. Shane-McWhorter cited experimental evidence showing that glyburide, glimepiride, glipizide, and tolbutamide all increased patients’ risk of all-cause mortality. She then moved on to a lesser-known safety issue associated with SFUs: ischemic preconditioning. She explained that glyburide has a high affinity for cardiac SFU receptors (glinides, glimepiride, and gliclazide have a lower affinity), and that SFU action at these receptors can prevent cardioprotective mechanisms during brief periods of ischemia.
  • Dr. Shane-McWhorter briefly posed the question of whether there is a mechanistic link between incretin therapies and pancreatitis, or if association seen in early studies was instead due to reporting bias. She highlighted the recent point-counterpoint articles by Drs. Peter Butler and Michael Nauck published in July in Diabetes Care (read our coverage of the series at http://www.closeconcerns.com/knowledgebase/r/6d3e6d53) on the issue. For educators, she recommended closely monitoring patients for signs of pancreatitis.
  • The presentation briefly touched upon the potential association between metformin therapy and lactic acidosis for people with renal impairment. Dr. Shane-McWhorter noted that most trials to-date have not shown much risk, but pointed out that most studies exclude participants with risk factors for the condition (renal impairment, heart failure, liver disease and alcohol abuse). Many geriatricians do not agree with the current NICE guidelines based on eGFR (which the ADA and EASD consider  “reasonable”), and believe that a more cautious approach is required in older patients.
  • TZDs are associated with a number of safety concerns, ranging from macular edema to bladder cancer. Starting with the cancer issue, she covered a number of key studies (including the Cochrane Review and the French National Health Insurance Plan cohort) that showed that patients (especially men) using pioglitazone for over two years had a significantly higher incidence of bladder cancer. However, she noted that some studies had missing data, and that it is possible that some subjects had undiagnosed cancer going into the trial. Meta-analysis of randomized control trials do not show a significant association between either pioglitazone or rosiglitazone and bladder cancer. Dr. Shane-McWhorter then discussed the potential connection between TZDs and diabetic macular edema (DME), explaining that PPAR-gamma agonists are thought to increase VEGF expression, which in turn results in leakage of fluid in the eyes and reduced visual acuity. Some early studies indicate that aspirin and ACE inhibitors protect from DME in patients on TZDs. She noted that the data is controversial, and that the DME seen in some studies may simply be due to the progression of diabetes (TZDs are rarely used as a first-line therapy). Next came the issue of fractures; FDA-AERS associates both pioglitazone and rosiglitazone with an increased risk of fractures. Dr. Shane-McWhorter recommended that providers and educators should reconsider TZD use in patients at risk for fractures, and consider calcium and vitamin D supplements in patients on TZDs.

Questions and Answers

Q: Could you talk a little bit about metformin and vitamin B-12 deficiency, including how often you screen for it?

A: Vitamin B-12 deficiency can occur with metformin use. It tends to happen more in older individuals, but it is something we need to keep an eye out for in everyone, as it can go undetected for a while.

Q: At the facility I work in, it seems like every patient is on CoQ10. Could you talk about the supplement a bit more?

A: CoQ10 supplements are very popular. They are used because it is thought that, with statin use, the body’s ubiquinone production is reduced. CoQ10 also has value as an antioxidant. Patients sometimes take it to eliminate the myalgia associated with statin use. Studies have not conclusively determined whether it helps, but cardiologists say it helps reduce endothelial dysfunction in patients with diabetes. It may also help a bit with blood pressure and ischemia. Be careful — it may also attenuate the effects of warfarin.

Q: It seems that vitamin D deficiency is associated with so many conditions these days. Is there any role for that deficiency in diabetes?

A: Vitamin D deficiency causes lots of different things, including possibly impaired beta cell function. People with vitamin D deficiency are often diabetes patients. We really need to be screening for this, because vitamin D deficiency may have a role in a number of disorders.

Q: I heard that the FDA is considering loosening restrictions on rosiglitazone?

A: Yes, we hear that the FDA is reevaluating the rosiglitazone data, but it’s still just an evaluation at this point, not a definitive reversal.

Q: You mentioned that the IOM has called for a single website. I was wondering if you know if there is a single site, or if there are better sources of information.

A: As far as I know, this “one site” doesn’t exist yet, but I do use the FDA’s MedWatch quite a lot. Also my patients are a great source of information because they come to me with things they find on the internet, and I can research them.

Q: Can you comment on the ischemic preconditioning in glimepiride more? My practice uses glimepiride a great deal.

A: The adverse effects of ischemic preconditioning are probably not associated with glimepiride as much because it doesn’t attach as much to those cardiomyocytes.

 

Breakout Session: AACE Comprehensive Diabetes Management Algorithm 2013

AACE COMPREHENSIVE DIABETES MANAGEMENT ALGORITHM 2013

George Grunberger, MD, FACP, FACE (Grunberger Diabetes Institute, Bloomfield Hills, MI)

Dr. George Grunberger reviewed the new 2013 AACE Comprehensive Diabetes Management Algorithm. He made clear from the beginning of the presentation that these were not guidelines but algorithms – by that, we think he meant a set of precise decisions and endpoints rather than a generic set of best practices. He walked the audience through a sequential overview of the algorithm, which was sectioned into a complications-centric model for care of an overweight/obese patient, followed by a prediabetes algorithm, then a set of decision matrices for the progressing condition. Dr. Grunberger prefaced the complications-model of care for the overweight/obese patients by dismissing BMI as an unreliable primary marker for clinical approaches to obesity. While acknowledging that the AACE guidelines were controversial, Dr. Grunberger did not address criticism directly, and instead pointed attendees to read the AACE’s position statement and to review the sources listed in the algorithm.

  • Dr. Grunberger outlined a complications-centric model for the overweight/obese patient that begins with an assessment of cardiometabolic disease or biomechanical complications. After this assessment, patients are assigned to lifestyle modification, medical therapy, surgical therapy, or a combination of the three depending on the severity of the complications. For patients without complications, only lifestyle modifications are recommended. In this model, if therapeutic targets for improving complications are not met, the algorithm suggests intensifying lifestyle and/or surgical treatment until goals are met.
  • The AACE’s glycemic control algorithm denotes entry A1C as the defining factor for therapy type and recommends monotherapy for A1C < 7.5%, dual/triple therapy for A1C ≥ 7.5%, and insulin for patients with A1C > 9.0% and symptoms of complications. Within each therapy type, the algorithm also ranks drug classes based on safety profile, and recommends more intensive therapy if the goal A1Cs are not met. This algorithm is supplemented by guidelines for insulin dosage, as well as full drug profiles of antidiabetic medications based on a variety of clinically relevant factors such as risk of hypoglycemia, weight effects, renal effects, cardiovascular risk, etc.

Questions and Answers

Q: How does one obtain a poster version of this algorithm?

A: Call the AACE office in Jacksonville, FL to request a copy of the poster version. I have one in my clinic, and it is very large as well as useful to be available. (Editor’s note – the phone number is (904) 353-7878. It also might be useful to email Joanne.Smith@springer.com who is in charge of reprints and may be able to direct readers on posters.)

Q: What treatment paradigm would you apply for someone who is otherwise perfectly healthy but has an A1C of 6.0%, and a slightly elevated LDL?

A: You have better long-term outcomes if you lower A1C below 6.0%. Based on the results of ACCORD, reducing A1C below 6.0% is beneficial to patients. I would also recommend statins to lower the LDL cholesterol. These measures will demonstrably improve long-term outcomes.

Q: How about if we categorize stages of diabetes?

A: There is no added benefit to defining stages for diabetes. The drugs are already approved so how we professionally define diabetes is up to us.

Q: Do you have any comment on using both ACE inhibitors and ARBs simultaneously?

A: It turns out that using both causes problems, so the algorithm recommends using one at a time. You can refer to the AACE guidelines from 2011, which are currently undergoing evaluation.

 

Breakout Session: Declare Your Independence in Your Understanding of the Practical Use and Management of U-500 Regular Insulin

INTRODUCTION TO U-500 INSULIN

Elaine Cochran, MSN, CRNP, BC-ADM (NIH, Bethesda, MD)

Ms. Elaine Cochran began by noting that the effect of continuously raising a patient’s insulin dosage is limited by the ability of intracellular mechanisms to respond to the hormone signal. Nonetheless, the high degree of insulin resistance seen in multiple forms of diabetes (she included type 1, type 2, and gestational diabetes) can necessitate high insulin dosages. Ms. Cochran pointed out that more concentrated insulin formulations such as U-500 can reduce the number (and volume) of injections for patients, which can improve the drug’s pharmacokinetic profile, as well as patient adherence. She shared an algorithm for U-500 dosing, and stated that the formulation has an onset and peak of action similar to regular insulin, but a full duration of action more like NPH. She emphasized that U-500 administration should be weighted more heavily towards the morning to compensate for its pharmacokinetic “tail.” She then discussed the use of U-500 insulin in pumps, noting that such use is technically off label and is not recommended for patients using more than 600 units each day. She ended by touching upon the use of U-500 insulin in the hospital setting, recommending that facilities define policies of U-500 use and utilize TB syringes for volume measurement.  

 

FROM THE FRONT LINES

Paula Bergen, RN, CDE (St. Elizabeth Regional Diabetes Center, Covington, KY)

The best candidates for U-500 treatment, Ms. Paula Bergen began, are those with a total daily dose of 200 units or more of insulin who are not at goal — they may be on MDI with poor adherence and unwillingness to carb count, may have injection site issues, or may benefit financially (fewer co-pays) from purchasing fewer insulin vials. Ms. Bergen then moved on to some of the practicalities of U-500 administration. She recommended using 6 mm needles, as 4 mm needles may be unable to fully penetrate the stopper on some U-500 vials. She emphasized the need for patients to start on a reduced dose and up-titrate over a few days, as sudden drops in glucose levels can cause patient discomfort. She added that significant drops in blood glucose can be harmful or uncomfortable for patients even if they do not approach formal definitions of hypoglycemia. In addition, Ms. Bergen noted that concurrent GLP-1 therapy usage could help to mitigate weight gain from U-500 treatment. Ms. Bergen ended by acknowledging the present barriers for success for U-500 insulin, which include insurance coverage issues, insufficient adherence, eating disorders, fear of hypoglycemia, and extreme insulin resistance.

 

PANEL DISCUSSION

Elaine Cochran, MSN, CRNP, BC-ADM (NIH, Bethesda, MD); Paula Bergen, RN, CDE (St. Elizabeth Regional Diabetes Center, Covington, KY)

Q: How important is it to time insulin injections with meals?

Ms. Bergen: Well, the onset of action of regular insulin is about 30 minutes, so in order to keep the patient safe from severe hypoglycemia, we like to time it before meals. We don’t find that we have a big problem with stacking — to be sure, the patient has to cooperate and routinely take their blood sugar levels, but we haven’t had a severe problem with meal stacking.

Ms. Cochran: Also up front, you prescribe it in a weighted manner, so that the heaviest dose happens earlier.

Q: Could you speak to the controversy about bolusing on a pump with U-500, and how mismatched it can be with food?

Ms. Bergen: I have several patients on pumps that bolus on U-500 that are doing just fine. You have to look at each patient individually, in my opinion.

Q: You mentioned that in patients with insulin resistance, there is often a lower level of leptin, which means that the more obese the patient is, the more insulin resistant they are.

Ms. Cochran: There is also a theory that patients may be leptin resistant. Leptin controls appetite but also has functions elsewhere in the cell, affecting these downstream processes.

Q: How do you put U-500 into the V-Go?

A: We’re using a 1 ml syringe. It’s off label, but there are lots of people I know doing it.

Q: Are you guys initiating U-500 and GLP-1 simultaneously?

A: It depends on the provider. Some of our patients are already on a GLP-1, and others start a GLP-1 soon after starting U-500. GLP-1 is not directly addressed in our U-500 protocol.

Q: Once patients are on U-500 for a while, do you ever give them an adjustment or correction factor?

Ms. Bergen: U-500 is hard to use to do a correction. I’ve had a couple patients who use U-100 to do corrections. The point is that with U-100 insulin, the volume you’re injecting into the subcutaneous space becomes a problem, so we try and adjust the U-500 first. We do do corrections with the pumps.

 

Workshop: Diabetes New Drug Updates

INTRODUCTION

Evan Sisson, PharmD, MHA, CDE (VCU School of Pharmacy, Richmond, VA)

Dr. Evan Sisson delivered the introductory remarks to this jam-packed session that discussed new type 2 diabetes drug updates. Dr. Sisson began by framing drug selection in the context of individualization of care. He remarked, “You can close your eyes and pick any drug, and it would work, but is it the best for your patient? That’s where your expertise comes into play.” He reviewed the ADA/EASD 2012 guidelines as well as the recent ACE/AACE guidelines, highlighting the most useful features of each. He pointed out that the ADA/EASD 2012 statement separates drug options by side effects, hypoglycemia, and cost, whereas the ACE/AACE guidelines provide guidance on treatment entry based on A1c at diagnosis. Dr. Sisson provided the STEPS framework to help educators think about factors that should drug selection: Safety, Tolerability, Effectiveness, Price, and Simplicity.

 

NEW TYPE 2 DIABETES DRUG UPDATES

Josh Neumiller, PharmD, CDE (Washington State University, Spokane, WA)

In his presentation, Dr. Josh Neumiller discussed some of the most important recent topics in type 2 diabetes pharmacotherapy. Because we do not usually hear about differences between the largely similar DPP-4 inhibitors, we found Dr. Neumiller’s discussion of the distinctions in this class very interesting. Notably, he highlighted Tradjenta’s (linagliptin) lack of eGFR restrictions and other differences based on drug interactions. Regarding incretins and pancreatitis, he expressed an overall positive opinion on incretins’ pancreatic safety. He highlighted the number of potential confounding factors clouding the debate, but called for providers to closely monitor patients for signs of pancreatitis. Also, quite significantly, he gave a detailed run down of the SGLT-2 Invokana’s (canagliflozin) pros and cons – we imagine this was highly valuable for the audience, some of whom had not yet heard of the drug or class. He touched briefly upon the increased cardiovascular risk seen in older patients on rosiglitazone, mentioning the FDA’s recent Advisory Committee meeting on the drug to reassess its Risk Evaluation and Mitigation Strategies (REMS) program. Because of this issue, along with concerns about bladder cancer (with pioglitazone) and bone fractures, Dr. Neumiller advocated against the use of TZDs in most cases. Dr. Neumiller also touched on lactic acidosis and use of metformin, noting that although incidence of lactic acidosis in patients on metformin is relatively rare, the risk should be taken very seriously because of the high fatality rate associated with the condition. As a result, patients with risk factors for lactic acidosis (including renal dysfunction and alcoholism) should be monitored closely.

  • Dr. Neumiller began his section of the presentation with metformin, discussing situations in which metformin therapy may not be appropriate. Because the drug is cleared through the kidneys, use in patients with renal dysfunction can lead to lactic acidosis. Advanced age, active liver disease, alcoholism, and therapy for heart failure can also contribute to this risk. Dr. Neumiller noted that lactic acidosis is relatively rare (0.03 cases per 1000 patient years) but that providers and educators should still exercise caution because the condition is frequently fatal when it does arise.
  • Next came the issue of Avandia (rosiglitazone) and cardiovascular adverse event risk: Dr. Neumiller shared observational study data demonstrating a significant increased risk for heart failure and all-cause mortality in elderly adults with rosiglitazone versus pioglitazone. He noted that the FDA Advisory Committee meeting called on Avandia had brought up the possibility of lifting the restrictions on its sale. He then moved onto other safety concerns involving TZDs, including their association with bladder cancer and bone fractures. Regarding the former issue, he cited fairly strong data showing that a statistically significant bladder cancer signal did appear after two years of pioglitazone exposure, especially at high doses. As a result, France has prohibited sales of the drug, and Germany has prohibited new prescriptions. The association between TZDs and fractures stems from PPAR-gamma’s action against the proliferation of bone-forming cells (osteoblasts). Ultimately, Dr. Neumiller advised against using TZDs in the majority of cases due to the number of unresolved safety concerns.
  • Moving on to incretins, Dr. Neumiller provided an informative comparison of the crowded DPP-4 inhibitor field, noting that Tradjenta (linagliptin) is the only member of the drug class available in the US that does not have restrictions based on renal function. There were some other differentiating factors in terms of drug interactions (Strong CYP 3A4/5 inhibitors, for example, can increase saxagliptin exposure), but in most other ways the field of candidates shared more similarities than differences.
  • Turning to the hot-button issue of pancreatitis, Dr. Neumiller overall fairly strongly supported keeping patients on incretin-based therapies. He cited a number of potential confounding factors that could explain the signal seen in early trials: a recent NIH analysis (presented at the NIDDK/NCI workshop) showed that, regardless of treatment, diabetes patients were at an 82% increased risk of pancreatitis. In addition, in many post-marketing studies, confounders such as alcohol abuse or gallstones are not reported. In conclusion, Dr. Neumiller emphasized the importance of monitoring patients on incretin therapies for signs of pancreatitis. Please see Close Concerns’ “Pancreatitis Primer” for a summary of all of our recent coverage on the issue (http://www.closeconcerns.com/knowledgebase/r/11fe7183).
  • Dr. Neumiller provided a thorough and balanced overview of Invokana (canagliflozin) and the SGLT-2 class, for which many ears in the audience perked up. A handful of audience members had not yet heard of the drug. He explained the SGLT-2 mechanism and reviewed Invokana’s advantages of ~2-3 kg (~4.4-6.6 lb) placebo-adjusted weight loss, a slight 3-5 mmHg systolic blood pressure reduction, and ~1.0% A1c reduction from a baseline of 8%. He also reviewed safety issues, noting that genital mycotic infections occurred both in men and women at several percentage points higher than placebo, but that they rarely led to treatment discontinuation and were effectively treated with Diflucan-like antifungals. He also noted that a few people experienced increased urinary volume and frequency, though not as much as one might expect given the mechanism of action. Finally, he noted that volume-related adverse events (postural dizziness, orthostatic hypotension) could occur as well (though pretty rarely), and more frequently in the elderly and people on diuretics.

 

CONSIDERATIONS AND APPROACHES TO INSULIN INITIATION

Evan Sisson, PharmD, MHA, CDE (VCU School of Pharmacy, Richmond, VA)

Dr. Evan Sisson presented on strategies for insulin initiation in type 2 diabetes. Because Dr. Sisson does a substantial amount of work at a free clinic, his presentation was, understandably, very cost-conscious. He provided an excellent overview of how each different type of insulin’s structure or formulation affects its subcutaneous kinetics and absorption and matched the different insulins’ PK profiles to case studies of different patient needs. Notably, he advocated for initiation of bedtime basal insulin with a daytime sulfonylurea, citing a study by Matt Riddle (Diabetes Care 1998) that found that SFU use can reduce daily insulin requirement by 30%. Dr. Sisson stated, “Maybe taking glimepiride, which costs $4, is a better option than committing them to an extra bottle of insulin.” While the reality is that many patients do rely on SFUs for their low cost, we wonder whether SFU-use is insulin sparing in the long term if it may potentially lead to beta cell burnout. Furthermore, when discussing differences between different basal insulins, Dr. Sisson remarked that while analogs are much more expensive than NPH, NPH and Lantus are identical in terms of efficacy. We were surprised that he did not emphasize the hypoglycemia benefits of basal insulin analogs for the CDEs whose patients are covered for analog insulin since the hypoglycemia profile would certainly be important to patients and would be a major factor to many. Overall, we thought the take home message of treatment individualization was extremely valuable, though he gave little time to the benefits of insulin analogs, and did not mention the combination of GLP-1 agonists with basal insulin.

 

PANEL DISCUSSION

Evan Sisson, PharmD, MHA, CDE (VCU School of Pharmacy, Richmond, VA); Josh Neumiller, PharmD, CDE (Washington State University, Spokane, WA)

Q: Could you talk about choice of insulin with a person with type 2 diabetes on oral steroids for COPD?

Dr. Sisson:  You treat that person as if they’re insulin resistant, and you keep working with it. There isn’t a specific insulin product preferred in that setting, but it will probably take a lot of insulin to overcome insulin resistance from the steroids

Dr. Neumiller: I’m looking at what their needs are, as far as specific agents.

Q: The patient is on Humalog, and I think she should be on a basal dose. So should I go with Lantus, NPH?

Dr. Sisson: There’s really no difference from an efficacy standpoint. I think either one would be a good choice. Based on the 4T study, I think you’re going to have less hypoglycemia and weight gain by switching to basal than by trying to chase those blood sugars with lispro.

Q: Two questions regarding metformin. When you have a patient you are managing using metformin immediate release, when you do switch to the ER formulation? Also, there have been some recent data suggesting that the serum creatinine cutoffs are too stringent, and that GFR should be used as the criteria.

Dr. Sisson: Generally the ER formulation is better tolerated. Now that the ER formulation is generic, we tend to use it from the beginning.

Dr. Neumiller: The clinicians in my area are using eGFR as the basis for those titrations — discontinuing treatment if patients are below 30, reducing the dose if they are below 45. In the UK and other areas, they have moved to that eGFR-based monitoring. Looking at the newer nephrology CKD guidelines, they also recommend the use of eGFR.

Q: We have a lot of patients who are uninsured. We have a type 1 patient on premixed 70/30 twice daily who is really uncontrolled. We suggested the Lantus assistance program and Novolog assistance program, but we thought oh that’s just a band-aid for one year. He really can’t afford anything aside from NPH or ReliOn brands. Would you suggest the band-aids for one year?

Dr. Sisson: Yes I would suggest the band aid for a year and next year, another band aid, etc. until there is a better way to catch these folks, I think that’s the best you can offer. I have several patients that we keep re-upping. As long as they meeting criteria they’re able to get the products.

Q: I have another 70/30 question. Could you speak to the use of NPH TID (three-times daily)?

Dr. Sisson: The original study trying to establish the idea of basal bolus therapy used TID NPH. Sometimes we look at 70/30 and think that 30 percent leads to a peak and 70 percent has a long effect, but it’s more complicated than that. You’re probably getting close to a true basal, but you’re going to lose the advantage of any extra boluses you may need, and you’re committing your patients to the same amount of carbohydrates for every meal.

Dr. Neumiller: I would echo those ideas. If people are having hyperglycemia mid-day, we would recommend adding a small dose of rapid acting insulin.

Q: Can you comment on the use of metformin in a type 2 adolescent with NASH?

Dr. Sisson: I think that’s called a curveball and a screwball [laughter].

Dr. Neumiller: My training’s in geriatrics so I’ll defer to Dr. Sisson.

Dr. Sisson: I treat patients that are adults. Certainly, there is unfortunately a growing need and interest to treat both patients that are adolescents but also patients with fatty liver. So I think it’s a reasonable option, but you have to be very careful. This is not something that should be done at home. It should be done under careful supervision. So far, I think the data looks good. It looks reasonable. As we said yesterday, the foundation of therapy for these patients is going to be exercise and diet.

Q: Well unfortunately, there are not a lot of other options for oral medicines, so we are torn between having to discontinue metformin or not. I didn’t know whether there were safety issues.

Dr. Sisson: That’s a hard one. Thank you.

Q: I work at a center where we actually prefer NPH – we use it a lot on cancer patients who need it for two to three months.

Dr. Sisson: I think that that’s a great point — newer is not always better. Sometimes switching from NPH to Levemir or Glargine may not be good for a patient who benefits from that peak.

Q: In your patients, how and when are you monitoring for B12 deficiency? I feel like I am not doing it enough, but I don’t know who or when to screen?

Dr. Neumiller: There is lots in the literature about B12 deficiency. We’re at a point, since it is dose and duration dependent, and the literature suggests it takes 12-15 years to develop. Some suggest we are at the edge of a pandemic of B12 deficiency. So we have been monitoring that in the clinic. Certainly there have been papers that have come out. There are no guidelines on what to do, but there are some commentaries out there where folks are giving annual B12 injections or oral B12 supplementation for people with metformin, since it’s relatively benign. A small study showed that administration of calcium carbonate could help counteract this B12 deficiency effect. In that same commentary, it said if you put people on metformin on calcium carbonate, it may also help with GI tolerability. Yes we’ve been looking at it and want to be on the front of it so people don’t present with neuropathic-type symptoms and are being put on therapies that aren’t necessary.

Q: Where do you see SGLT-2 inhibitors fitting in?

Dr. Neumiller: I think that’s the million dollar questions. It looks like a fair number of audience members are using them. The nice thing about their Invokana’s program is that they have studied it as a monotherapy and as an add-on to metformin, SFUs, as a triple therapy, and with insulin, and the data looks good across the board. I think it remains to be seen how prescribers are going to use it. I think that because of its profile of low hypoglycemia and weight loss, it makes sense to add it on to metformin as a second-line agent. Of course there are safety considerations that need to be taken into account. We’re actually a recruitment site for the CANVAS trial, which is a double-blind placebo controlled study, but we often get a good idea of who is in what group when we see the results. It’s been eye-opening to me in some of the patients on insulin to see how much we need to drop their insulin dosage – their dose decreases substantially and they end up losing some weight.

Q: How much would you say it’s recommended to increase a Lantus/Levemir one injection at a time? For example, for people taking 100-200 units/day.

A: From a patient standpoint, they don’t want to get hypoglycemic from a dose change, but at the same time, they want to see some movement. For patients on very high doses, we often get very nervous about it. Keeping a relative number is a good idea. A reasonable dose chage10-20% of the dose max would be a reasonable dose change.

Q: If the doctor has recommended 150 units of Lantus/day, can that person take the entire dose at one time? Is it as effectively absorbed as someone taking only 50 units at a time?

A: You’d have to do two shots. I’d break them into two different times of day. Nothing in the literature says you have to do that. It comes back to a comfort standpoint and asking the patient what they want to do. I would certainly inject on two different sides if at the same time. 

Comment: But if they are on large amounts of insulin, is there something in the literature a maximum for a single dose of insulin?

Dr. Sisson: No there is not a maximum.

Q: Are you aware of any TZDs in the development stage, or have people given up on that class?

Dr. Neumiller: There are second-generation TZDs in development. I’m not very up to date on the differing properties, but there is the hope that they won’t have the same cardiovascular concerns or other problems associated with the first-generation TZDs.

Dr. Sisson: There’s nothing that’s that close. Aleglitazar was on its way but was pulled from the pipeline.

Q: So I’m often asked to take people from orals to basal/bolus, though the providers are taking them off SFUs right away. My thinking is they should stay on SFUs until they are at a physiological dose of insulin. Do you agree?

A: Going back to that Matt Riddle study, when you kept an SFU on board, the patient didn’t require as much insulin to get to goal. If for the SFUs, they are, I like to think of them as enhancing insulin output at mealtime. So if somebody has sufficient pancreatic stores of insulin, that’s what you want. You want extra insulin output at mealtime. If I’m starting with basal insulin, to me, keeping the SFU on board until I know it’s failed makes sense. 

Q: Could you talk about insulin degludec?

A: It was expected to be approved, but the FDA declined its application. It was going to be an ultra-long acting insulin. It was approved in Europe. They have been asked to go back and do some cardiovascular studies, and they hope to re-submit back to the FDA in the near future.

 

Workshop: ADA/EASD Guidelines for Management of Hyperglycemia in Type 2 DM - A Patient Centered Approach

ADA/EASD GUIDELINES FOR MANAGEMENT OF HYPERGLYCEMIA IN TYPE 2 DM - A PATIENT CENTERED APPROACH

Silvio Inzucchi, MD (Yale University, New Haven, CT)

Dr. Silvio Inzucchi tag-teamed this session on the ADA/EASD Position Statement with Ms. Deborah Hinnen. As expected, he emphasized the importance of individualizing therapy – see below for a valuable table of Dr. Inzucchi’s own synthesis of when to favor/avoid each of the main therapy classes. Many in the audience appeared to appreciate the simple cut-through-the-clutter approach. In the session’s concluding case studies, he seemed to prioritize cost very high along with choosing an appropriate target A1c in the elderly (he typically chose A1cs <7% for most patients, but usually higher in elderly patients with lots of comorbidities, sometimes even around 8%). Dr. Inzucchi appeared generally unimpressed with the efficacy of DPP-4 inhibitors relative to their cost and recommended these earlier in disease therapy or for patients very close to goal. Interestingly, he sometimes leaves sulfonylureas on top of basal insulin, as it may reduce how much insulin patients need to take. Last, he took a notably direct shot at the new AACE algorithm – instead of adding multiple therapies right at diagnosis, he favored a slower, stepwise approach of adding new therapies every three or six months. We were initially surprised to hear him ask, “What’s the rush?” given the large loss of beta cell function that’s already happened in many type 2 patients at diagnosis. However, his point was that, as long as there is good follow-up and good communication between the patient and HCPs, a step-wise approach is probably just as good as the initial combination approach suggested by AACE.

  • Dr. Inzucchi’s comment – “What's the rush?” – was in reference to the more aggressive AACE algorithm. It came in the context of a discussion about AACE’s recommendation of using combination therapy when the A1c >7.5% or potentially triple therapy when the A1c is >9.0%. For comparison, the ADA/EASD position statement suggests double therapy when a person has an A1c of at least 9.0%. In Dr. Inzucchi’s view, very few practitioners tend to follow the AACE strategy in practice, especially because such aggressiveness can add costs and increase the risk of adverse effects.
  • Dr. Inzucchi admitted that patients on combination therapy get to a lower A1c more quickly than using sequential therapy, but in the end, he argued that the results are the same. For instance, a patient can drop his or her A1c from 8.0% to 6.5% with an initial combination approach (e.g., metformin/sitagliptin within 3 months. In contrast, using the more conservative strategy of metformin first (A1c falls from 8.0% to 7.0% after three months) and then adding sitagliptin, a patient will still get to an A1c of 6.5% – albeit after a total of six instead of three months. Dr. Inzucchi proposed that there is no clinical difference between these two approaches at the six-month point, with the added benefit that sequential therapy is less expensive – this is especially true if the patient actually happens to get to target with just one drug, which can occur given the wide variability in responses to medications.
    • We think patients looking to get to target would do well to consider combination therapy if monotherapy isn’t working – we would ask why HCPs would not want to move quickly to enable patients to reach target, given the landmark studies that have shown complications are highly associated with out of control diabetes management. Dr. Inzucchi stated that while you do not want it to take “two years” to get to target, he thinks it is ok to have a strategy that ramps up over three to six months (we can also imagine three months being an acceptable length of time to reach goal but would worry about HCPs who take Dr. Inzucchi’s advice but take significantly longer than this). To demonstrate his point, Dr. Inzucchi described a new-onset type 2 diabetes patient who came to him with an A1c of 11.4%. Because the patient was asymptomatic, Dr. Inzucchi decided to place him on metformin monotherapy because, with diet alone prior to his office visit, he had already dropped to 10.1%.
    • Ms. Debbie Hinnen (Mid-America Diabetes Associates, Wichita, KS) countered that she prefers to escalate treatment over the timeframe of a couple weeks not a few months. She tries to get to goal quicker because patients feel reassured seeing quick improvements. To do so, Ms. Hinnen often starts a person on metformin and education. A week later, she looks at a person’s blood glucose level to determine if she should add additional agents.
  • Broadly speaking, Dr. Inzucchi was very cautious about driving elderly patients to low A1cs; “If you think you’re going to her affect life expectancy by getting her down to an A1c of 6.9% from 7.5%, you’re not reading the literature.” During his talk, he highlighted a paper from Currie et al. (Lancet 2010) mortality as a function of A1c in people with type 2 diabetes >50 years. A U-shaped curve was observed in this retrospective cohort study, such that the lowest risk for mortality was seen at an A1c of 7.5%. While we understand there may not be a major difference between 7.5% and 6.9%, we worry that some HCPs will move to thinking there aren’t major differences between 6.9% and, for example, 8.5%. We know many over 65 who would not be happy at all with a “new” target of 8.5% that may be easier for HCPs to attain and manage for patients. We also recognize the danger of pushing patients to fast toward a target that is lower but where hypoglycemia will be an ever-present danger (we do think many glycemic-dependent newer drugs will help on this front and look forward to the time when they are generic). 
  • Notably, the approval of an SGLT-2 inhibitor in the US earlier this year brings the number of type 2 diabetes drug classes to 12, more than (!) the 11 available for treating hypertension – this was a compelling slide that also really highlighted the flurry of diabetes drug development since metformin came on to the scene in 1995. Said Dr. Inzucchi, “This is both good and bad news. The good news is we have more options to treat our patients…the bad news is it gets very confusing.” While we are sorry for HCPs who might be confused, we’re very happy for patients to have more alternatives, especially given that the much better alternatives will become generic some day and accessible to a much broader group of patients all over the world.
  • Dr. Inzucchi presented a useful table to digest when to use the different drug classes; he emphasized that this should not be viewed in a vacuum. Certainly, there is a lot of nuance to picking the right drug for the right patients. While we were initially bothered by the terms “weight obsessed” and “needle phobe,” in talking with Dr. Inzucchi after the talk, he emphasized that these were written in shorthand to make readability easier.

AGENT/CLASS

FAVOR

AVOID

metformin

All patients without contraindications
Polycystic ovarian syndrome
High fasting glucose
Self-pay

 

CKD (eGFR <30)
Unstable heart failure, COPD, lactic acidosis
Cirrhosis
EtOH
Baseline GI disease

sulfonylureas

Self-pay

Hypoglycemia-prone
CKD (eGFR <15-30)
Coronary artery disease (?)*
“Weight-obsessed”

TZDs (pioglitazone)

Highly insulin resistant
Metabolic syndrome
NASH (Fatty Liver)
Coronary artery disease (?)

 

Heart failure (low EF?)
Baseline Edema
Osteoporosis
Cirrhosis
Bladder cancer (risk factors?)
“Weight-obsessed”

DPP-4s

Close to A1c target
High postprandial glucose
Advanced CKD (dose adjust)
Side-effect prone

History of pancreatitis
History of urticaria, angioedema
Self-pay

GLP-1s

Obese
“Weight-obsessed”
High postprandial glucose (shorter-acting)

“Needle phobes”
History of pancreatitis
CKD (eGFR<30) – exenatide
Baseline GI Disease/sxs
Gastroparesis
Medullary cancer/MEN-2
Self-pay

Insulin

Far from A1c target
LADA, Type 1.5’s
“Compulsive controllers”
Advanced renal disease (ESRD)
Advanced liver disease

“Needle phobes”
Hypoglycemia-prone
Non-adherent
Cognitive impairment
“Weight-obsessed”

SGLT-2s

Obese
Need additional blood pressure reduction
Heart failure (?)

History of yeast infections, stroke (?), UTIs (?)
CKD (eGFR <45)
Baseline orthostatic sxs
Self-pay

*Editor’s note: the questions marks noted were part of the slide shown

 

HOW TO INDIVIDUALIZE THERAPY

Debbie Hinnen, APRN, BC-ADM (Mid-America Diabetes Associates, Wichita, KS)

Ms. Debbie Hinnen described the ADA/EASD position statement’s guidelines on the patient-factors around which to individualize care. Regarding the overall target, she explained that while an A1c <7.0% is the average goal; people who are younger might have a lower target (A1c of 6.0-6.5%) and those who are older might have a looser goal (7.5-8.0%). She pressed that “hypoglycemia is the deal breaker in this discussion,” meaning that the selected goal should minimize hypoglycemia. Reviewing the ADA/EASD position statement’s differing treatment algorithms, Ms. Hinnen had four critiques. First, she was disappointed in its preponderance of discussion surround the physician’s role in contrast to the dearth of description of Advanced Practice Nurses, Pharmacists, and Physician Assistant’s involvement. Second, she felt the position statement left out the needed frequency of SMBG, noting that problem solving around glycemic control cannot be performed with only A1c. Third, Ms. Hinnen felt that the position statement should have been more explicit about psychosocial considerations. She believes that a person with few motivation drivers is likely depressed. Fourth, she wishes that it addressed how prediabetes should be treated, pressing “prediabetes is just early diabetes; let’s face it.”

  • “For fairness,” Ms. Hinnen briefly described AACE’s guidelines. She asked the audience of about 100 people if they had heard of AACE’s algorithm before and noted that “a number” of people (we estimate about 10%) were shaking their head “no.” For more information on AACE’s treatment algorithm, please see our April 24, 2013 Closer Look at http://www.closeconcerns.com/knowledgebase/r/a331db88
  • Ms. Hinnen remarked that the ADA/EASD position statement does not provide a target A1c range for each patient characteristic around which to individualize (i.e., life expectancy, patient resources, etc.).  According to Ms. Hinnen, this contrasts with an earlier set of individualization guidelines Dr. Silvio Inzucchi (Yale University, New Haven, CT) was involved in (Ismail-Beigi et al., Annals Intern Med 2011). Dr. Inzucchi explained that such a range was not included in the ADA/EASD position statement because some authors strongly felt that its intentions would be misinterpreted. For example, they though it might imply that an elderly person with an A1c around 6.0% on a low dose of metformin, should be taken off the metformin to reach the higher A1c indicated by the range. This, the group felt was illogical. Accordingly, they decided to refer to how stringent glucose control measures should be as opposed to delineating the actual numerical A1c target.
  • The patient characteristic she focused most on was patient attitude and expected treatment efforts. Speaking to the educators in the audience, she remarked that “this is our world; this is the area where we live everyday.” To determine a patient’s motivation level and driver, she recommended asking a patient “why is it important for you to be healthy?” and “why is it important for you to be in control of your diabetes?”
  • Regarding complications and cardiovascular disease, Ms. Hinnen highlighted the presence of pre-established cardiovascular disease in people with new onset type 2 diabetes. She noted that while her patient who has had type 1 diabetes for over 30 years and has gastroparesis, might have apparent complications she would also be concerned about pre-established cardiovascular disease in her new onset type 2 diabetes patient who is “African American and fluffy” (i.e., weighs 350 pounds). Dr. Inzucchi added that he tends to be most concerned about complications that can shorten a person’s life expectancy: COPD, some rheumatic syndromes, etc. Ms. Hinnen continued to point out that cardiovascular disease and outcomes are “so important,” they received their own category separate from other complications.   
  • Discussing the need for SMBG for problem solving, Ms. Hinnen sighed that Medicare only covers 90 strips per 100 days. She noted, however, that providers can still benefit from seeing four tests two days a week or a test before and after some meals.

 

PANEL DISCUSSION

Debbie Hinnen, APRN, BC-ADM (Mid-America Diabetes Associates, Wichita, KS); Silvio Inzucchi, MD (Yale University, New Haven, CT)

Q: You mentioned that patient with gastroparesis should not take a GLP-1?

Dr. Inzucchi: It is contraindicated. One of the things GLP-1 agonists do is delay gastric emptying. I certainly would not want to be the person who learns that a GLP-1 aggravates gastroparesis. It is logic in terms of trying to choose the right drug.

Q: Can you speak to GlycoMark and how you would use it?

Dr. Inzucchi: I do not use it very much. I imagine if you have a person with a disappointing A1c and terrific fasting levels, then the problem must be post-prandial levels. I would have them check their blood glucose five times over the next couple of weeks postprandially. If the patient refuses, I guess that you can use the GlycoMark. I don't see a role for it otherwise.

Q: I’m from the International Diabetes Center, and we’ve certainly had our share of algorithms. We’ve had the opportunity to work with the Mayo Clinic on shared decision-making in choosing diabetes medications. So when a treatment fails, what is the next choice? What are your thoughts on patient adherence to medication if its their choice?

Dr. Inzucchi: It’s hard to argue with shared decision making. The challenge is how to do that in a busy clinical practice. How to do that in an efficient way to accomplish it in the 12-15 minute format of most office visits. I think many of use have been doing that all along. Engaging the patient to some degree is going to enhance compliance. That will translate to better glycemic outcomes.

Ms. Hinnen: It’s critical. If you look at the Roper data for patients on insulin. 70% of the time they don’t take insulin if they are away from home. This can help address those barriers – that shared decision that this is a good treatment. I’m not sure it can be done in a 10-minute visit. But it has to happen, or we’re not as a team being successful. I would say to the patient, “Let me have you work with the educator.”

Q: I’m wondering about the cultural and ethnic question marks. We cannot glean many things from what we know…

Dr. Inzucchi: Our group discussed this. We were frustrated because there is no data. Experts keep saying Asians have more beta cell dysfunction. Latinos have more insulin resistance. But how does that translate to individual decisions? I don’t think we’ll ever have those clinical trials powered enough.

Ms. Hinnen: In my Ramadan patients, we put them on mixed insulin. They eat before daylight and after dusk, so they needed a fast-acting insulin to cover the meal and the long-acting to carry them through. We need to keep in mind these religious observations.

Q: Can you address the issue of stopping orals when a patient is on insulin and wishes to continue?

Dr. Inzucchi: There is not a lot of data. I always keep metformin. If a person is on a TZD, I will continue the TZD. There is very good evidence that it decreases insulin requirements. It’s a double edged sword, however – when you add insulin to a TZD, you get much more edema. DPP-4 inhibitors will have a modest 0.5-0.6% A1c lowering effect when you add it to insulin. Is it worth $8 a day? I’m not convinced. There is increasing evidence that GLP-1s may prevent the need for prandial insulin. But they’re also expensive. For sulfonylureas, I tend to eliminate them if I’m using any form of prandial insulin (e.g., rapid analog boluses or premixed) Patients get discouraged if all you keep doing is adding another agent. Cost is also a prohibitive factor. You must individualize, but always try to cut down on complexity and costs whenever feasible. There’s not just diabetes; there are other comorbidities that patients are dealing with. Prioritization is really important.

Ms. Hinnen: I don’t use TZDs very much because of all the baggage and weight gain. With insulin, there is not a reason to continue sulfonylureas and secretagogues. That’s belt and suspenders. Choose one! [Laughter] I’m very fond of GLP-1s and basal insulin. The hypoglycemia risk is so low. If I’m queen of the world, that’s what I would do in my elders. Some of the Medicare Part D plans are having it as a tier 2. If I can get diabetes managed by basal plus GLP-1, that really does simplify it for patients. 

 

Workshop: Management of Type 2 Diabetes in Older Adults

EPIDEMIOLOGY AND PATHOPHYSIOLOGY OF DIABETES IN ADULTS

Elbert Huang, MD, MPH (University of Chicago, Chicago, IL)

Dr. Elbert Huang opened the workshop by describing the general epidemiological state and risks of type 2 diabetes in older adults (age 65 years and older). With 29% prevalence, the elderly has the highest prevalence of diabetes of any age group. Additionally, more than one in three with diabetes are undiagnosed, 40% have prediabetes, and type 2 diabetes prevalence is higher with age for all ethnicities and genders. Predictions that the prevalence of type 2 diabetes will double by 2030 and quintuple by 2050 are made more terrifying by the fact that historically, diabetes assessments have always underestimated what comes to fruition. Despite trends that older-onset diabetes often have lower mean A1c, insulin use, and incidence of retinopathy when compared to middle-age onset diabetes, it is clear that elderly patients with diabetes are sicker in every conceivable way compared to people without diabetes. Rates of dementia, incontinence, depression, chronic pain, and falls are all far higher in older individuals with diabetes. Dr. Huang included graphics on trends in Medicare spending and impact of diabetes on geriatric syndromes, emphasizing the taxation that diabetes can wreak in the elderly patient.

  • Cognitive impairment is an important consideration when evaluating elderly patients with type 2 diabetes. 20% of elderly diabetes patients have undiagnosed cognitive impairment, despite the fact that Alzheimer’s and multi-infarct dementia are three times as likely to be diagnosed in this patient group. Important to diabetes treatment, the connection between cognitive impairment and hypoglycemia, hyperglycemia, insulin resistance, and insulin insufficiency is bidirectional and critical. Dr. Huang emphasized the necessity of periodic screening, standardized cognitive assessments, and self-care regimens after citing that 30% of patients who passed tests of medical adherence in the ACCORD trial were later diagnosed with cognitive impairment.
  • “Isn’t aging great?” Dr. Huang cracked a joke after elaborating on data that elderly patients with type 2 diabetes have over 50% higher rates of severe hypoglycemia requiring assistance, more severe deterioration of psychomotor coordination, and impaired awareness of autonomic warning symptoms. He explained that contributing risk factors include erratic meals, renal insufficiency, advanced age, polypharmacy, and duration of diabetes.

 

SHARED DECISION MAKING AND BEHAVIORAL MANAGEMENT

Vanessa Briscoe, PhD, CDE (Vanderbilt University Medical Center, Nashville, TN)

Dr. Vanessa Briscoe began by emphasizing the importance of shared decision-making in establishing an ongoing partnership between patient and provider. She highlighted congruence on realistic goal expectations as important in chronic management. Dr. Briscoe cited hurdles such as social isolation, high prevalence of depression, reliance on caregivers, polypharmacy, and frailty as significant obstacles that should be seriously addressed by healthcare providers in order to increase patient understanding, value, and adherence to treatment plans. Dr. Briscoe also underlined the importance of self-management education tailored to the patient’s unique medical, cultural, and social situations. Stress was also placed on involving caregivers to increase self-care behavior, account for impairments, and increase awareness of patient healthy literacy. Dr. Briscoe recommended using simple terms, memory cues, verbal analogies, and models, enthusiastically demonstrating with a personally-devised jingle proclaiming “Keep, your blood glucose under control, before you break your heart” (sung to the tune of Stop, in the Name of Love). Overall, this workshop session summarized general and fundamental communication tips aimed to maximize patient and provider communication.

 

MEDICATION CONSIDERATIONS: INDIVIDUALIZING TREATMENT FOR AGING ADULTS WITH DIABETES

Peggy Soule Odegard, PharmD, CDE (University of Washington, Seattle, WA)

Ms. Peggy Odegard reviewed the major complications the older population experiences with diabetes. She strongly emphasized how important it is to reevaluate medications and doses each year in the older population because, as patients’ organs and metabolism begin to change, their bodies respond differently. She explicitly stated all older diabetes patients should avoid glyburide because it is eliminated through the kidneys and thus increases risk of hypoglycemia. She told some stories of patients who were prescribed an unreasonable amount of medications, often seeing 14 medications per patient and many of these were simply to treat side effects of other medications. The audience reacted with visible incredulity when she told of one patient who was on 38 different prescription medications.

  • As kidney function deteriorates with age, the same dose of certain medications taken earlier in life can become toxic to the older adult; however, liver function remains relatively the same with aging as does absorption. Ms. Odegard recommended having patients check their blood glucose level two hours after beginning a meal and to perform fasting glucose for diagnosis. If an older adult has normal fasting glucose levels, looking at post-prandial or oral glucose tolerance is important. With these, the age related pharmacokinetic and pharmacodynamics changes must be considered. Safety is another factor that must be taken seriously as increased risk of hypoglycemia can cause dementia, falling and sometimes, death; the impairment of dexterity, vision, and many other abilities may also lead to further safety issues. Balancing risk of hypoglycemia and hyperglycemia risks of cognitive impairment should be carefully analyzed.
  • Ms. Odegard explained that studies show that prescribing six or more prescriptions is associated with the patient having an increased risk and fear of falling. When four or more prescriptions are taken by an adult diabetes patient, they have a nine-fold risk of cognitive impairment. Some medications put the patients at greater risk for cognitive impairment, specifically amnesia.
  • Ms. Odegard suggested considering whether a patient’s lifespan makes prescribing a complex regimen to add on glucose control worth it? For example, it takes one-to-two years of lipid management to see improvements in patients. Ms. Odegard recommends a risk versus cost assessment prior to prescribing medications. Carefully chosen anti-hyperglycemic therapies and minimize polypharmacy by looking for one or minimal medications that can achieve the desired outcome. She also suggested considering the age related shift in prandial insulin secretion when evaluating needs for therapy, and assessing the treatment burden on older adults and their caregivers. She emphasized they must include them in the discussion because a disconnect in goals can form if the caregiver and adult have different objectives for the same disease.
  • Even though polypharmacy increases the chance of adverse drug reactions, it is potentially high in treating diabetes, especially in older adults where comorbidities and geriatric syndromes are more prevalent. A periodic medication regimen review for benefit and risk of each agent is critical in minimizing unnecessary polypharmacy. Lastly, when prescribing medications, remembering to keep in mind blood pressure, lipids, and blood glucose levels need not be forgotten.

 

NUTRITION AND WEIGHT MANAGEMENT IN OLDER ADULTS WITH DIABETES

Carrie Swift, MS, RD (Kadlec Medical Center, Richland, WA)

Ms. Carrie Swift opened her presentation by highlighting the key physiological changes in aging diabetes patients that need to be considered when making nutrition recommendations. She pointed out that sarcopenia (muscle wasting) and bone loss are two of the most common health problems among the elderly and can apply not only to underweight patients, but to overweight patients as well.  Based on her research, she recommends and has found that improving diet and decreasing caloric intake in combination with exercise to be the most effective means of improving functional status and increasing bone density. We were very pleased to learn more about nutrition with respect to a very specific population, namely the one that comprises the age population with the highest prevalence and highest rising rate of diabetes.

  • On average, people require fewer calories (20-30% fewer) as they age, but their macronutrient requirements are the same. The implication of this is that people must eat much more wisely.  Common deficiencies among aging adults are folate, iron, B12, calcium and vitamin D. In fact, most adults in general don’t even receive adequate vitamin D.
  • Factors affecting the nutrition status of older adults commonly include poor appetite, altered taste sensation, decreased sense of smell, oral/dental issues, gastrointestinal issues, and polypharmacy. In addition, older adults are at greater risk for food safety issues. Ms. Swift recommends nutrition screenings (MNA-SF) to screen for malnutrition for adults 65 years of age or more. The screenings assess weight loss, mobility, psychological stress, presence of dementia or depression, and BMI.
  • An environmental factor which Ms. Swift deemed prominent to discuss with patients is food insecurity. This can significantly impact the food choices and energy intake of patients. The incidence of food insecurity is highest in the South and least in the Northern Midwest regions of the US. Ms. Swift stressed that there are multiple ways to manage weight with diets that are healthy and they should be adjusted to meet the preferences and nutrition requirements of the individuals.

 

CME Event: The Importance of Being Glucagon: Roles in the Pathophysiology and Management of Diabetes (Supported by Lilly)

GLUCAGON IN THE PATHOPHYSIOLOGY OF DIABETES

Carol Wysham, MD (Washington State University, Spokane, WA)

Dr. Carol Wysham quickly opened the CME event to a packed hall with a ten-minute presentation detailing the role of glucagon in the pathophysiology of type 1 diabetes and late-stage type 2 diabetes. She emphasized the intimate relationship between inter-islet endogenous insulin levels and the secretion of glucagon from the alpha cell. During the subsequent panel discussion, Dr. Wysham noted that this relationship, as it relates to diabetes, only recently began to be appreciated. She emphasized that in people with either type 1 diabetes or late-stage type 2 diabetes, glucagon is involved in hyperglycemia and hypoglycemia. Thus, she suggested that approaches to correct hyperglucagonemia might improve glycemic control among people with type 1 diabetes and type 2 diabetes, thereby setting the stage for subsequent presentations on this topic.

  • Hyperglucagonemia is a key contributor to hyperglycemia in both type 1 diabetes and type 2 diabetes. In a study of people with type 1 diabetes, suppressing glucagon with somatostatin was associated with more than a 50% reduction in people’s mean prandial – from ~250 mg/dl to ~100 mg/dl (Raskin et al., NEJM 1978). Similarly, in another study, suppressing glucagon in people with type 2 diabetes lowered people’s post prandial glucose levels from a peak at ~200 mg/dl to ~160 mg/dl (Shah et al., J Clin Endocrinol Metab 2000).
  • Hyperglucagonemia results from impaired intra-islet insulin signals from beta cells to alpha cells. Among healthy people, insulin levels increase as glucose levels rise, inhibiting the secretion of glucagon. In people with type 1 diabetes and late-stage type 2 diabetes, this increase does not occur and the production of glucagon remains high. Dr. Wysham noted that hyperglucagonemia can account for abnormalities associates with the lack of insulin, including increased ketogenesis.
  • Dr. Wysham explained that people with either of these diseases are more prone to hypoglycemia due to their impaired glucagon response (as well as their use of exogenous insulin). People with these diseases have an impaired glucagon response because 1) a declining level of inter-islet insulin stimulates the secretion of glucagon, and 2) people with either type 1 diabetes or late-stage type 2 diabetes do not produce enough insulin to have this decline. Thus, they do not secrete as much glucagon as a healthy person in the presence of low blood glucose levels.
  • Dr. Wysham noted that people with type 1 diabetes and late-stage type 2 diabetes have similar rates of hypoglycemia when they are matched for duration of insulin therapy (Hepburn et al., Diabet Med 1993).

 

PANEL DISCUSSION

Davida Kruger, MSN, APN-BC, BC, ADM (Henry Ford Health Systems, Detroit, MI); Geralyn Spollett, MSN, ANP-CS, CDE (Yale School of Medicine, New Haven, CT); Carol Wysham, MD (Washington State University, Spokane, WA)

Dr. Wysham: I think the concept that islet cell insulin is playing such a large role in glucagon secretion is generally unknown as it related to diabetes. We are just relatively recently appreciating the impact of what is happening at the islet cell and what happens on insulin secretion.

Q: Can you speak to how to safely address post-exercise hyperglycemia?

Ms. Spollett: When you stop exercising and your body has been using your muscle glucose, your body tries to compensate so the liver is releasing glucose. One of the ways that we first approach it is ensuring that people are eating something both to prevent hypoglycemia and to not rely on hepatic glucose. Many people do not take insulin during exercise because they are afraid of hypoglycemia and do not realize that they need the insulin to uptake their glucose.

Dr. Wysham: When you exercise, your stomach does not empty very well. If you are replacing your carbs with solid glucose rather than liquid carbs you might not digest it for some time. Make sure people understand the importance of using liquid carb sources.

Ms. Kruger: If they are going to be running, use your stomach not your legs or arms for insulin. Once those muscles get going the insulin will get going.

Dr. Wysham: I also recommend that they do interval exercise – between aerobic and weights. Studies suggest that by doing intervals you can min the fluctuations in glucose.

Ms. Spollett: I tell people to do their weights first and aerobic last because it reduces that spiking.

Q: How do you define late stage type 2 diabetes?

Dr. Wysham: I look at their glycemic variability – the more variable their glucose level is the less endogenous insulin they have.

Ms. Spollett: You cannot always depend on how much insulin they are using; it could be that they are very insulin resistant. I think that Carol is correct. The question is how you have to use that insulin during the day. I do some C-peptides on patients, if I am wondering where we are on the insulin deficiency spectrum.

 

HYPOGLYCEMIA: MANAGING RISKS AND OCCURENCES

Geralyn Spollett, MSN, ANP-CS, CDE (Yale Diabetes Center, New Haven, CT)

Ms. Geralyn Spollett gave a broad overview of glucagon and covered data on its prevalence, burden, associated risk factors, and findings from major studies. She highlighted the most recommended therapies for minimizing the risk of hypoglycemia: metformin, GLP-1 agonists, and DPP-4 inhibitors. By contrast, therapies that increase the risk of hypoglycemia (Liu et al., Diabetes Obes Metab 2012) are: biphasic insulin (by far the worst, with an odds ratio of 17.8 relative to placebo), glinides (10.5), sulfonylureas, and basal insulin (an odds ratio of 4.8 relative to placebo). To minimize the risk of hypoglycemia with insulin therapy, Ms. Spollett recommends using analog insulin. She summed up her talk quite succinctly: Avoiding hypoglycemia is a high priority in blood glucose management.” We couldn’t agree more.

  • “The ACCORD study scared a lot of us.” Ms. Spollett highlighted that when trying to achieve tight glucose targets, minimizing the risk of hypoglycemia is a priority. Data from ADVANCE and VADT suggests that severe hypoglycemia is associated with significantly increased risk of mortality and cardiovascular events (Zoungas et al., NEJM 2010; Duckworth et al., ADA 2009).
  • Ms. Spollett reviewed the literature for estimates of hypoglycemia incidence in type 1 and type 2 diabetes. Data suggest that: 1) patients with type 1 diabetes experience two symptomatic hypoglycemia episodes per week; 2) in all patients with type 2 diabetes, the overall incidence of hypoglycemia is ~10-20% of the rate estimated for type 1 diabetes; 3) rates of severe hypoglycemia are comparable for type 1 diabetes and type 2 diabetes treated with insulin: 11.5-11.8% (Kedia et al., Diabetes Obes Metab 2011).
  • Hypoglycemia is more feared than any other part of diabetes management.” Ms. Spollett briefly showed data from several studies, highlighting the negative impact of hypoglycemia on work productivity (a loss of 5-11 hours per month due to non-severe nocturnal hypoglycemia), quality of life, treatment satisfaction, and the cost of diabetes ($1,510-2,550 greater). Hypoglycemia has been linked to 2-6% of all deaths in type 1 diabetes, and in type 2 diabetes, severe hypoglycemic events have a 9% mortality rate (Kedia, Diabetes Metab Syndro Obes 2011).

 

PANEL DISCUSSION

Davida Kruger, MSN, APN-BC, BC, ADM (Henry Ford Health Systems, Detroit, MI); Geralyn Spollett, MSN, ANP-CS, CDE (Yale School of Medicine, New Haven, CT); Carol Wysham, MD (Washington State University, Spokane, WA)

Q: Can you explain the physiology of infection causing hypoglycemia?

Dr. Wysham: The vast majority of the time, infection causes hyperglycemia. It’s probably either related to the changes that occur because of bacterial and viral agents and changes with hormones like TNF-alpha causing insulin resistance. Hypoglycemia is much more difficult to explain.

Ms. Spollett: If people are having diarrhea and vomiting, they are losing calories. That’s particularly true if the liver is not storing calories because they have not been eating. When people are ill, we automatically think of them as hyperglycemic. There may be times when they need to be careful with how much insulin they are taking.

Dr. Wysham: Any of the floxins can cause hypoglycemia. We have a tendency to not pay attention to hypoglycemia.

Ms. Kruger: I’ve been impressed with patients on Levoquin that needed 50% less insulin. It’s something for me to be aware of too.

Q: Many of our older patients have hypoglycemia unawareness. What can we do to get Medicare to cover CGM?

Ms. Kruger: There is a huge task force tackling this at ADA and working with industry. They are trying really aggressively.

Dr. Wysham: I have had one patient successfully appeal Medicare. If he patient wants to be a squeaky wheel, they can be successful.

Q: For treating hypoglycemia in patients with cardiovascular disease, I use an A1c target of 8%. Do you agree?

Dr. Wysham: In ACCORD, it was 7-7.9%. In general, for someone in their 80s with lots of comorbidities, I’m okay with that. Decade of life divided by 10 is not a bad target.

Ms. Spollett: I go with 7-7.9% from ACCORD. There are risks of hypoglycemia, especially if they live alone and you talk about psychosocial issues and support systems. For an older person, the less able they are to function and the more alone they are, the higher the A1c can be.

 

EDUCATING PATIENTS IN THE USE OF GLUCAGON FOR TREATING MAJOR/SEVERE HYPOGLYCEMIA

Geralyn Spollett, MSN, ANP-CS, CDE (Yale School of Medicine, New Haven, CT)

Ms. Geralyn Spollett’s presentation on the use of glucagon to treat severe hypoglycemia focused on the strengths and weaknesses of current kits and what people need to know in order to use a glucagon kit. She closed her presentation, however, discussing future directions for glucagon therapy in both emergency glucagon administration and the use of glucagon in the bihormonal pump. Ms. Spollett stated that an IND application for a (we note it is Biodel’s) dual-chamber glucagon pen is expected to be submitted in 2014 and that an NDA submission is anticipated in 2015. She stated that phase 2 trials are anticipated for a (Xeris’) pen containing room-temperature stable glucagon (she did not specify when). Turning to the bi-hormonal pump, Ms. Spollett noted that studies have demonstrated that when glucagon is used in an artificial pancreas, people have good glycemic control with lower rates of hypoglycemia (Bakhtiani et al., Diabetes Obes Metab 2013). She explained, however, that glucagon’s instability in solution remains a major hurdle to the development of both a bihormonal artificial pancreas and a glucagon pen. Ms. Spollett noted that the JDRF announced several partnerships (we note with Xeris and Latitude) to develop stable, soluble glucagon for pump use. During the subsequent Q&A session, Ms. Spollett voiced strong support for the use of micro-dosing of glucagon, particularly when a person’s blood glucose level is not responding to carbohydrate interventions or when a person realizes they have made an insulin error and there is not a need to wait and watch them go very low. 

  • Ms. Spollett indicated one glucagon formulation (Biodel’s) has demonstrated room temperature stability over seven days – the length she believes is needed for real-world bihormonal artificial pancreas use. Additionally, the researchers found no gel formulation over 50 days (Steiner et al., J Diabetes Sci Technol 2010). We note that Biodel has not provided a recent update on its stable glucagon program. For more details on Biodel’s pipeline, please see our Biodel F3Q13 report at http://www.closeconcerns.com/knowledgebase/r/ed7d7091.
  • Ms. Spollett noted that another formulation (Xeris’), in a preclinical study demonstrated superior stability over six months storage at room temperature. Dr. Spollett also noted that its preclinical safety profile was comparable to that of currently marketed glucagon formulations. Xeris is planning to begin a clinical trial of glucagon use in a pump in 2014.
  • Ms. Spollett highlighted Glucagon App. Glucagon App tells users where their glucagon is stored, reminds them to replace soon-to-expire pens, and reminds them of important safety information.

 

PANEL DISCUSSION

Davida Kruger, MSN, APN-BC, BC, ADM (Henry Ford Health Systems, Detroit, MI); Geralyn Spollett, MSN, ANP-CS, CDE (Yale School of Medicine, New Haven, CT); Carol Wysham, MD (Washington State University, Spokane, WA)

Q: Are either of you aware of guidelines for mini-dosing glucagon?

Ms. Spollett: I think it is a great idea for us to think about glucagon being used with patients when they are having a hard time bringing the blood glucose level up after multiple attempts.

Dr. Wysham: When you Google “mini-dose of glucagon: there is a nice article on mini-dosing of glucagon that is really nice [http://www.ncbi.nlm.nih.gov/pubmed/11315823].

Ms. Spollett: I think that it is worth the cost when compared to the ER visit.

Q: Is anyone addressing the issue of getting CGM reimbursed?

Ms. Kruger: We do about 500 professional uses of CGM. Most patients, I can almost guarantee you that if you do look for hypoglycemia for seven days you will find that they are having a number of BGs less than 70 or less than 50 that they are unaware of. I ask patients if they are feeling hypoglycemia and then I ask them at what level they feel hypoglycemia. Usually in the patients that need it, you can document the hypoglycemia.

Ms. Spollett: Where I am from, the insurance companies seem to be becoming a little bit looser on this.  I think it has been really helpful for our patients.

Dr. Wysham: Severe hypoglycemia doesn't have to be somebody passing out. I count it as a third party event when a person has to tell a patient to check because they are acting stupid or weird. If somebody has had this happen, I count that in the paperwork as a severe hypoglycemia.

Ms. Kruger: I always tell people not to report that they do not have hypoglycemia unawareness. I document the level at which they feel hypoglycemia.

Q: How much is too much utilization of glucagon?

Ms. Spollett: I have never had somebody who wanted to use glucagon daily. The expense would have already flagged them to the insurance company. I was wondering – what about patients who do not want to eat because they have other eating disorders. It could be that an eating disorder is going on.

Dr. Wysham: I give patients one refill and I ask them to call me when they need a second refill so that I can keep track of their use. Any patient who comes to me for their routine three-month check-in that has used glucagon is flagged for a conversation surrounding their regime and if changes need to be made.

Ms. Kruger: I can usually write for two-kits with the same copay. Sometimes that is important, if you want one at work and one at home. I only give one refill because I want to know that they need the next refill.

Q: Would you use glucagon in a person with severe hypoglycemia at the same time as a large amount of alcohol in their system?

Dr. Wysham: No.

Ms. Spollett: No.

Ms. Kruger: If the problem is alcohol, they are not going to respond to the glucagon. In that situation I call the emergency services.

Dr. Wysham: If you give the glucagon, you are only going to be delaying them getting to the ER where they are absolutely going to need that IV glucose.

Ms. Spollett: Both companies that produce glucagon kits, have demonstration kits that can be reused as well as DVDs and booklets. I have never had difficulty getting demo kits. The companies understand how important getting that drug is and that it can be a life saver.

 

AFFECTING GLUCAGON LEVELS TO MANAGE HYPERGLYCEMIA IN DIABETES

Carol Wysham, MD (Washington State University, Spokane, WA)

Dr. Carol Wysham provided a nice overview of the therapeutic potential of targeting glucagon, beginning with a review of Dr. Roger Unger’s pioneering work. She highlighted the three currently approved drug classes that suppress glucagon (DPP-4s, GLP-1s, and amylin analogs) and ran through their pros and cons. On incretins specifically, Dr. Wysham delved into a few head-to-head studies examining whether different compounds have different effects on glucagon suppression – the largest differences were seen with exenatide twice-daily over sitagliptin and exenatide once-weekly over exenatide twice-daily. Dr. Wysham got the audience’s attention with a before/after one-week CGM trace of a type 1 patient who added liraglutide – the slide showed a striking improvement in time in zone and virtually no values over 160 mg/dl. She concluded with several slides on LY2409021, Lilly’s glucagon receptor antagonist – the candidate is in phase 2 for type 2 diabetes and is coming off a pilot study in type 1 diabetes. In preliminary trials (two presented at ADA 2013), LY2409021 has improved glycemic control in patients with type 2 diabetes (though consistently increased liver enzymes) and reduced insulin requirements in type 1 diabetes.

  • Dr. Wysham showed data from Dr. Roger Unger on the inability of insulin therapy to suppress excess glucagon secretion in type 1 and type 2 diabetes (Unger et al., J Clin Invest 2012; Unger et al., NEJM 1971). She also highlighted interesting preclinical data suggesting that a leptin infusion to suppress glucagon decreased glucose variability when mice were given a suboptimal insulin dose (Unger et al., J Clin Invest 2012). Overall, Dr. Unger’s work implies that pharmacological suppression of glucagon might increase the effectiveness of available insulin, reduce insulin requirements, and improve glycemic control.
  • Dr. Wysham highlighted the three non-insulin agents that suppress glucagon: amylin analogues (BMS/AZ’s pramlintide), DPP-4 inhibitors, and GLP-1 receptor agonists. She briefly covered a handful of studies supporting the positive effects of these agents on suppressing glucagon, reducing insulin doses, and reducing glycemic variability.
    • There have been a few head-to-head studies of incretins comparing differences in glucagon suppression: sitagliptin and saxagliptin produced similar changes in fasting glucagon levels (Scheen et al., Diabetes Metab Res Rev 2010); exenatide twice-daily outperformed sitagliptin in terms of reducing postprandial glucagon (DeFronzo et al., Curr Med Res Opin 2008); liraglutide and exenatide twice-daily comparably reduced fasting glucagon levels (Buse et al., Lancet 2009); and exenatide once-weekly outperformed exenatide twice-daily in reducing fasting glucagon (Drucker et al., Lancet 2008).
  • “One of the most exciting studies” was the small study on the use of liraglutide (Novo Nordisk’s Victoza) in type 1 diabetes (Varanasi et al., Eur J Endocrinol 2011). Dr. Wysham showed a compelling CGM graph before and after adding liraglutide in type 1 diabetes – the audience gasped at the reduction of peaks and valleys, with nearly all the glucose values in zone after just one week. Insulin was preemptively adjusted by about 25%, and patients experienced a reduction in A1c, a reduction in weight, and an improvement in glycemic variability.
    • As a reminder, the phase 3a trial for liraglutide in type 1 diabetes is expected to begin in December 2013 (ADJUNCT ONE, ClinicalTrials.gov Identifier: NCT01836523). The trial is expected to randomize 1,404 people with type 1 diabetes to liraglutide 0.6 mg, liraglutide 1.2 mg, liraglutide 1.8 mg, 0.6 mg placebo, 1.2 mg placebo, or 1.8 mg placebo as an adjunct to their pre-trial insulin regimen. For greater detail on the study design, please see our report at http://close.cx/NovoNordisk1Q13.
  • Dr. Wysham discussed the potential of blocking the glucagon receptor, highlighting ADA 2013 data on Lilly’s phase 2 glucagon receptor antagonist, LY2409021. Use of the compound was associated with a 0.6-0.8% A1c decline in type 2 diabetes (with increases seen in liver enzymes), and in a pilot study in type 1 diabetes, mean 24-hour insulin requirements dropped 17-20%. For more on these studies, see pages 183 and 189 at http://www.closeconcerns.com/knowledgebase/r/94f937d8. The only other glucagon receptor antagonist to advance to phase 2, Merck’s MK0893, was discontinued – A1c declined by up to 1.5% in a 12-week trial, but the compound increased LDL, liver transaminases, and body weight. 

 

PANEL DISCUSSION

Davida Kruger, MSN, APN-BC, BC, ADM (Henry Ford Health Systems, Detroit, MI); Geralyn Spollett, MSN, ANP-CS, CDE (Yale School of Medicine, New Haven, CT); Carol Wysham, MD (Washington State University, Spokane, WA)

Q: Do individuals that use mini doses of glucagon waste the unused portion?

Ms. Kruger: Yes, once it’s mixed.

Q: Do patients self-inject glucagon?

Ms. Kruger: In some instances, patients cannot get their glucose up with food. I do have some patients that will self inject when they have had enough calories.

Dr. Wysham: For patients fasting for a colonoscopy that have a mildly hypoglycemic number, you can give a small dose to keep blood glucose up.

Q: How low does blood glucose have to go for someone to become unconscious and seize?

Ms. Kruger: It’s so individual. I’ve seen a fingerstick blood glucose of 80 or 90 mg/dl. There are all kinds of places to lose blood glucose from. The fingerstick may not be what he brain knows. Some people tolerate 40 mg/dl.

Dr. Wysham: It depends on how well controlled that patient is. The better controlled people have better tolerance. We have patients with subclinical brain injuries. It doesn’t take a lot of change in glucose to cause a seizure. The majority of my well-controlled patients are able to function reasonably well into the 50s.

Q: How does raising glycemic goals improve hypoglycemia unawareness?

Ms. Spollett: The more carefully controlled blood glucose is, the more body gets used to that level. That means the less your brain responds to adrenaline and telling you are low. When you raise blood glucose levels, you are retraining the body so it knows when it drops into the danger zones, it needs to begin to warn you. If you are used to running at a very low level, and you drop even lower, the body tolerates it.

Dr. Wysham: It’s like a hypoglycemia battery. It takes 24 hours to recharge. One hypoglycemia event reduces the ability to feel a subsequent hypoglycemia for 24 hours.

Q: So is there a risk for another hypoglycemia after an earlier event?

Ms. Kruger: People who tend to get hypoglycemia events tend to get more events.

Ms. Spollett: Patients need to follow that episode by a snack after treating.

Q: Could you discuss renal failure, renal adjustments, and glucagon efficacy?

Dr. Wysham: In patients with poor renal function, they don’t have renal gluconeogenesis, which contributes to about 25% of fasting glucose production. They usually need a reduction in basal insulin. For older individuals and patients on dialysis, you must throw out the 50% bolus/50% basal rule. You need a greater percentage of meal insulin and less in basal insulin. That's primarily based on the risk for fasting hypoglycemia.

Q: Will injectable glucagon be needed when GLP-1 or amylin analogs are used?

Ms. Kruger: None of those are causes of hypoglycemia, unless they are in conjunction with insulin or sulfonylureas. The drugs have a mechanism to turn themselves off when hypoglycemia occurs.

 

CME Event: Insulin Best Practice for People with Diabetes: Translating Research into Practice (Supported by BD)

INTRODUCTION

Gary Scheiner, MS, CDE (Integrated Diabetes Services, Wynnewood, PA)

To begin the session, Mr. Gary Scheiner posed the question, why aren’t people using more insulin? He answered this himself, humorously characterizing insulin injections somewhere between shooting a rocket into their body and hobbling into the grave. He also noted that starting a patient on insulin is not easy for the physician, either, requiring long hours and addressing patients’ weight gain and ravenous hunger.

 

INTRODUCING INSULIN TO THE TREATMENT PLAN

Frank Lavernia, MD (North Broward Diabetes Center, Coconut Creek, FL)

Dr. Frank Lavernia opened the symposium and discussed the role of insulin therapy in patients with type 1 and type 2 diabetes. The talk centered on initiating insulin therapy in type 2 diabetes, with an emphasis on early screening and pre-emptive treatment before beta cell function deteriorates. He also reviewed his recommendations for insulin dosage in patients initiating insulin therapy, including tips for using pramlintide in conjunction with insulin.

  • Clinically, insulin therapy is necessary when beta-cells begin to fail. However, UKPDS highlighted that as much as 50% of beta cell function is already lost by the time of type 2 diabetes diagnosis. Dr. Lavernia opined that diagnosis is made too late at the point of beta cell deterioration – we certainly agree. For initiating basal insulin and establishing insulin therapy, Dr. Lavernia recommends 40-50% of total daily insulin, with a starting dose of 0.2 units per kg per day (0.25 to 0.5 units). Although guidelines are in place, it may take weeks for patients starting insulin therapy to determine adequate starting dosages.
  • For patients with very little or no physiological insulin secretion, Dr. Lavernia recommends using insulin plus pramlintide instead of insulin plus a GLP-1 agonist. Citing pramlintide’s many benefits for patients with diabetes, he noted that it slows postprandial glucagon secretion, provides some weight loss benefits, and slows gastric emptying. However, from a patient perspective, he explained that the nausea and increased frequency of injections tend to deter patients from adding pramlintide to their insulin therapy regime. We’d note that the benefits and barriers to using pramlintide are similar to those associated with using GLP-1 agonists – we’d be interested to see the two approaches compared in a head-to-head trial in patients with late-stage type 2 diabetes on insulin therapy at baseline.

 

BARRIERS TO INSULIN THERAPY

Kellie Antinori-Lent, MSN, RN, CDE (University of Pittsburgh Medical Center, Shadyside, PA)

Ms. Kellie Antinori-Lent began her presentation noting that “barriers are a part of life, and the problem with barriers is that they prevent us from going where we want to go.” She remarked that although the percent of patients meeting A1c goals has improved, there are still disparities across ethnic minority groups. After outlining the benefits of insulin usage, she explained patient, physician, and systemic barriers to beginning treatment, focusing primarily on psychological barriers of patients and physicians. Ms. Antinori-Lent also picked out the most significant barriers to treatment based on previous studies such as DAWN, TRIAD, and the MODIFY survey. In a study published in The Diabetes Educator (Polonsky 2007), perceived lifestyle restriction, feelings of guilt and failure, and low self-efficacy impacted patients’ willingness to begin insulin therapy. Broadening the scope of her presentation, Ms. Antinori-Lent noted that these barriers are not unique to the US, as indicated by the MODIFY Survey. This survey also highlighted that the main barriers for diabetes-experts to initiate patients on insulin therapy were lack of experience and lack of education. Notably, one study showed that US physicians have the greatest clinical inertia when it comes to insulin resistance out of any other country surveyed. Physicians noted that they desired greater collaboration between primary care and secondary care teams, increased utilization of nurses and other diabetes educators, and improved physician and patient education guidelines. Turning to systemic barriers, Ms. Antinori-Lent highlighted that the lack of structure for determining follow-up visits is a “big concern.”

  • Ms. Antinori-Lent remarked that insulin is the most effective glucose lowering medication available, highlighting its ability to lower A1c levels from any baseline and the lack of ceiling on insulin dosage. She also mentioned other benefits of insulin, such as an improvement to beta-cell function, improvement to hepatic and muscle sensitivity to insulin, lowering of free fatty acids, an increase in HDL, and a decrease in LDL. Ms. Antinori-Lent even suggested that because of its anti-inflammatory action, insulin may help prevent stroke and dying of complications. Ms. Antinori-Lent remarked that amylin and GLP-1 agonists were injectables that could be just as powerful as insulin.
  • Psychological insulin resistance (PIR) such as perceived lifestyle restriction, feelings of guilt and failure, and low self-efficacy can impact patients’ willingness to begin insulin therapy according to a study done by Polonsky (The Diabetes Educator 2007). Other patient barriers include financial burden, fear of weight gain, and “horror stories” from family and friends. Ms. Antinori-Lent also pointed out that the rates of insulin uptake vary across population, with women more unwilling to begin treatment than men, and Hispanic patients more unwilling than non-Hispanic whites – in fact, Ms. Antinori-Lent noted that 72% of Hispanic patients believed that insulin therapy could cause additional health problems. Ms. Antinori-Lent also remarked that results from Novo Nordisk’s DAWN study demonstrated that self-blame was significantly less in patients who watched their diet, were physically active, and had less diabetes related stress.
  • US physicians waited until absolutely necessary to begin insulin treatment 50-55% of the time – the highest rate of clinical inertia among all of the countries evaluated. Additionally, 80% of physicians said they would be less likely to initiate treatment on non-adherent patients, which Ms. Antinori-Lent remarks may be the population that needs it the most.
  • “Patient follow-up is a big concern for me” Ms. Antinori-Lent commented on the lack of system in place for patient follow-up. Other systemic barriers that she outlined were great workload, lack of access to education, underutilized resources, reimbursement issues, and a lack of team collaboration.
  • One way to ease patient anxiety about insulin injections is to have the patient try a putting a needle into a pen. Other suggestions to ease anxiety included using smaller, thinner needles (she specifically highlighted the small 4 mm needles), increase self-monitoring of blood glucose if patients are concerned about hypoglycemia, and discuss the progressive nature of type 2 diabetes so patients do not feel like they have failed (Peragallo-Dittko V., Diabetes Educator 2007).

 

GIVING IT YOUR BEST SHOT: EVIDENCE-BASED PRACTICES FOR INSULIN ADMINISTRATION

Carolyn Banion, RN, MN, CPNP, CDE (Barbara Davis Center for Diabetes, Aurora, CO)

Ms. Carolyn Banion reviewed some of the latest information on insulin administration, including an extensive overview of needle types and acceptable practices for injection. She highlighted that 4 mm needles have been controversial and characterized as “too short”; however, an AADE 2011 white paper (“Strategies for Insulin Injection Therapy in Diabetes Self-Management”) emphasizes that a 4 mm needle is of sufficient length to reach subcutaneous tissue when injected at a right angle. In fact, she noted, insulin therapy with 4mm needles produces equivalent glycemic control to other needle lengths regardless of the patient’s BMI (in line with BD’s extensive research and recent marketing for the 4 mm Nano pen needle). Additionally, such shorter needles have an advantage of being safer (less risk of intramuscular injection) and better tolerated by patients. According to Fleming et al., injecting through clothing is also acceptable as long as the needle is at least 6mm in length.

 

PANEL DISCUSSION

Gary Scheiner, MS, CDE (Integrated Diabetes Services, Wynnewood, PA); Frank Lavernia, MD (Broward Diabetes Center, Coconut Creek, FL); Kellie Antinori-Lent, MSN, RN, CDE (University of Pittsburgh Medical Center, Shadyside, PA); Carolyn Banion, RN, MN, CPNP, CDE (Barbara Davis Center, University of Colorado, Aurora, CO)

Q: Do you split large doses of Lantus when you get above 50 units? What do you recommend?

Dr. Lavernia: Lantus is acidic in nature, so when you get to higher doses, some patients complain. Usually I go above 50 units before splitting the doses. When I get to up 100 units I definitely split the dose. It is truly a better 24 hour insulin, but the large amounts you are putting in there become too acidic for some patients. We usually start talking about using the U-500 insulin when you get above 200 units. I believe Sanofi is coming out with a U-300 of glargine.

Q: Does insulin action change at higher volumes and larger doses?

Dr. Lavernia: At higher doses, the profile is about the same. It all depends on how much you are taking to bring down post prandially. But it should not be more potent or more powerful. It follows the normal profile.

Mr. Scheiner: I have seen a change in the tail of the rapid analogue in larger doses – it has to do with the fluid dynamics.

Q: Can you start your patient on both basal and prandial at the same time?

Dr. Lavernia: You can do anything you want, but it gets complicated for the patient. The most that I have done is basal-bolus. If you have a 7-point profile, they get very frustrated, and it becomes a mess. We try to fix fasting first, and then we move to the biggest meal of the day and try to get that under control. You can also use GLP-1 agonists. Also, remember that having shorter acting insulin can have more of an effect on post-prandial levels, around the bolus, without gaining weight or hypoglycemia.

Q: Do you recommend putting a type 2 pediatric patient on insulin right away?

Dr. Banion: I think if they have an A1c over 10% or 11%, we would start insulin with the hope that we could eventually wean them off. However, with the glucose toxicity at that level of A1c, I think the requirement for insulin is there.

Q: How do you avoid leakage of insulin onto the skin with large doses and the 4 mm needle?

Ms. Antinori-Lent: I find that patients definitely prefer the 4 mm over the 8 mm. If they are using the 4 mm needle and seeing leakage, I would recommend that patient try a longer needle.

Q: Do you try angling the injection?

Ms. Antinori-Lent: I do not routinely recommend that technique, but thank you for the suggestion.

Mr. Scheiner: I find that angling helps.

Q: How long do you suggest to patients to leave the needle in for?

Ms. Banion: I usually recommend five to 10 seconds.

Ms. Antinori-Lent: I tell patients to push the plunger down, hold for a second, and then remove the needle. There are different pens that tell patients to hold for 10 seconds. If they have leakage at the sight, I tell them to make sure that they are holding the needle in the whole time.

Q: Are there special considerations for injections during pregnancy?

Ms. Antinori-Lent: I do not really deal with pregnancy. As for injecting in the abdomen during late months? It is the only place you can inject them. I know of one patient who splits larger doses; the largest she gives is 40 units in one shot.

Q: At what age can you add amylin to the treatment of a patient with type 1 diabetes?

Ms. Banion: We almost never use amylin in kids. So I do not know.

Mr. Scheiner: It is indicated for patients over the age of 18. Some published on efficacy in teenagers; it is questionable before age 12.

Q: Can patients have lipohypertrophy [fat accumulation at the site of injection] with injection ports?

Ms. Banion: Yes, they can.

Mr. Scheiner: The rotation of the port is analogous to the rotation of the pump. If you are not moving the port in an organized fashion, the chance of lipohypertrophy goes up.

Q: Does the U-500 change the insulin requirement?

Dr. Lavernia: If we use the U-500, we have to be sure they also use rapid acting analogue to take care of the mealtime spikes that they have. You still have to use a bolus.

Mr. Scheiner: Devices using the U-500 have not been cleared officially, but insulin pumps and ports can handle the U-500 without a problem. It seems to be universally accepted in that regard.

 

Corporate Symposium: Complementary Approaches to Improve Glucose Control -- Insulins and Incretins? (Sponsored by Novo Nordisk)

USING INSULIN AND INCRETINS TOGETHER

Jerry Meece, RPH, CDE (Plaza Pharmacy and Wellness Center, Gainesville, TX)

Mr. Jerry Meece emphasized that incretin-insulin co-therapy is effective in controlling patient glucose levels, has a better weight control profile than insulin monotherapy, and does lead to a substantial increase in hypoglycemia. He began his presentation with the case of Billy Bob, a type 2 diabetes patient on insulin glargine who needed additional help with his glycemic control. Mr. Meece shared study evidence indicating that GLP-1 receptor agonists can confer an additional 0.7% A1c improvement (along with a 4 pound loss in weight) when added to basal insulin treatment (Buse et al., Ann Intern Med 2011). He noted that the FDA has approved the use of exenatide and liraglutide (two GLP-1 agonists) as add-ons to basal insulin. Comparing data available on the currently marketed GLP-1 agonists, Mr. Meece noted that Byetta (exenatide twice daily) has the best impact on postprandial glucose levels, while Bydureon (exenatide once weekly) and Victoza (liraglutide) have a more pronounced impact on fasting plasma glucose. He used a second case study to demonstrate that insulin can also work well when added on to existing incretin therapy (the reverse order from the previous case). In conclusion, he encouraged providers to “start low and go slow” with insulin titrations, to encourage concomitant lifestyle modification, and to adopt a patient-centered approach.  

 

GLP-1 AGONISTS VERSUS DPP-4 INHIBITORS

Teresa Pearson, MS, RN, CDE (Halleland Habicht Consulting, Minneapolis, MN)

Ms. Pearson took over from Dr. Meece to discuss a key issue: the difference between GLP-1 agonists and DPP-4 inhibitors (the two most common classes of incretin therapies currently available). She cited evidence demonstrating that GLP-1 receptor agonists have greater A1c-lowering efficacy, positive impacts on cardiovascular risk factors, and they often lead to weight loss. She acknowledged that nausea is an important side-effect of the GLP-1 agonist class, but noted that it can be managed with step-up titration. She noted that after six weeks of treatment, patients on liraglutide experienced significantly less nausea than patients on exenatide.

 

SIDE EFFECTS

Linda Siminerio, PhD, RN, CDE (University of Pittsburgh, Pittsburgh, PA)

Dr. Linda Siminerio began her presentation with a discussion of hypoglycemia: studies have shown that over 50% of patients’ hypoglycemia episodes are nocturnal, and that a high proportion of these events go unrecognized. Dr. Siminerio noted that when looking at only agents with low risk of hypoglycemia in the ADA/EASD Position Statement, insulin and insulin secretagogues are eliminated while incretins remain. Because GLP-1 agonists and basal insulin have demonstrated similar efficacy in clinical trials, she argued that going with GLP-1 can be the safer bet (at least with regards to hypoglycemia). She then moved on to the hot topic of GLP-1 agonists and pancreatitis. After mentioning that the early studies that supported the association contained a number of confounders, such as hypertriglyceridemia and gallstones, she reminded the audience that the ADA, AACE, Endocrine Society, and other high-profile groups have confirmed that current evidence does not justify a change in prescription behavior. She recommended that CDEs educate patients on the symptoms of pancreatitis and immediately discontinue therapy if signs of the condition appear. She concluded by noting that the NDEP website contains a number of great resources for diabetes educators and patients, available in a number of languages.    

 

PANEL DISCUSSION

Jerry Meece, RPH, CDE (Plaza Pharmacy and Wellness Center, Gainesville, TX); Teresa Pearson, MS, RN, CDE (Halleland Habicht Consulting, Minneapolis, MN); Linda Siminerio, PhD, RN, CDE (University of Pittsburgh, Pittsburgh, PA)

Q: In the first case, if you wanted something simple to administer, why didn’t you switch Billy Bob to once-weekly exenatide instead of liraglutide?

Mr. Meece: We didn’t switch Bill to once-weekly exenatide because at the time we had him as a patient, it was not out. Even if it was, I’m not sure we would have used that. He wanted something repetitive that worked well for him: right leg basal insulin, left leg liraglutide, each day. One shot, one shot, and he’s done. There are advantages and disadvantages of using exenatide twice daily versus exenatide once weekly. Every time you decrease dosing you increase adherence, but the disadvantage is that exenatide once-weekly takes a few minutes to prepare and needs a bigger needle. In my case, it was just a professional call.

Q: At what age should patients be taken off metformin?

Dr. Siminerio: The FDA says age 80. As patients age, they have reduced kidney function and more congestive heart failure. We should be looking at creatinine clearance to see how their renal health is. So at age 80 we should start monitoring that patient more closely.

Q: Can you comment on the use of glipizide, metformin, and Januvia together?

Mr. Meece: I always like to consider what we’re doing for a patient’s lifestyle. Frequent hypoglycemia can clean out the cabinet, so to speak. I have patients who say that they never want to have a single episode of hypoglycemia. I had a patient who would eat a bowl of ice cream before bed so that they wouldn’t have nocturnal hypoglycemia because the first experience scared them so much.

Q: If the dose of a GLP-1 is increased, will the patient experience nausea again if the treatment duration has been longer than six weeks? 

Ms. Pearson: The expectation is that if there is any, it will be less, but it depends on the patient. That’s where having the conversation is really important, and you can ask if it is truly nausea or fullness. Most people will not experience nausea to same degree with that increase in dose

Mr. Meece: I think we have a great opportunity with GLP-1 agonists to change lifestyle while adding a medication. In having conversations with patients, I would say you may experience some queasiness, and you may even consider it nausea, but let’s go with that. Maybe you’ve been stopping by Sonic everyday for a cheeseburger and fries, and maybe we could try a salad instead. I had a patient who did not lose a pound on GLP-1 therapy. I asked him whether he experienced any nausea, and he said he did, but was able to eat his way right through it. GLP-1 could be an opportunity to be able to work with the nausea and get them adjusted to eating less.

Q: Are you still using TZDs? They are out of favor in my region.

Dr. Siminerio: On behalf of what I see, we’re using less and less of them, mainly because of the side effects. Are you having the same experience?

Mr. Meece: We did see the decline. TZDs are amazing medications. We love them, and we hate them. Now that we’ve seen them move to generic, they’re regaining some popularity. Like every other drug out there, it’s about choosing what is right for the patient in front of you. It is a viable alternative if you choose wisely who uses it.

Q: When adding liraglutide, would you stop DPP-4?

Ms. Pearson: Yes you would. You would not use both of those agents at the same time.

 

Product Theaters

A NEW TREATMENT APPROACH FOR TYPE 2 DIABETES (SPONSORED BY JANSSEN)

Virginia Valentine, APRN-CNS, BC-ADM, CDE (Northside Family Medicine, Albuquerque, NM)

The packed, and short-but-sweet product theater emphasized the mechanism of action behind canagliflozin (the SGTL-2 inhibitor Invokana), as well as its superiority to sitagliptin (DPP-4 inhibitor Januvia). Expert CDE Ms. Virginia Valentine began by explaining the role of SGLT-2 and SGLT-1 in filtering glucose, noting that the diabetic patient has a higher renal threshold for glucose excretion at 240 mg/dl (individuals without diabetes have a renal threshold of 180 mg/dl). Valentine explained how canagliflozin blocks SGLT-2 to reduce renal glucose reabsorption and increase urinary glucose excretion, emphasizing that this is not a drug for patients with type 1 diabetes or patients with severe renal impairment. The starting dosage for canagliflozin is 100 mg once daily, but is increased to 300 mg once daily for patients who tolerate the starting dosage and have sufficient renal function. She highlighted both the monotherapy study (canagliflozin vs. placebo) and combination study (canagliflozin + SU + metformin vs. sitagliptin + SU + metformin) to establish that the 100 mg and 300 mg doses provide significant A1C reductions compared to placebo, and that the 300 mg dose provides greater A1C reductions than sitagliptin. With the manner in which Invokana was compared to sitagliptin, it was reinforced to us the potential for SGLT-2 inhibitors to become major, frequently-prescribed diabetes drugs.

  • Ms. Valentine noted that in various studies, canagliflozin showed greater A1C, weight and blood pressure reductions compared to placebo. The phase 3 clinical development program included 10,000 patients in a 26-week randomized double-blind controlled trial. By the end of 26 weeks, the baseline 8.0% A1C declined 0.9% on the 100 mg dosage and 1.2% on the 300 mg dosage, compared to a 0.14% A1C increase on placebo. In the placebo group, 21% of patients achieved an A1C below 7.0% at 26 weeks, compared to 45% of the 100 mg group and a striking 67% of the 300 mg group. In the placebo group, patients lost an average 0.6% bodyweight at 26 weeks, compared to a placebo-relative 2.2% decline in the 100 mg group and a placebo-relative 3.3% decline in the 300 mg group. In the placebo group, patients saw a 0.4 mm Hg increase in systolic blood pressure. In the 100 mg group, blood pressure was -3.7 mm Hg lower compared to placebo, while in the 300 mg group, blood pressure was -5.4 mm Hg lower compared to placebo.
  • At the 300 mg dosage, canagliflozin helped more patients than sitagliptin (at a 100 mg dosage) achieve a <7.0% A1C level. Canagliflozin was compared to sitagliptin in a 52-week study that combined both with metformin and sulfonylurea. At the end of 52 weeks, 35% of patients on 100 mg of sitagliptin achieved an A1C lower than 7.0%, compared to 48% on 300 mg of canagliflozin. At 40.7% and 43.2% respectively, sitagliptin and canagliflozin had similar incidences of hypoglycemia at 52 weeks – this sounded very high to us and we assume that either the definition was very “conservative” or that patients were also taking SFUs, insulin, etc.(It was totally because of sulfonylurea, in monotherapy study neither 100 mg or 300 mg dose was different from placebo in causing hypoglycemia) Canagliflozin also demonstrated a greater weight loss, with a 2.8% decline relative to sitagliptin from baseline. Where sitagliptin increased blood pressure from baseline by 0.9 mm Hg at 52weeks, canagliflozin decreased blood pressure by 5.1 mm Hg.
  • Total adverse events were similar between sitagliptin and canagliflozin at a 52-week tally of 293 and 289, respectively. Ms. Valentine did highlight that urinary tract infections were higher in the sitagliptin group, with 21 events compared to 15 in the canagliflozin group. But Canagliflozin has about 10-12% genital mycotic infection in women. With a twinkle in her eye, she observed that the yeast infection treatment Monistat recently began advertising for the first time in 15 years.

Questions and Answers

Q: Why can’t you use Invokana for Type 1?

A: Because the slide says so (laughs). You can use it in combination with insulin with type 2 patients. It hasn’t been studied yet for type 1, so it isn’t approved for type 1. It would be off-label.

Q: How much does this cost out of pocket?

A: I don’t know, but you could ask at the booth. They probably couldn’t tell you either (laughs). (Editor’s note: It is about $300 - $350 / month for a 300 mg dose.)

Q: In part of my class I teach about complications in the kidney. I say too much glucose is filtered through the kidney causes damage. If we’re lowering the threshold, we’re putting more glucose through the kidneys.

A: Nothing changes with the glomerulus; the only thing that changes is where the sugars are reabsorbed. If the kidney were a car, the analogy would be taking out the catalytic converter to let more exhaust through.

Q: How long has Invokana been on the market?

A: Since about March or April.

Q: Talk a bit more about the 100 and 300 dose. I sampled the 100 and get a good response. I don’t know always when to step it up. For my patients on Levemir, I don’t need to give 300 mg, do I?

A: 100 mg isn’t the optimal dose. With Januvia, 50 mg is their dose for renal impairment. Everyone starts Invokana on 100 mg, and in a few weeks I write a script for 300 mg.

Q: Our Department of Transportation checks urine for glucose.

A: I need a card that says this so they don’t freak out, much like how people who have had a knee replacement show a card at airport security.

Q: Do you make insulin adjustments?

A: It’s like adding any other drug. If their blood sugar is good you might want to lower their insulin a little. 

 

GLP-1 IN FOCUS: THE KNOWLEDGE CHALLENGE (SPONSORED BY NOVO NORDISK)

Melissa Magwire, RN, CDE (Shawnee Mission Medical Center, Shawnee, KS)

Ms. Melissa Magwire led a repeat performance of the informative and extremely entertaining corporate symposium she co-ran at this year’s ADA — see page 28 of our ADA 2013 Incretins Report at http://www.closeconcerns.com/knowledgebase/r/6001b62d for our complete coverage of that presentation. In “The Knowledge Challenge,” the room was divided into four teams that competed on quiz questions linked to the presentation subject material. Ms. Magwire touched upon a familiar set of topics, which ranged from the incretin effect, to GLP-1 agonists’ effect on both glucagon and insulin, to their greater efficacy when compared with DPP-4 inhibitors. She noted that GLP-1 agonists are featured as recommended options in both the ADA/EASD and ACE/AACE treatment algorithms. Focusing on Victoza (liraglutide), Novo Nordisk’s once-daily GLP-1 agonist, Ms. Magwire cited evidence that the product is effective as a monotherapy and in combination with metformin and TZDs, among other agents. With regards to the well-known pancreatitis issue, she noted that a number of type 2 diabetes drugs have a label warning related to pancreatitis, but in Q&A she noted that she would reconsider Victoza in patients at risk for pancreatitis. On a side note, we appreciated that the lunch included low-carb versions of a number of dishes (although we wonder how low-carb cheesecake can possibly be!).

 

3. Obesity Management

Keynote

THE 5 A'S OF OBESITY MANAGEMENT

Arya Sharma, MD, PhD, (University of Alberta, Canada)

Dr. Arya Sharma began his keynote address poking fun at the evening’s networking events, some of which presumably were not offering the healthiest of foods.  The takeaways of his presentation reminded us of the opportunity we had to interview Dr. Sharma last year (https://app.box.com/files/0/f/207540711/1/f_2089272205), in which he spoke to many of the same themes – chief among them, the emphasis that obesity management is not about weight loss, but improving health outcomes. At AADE 2013 Dr. Sharma shared that obesity was not at all a focus in his medical education – clearly a major concern to him. What we now know, he says, is that obesity is complex and heterogeneous, which means we’re “dealing with many obesities” with different root causes and different treatment efficacies.

Most of this talk was spent discussing the Canadian Obesity Network’s five principles for obesity management, which are separate from the 5A’s referenced in the talk title. The first principle establishes obesity as a chronic disease, one that has no cure and must be treated for a lifetime. This view implores the healthcare provider to carefully consider what treatment regimens can be sustained over that long a period. The second principle reinforces the notion that obesity management should focus primarily on making patients healthier, not thinner. Here Dr. Sharma distinguished the difference between running a mere weight loss center and an obesity management center. The third principle builds on the first to argue that obesity is not just a chronic condition, but also a progressive one. In this way, the first step of obesity management (which he compared to diabetes management) is to stop or slow disease progression. The fourth principle instructs care providers to build success by the individual by determining their parameters of health, be they functional health, risk factors, quality of life, or other measures. Weight loss itself is not a health parameter. The final principle is that it is better to determine for patients a “best” weight than have them strive for an “ideal” weight. The difference is that an ideal weight might be established by image or BMI, where best weight is a person-specific goal mediated by their age, mobility, medications, and other personal factors. In a notable line, Dr. Sharma said, “I’m a healthcare provider, so I don’t care how big my patient is. I care how sick they are.” These five principles, which we found to be so trailblazing in a moment where obesity is now gaining traction as a disease, lay the groundwork for the still simpler 5A’s of obesity management.

  • Dr. Sharma’s 5 A’s of obesity are Ask, Assess, Advise, Agree, and Assist. He implores that healthcare practitioners acknowledge the personal intimacy of weight issues and begin by recognizing and alleviating the fear, stigma, and judgment obesity management patients feel. By asking permission to discuss weight, creating a weight-friendly practice, eliminating assumptions about lifestyle or motivation, and striking blame or guilt from the conversation, obesity management can be much more productive and healthy. Second, assessing the patient is crucial—defining the root causes of weight gain leads to greater understanding and higher efficiency in practice. Assessing the patient includes answering why the patient has a weight problem, the effects of the excess weight, and formulating a treatment plan based on these details. Dr. Sharma extrapolated on the 4 M’s of obesity: mental (depression, addiction, trauma, etc.), mechanical (apnea, chronic pain, reflux, etc.), metabolic (hypertension, diabetes, fatty liver, etc.), and monetary (education, income, disability). By assessing the underlying factors in patient weight gain, obesity management is much more strategic and effective.
  • Measure success based on health outcome parameters, not loss in pounds. Dr. Sharma’s third ‘A’ notes that health practitioners should advise on obesity risks, discussing the benefits and options of treatment as well as the need for a long-term strategy. He cited the idea that sleep, time, and stress management can significantly improve eating and activity behaviors, and physical activity should be more about overall health improvement than burning calories. Dr. Sharma also noted that medically supervised low calorie diets, anti-obesity medications, and surgery could all readily be a part of an obesity management ‘arsenal.’
  • Losing weight is not a behavior, but it may be a consequence of a behavior. The final steps of Dr. Sharma’s 5 A’s of obesity include agreeing on realistic weight loss goals and expectations, and assisting through the process. Unsustainable goals and health outcomes may only serve to discourage patients. Patients and healthcare providers should focus on behavioral goals instead of numerical weight-loss cutoffs. Providers can assist in achieving targets by addressing drivers and barriers, offering education and resources, and arranging follow up appointments. When asked how often he sees his patients, Dr. Sharma turned the question around and asked, “How often do you see your patients with diabetes?”

 

Breakout Session: The Obesity Epidemic -- Is There a Solution?

THE OBESITY EPIDEMIC -- IS THERE A SOLUTION?

Eva Vivian, PharmD, MS, CDE (University of Wisconsin-Madison School of Pharmacy, Madison, WI)

In a 90 minute long presentation, Dr. Eva Vivian detailed potential causes of the obesity epidemic (i.e., genetics, diet, activity levels) and strategies for potentially addressing the epidemic. Dr. Vivian voiced very strong support for the use of medical nutrition therapy (MNT) either as a “monotherapy” or in combination with pharmacotherapies or bariatric surgery. Though Dr. Vivian acknowledged that pharmacotherapies and bariatric surgery are available treatments, she described them in a cautionary tone. She painted herself as “not a big advocate of pharmacotherapy for weight loss.” Dr. Vivian seemed to be particularly concerned about the long-term safety and use of anti-obesity agents. She was even more negative on the use of bariatric surgery, noting that people (particularly if they “drink their calories”) can still gain weight following surgery, if their behaviors are not addressed.

  • While Dr. Vivian stated that anti-obesity pharmacotherapies can be used in combination with diet and exercise, she described them in a cautionary tone. Dr. Vivian explained, “as a CDE [she feels] that medical nutrition therapy and exercise are the best meds.” Surprisingly, in describing the labels for Vivus’ Qsymia (phentermine/topiramate ER) and Arena/Eisai’s Belviq (lorcaserin), Dr. Vivian did not include each agent’s weight loss efficacy. Instead, she focused on each agent’s dosing, side effects, and potential interactions with other medications.
  • In particular, Dr. Vivian appeared to be concerned about the long-term safety of anti-obesity agents and how long a person should stay on them. During Q&A she reminded attendees that sibutramine was on the market for several years – longer than Qsymia or Belviq have been available – before its potential association with increased cardiovascular risk was detected. Also during Q&A, Dr. Vivian stated that the only anti-obesity agent she would use in a person with hypertension (which we note likely comprises a large portion of overweight and obese people) is orlistat, due to her belief that not enough data is present on the blood pressure impact of either Qsymia or Belviq.
  • Similarly, Dr. Vivian characterized bariatric surgery as an option for “a limited number of patients” and warned that it is sometimes not efficacious. Dr. Vivian focused on this latter point, pressing the necessity of lifestyle intervention in conjunction with bariatric surgery.
  • Regarding MNT and exercise counsel, Dr. Vivian pressed the validity of the “calorie in, calorie out” model for understanding weight loss or gain.
  • Interestingly, Dr. Vivian noted that the CDC continues to use its 1992 growth categories for pediatric the BMI percentiles on growth charts. She explained that in the ‘90s the CDC recognized that children were on average getting heavier and did not want to skew the perception of a normal weight by elevating the BMI associated with the 50th percentile etc. for a given age.
  • During Q&A attendees appeared to be somewhat disturbed by the planned presence of companies like Sensa in the exhibit hall. For background, according to an attendee, Sensa advertises that one does not need to diet or exercise in order to lose weight on its product.

Questions and Answers

Q: How different are the growth charts from the ‘50s and ‘60s to today’s?

A: I don't have the answer to that. I am not sure if there were growth charts in the 1950s. The rates of obesity started to rise in youth and the NIH decided to not modify the growth charts because they were concerned that what we would consider a normal weight in 2004 might reflect the growing obesity epidemic. In 1994, I think that the average child was at a healthier weight than in 2000 and 2004.

Q: What can you tell us about some of the weight loss products profiled on Dr. Oz?

A: There is not a large number of clinical trials to assess how effective they are. I am very hesitant to promote a drug or product that has not been tested in a large number of individuals. Some patients ask me about cinnamon. There is conflicting data on cinnamon. Some studies showed a beneficial effect. However, different studies used different patient populations. A study in 2010, enrolled people with advanced diabetes – some were receiving insulin. The study published in Diabetes Care had people with newly diagnosed diabetes. It might be effective in people with residual beta cell function. I think that Dr. Oz does an incredible job but I would be careful to support some of the products he is endorsing.

Q: Would you recommend using Belviq in a person on Lipotrol? It could reduce a person’s heart rate.

A: I would not recommend using that drug in somebody on a beta blocker. The only obesity drug I would use in someone with hypertension is orlistat because we just don't have the data yet on the new agents.

Q: A patient should monitor their blood pressure more if they are on one of these agents?

A: Absolutely. You have to remember that sibutramine was on the market for quite a few years, longer than these new agents, and it was removed. That is what happens with drugs. We learn a lot about them after the FDA approves them.

Q: Are people who have had a bariatric surgery trying these drugs?

A: Usually patients who go for bariatric surgery have tried orlistat. The new agents – lorcaserin, phentermine, topiramate – I don't have an answer to that cause we do not have data on that yet.

Q: What do you think about a product like Sensa, which advertises that you don't have to diet or exercise, if you are on it. I think that Sensa is in the exhibit hall here.

A:  I will ask you to taste Sensa and then you can tell me why people don't overeat when they put it on their food. I was just curious about this miracle drug. When you taste your food after you try Sensa there is a good reason why people don't eat too much. So ask them to let you taste it.

Comment: Sensa cancelled it exhibition.

Comment: There was an article in NEJM, “Myths Around Obesity and Weight Loss.” It described a number of very interesting areas. One was the idea that rapid weight loss being unsustainable is a myth.

A: Well I think that in their study they found evidence to support that some individuals are able to retain the weight loss. There is a lot of data out there that conflicts with that study. Studies that looked at the Atkins data found that people who lose over 20% of their body weight in under six months will gain that weight back in under a year. My sense is that people who lose weight in that way they do not have enough time to change their behavior. When I submitted a grant application to the NIH for a six-month intervention, the reviewer said that it was not long enough. So when I resubmit it, I am going to do the intervention for a year. The NIH wants to see interventions that result in sustainable behavior changes and weight loss. The NIH has found that with the other trials it has supported, short-term weight loss is not sustainable. I think that losing weight and maintaining that weight loss is more challenging than stopping smoking cigarettes. It is really tough.

 

Breakout Session: Beyond the Clinic: Tackling Obesity and Diabetes Where They Live

PLANT-BASED NUTRITION FOR THE DIABETES COMMUNITY OF INTEREST

Meghan Jardine, MS, MBA, RD, CDE (Parkland Health and Hospital System, Dallas-Fort Worth, TX)

Ms. Meghan Jardine began her talk with daunting statistics about the prevalence and cost of diabetes that we’ve come to know very well. Ms. Jardine’s hypothesis is that this epidemic is facilitated by our increased consumption of refined carbohydrates – in 1913 Americans consumed an average 40 lbs. of refined carbohydrates per capita; today we consume 152 lbs. per capita, much of it as high-fructose corn syrup. She then helpfully walked the audience through a number of studies and findings from her practice that tout the benefits of a plant-based diet or criticize meat and refined carbohydrates based diets. Among the first of these is the European Prospective Investigation into Cancer and Nutrition (EPIC), which found that each additional 5% of a diet that is filled with animal protein increases the risk of diabetes by 30%. Similarly, the Nurses’ Health Study found that a half-serving of meat a day increases the rate of diabetes by 40% in four years. The mechanism behind this may be linked to carnitine and choline, which is found in meat, eggs and dairy. Both are metabolized by gut microbes into trimethylamine, which is absorbed into the blood stream and metabolized to trimethylamine-N-oxide (TMAO) by the liver, increasing the risk of cardiovascular disease. Finally, Ms. Jardine detailed a 22-week randomized control trial of 99 patients with type 2 diabetes treated 49 patients with a low-fat vegan diet and 50 patients in the control group with a conventional diabetes diet (Barnard et. al., Am J Clin Nutr 2009) where patients in the vegan group achieved a 1.23% reduction in A1C, compared to a 0.85% reduction in the control group. Each group received weekly classes for 22 weeks, with the option of attending biweekly courses for an additional 52 weeks. At 22 weeks, the vegan group lost an average 5.8 kg, compared to the 4.3 kg of the control group. The most notable difference was between the 19% decline in triglyceride levels in the vegan group, where the control group saw no change. We found it interesting that the vegan group had a higher rate of adherence (67%, compared to 44% in the control group).

 

PLANT-BASED NUTRITION AND DIABETES PRACTICE

Dana Armstrong, RD, CDE (Diabetes and Nutrition Support Services, Salinas, CA)

Ms. Dana Armstrong delivered an inspiring talk on the benefits of plant-based diets for diabetes patients by telling the story of her private practice in three patient vignettes. She started by sharing the story of Frank, a state prison investigator of 37 years old with type 2 diabetes and an initial BMI of 51.1 kg/m2 with an A1C of 10.3%. He came to her clinic to avoid starting insulin. Each patient was provided an initial individual assessment, a diabetes education class series, a cooking class series, and diet education (on plant-based, low fat, low glycemic index diets). Since he started attending her clinic, Frank’s BMI has dropped to 44.5 kg/m2 and his A1C to 5.8% (many members of the audience audibly gasped at this). He is on six fewer medications, and has since become a champion for the program’s teaching among his peer circle. Stepping back for a moment to speak of broader patient trends, Ms. Armstrong shared that patients see changes in blood glucose almost immediately, achieve lower blood pressure, lower lipids, weight loss, improved GI function, enhanced mood, and decreased joint pain. Most important is that they feel better and thus are more motivated in their diabetes management.

 

UNIQUE MODELS OUTSIDE THE CLINICAL PRACTICE: REACHING BUSINESSES, SCHOOLS, AND COMMUNITIES

Neal Barnard, MD (George Washington University School of Medicine, Washington, DC)

Dr. Neal Barnard presented how healthcare providers can encourage a plant-based diet in their office, in the workplace, in the community, and in schools. He emphasized the success he has seen with the plant-based diet among adults and children, and encouraged attendees to implement it in their own and their patients’ lives.

  • Dr. Barnard noted that providers don't dedicate time to nutrition, feeling there is not reimbursement for it. Dr. Barnard suggested that educating people on the plant-based diet can be “incredibly efficient” if you conduct group classes in the office waiting room after hours. Dr. Barnard conducted a 20-week trial in the clinic of people on either a vegan diet or ADA diet and is analyzing the data. He noted, however, that patients responded very positively to having providers offer nutrition education.  
  • Dr. Barnard has conducted two trials of the plant-based diet in GEICO offices.
    • The first enrolled 113 people with men and women who had a baseline BMI ≥25 kg/m2 and/or type 2 diabetes at a single GEICO site. People were placed on either an 18-week vegan diet intervention or a control of no intervention. The control group weighed 220 pounds throughout the study; whereas, people in the intervention went from a baseline weight of 217 lbs. to 206 lbs. (Barnard et al., Am J Health Promotion, in press).
    • The second was a multicenter study at several GEICO offices. Enrollees (n=292) had a BMI of at least 25 kg/m2 and/or type 2 diabetes. After 18 weeks, people who received no intervention lost 0.2 lbs., while those who were on the vegan-diet intervention lost 9.5 lbs. (both from a baseline of ~205 lbs.). Additionally, people on the vegan diet with type 2 diabetes had a mean A1c decline of 0.7%, whereas, the control had an increase of 0.1%.

 

PANEL DISCUSSION

Meghan Jardine, MS, MBA, RD, CDE (Parkland Health and Hospital System, Dallas-Fort Worth, TX); Dana Armstrong, RD, CDE (Diabetes and Nutrition Support Services, Salinas, CA); Neal Barnard, MD (George Washington University School of Medicine, Washington, DC); Caroline Trapp, MSN, CDE (Premier Internists, Southfield, MI)

Q: I am a dietician. I hear from a lot of patients who say that it is too expensive to eat healthy. Do you have any side-by-side data that shows grocery bills?

Ms. Armstrong: I think what some of my patients said that it was quite thrifty and inexpensive. That is a great idea. I wonder if I could buy all of that meat stuff and then return it. I don't even go into that part of the store.

Q: How do we access your program?

Dr. Barnard: Let me introduce our curriculum director, who is giving our curriculum to you for free. If you say you were at the AADE meeting, I’ll send it to you for nothing.

Ms. Trapp: Email ctrapp@pcrm.org. Be sure to put “AADE Follow-Up” in the subject-line. That would be for a support group, the other being for Food For Life. In the latter you can come to Washington where we have a program where you leave with the diabetes curriculum.

Ms. Armstrong: Let me tell you that has changed the way I worked. When I applied online, I had to submit a video and I’ve never uploaded anything to YouTube. My video was beans and rice in my crockpot.

Ms. Trapp: The website for that is foodforlifeclasses.org. It’s a competitive process to come to our program. We currently have 150 applicants for 30 spots.

Q: What do you tell your patient who eats only fast foods and doesn't cook?

Ms. Armstrong: Talking about expensive – fast food is expensive. I think the main thing is learning what they are concerned about with cooking.

Dr. Barnard: One option is Subway. You can have the veggie delight and it is the cheapest of the options in the store. Taco Bell you can have them hold the meat and cheese. The Chipotles of the world are pretty easy because they have vegan things. I also encourage people to go into the grocery store and use the salad bar.

Q: No fish?

Dr. Barnard: Fish is now the current thing for people who have problems related to meat consumption, but there are a couple things that need to be understood. While there are Omega-3s, most of the fat in fish is not Omega-3s. For a little bit of Omega-3s, you get too much other stuff. Some people will argue fish is the healthiest type of meat, but it’s nothing like asparagus and broccoli.

Comment: I just want to share what I do surrounding the cost issue. I partnered with the local ethnic grocery stores and we have a starter kit: 11-days’ worth of beans, spices, and vegetables, and a coupon to go to a vegan/vegetarian restaurant. When they see the difference in their health, the cost becomes secondary. Then they know what to buy and how good it feels. You have to twist arms a few times, to get these donations. I work with an Indian restaurant and I have told them that they needed to start donating coupons for my patients, since I helped them with their menu. The whole kit comes out to $15 to $18 for 11-days of food. Most of it is brown rice and quinoa, but it does not have any fruits or vegetables. They have to supplement it with fruits and vegetables.

Ms. Armstrong: Eating vegan is a personal challenge. We need to look at where we are; it is a personal aspect as well. As you think about that, you realize I had bacon this morning. I would encourage all of you to try the 21-day kick start. What do you feel like and where are you at the end of the three weeks? We always put up our disclosures and I wonder if we should have to list our meds as well? I want to find out how many doctors are on Lipitor.

Q: I am intimidated by my own lack of cooking skills – I’m picturing myself talking to my superior about this. I consume a mostly plant-based diet myself, but I feel like we need to give patients practical tools like cooking classes. But if I say host a cooking class, and there’s little enthusiasm, what do you do?

Ms. Jardine: You should look at the 21-day kick starter, it’s easy to prepare and good-tasting. There are also YouTube clips of cooking lessons.

Ms. Armstrong: You should look for a Food for Life instructor in your area.

Dr. Barnard: A plant-based diet changes your health, but it doesn’t change your personality. Your patients might not want to change how they prepare food. When I cook it’s very basic and simple stuff. Overall, plant-based foods are cheaper, for their cost it’s an issue of how much labor goes in.

Q: I think my patients are going to want to know how long they need to do it, in order to know if it works for them?

Ms. Armstrong: I would say within the first three to five days their blood glucose levels drop. What you need to do is have them check before they start. They will see drops in their fasting levels. A lot of immediate feedback happens.

Q: The program that you do twice a year in Washington, when is it?

Ms. Trapp: The next one is in October, and the website can say when the next ones are as they get scheduled.

Q: I am very intrigued over your sole practitioner set up. I would really like to do that. Can you talk a little bit about reimbursement?

Ms. Armstrong: Well that is a story. I set it up as a necessity. I went into a meeting one day at a big organization and they told me that they were eliminating my position. There are reimbursement challenges but as an RD I can bill for medical nutrition classes. I am successful at getting reimbursement. The maximum OOP cost that they will have is $200. I have figured out my costs. Even people who do not have coverage pay for my classes.

Comment: There is an app on your phone for the 21-day kick start.

Q: Do you charge an additional fee to cover the cost of the foods in the cooking class?

Ms. Armstrong: The reimbursement for some of the things is rather surprising in its generosity. I tend to get 12-15 patients a class and the food is not terribly expensive. I do my shopping in the morning. I do have one of my patients of many years act as my sous-chef – who purely volunteered for a year before I paid her anything. I did put in a dishwasher that my landlord split with me. It’s been relatively inexpensive.

Q: Is it worse to kind of do the diet or is worse to do a non-organic plant-based diet?

Dr. Barnard: I would do the diet all the way. You do not want to sort of do it, because you are not going to get the result. At the same time, you do not tell them that they have to do it for the rest of their life. Organic is for extra-credit but I don't usually start there.

Ms. Armstrong: For some patients it feels a little daunting. I tell them that the greater a change they make, the greater a change they will see. I say that two legs is better than four legs, and that no legs is better than two legs, and that no face or mother is best of all. It is over time that they make some of those changes. The more that they do it, the better they feel.

Comment: I just want to thank PCRM. When my husband was put on this diet he had a remission of all of these symptoms, and he’s lost 25 pounds. 

 

Breakout Session: Updated ADA Nutrition Guidelines

UPDATED ADA NUTRITION GUIDELINES

Jackie Boucher, MS, RD, CDE (Minneapolis Heart Institute Foundation, Minneapolis, MN)

The speaker reviewed the latest iteration of the ADA nutrition guidelines issued in 2013, and noted the new information that led to changes from the previous position statement published in 2008. Guidelines for medical nutritional therapy (MNT) placed a focus on eating patterns and not any particular diet. As before, weight loss and physical activity were recommended for all overweight and obese individuals at risk for diabetes. One notable difference was a recommendation for Medicare and other insurance plans to reimburse MNT when prescribed by healthcare providers. The position statement also cautioned against routine supplementation with antioxidants such as vitamins E and C due to efficacy and long-term safety controls. The revised nutrition guidelines will be published in the October 2013 issue of Diabetes Care.

 

4. Mobile Health and Social Media

Breakout Session: The e-Patient Revolution, Personal Health Records, and Diabetes Self-Management Support

THE E-PATIENT REVOLUTION, PERSONAL HEALTH RECORDS, AND DIABETES SELF-MANAGEMENT SUPPORT

Deborah Greenwood, RN, MEd, CDE (American Association of Diabetes Educators, Sacramento, CA); Perry Gee, RN, MSN (University of California Davis, Redding, CA)

President-elect of AADE, Ms. Deborah Greenwood, and Mr. Perry Gee, both of whom went back to school to pursue doctorates, spoke of their research and extensive experience with diabetes management, e-patients, health records, and health informatics.  This talk provided a tremendous overview of these topics, defining a number of terms and topics for the audience. Mr. Gee underscored the critical role of personal health records by reminding the audience of Hurricane Katrina, in which thousands of people were suddenly without access to their medications, and to make matters worse, did not know what medications they were on. In this example, storing health records in an online space would mitigate that element of the disaster. Indeed, while a number of national associations and legislative policies call for expanded use of personal health records (PHRs), the uptake has been less than widespread. Fundamentally, Mr. Perry explained that the goal of data collection in health informatics is to garner wisdom. There are several steps data must move through to reach this stage. And even after data has been patterned into information and then incorporated as knowledge for clinical guidelines, the wisdom of how to apply findings to patients sometimes forget the role of the patient. It is for this reason that Ms. Greenwood and Mr. Gee advocate for a model of collaboration, in which collective wisdom is valued over individual wisdom. Practically, this approach entails facilitating “productive interactions” where patients and HCPs can translate knowledge from data into treatments with more buy-in. At the very end of this session, Mr. Gee and Ms. Greenwood wowed us by reading to the audience a statement that, when read normally sounded like an indictment of the e-patient revolution, but, when read in reverse, read like an affirmation for supporting the e-patient community. Similarly, they called for the audience to reserve their thinking on the topic to embrace the coming revolution.

  • Patients are not widely using personal health records (PHRs). About 7% of adults in the US use PHRs. In California, 15% of patients use PHRs -- presumably because of Kaiser Permanente and school-based medical facilities). Among those with chronic disease, 9% use PHRs. 26% of those using PHRs are supplied them by providers, and 42% those who use PHRs use the platform Epic MyChart.
  • PHRs provide many benefits. The benefits include portability, patient empowerment, the ability for HCPs to send reminders, enhanced patient/provider communication, shared decision-making, preparation for visits, and accuracy checking.
  • However, the barriers to PHR-adoption include patient factors and environmental factors. Patients are less likely to use PHRs if their disease is well-managed (or non-existent), they have to go through an authentication/sign-on process, they have age-related functional issues, they have prohibitively low health literacy/numeracy, or they have concerns about security and confidentiality. Environmental factors challenging PHR-use include a reticent organizational structure, difficulties with PHRs communicating with other established care systems, and educating both patients and HCPs about their use.

Questions and Answers

Q: With respect to telehealth, have you engaged with patients live on something like Skype for diabetes case? Do you require any documentation? Do they have to sign something?

Ms. Greenwood: The technology I’m using does have that capability, but I’m not using it to limit that variable in my research. Other studies do investigate this. We are doing research, so patients do have to sign a consent form.

Q: As a provider, I find the idea of using a lot of patient emails very daunting. How is anyone using this getting reimbursed?

Ms. Greenwood: In our system, the messages go to a pool, where the medical assistant triages them, or scales up to nurse or provider. In our program it comes to the diabetes education pool where it is triaged.

Mr. Gee: They are in the process of working on reimbursement. Kaiser and other like groups give their providers a day off to respond to email. Many places give their providers 24 hours to respond.

Q: My patients, especially from mental health patients, might email me seven to eight times a day. I can get reimbursed, but I have to respond to those by mandate. How do you handle that much email?

Mr. Gee: I don’t have the answer to that, but I have heard of providers who talk with their patients about the proper way to form emails to them.

Q: With all of that business, do you have practical suggestions for what the provider can do to synthesize the information? We’re getting application after application – I can download 20 apps on my iPhone. Do you have any tips for us to help our patients?

Ms. Greenwood: On a more global answer, talk to WellDoc, because that’s what they’re trying to do. Maybe next year I’ll have better information.

 

Breakout Session: Mobile Applications and Glycemic Control

MOBILE APPLICATIONS AND GLYCEMIC CONTROL

Richard Katz, MD (George Washington University Medical Center, Washington, DC)

In a talk that provided a comprehensive introduction to mobile health (mHealth), Dr. Richard Katz defined mHealth, provided examples of its function, and reviewed evidence on its efficacy for supporting disease management. Broadly defined, mHealth is the application of personal communication and information technology to healthcare. It can function through many platforms, such as basic cell phone text messaging, smart phone applications, and dedicated devices (like the Fitbit). A meta-analysis on the effect of mobile phone interventions on glycemic control, mHealth interventions trend toward reductions in A1C, but there are few good RCTs to substantiate this claim further. One such example could be found in a cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control, in which 163 patients ages 18 to 64 with type 2 diabetes with a baseline A1C greater than 7.5% were randomized to either a usual care group or a group with access to a coach, virtual portal to access their physician, and a decision support program that sent automated, real-time educational and behavioral messaging in response to cell phone glucose, medications, and lifestyle behavior (Quinn, et. al., Diabetes Care 2011). At 12 months, those patients in the usual care group achieved a 0.7% decline in A1C, compared to the 1.9% decline in the coach/portal/decision support group. Looking at the field of mHealth as a whole, Dr. Katz believes we are still in “Version 1.2,” but that Version 2.0 is not too far away.

  • Dr. Katz covered the potential benefits of integrated mobile health systems to HCPs and patients. For HCPs, mHealth apps can provide clinical decision support, access to real time clinical data, pattern analysis and recognition, and improved adherence to evidence-based guidelines. Potential benefits of integrated mobile health systems to patients: improved treatment adherence, frequent reinforcement of treatment goals, improved patient understanding of the impact of behaviors on diabetes control, education resources, and reminders.
  • Currently mHealth can work in many directions between patients and HCPs. They can be unidirectional, in which case a cell phone might provide a reminder for the patient, bidirectional, in which a patient phone and healthcare team independently interact with each other through a server, or multidirectional, in which an Electronic Medical Record facilitates many different levels of interaction between the data, patient, and HCPs.
  • There are a number of challenges to mHealth as well. These factors include patient literacy with phones, software factors (ease of use, forgetting passwords, keeping the program fresh for adherence), support staff factors (training, running helplines), and primary care provider factors (Dr. Katz argues that you need a champion for using mHealth in the clinical setting).

Questions and Answer

Q: I think the big challenge here is the lack of a national system. How do we communicate with people in other systems? The other issue you didn’t mention is HIPPA, which also makes this work challenging.

Dr. Katz: The first thing, called Health Exchange Technology, is a major problem. You can use many of these tools independent of EMR, but that makes the workflow messy. And when you have outside groups like homecare it’s a real challenge. With respect to HIPPA, I think it will get easier. The other area is the FDA – that’s a mess. mHealth could be informative, or it could be prescriptive. Many companies don’t even want to touch prescriptive parts, in part because of the need for updates. Little companies don’t have the money to go through FDA approval.

 

Workshop: Current Apps for Diabetes: Embracing the Technology at Your Fingertips

THERE'S AN APP FOR THAT?

Molly McElwee, RN, CDE (University of Virginia, Charlottesville, VA)

Ms. Molly McElwee began her session with a somewhat unusual request: “Please turn your cell phones on.” She noted how important technology is becoming to healthcare management and suggested that to improve patient and HCP technology competency, clinics could hold an open house where people can ask technology-based questions. She outlined the four evaluation points of a patient acceptability scale (based on the DCCT) that a technology must pass: verification, validation, human factors assessment, and clinical assessment (Lehmann, Diabetes Technology & Therapeutics 2004). She especially emphasized that a technology will fail if it does not pass the human factors assessment (which encompasses usefulness, intention to use, and ease of use). She noted that, more and more, this applies to apps, highlighting the fact that 91% of the population currently uses an iPhone (Editor’s note: according to a 2013 Pew Internet survey, 56% of American adults use smartphones). Cells phones have been shown to provide clinical results, with one study demonstrating a 1.5% decrease in A1c levels after a six-month use period of a cell phone-based platform (Noh, Diabetes Technology & Therapeutics 2010). After providing a convincing argument on why technology is more and more important for diabetes management, Ms. McElwee gave an overview of, what we counted to be, 12 apps. She noted that she had downloaded most of them to both an iPhone and an Android and had tested most in-depth. She also noted that most apps can be exported into a CSB file (humorously adding that “it’s not hacking – we’re researchers”). We were especially impressed that Ms. McElwee gave her email to the audience and encouraged the group to email her with opinions on any diabetes apps.

  • Ms. McElwee highlighted SweetSpot diabetes and Diasend as platforms to upload data. She listed the impressive number of devices that both programs are compatible with, particularly emphasizing Diasend’s ability to sync with the OmniPod through its PDM number. Ms. McElwee also noted that SweetSpot is the only cloud-based program approved for use by the VA hospital.
  • Ms. McElwee highlighted the following apps for patient use:
    • Diabetes WaveSense (tracks carbohydrate intake, blood glucose levels, and insulin dose; includes notes section): Ms. McElwee highlighted that this had been rated the most user-friendly in an app study. Results on the app are easy to share, and data (seven to 90 days) can be shared with clinics and hospitals.
    • iBGStar (tracks carbohydrate intake, blood glucose levels, exercise, and insulin dose; includes notes section): The app also integrates with the Sanofi iBGStar meter, and records can be easily emailed. Patients also have the option to tag blood glucose readings with notes.
    • dLife (tracks blood glucose levels, carbohydrate intake, insulin dose, and exercise; includes food database and notes section): Ms. McElwee stated, “I love this app.” The app gives specific exercises for patients to input, and the patient can specify their insulin type. Additionally, there is a Q&A that links to an online community – although we agree that not all online information is completely accurate, it is very valuable to have a support community connected to an app.
    • Diabetes Pal (tracks blood glucose levels, A1c level, nutrition, medication, weight; analyses blood pressure): Ms. McElwee called this app “fantastic.” It works with the Telcare meter and requires no extra entry. Patients can document their specific medication dose.
    • My Glucose Buddy (tracks blood glucose levels, medication, food, and exercise) is more commercial and has more pop-ups. Although the app has added benefits of weight and blood pressure tracking, the pop-ups may become a deterrent for some patients.
    • Other apps Ms. McElwee recommended: Pancreum IOB calculator (calculates IOB and correction bolus); Pancreum Insulin to Carb Ratio (calculates insulin to carbohydrate ratio); MedSimple (searches cost-saving medications; includes a medication reminder; ability to email reports); MedCoach (refill online with most pharmacies; includes medication and refill reminders).
  • Ms. McElwee also highlighted apps that are useful for caregivers including the Dexcom app (includes system-use refreshers, video tutorials, and information on troubleshooting), My Medtronic (includes an option to save pump settings, video tutorials, information on troubleshooting, and travel checklist; ability to order supplies), My Care Connect/Blue Loop (ability to send email and text alerts to caregiver), Glucagon App by AADE (includes video tutorials, location information for kit; useful so that patients do not get overwhelmed).

Questions and Answers

Comment: I write for a blog called Blood Sugar Whisperer, and I have a few more apps to recommend. One app I have been using for about the last year or so after I went off my pump and lost my bolus calculator. The app, RapidCalc, is a bolus wizard for the iPhone. This is a good one for people who are not mathematically inclined – which is, essentially, everyone. This app does cost a $7.99 one-time fee. If you want more information before you buy the app, there is more information at the website gilport.com. The site has images and FAQs. The other app is BG Monitor Diabetes for the Android. This is also a bolus calculator and looks at factors like the carbohydrate ratio and insulin on board. Both of these apps are created by people with diabetes.

Q: I use a Medtronic pump and was recently on their website looking at their app. Their site says that it is not yet available for the Android. I emailed asking when they were coming out with an Android version, but I have not gotten response, yet.

Ms. McElwee: At the time I was writing this, I checked that the app worked on both the iPhone and Android.

Mr. Gary Scheiner (Integrated Diabetes Services, Wynnewood, PA): Can you tell us anything about the record keeping systems that are on apps? Which apps generate the best report?

Ms. McElwee: It depends what you are looking for. I would not suggest iBGStar. I really like the reports from GoMeals by Sanofi. In general, the reporting from apps are for patients with type 2 diabetes. I think the reports for patients with type 1 diabetes have a larger variety than patients with type 2 diabetes, such as pump downloads. I would also suggest Diabetes Wave Sense.

Q: Could you go over again what you said about the OmniPod and downloads?

Ms. McElwee: You can download using Diasend. If you are going to download the Insulet OmniPod pump, register it as a meter under Freestyle. There is a 12-digit number on the OmniPod, and if you put that in, it will say ‘connect your device.’

Q: Does Diasend collect the carbohydrate and bolus data, as well?

Ms. McElwee: It gets everything, and you can export the data from there. It will export CSB files. If you do not like the format you are seeing, let’s talk. You can email me at artificialpancreas@virginia.edu or get in touch with me via twitter at @mollymac.t1d. I can also be reached on LinkedIn. I would love to keep in touch with everyone and hear what works what does not work; I am always looking for new ideas.

 

NUTRITION APPS FOR DIABETES

Marisa Moore, MBA, RDN, LD (Marisa Moore Nutrition Communications, Atlanta, GA)

The session began with Ms. Moore asking the audience to write down three words that come to mind when they think of the word app. The audience did a comprehensive job, coming up with fun, easy, cumbersome, free, too many, and essential. Echoing what Ms. McElwee discussed, Ms. Moore noted that nutrition apps for diabetes are great for carbohydrate counting, food and activity tracking, meal planning, and eating out. Although Ms. Moore was very positive about the nutrition apps, she also acknowledged that challenges remain, including lack of evidence that these apps are clinically effective and the fact that there is no formal regulation process. Although the FDA is beginning to regulate medical apps, they have not yet turned to health apps. To make sure that HCPs are recommending safe apps, Ms. Moore suggested that the audience look to see if HCPs helped to develop the app, and that the audience try the program themselves. While Ms. Moore emphasized that no app will ever replace HCPs, she also challenged the audience to improve and create new apps to further improve what is already available. 

  • Ms. Moore highlighted the following nutrition apps:
    • MyFitnessPal (track exercise, food intake, and water intake): she stated, “You absolutely want to become familiar with this app.” Ms. Moore noted that MyFitnessPal has a larger food database than other similar apps (such as Lose It! and Calorie Counter Pro).
    • Carb Counting with Lenny (tracks carbohydrates, educates users): Although originally designed for kids, Ms. Moore stated that the app is good for educating patients on how many carbs different foods have.
    • Fooducate (grades foods): The smartphone scans barcodes, and the app gives a grade. Ms. Moore noted that there is also a Fooducate DM ($9.99) that takes into consideration how food might impact blood glucose levels. If there is a food that is high in carbohydrates, it recommends a lower carbohydrate option. She remarked that this is one of the best apps for packaged foods.
    • Diabetes Companion (finds recipes and foods): An app with intuitive navigation, Ms. Moore stated that it was one of the most comprehensive apps. It also has over nine thousand diabetes-friendly recipes.
    • Other apps Ms. Moore recommended: CarbMaster (tracks carbohydrates), Lose It! (tracks weight, food, and exercise), Calorie Counter Pro (tracks weight, food, exercise, and water), ShopWell (grades food), GoMeals (tracks food, activity, water, and blood glucose levels), iCookbook Diabetic (provides recipes), My Glucose Buddy (tracks blood glucose, medication, food, and exercise), Diabetes WaveSense (tracks carbohydrates, blood glucose levels, insulin dose; includes a notes section).

 

 

PANEL DISCUSSION

Molly McElwee, RN, CDE (UVA, Charlottesville, VA); Marisa Moore, MBA, RDN, LD (Marisa Moore Nutrition Communications, Atlanta, GA)

Comment: I use MyFitnessPal, and one unique aspect of the app is that it syncs with other apps and devices. If you have a specific scale where you weigh yourself or your patient, the MyFitnessPal can sync with the application. Additionally, other workout apps will also sync with MyFitnessPal.

Q: I’m interested in making some apps. But I certainly don’t know how to make an app…

Ms. Moore: I would start with AADE. They would have those connections that are most relevant for you.

Ms. McElwee: There is a COI through AADE. It’s not the easiest process I’ve ever seen, and it can be kind of expensive. You’ll want to have some backing before you get started.

Comment: Another nutrition app I would recommend is Restaurant Nutrition. It’s free and available on iPhone and Android.

Moore: That one is great, as is Healthy Out.

Q: I’ve been trying to try out a few apps myself. I notice that with exercise, there is a big difference when reporting back calories. How do you know what is accurate and what isn’t? One app says 2,000 calories for a two-hour bike ride, and another says 1,400.

Ms. Moore: That is a problem across the board. The best thing is to estimate it, and I always just go with the smallest margin of error. If I did a bike ride, I’m probably not burning 2,000 calories. Also, put in all accurate information. The default information may not apply to the actual person using it.

Q: What are your thoughts on the Calorie King app?

Ms. Moore: It’s another good one. I usually use the online version. If you are using MyFitnessPal, it’s the same as Calorie King – they both pull from the same back-end platform, ESHA, or the USDA database.

Q: I work in a pediatric endocrinology practice. We were stopped from using programs from our IRB because we didn’t have business agreements with the company – in this case Medtronic. What do you suggest if your institution is cautious about using apps to communicate?

Ms. McElwee: That’s true. I work with IRBs all the time. What you need is a Materials Transfer Agreement. It’s easy, but a lot of paperwork.

Q: MyFitnessPal uses crowd sourcing, meaning that people can put their own data and information in. Sometimes you will search and it will pull up seven or eight foods. What do you trust?

Ms. Moore: I would treat it just like Wikipedia. I wouldn’t trust it. The information you get from oatmeal, however, should come from the USDA database. It hasn’t been a problem in my experience. It does have a barcode scanner as well. [Editor’s Note: We would counter that some studies have shown that Wikipedia is more accurate than traditional encyclopedias – not that encyclopedias are what we would recommend as sources either! In this case, we agree that the USDA database makes the best sense! While caution is always prudent, James Surowiecki points out in The Wisdom of Crowds that the power of crowdsourcing is not to be underestimated, however.]

Ms. Malinda Peeples (WellDoc, Baltimore, MD): Good job of distilling what’s going on out there in the mobile health space. I would like to share with the audience about what I’m working on with WellDoc. We are building a clinical and behavioral platform. We have just introduced a mobile prescription therapy [BlueStar; see our report at http://close.cx/WellDocBlueStar]. It’s had a soft launch this year and will have a national launch next year. It provides patient coaching and provider decision support. I think the next-gen is coming. Our strategy is to build a growing body of evidence, but that’s still pretty small in the field. Another part is FDA clearance – any of these apps that are really involved in the treatment and mitigation of a disease must be cleared by FDA. If you are interested in building apps, the mobile guidance app from the FDA might be something you want to look at. Happtique has also put together standards around evaluating mobile technologies. And if you want to get smarter about the whole space, go to the mHealth Summit in December – that’s a conference you might think about attending, especially for those wanting to do app development. That includes vendors, researchers, and technologists.

Q: I’m a dietician at a small hospital. I’ve been using MyNetDiary. It tracks exercise, water, and food. Then, things are graded on nutritional content. I didn’t see that mentioned.

Ms. Moore: I listed that one along with MyFitnessPal and Lose It!

Q: Calorie King has a feature that allows patients to create a meal. Then, they know what they’re doing before they go in.

Ms. Moore: Most of the fast food restaurants have apps. You can build a meal and see where you are with the carbs and calories and fat. That’s not saying it’s always going to be a great outcome, but you can find things on the go.

Ms. Allison Nimlos (Author, The Blood Sugar Whisperer, Westchester, NY): As probably one of the youngest people in the room, I can say I’ve used a lot of apps. For MyFitnessPal, I just have a comment on the accuracy of the food data. When you are looking up an item, there are confirmations that folks can input as a self-policing feature. That helps make sure the items you are choosing are accurate. One might have zero confirmations, while another might have 37 confirmations. It’s likely that many people have looked at that one and compared the nutrition label to make sure it is accurate and complete. Another feature of MyFitnessPal that I really like is the website – if you are cooking, it allows you to build recipes and divide by the number of servings. So for lasagna, if you are using something out of cookbook, you can put the recipe in and divide by six or 12. It’s invaluable I think. A lot of people like to eat processed junk food because it has a nutrition label on it. That’s the last thing we want people with diabetes to be eating. Regarding the accuracy of calories for exercising, remember that a lot of the stuff we’re getting number-wise is not accurate anyways. Nutrition labels on foods have a margin of error; blood glucose meters have a margin of error – everything is going to have a margin of error. I wouldn’t be concerned about whether it is precisely what I’m doing. If it gives you a general sense, that’s really why people should be using this. Like a CGM it helps you track the trends.

Ms. Moore: Very well said.

Ms. McElwee: One other thing with MyFitnessPal is there is no time stamp with a meal. However, there is a notes section and that will give it a time stamp. You can also export to excel with MyFitnessPal.

Comment: Excellent presentation on the last hour of a Saturday afternoon. It was terrific. I haven’t wanted to stay until Saturday afternoon of AADE in a long time. An app I’ve been using is SuperTracker. It’s really for diabetes educators – they have micro and macronutrients. It’s a good site, but it’s somewhat complicated. However, it’s worthwhile for diabetes educators.

Q: MyFitnessPal also helps people because they can connect with other people. Many use it for weight loss. Research has shown that the support from social media helps people. “You haven’t tracked in three days; how’s it going?” That social aspect also allows you to congratulate people. That can help people.

Ms. Moore: That’s also one of the privacy issues. Sometimes people want that, and sometimes they don’t. That makes me think of something else – when dealing with diabetes, it’s not just about food and nutrition. It’s about meditation and keeping stress at bay. There are apps that help you sleep at night, meditate, exercise, pedometers that are active on your phone, Nike Training Club; it’s not just about food.

Q: I want to bring up the mental health component. One app is MoodPanda; it’s one of my favorites. It allows you to track mood on a numeric scale, and you can comment next to it. You can then look at the trends in your mood and identify what times of the day you are feeling worst or best. We all know the effect of mental health on blood glucose. And it has the built in online support system. I’ve found it to be really helpful.

Ms. McElwee: MoodPanda is awesome. My husband swears that I am incredibly belligerent when my blood glucose is low. So we tested it on MoodPanda. And he was right. When my blood glucose is low, I’m not a nice person. [Laughter]

Comment: One thing I love is the Fitbit. It is very motivating. When I wake up, it says, “Hi Cynthia, let’s get walking.” Once a week, it sends you a record of how many steps you’ve walked. “You’ve walked up Mount Everest!” It also syncs using Wi-Fi and with MyFitnessPal.

Ms. Moore: Another one people use is Jawbone.

 

Workshop: Diabetes Best Practices and Technology

DIABETES BEST PRACTICE AND TECHNOLOGY

Irina Sigal, RN, CDE (Montefiore Medical Center, Bronx, NY)

Ms. Irina Sigal opened our eyes to the current health issues in the Bronx, NY. She reported that 13% of the 1.4 million residents have diabetes, at the same time that 30% of residents and 43% of children live below the poverty line. Additionally, 80% are on Medicare/Medicaid, 15% are uninsured (2010), and their hospital, Montefiore has the second busiest Emergency Department (ED) in the nation (over 300,000 emergency department visits per year). The hospital was able to implement a Telehealth monitoring system in 2005 that drastically cut costs and improved patient outcomes. The device guides patients to measure weight, blood pressure, heart rate, pulse oximetry, and blood glucose on a daily basis. Average A1c declined by 0.9% from a baseline of 8.5% over 6-12 months, with an additional 0.6% reduction seen to date. Impressively, the system only costs $100-120 per patient per month, and it is currently covered by New York Medicaid and some private insurers (though not by Medicare); however, Ms. Sigal was optimistic, “Ideally, I see hospitals giving patients telemonitoring devices because they will then be connected to someone and this will improve adherence and patient services.” We think the results are quite impressive, especially in a low-income population, and it’s great to see that the Telehealth program has reimbursement.

  • Diabetes is the fifth leading cause of death in NYC as reported in 2011. Of the five boroughs, the Bronx has the highest prevalence of diabetes: one in every eight adults. The annual cost of NYC hospitalizations with a principal diagnosis of diabetes (a small portion of diabetes-related costs) doubled from 1990 to 2003, reaching $481 million. More details are at http://www.nyc.gov/html/doh/downloads/pdf/epi/diabetes_chart_book.pdf.
  • The Telehealth home monitor is a device that guides patients through a series of steps to measure weight, blood pressure, heart rate, pulse oximetry, blood sugar, and customized clinical questions to assess how the patient feels. The graphic screen is large and intended to be very simple and easy to use. The device costs $100-120 per patient per month.            
  • In patients using the Telehealth system, average A1c declined by 0.9% from a baseline of 8.5% over 6-12 months; to date, average A1c is now down another 0.6% to 7.0%. Patients’ comments expressed gratitude for the system and the additional assistance, education, convenience, and improvement provided by the program.
    • The Telehealth program was established in 2005 with only 50 patients – that number is now up to 120 patients currently. Twenty-seven percent of the patients have heart failure, 13% have diabetes, 52% have heart failure and diabetes, and 8% have hypertension or other CV diseases. The average age is 72 years.
    • The Telehealth Program’s initiatives include education, monitoring, scheduling follow-ups, increasing patient encounters, complex case presentations, specialty treatment groups (e.g., for heart failure and diabetes patients), and Telehealth monitoring. In 2012, the MHHA Telehealth Program was nominated by The New York State Home Care Association as a champion program of the year.

Questions and Answers

Q: I know Medicare used to cover a machine like that for people with congestive heart failure. What if someone only has Medicare – can they use the device?

A: Unfortunately, Medicare does not cover this, but often the organization will still do it because it has decreased the rate of hospitalizations.

Q: Did you have a psychiatric nurse on your staff?

A: No, but we have a strong social worker team who trains in dealing with social and psychiatric problems. We try to contact the PCP and then refer patients to psychiatrists or behavioral professionals.

Q: Does private insurance cover it? Medicaid is a state program. New York covers it, but do other states? Do you have a cost estimate?

A: Yes, of course. We are paying for these devices at, I would say, $100-120 per patient so it is not significant. The device for transmitting blood sugar is significantly cheaper. If you are touching only the scale, it is only $50-60. If you check blood pressure and pulse oximetry, then it is $100-120 per patient per month. We hope other insurance companies will fund this and some private organizations do. In the future, ideally, I see hospitals giving patients telemonitoring devices because they will then be connected to someone and this will improve adherence and patient services.

 

DIABETES BEST PRACTICE AND TECHNOLOGY

Patricia Farrell, MSN, RN, CDE (Montefiore Medical Center, New York, NY)

Patricia Farrell spoke about innovative software tools to facilitate lifestyle modification and outpatient care for patients with diabetes, using firsthand experience from Montefiore Medical Center’s tools. Montefiore’s software tool for outpatient care in patients with diabetes featured relevant information on each patient, categorized into health profile, educational goals, dosage history, and patient health questionnaire. Combined with the AutoLink monitoring device, the telehealth program at Montefiore has been effective in increasing patient knowledge, reducing hospitalizations, and improving glycemic control. In addition, the presenter introduced the MedAdherence Diabetes Pilot program based in Louisiana and California, which helps engage patients with mobile phones. The pilot program, set to begin in September 2013, will enroll 100 patients across 3 sites, with the intent to improve A1C reduction as well as increase eye and foot exams.

Questions and Answers

Q: Do you have a way to help figure out which specific factors contribute to the improved outcomes or is it a holistic approach?

Ms. Farrell: No, we don’t know. I think you need all of the components to have a good program.

 

Pre-Conference Course: Social Media for Diabetes: Step Up to the Genius Bar

INTRODUCTION

Amy Tenderich (DiabetesMine.com, San Francisco, CA)

Star blogger and Editor in Chief of DiabetesMine.com Ms. Amy Tenderich opened the preconference session with the note that the session could be live-tweeted with the hashtag #AADE13Genius. Over the following several hours, a number of the room’s participants and panelists took advantage of this suggestion, such that Ms. Hope Warshaw, MMsc, RN, CDE (Hope Warshaw LLC, Alexandria, VA) at one point poked fun at the entire panel for being on their phones during her talk. Ms. Tenderich encouraged all the participants to use the session to think about their social media goals, what specific objectives they want to accomplish by use of various tools online. The deluge of information and never-ending collection of platforms that facilitate social media engagement make goal-setting a critical priority. She then placed social media into three buckets: patient-driven social media, HCP social media presence, and social media for the use of professional development. With this framework, she passed the baton to the remaining panelists.

 

STATE OF THE SOCIAL MEDIA UNION

Manny Hernandez (Diabetes Hands Foundation, Berkeley, CA)

Mr. Manny Hernandez began his address by asking what benefits patients derive from engaging online. He stated that the primary benefit to patients is that they can offer and get support. Aside from this, patients often use social media to increase their knowledge. Mr. Hernandez then presented data to highlight the rise of social media use among patients with diabetes. He also shared with the audience the international extension of these online communities, presenting the popular weekly tweetchat #DSMA alongside #GBDOC (for the English diabetes online community) and #OzDOC (for the Australian diabetes online community). Particularly standout was his mention of the Diabetes Hope Conference, a series of sessions hosted entirely online using video chat. He ended the session with the assurance that the state of the diabetes social media union is strong, but that it needs more users like the educators in the audience to continue being a valuable space.

  • Social media use is increasing in the diabetes online community. In 2011, 230,000 Facebook profiles ‘liked’ diabetes. By 2013, this number had grown to 2.4 million. Between 2011 and 2013, the membership registries across three online diabetes communities grew 66%. Participants in Diabetes Blog Week increased 48% from 2010 to 2013, from below 150 to over 200 participants.
  • The diabetes online community is still disproportionately type 1 centric. Mr. Hernandez spoke of noticing a visceral increase in type 2 users, but acknowledged that type 1 users remain the majority. He did make the cautionary note that this finding might over-represent the proportion of type 1 users, as type 2 users are less likely to identify themselves and their type of diabetes online for fear of stigma.
  • Self-correction is a key theme of the diabetes online community. When any utterance that makes a strong claim is touted as fact, the community will jump to identify this. It is important to have a humble position and rigorously self-correct when engaging with the community. This is important to earn respect from medical professionals, address misinformation from patients, and identify and reject quackery.

 

PATIENTS AND SOCIAL MEDIA: THE RESEARCH

Hope Warshaw, MMsc, RN, CDE (Hope Warshaw LLC, Alexandria, VA)

Ms. Hope Warshaw introduced her website, blog, Twitter, and Facebook pages with a series of cyclical arrows between the platforms to underscore the point that social media is a 360-degree space, where everything one does pushes to and pulls from the space. Prefacing her literature review, she quoted Dr. Edwin Fisher of the Peers for Progress initiative from his ADA 2013 talk, in which he said, “Humans have a fundamental need for support and social connection.” While various verify the role of social media in peer support and patient validation, Ms. Warshaw asked what proof there is that social media improves outcomes, such as A1c and blood pressure. To this she says there are no answers yet, but the research is being conducted, the data accumulating. Of the research there is, she did acknowledge that it seems social media helps patients make more informed treatment decisions, manage symptoms more effectively, and cope better with the side effects of treatments (Wicks et al., J Med Internet Res, 2008).

 

ENGAGEMENT GUIDELINES: DOS AND DON'TS

David Edelman (Diabetes Daily, Cleveland, OH)

In a very humorous talk, Mr. David Edelman shared a list of several tips for engaging with social media. Reiterating Ms. Tenderich, Mr. Edelman underscored the importance of establishing and focusing on goals – otherwise, social media can be an incredible time sink. Next, it’s important to be authentic by speaking in your voice, interacting as you would in a professional space in person. Mr. Edelman then strongly encouraged users to observe before participating, citing some horrific faux pas made by those in the media. While not all social media must be entertaining, he thinks it is very important not to be boring. In this way, he uses the litmus test of whether he would find what he is posting interesting. To Mr. Edelman, the key to self-promotion is being a giver online by praising and supporting others, being helpful where there is a need. He also encourages first-time users to be consistent with their usage, and invest time in learning what works by seeing what they like from others’ posts. That said, Mr. Edelman has found that top-10 lists, motivational quotes, affirmations, little-known facts, highlighting heroes, and posts that juxtapose good with evil tend to do well. On a more serious note, he strongly encouraged the participants to respect ownership and give credit to wherever content is found. Because the audience was mostly professionals, he advised them to monitor their online presence to see what others are saying about them, good or bad. To close his helpful list, Mr. Edelman said it is most important to experiment and learn from social media.

 

Hope Warshaw, MMsc, RN, CDE (Hope Warshaw LLC, Alexandria, VA)

Ms. Warshaw once again took to the podium to cover another topic many social media users tend to be concerned about. At the outset, she encouraged participants to ask their institution or employer if they have a social media policy. Aside from this step, it is advisable as a general practice to respect patient privacy, employer risk, and otherwise generally-accepted ethical and legal standards. She then shared the Mayo Clinic’s very elegant 12-word social media policy: “Don’t lie, don’t pry, don’t cheat, can’t delete, don’t steal, don’t reveal.” While it is important to respect ethical and legal concerns, Ms. Warshaw and the rest of the panel strongly emphasized that the participants ought not let these concerns stop them from engaging with social media.

 

UP AND COMING: PLATFORMS TO WATCH

Amy Tenderich (DiabetesMine.com, San Francisco, CA)

Ms. Tenderich closed the session by looking at the horizon of social media, to help program participants prepare for the next wave of platforms, applications, and trends. She told the audience to keep an eye on four social media tools: Pinterest, a platform that acts as a virtual pin board for items like recipes or images; Instagram, a tool similar to Twitter for its use of hashtags with image-sharing; Twitter Vine, an application composed entirely of shared six-second videos; and Google+, the social media arm of Google. From these she surmised that visual content will continue to play an important role in social media, explaining that her writing-focused site will often pair article titles with interesting images on these platforms to draw users in. She then encouraged the audience to familiarize themselves with diabetes mobile applications. While not technically social media, apps also let patients mediate their chronic illness with technology. Important in this category are diabetes-specific applications like WellDoc, as well as more generally-focused lifestyle apps like Lose It! and MyFitnessPal.

 

PANEL DISCUSSION

Amy Tenderich (DiabetesMine.com, San Francisco, CA); Hope Warshaw, MMsc, RN, CDE (Hope Warshaw LLC, Alexandria, VA); David Edelman (Diabetes Daily, Cleveland, OH); Manny Hernandez (Diabetes Hands Foundation, Berkeley, CA)

Questions and Answers

Q: If you were to run a Facebook contest and the users agree to release stories, does it violate HIPAA to share them?

Ms. Warshaw: Being that you’re wearing a shirt from Tandem, you’re probably not interacting in a clinical environment, and so have a different set of obligations.

Ms. Tenderich: If you’re doing it as an educator, I would take the precaution and get them to sign an agreement using a template easily obtainable online. You also want to keep the email trail in case anything comes up. On my website we share stories, and there have been cases where people go back and no longer want their stories shared.

Mr. Hernandez: On the Big Blue campaign, even if their image is in the video or anywhere in the content, we had them sign a release. There are apps for this now to obtain a release.

Q: I’m a pediatric diabetes educator. At times we’re tearing our hair out with preteens and teens, and with some of the younger parents with younger kids. Kids and young adults are very savvy on the web; do you have websites or Twitter sites that I can send these kids to that are safe?

Ms. Tenderich: There is Type One Teens, an online community. There’s College Diabetes Network, and TypeOneNation, which is run by JDRF. The next wave will be Instagram and Tumblr. At those places, they’re not necessarily learning about clinical care, but it’s a great place for teens to feel like they’ve found a home.

Mr. Edelman: Those sites are not moderated; those are just people living with diabetes sharing their stories.

Ms. Tenderich: The community sites I mentioned are more moderated, and have richer content. But in terms of just finding other teens that are walking in their shoes, Children With Diabetes is good.

Q: What about some game-type sites, for younger children who are just starting out?

Ms. Tenderich: The Sanofi folks have been making a big deal of their Medikidz series, which is also online I think. Lilly is publishing these Disney books. There are some online games such as Jerry the Bear, which was one of the winners of our Diabetes Mine competition.

Ms. Warshaw: You should ask what the kids are engaging in, and what they’re finding helpful. The other point I would add is that there are a number of mom and dad diabetes bloggers. There are books that have been written by several of these people.

Ms. Tenderich: There is a new book called Raising Teens with Diabetes. It is extraordinary.

Mr. Edelman: I would want to do an informal study asking where patients go for support, what sites they like and what they don’t, and just compile and share that. It doesn’t need to be rigorous.

Ms. Tenderich: That would be great information to share on your blog.

Mr. Hernandez: There is another resource called Diabetes Advocates: a number of us here are participants, and it is a vetted process and approval process where we examine the site and the content on it. Things are categorized there by diabetes type, age, language, and other categories. It’s a good starting point for exploration. It’s at diabetesadvocates.org.

Q: Speaking from the point of view of a part-time clinical nurse, my question is, where is your income coming from if you focus on social media?

Ms. Warshaw: I think that once you jump into this, you may pick out one platform that you choose initially. Think about it as baby steps, and setting those smart goals, just like we encourage our clients to do. Do you want to first engage in Twitter, for example? It only needs to be ten to fifteen minutes a day. I wouldn’t think of this as a revenue stream: it may be something you engage in to promote your private practice. It’s important that you set your goals, bite off little pieces, and see what your return on investment is. Does it feed your professionally? Does it feed your practice? Does it feel you personally?

Ms. Tenderich: There have been stats that show that you can really grow your practice if you get the word out. And if you’re looking for speaking opportunities, or opportunities for paid blogging or getting paid for articles, you can use social media to make those connections. But it’s certainly not going to make money right away.

Q: Do you have any advice about communicating to providers and physicians? Can we use social media to connect with physicians?

Comment: I was going to say that the conversation about how professionals can work with social media was a topic at this year’s Friends For Life, and the talk is available on social media.

Q: We keep hearing that AADE is going to promote us diabetes educators. We need a way to get our names out there.

Ms. Warshaw: This is me putting my Board of Directors hat on: you are going to hear a lot in the next couple days about a brand new public awareness campaign about diabetes educators, promoting who we are and what we do. It is in early stages, it is a multi-year program, but the organization is putting a significant amount of energy and dollars into this effort.

Q: Today we’ve been talking about social media as it relates to diabetes. Do you interact with any other chronic illness groups?

Mr. Hernandez: There’s an e-patient movement underway. I would say diabetes, because it is a chronic condition and its incidence, is at an advanced stage in social media participation and engagement. Similar communities exist for breast cancer and rheumatoid arthritis. The Society for Participatory Medicine is another hub to connect with.

Q: In terms of your individual experiences, can you give me one challenge you face using SM to address diabetes?

Mr. Hernandez: The biggest challenge for me is how to make social media a welcoming place for patients with type 2 diabetes. I think the reasons for why it isn’t aren’t related entirely to social media, but there’s more work to do here.

Ms. Tenderich: I would agree. How do you reach people who aren’t active online to show them these resources? We think about how to connect with people in the offline world, where care providers like you are so important. We hear stories all the time of patients hitting rock bottom, and only then finding these communities where there are people like them.

Mr. Edelman: There are so many people out there with diabetes whose voice isn’t being heard. So the challenge is how you get these people to speak out, even politically. A patient should never have to choose between insulin and food.

Ms. Warshaw: A challenge for me as an educator is how to help other educators see the value of helping people with diabetes and their caregivers engage in the diabetes online community to improve ease of managing their care. That’s been really fulfilling for me.

Ms. Tenderich: As a technology enthusiast, I was shocked there was so little patient voice from everything including how industry produces products to how they’re regulated. Our advocacy soapbox is how to get patients heard. With healthcare plans, we ask how they gauge what outcomes matter to patients. Healthcare engagement is a new term and we’re still figuring out what it means.

Q: What are the top five hashtags we should be following?

Mr. Hernandez: #DSMA, #diabetes (which could be hijacked by spammers, but it will be used by legit people), #bgnow (which refers to blood glucose), #doc (diabetes online community) and #dblog (for diabetes blog).

Ms. Warshaw: You might also want to check out #RDchat.

 

Poster

SOCIAL MEDIA USE AMONG INDIVIDUALS WITH DIABETES

Emily Shaffer-Hudkins, PhD (University of South Florida College of Public Health, Tampa, FL); Nicole Johnson, DrPH, MPH, MA (University of South Florida College of Public Health, Tampa, FL); Stephanie Melton, MPH, MA (University of South Florida College of Public Health, Tampa, FL)

This poster responded to the lack of research on online use and its associated outcomes among patients with chronic disease, including diabetes. The most common themes of discussion found among patients with diabetes included sharing personal clinical information, requesting disease-specific guidance, and receiving emotional support. The top reason for using social media was "having my voice heard," followed by finding information related to disease coping and finding supportive stories. When asked of their preferred topics, the most cited ones were diabetes management (27%), diabetes technology (23%), and nutrition (19%). Moreover, 22% of responded feeling "a lot better" right after reading or sharing about diabetes online (50% felt "a little better" and 25% felt "about the same"). To improve social media, respondents said they would like the latest news and medical advances, inspirational and coping-related content, and more ways to connect (notably, connecting locally and ways for kids with diabetes to connect).

  • This study included participants from four websites from the diabetes online community: JDRF, TuDiabetes, Children with Diabetes, and Diabetes Daily. 244 respondents completed a survey, 78% of whom where patients with type 1 diabetes, 22% of which were parents or spouses of patients, 81% of which were female, and 60% of which were aged 18 to 30.
  • It appears the diabetes online community has a strong motivating effect on its users. When presented with the statement "I am typically more motivated to maintain a healthy lifestyle after reading or sharing online," 21% of respondents strongly agreed, 49% agreed, and 28% were neutral.
  • Frequency of social media use varied widely. 22.7% of respondents reported using social media more than once a day, 12% of respondents reported using social media daily, 16.1% reported using it most days, 14.9% reported two to three times weekly, 11.6% reported using it once a week, and 14% reported using it one to two times a month, 8.7% reported not using it.

 

5. Health Policy, Reimbursement, and Healthcare Models

Breakout Session: Using Virtual Patient-Centered Medical Home Model to Reduce the Prevalence of Diabetes and Prediabetes

USING VIRTUAL PATIENT-CENTERED MEDICAL HOME MODEL TO REDUCE THE PREVALENCE OF DIABETES AND PREDIABETES

Teresa Pearson, MS, RN, CDE (Halleland Habicht Consulting, Minneapolis, MN)

Ms. Teresa Pearson gave a motivating presentation on the collaborative effort of 12 counties in Minnesota to implement a patient-centered medical home model (specifically, the Southern Prairie Community Primary Care (SPCC) model) to reduce total cost, increase member satisfaction and improve quality of care for high-risk patients. She defined these counties as ‘hot spots’, or areas that were key targets for improvements. She explained the need for improvement in these areas as obesity rates were over 20%, 21-26% of adults were physically inactive, and 8.4% lived below poverty compared to the 7.9% for the state as a whole, and 19.5% were 65 years of age and older, compared to the 12.9% statewide. Over 36,500 adults with diabetes and over 100,000 residents of SPCC have prediabetes.

  • The Southern Prairie Community Primary Care (SPCC) model was introduced with the mission to enhance the quality of life for citizens by facilitating the integration of services and support provided within the community. The SPCC model is patient centered, emphasizing thorough pre-visit planning and focusing on engaging patients and consumers to the fullest extent possible. This collaboration of the Southwest Minnesota counties, with joint powers agreement, was finalized in July 2012 for building the service delivery network.
  • A program called Avera – telehealth, an eEmergency technology service used to create a virtual interface between the patient and the physician, provided services to more than 9,100 patients. The implementation of this service proved to be very successful as 860 patients who otherwise would have transferred were able to receive care in their own communities and, because these transfers were ultimately avoided, more than $6.8 million dollars was saved in transfer costs.
  • Unlike their previous model, this program placed emphasis on survival skills at time of discharge rather than diabetes education at time of discharge. The CDEs received updates on all hospital patients every day and triaged those who needed diabetes education. The purpose was to ensure they received proper education prior to leaving the facilities, especially for the newly diagnosed.
  • Other aspects of the program sought to take further measures of prevention which included training more lifestyle coaches for diabetes prevention and key steps of screenings, counseling, referrals and follow-ups. The Southwest Minnesota Food Network was able to get locally farmed food to markets, schools, and restaurants to attempt to make healthy eating widely accessible. Additional programs included English languages classes for immigrant and refugee populations.

Questions and Answers

Q: What was sustaining those programs in terms of Medicaid or other programs? Is this a benefit?

A: The question is about the closings. We are fortunate in Minnesota that Medicaid does cover it. 64% of costs of diabetes are paid for by government (Medicaid, Medicare or the military). When I worked at Fairview I was brought into the president’s office on a number of occasions to talk about the diabetes program because they don’t see it as a money maker. We just hope we can cover our costs and would be grateful for even a little revenue. Hospital administrations look at how they can make more money so they can charge higher prices for things such as bone scans and ultra sounds. I had to defend my program. You need to get financial statements. I relied on hospital data such as readmissions rates and compiled this and scheduled a 15 minutes appointment with the president. I wanted to do it face-to-face. I knew all my facts about how many improvements our program had made; I projected our program saved that hospital $1.2 million dollars, so in the end we did not close it. We have to save our programs to serve our patients.

 

Breakout Session: Alternative Models -- Shared Medical Appointments: One Size Does Not Fit All

ALTERNATIVE MODELS -- SHARED MEDICAL APPOINTMENTS: ONE SIZE DOES NOT FIT ALL

Elaine M. Massaro, MS, RN, CDE (Northwestern University Feinberg School of Medicine, Chicago, IL)

Ms. Elaine Massaro opened her presentation by identifying several current problems with the standard 1:1 care model in private practice: the average patient visits with his/her physician 3-4 times/year for 15-20 minutes/visit and only 48% of patients have achieved a desirable A1c level, 33% have achieved appropriate LDL and BP goals and a mere 7% have reached all three of these goals. This physician-patient struggle has served as a catalyst in searching for a new physician-patient care model. Current single serving models create barriers to success due to the high demand for expert and top providers, overbooking, closure to new patients, and increased volume of patients with chronic disease. Shared Medical Appointment (SMA) is a voluntary group model and is designed to be autonomous and participatory, engaging, integrative of disease oriented medical visits, include group patient education, target behaviors or indicators, set specific goals and facilitate group sharing. Literature suggests 6-8 patients as the ideal group size, with visit blocks of 2-2.5 hours per group and frequency of visits must be determined on a group basis. Phases of the SMA are as follows: Check-in: download devices, take vitals, foot screening, lab and med review; Intro: 1:1 sessions, review labs, review meds; Group Discussion: problem solving, behavior strategies; Debriefing; Team Building; Brainstorm; CQ. This SMA holistic approach has been shown to increase patient satisfaction scores, improve the provider-patient relationship and improve health measures such as A1c, LDL, HDL, and blood pressure. Provider efficiency, patient appearances and adherence to guidelines, have been shown to increase and overall hospital admissions and ED visits to decrease. The presentation concluded with a summary of a site SMA visit in Torino, Italy. This was the site of a multicenter randomized 4 year trial of lifestyle intervention by group care to manage type 2 diabetes: “Rethink Organization to iMprove Education and Outcomes (ROMEO). Conclusions: favorable clinical, cognitive, and psychological outcomes of group care can be reproduced across clinical settings.

Questions and Answers

Q: Could you tell us how we can get your slides?

A: Go to AADE website 2013 and look up my presentation; everything will be there.

Q: You addressed HIPPA, but it is unclear when you have a group appointment as to when and where you should review personal labs.

A: We do not disclose identity of lab results in the group setting; we privately give every patient a number and post their lab reports with the identity number onto a display board. This way no individual is identified by other members of the group. This is our preference, but others may conduct this differently.

Q: I work in a large practice and I want to know, one, how long did it take you to develop and implement this model and two, how did you get senior leadership do comply?

A: It took me 2 years to get everything in place with 2 physicians who were thought leaders and champions. I had a lot of naysayers, which is why implementation took me so long.

 

Workshop: Reimbursement and Diabetes

Patty Telgener, RN, MBA (VP of Reimbursement, Emerson Consultants, Excelsior, MN)

Ms. Patty Telgener gave one of the very most valuable presentations of the conference in our view; she clearly and thoughtfully detailed Medicare reimbursement policies as they relate to CDEs, and provided background on the impact competitive bidding, Accountable Care Organizations, and healthcare reform will have on people with diabetes. Overall, Ms. Telgener characterized herself as a "glass half-full person" on healthcare reform and explained her view that implementation of the Affordable Care Act and the rise Accountable Care Organizations is aligning financial incentives with the work CDEs perform. Thus, she provided significant encouragement to attendees, highlighting that their job security is generally increasing. By contrast, Ms. Telgener was more foreboding about the impact competitive bidding will have on patients’ access to testing supplies. She explained that CMS states it implemented competitive in part to protect beneficiaries' access to supplies, but emphasized that many beneficiaries will have to change what distributor they receive their supplies from and noted there was certainly potential for people to also have to change the BGM brand they use. She caveated her concerns with the presence of an "anti-switching rule" that prevents Medicare suppliers from "influencing or incentivizing" patients to switch to a different brand, but warned "nobody knows how it is going to work out." Still, she encouraged providers to educate their patients on this rule, which we applaud, so that patients are not caught blindsided. Ms. Telgener also warned that CMS is expected to begin implementing competitive bidding of insulin pumps in January 2014.

  • Ms. Telgener warned that competitive bidding “is coming your way” (again) and that educators must be informed on how it will impact their Medicare patients. About 90% of attendees indicated they had heard of competitive bidding before. Some attendees, however, seemed to not recognize the full impact competitive bidding of diabetes testing supplies will have, since their were audible “wows” upon Ms. Telgener underscoring that Medicare reimbursement was cut by about 60% (more specifically, 68%). Due to the steepness of these cuts, Ms. Telgener noted that she only referred to the selected contracts as “winners.”
  • Ms. Telgener indicated that it was ironic CMS stated one purpose of competitive bidding was to protect beneficiary’s access to quality goods, since most people will have to change who they receive their testing supplies from. Ms. Telgener explained that the main reason CMS implemented competitive bidding was to reduce the amount Medicare spends on testing supplies. Medicare beneficiaries’ access to testing supplies will be impacted, since only contract suppliers will be reimbursed by Medicare for diabetic testing supplies delivered to beneficiaries’ residences. Ms. Telgener also expressed concern that beneficiaries might not have access to their testing supplies brand given the new low reimbursement rates.
  • Ms. Telgener caveated her concern by noting that an anti-switching rule in place is to prevent competitive bidding from forcing people to change brands. She was uncertain how the rule would be implemented and enforced. For background, the anti-switching rule requires contract suppliers to provide the brand of testing supplies that works with the beneficiary’s monitor. If the supplier does not carry the beneficiary’s brand, the beneficiary can ask the supplier about alternative brands at which point, the supplier can describe what brands it offers (the supplier cannot initiate the conversation). Providers can still prescribe a specific brand to avoid a patient experiencing an adverse medical outcome. For more details on competitive bidding, please see our extensive February 13, 2013 Closer Look on this topic dated at http://www.closeconcerns.com/knowledgebase/r/993d586e.
  • Ms. Telgener warned that competitive bidding on insulin pumps is to be gradually implemented beginning in January 2014. She did not provide details on how she foresees this impacting people with diabetes. We have become recently focused on this at Close Concerns and will be working hard to find the relevant information on what this looks like going forward.
  • Reviewing other changes in Medicare reimbursement, Ms. Telgener highlighted that CMS is trying to remove barriers to preventive services. Medicare beneficiaries have not had a copay for either diabetes screening or medical nutrition therapy since 2011. This is great though we think even more important is awareness and motivation – it’s easy for many patients to ignore these benefits. Currently, diabetes self-management training (DMST) does still have a co-pay; however, according to Ms. Telgener, AADE continues to work with CMS and the US preventive screening task force to eliminate the copay on this service as well. We don’t have a sense of how likely this is at this stage.
  • Accountable Care Organizations (ACOs) are managed care of the 1980s and 1990s under a new name, according to Ms. Telgener. She pressed that “conceptually [ACOs] make sense.” ACOs move away from the former model of “a provider getting paid to keep the patient sick” and towards having the payer, hospital, and physician share responsibility for the patient. According to Ms. Telgener, the intent of ACOs is to give doctors and hospitals, financial incentives to provide quality care while keeping costs down. Ms. Telgener was so optimistic about ACOs’ incentives being aligned with that of CDEs that she urged attendees to find out who the ACOs are in their areas. She encouraged educators to reach out to ACOs to see if they can be a part of the ACO or if the ACO can refer patients to them. We look forward to learning how successful this is.
  • We were shocked to find out from Ms. Telgener’s talk that Medicare still does not use A1c as a diagnostic for diabetes. She expressed “hope that Medicare will catch up” and will begin using A1c as a diagnostic test for diabetes. Currently, Medicare diagnosis diabetes by a person having a fasting blood glucose level ≥126 mg/dl on two different occasions, a two-hour postprandial glucose challenge ≥200 mg/dl on two different occasions, or a random glucose test >200 mg/dl for a person with symptoms of uncontrolled diabetes. Many patients will not, of course, bother to go through all these different time-consuming tests, especially if they are avoiding the knowledge that they have diabetes. Given all the success the non-Medicare world has had with diagnosing diabetes using A1c, it is quite unfortunate this hasn’t become a Medicare guideline. During Q&A, attendees were clearly frustrated by the exclusion of A1c as a diagnostic. We note, however, that KOLs such as Dr. Timothy Garvey have critiqued the use of A1c as a sole diagnostic tool for diabetes due to its high false negative rates (for more details on Dr. Garvey’s comments, please see page 68 of our AACE 2013 full report at http://www.closeconcerns.com/knowledgebase/r/1c4a916f). We do see the downside of a high false negative, but think the tradeoff of people not getting accurate information easily is much worse.
  • An “important initiative for AADE,” according to Ms. Telgener, is persuading Medicare to cover prediabetes. An attendee did note that Medicare is covering obesity counseling, which will overlap to some extent with people with prediabetes. We believe that Medicare reimbursement for prediabetes would further the use of preventive services, reducing people’s progression to type 2 diabetes, and potentially the nation’s expenses due to diagnosed diabetes. As a reminder, ADA’s report on the expense of diagnosed diabetes, hypothesizes that the cost of diabetes is rising predominately due to the increasing prevalence of diabetes rather than the cost of medications (for more details, please see our March 6, 2013 Closer Look at http://www.closeconcerns.com/knowledgebase/r/7dd4a6e6).  
  • CMS does not recognize registered nurses or CDEs as providers able to bill individually for diabetes self-management training (DSMT). CMS recognizes registered dieticians, pharmacies (not pharmacists), physicians, physician assistants, and nurse practitioners. RNs bill as part of an ADA- or AADE-certified DSMT program. Ms. Telgener noted that legislation has been submitted to recognize CDEs as certified providers.

 

AADE, ACCREDITATION PROGRAM, AND REIMBURSEMENT

Leslie Kolb, RN, BSN, MBA (Director of Accreditation and Quality Initiatives, AADE, Chicago, IL)

Ms. Leslie Kolb advised audience members on how to get reimbursement for diabetes self-management education (DSME). She emphasized that Medicare only reimburses accredited or recognized providers and noted that all accreditation programs must meet the National Standards for Diabetes Self-Management Education and Support. She noted that accreditation lasts four years (at a cost of $800), urging audience members not to let cost be a barrier since the ROI for accreditation is high. Medicare will reimburse up to 10 hours of DSME in a patient’s first year and two hours for subsequent years. As we understand it, this benefit is very under-utilized. Her presentation contained some interesting statistics: currently, between the ADA and AADE, there are about 5,000 accreditation sites in the US (618 run by the AADE). She emphasized that this is not enough and that numbers are trending downwards due to site closings, presumably due to poor reimbursement. The utilization rate of the Medicare DSME benefit is only 1.5%, which she said meant that DSME providers are only being reimbursed for 1.5% of patients’ last visits – she wondered aloud if this is because educators were not billing for it or if it is due to just not getting paid. Finally, a total of 18 states have no Medicaid reimbursement for DSME (Alaska, California, Arizona, Colorado, Texas, Oklahoma, Kansas, Arkansas, Alabama, Georgia, Virginia, Ohio, DC, Delaware, Massachusetts, Rhode Island, New Hampshire, and Mississippi). This is tragic from our view, as it seems to us like these are many of the states that may need it the most. 

 

PANEL DISCUSSION

Leslie Kolb, RN, BSN, MBA (Director of Accreditation and Quality Initiatives, AADE); Patty Telgener, RN, MBA (VP of Reimbursement, Emerson Consultants, Excelsior, MN)

Q: We have RDs and RNs on staff in our program. Is there a limit to the MNT (Medical Nutrition Therapy) benefit for Medicare?

Ms. Telgener: The initial is three hours, and the follow up is two. There is an exception for new diagnosis or a change in status. In those cases you can get hours beyond that, and there are more flexible hours on MNT than DSME.

Q: We are trying to get more people in for prediabetes, obviously, but if I ask the doctor for an MNT order for prediabetes, because we know the focus is on weight management, I can see those prediabetes patients under MNT, right?

Ms. Telgener: Medicare still only covers once they have a diagnosis for diabetes.

Q: What if the patient has already been diagnosed with diabetes – it is not a new diagnosis – can we then use the A1c?

Ms. Telgener: They still need to have all of the labs in their chart and show that they meet all of the criteria for Medicare, even if they have had diabetes for a number of years and is only now being referred.

Q: You care going to put a 75 year old through an OGTT to show that they still have the diabetes that they have had for 20 years?

Ms. Telgener: I feel for you. I am just the messenger.

Q: When do you think Medicare will recognize A1c for diagnosis?

Ms. Telgener: If I knew that, I would go buy a lottery ticket today. It is the same thing for insulin pumps – the labs they use for insulin pumps don't make any sense either.

Q: What if their A1c meets the definition of diabetes and the doctor says that they have diabetes and has them on medications, but their fasting or other measures appear normal?

A: I would just caution you. One situation is that they do not have the labs and you are asking Medicare to pay. That is a different situation from them not meeting the criteria and you are asking them to pay. The physician is also liable and is technically the one responsible, but if Medicare finds out that you have been billing for DSMT for a person who does not meet their criteria for diabetes, even if the doctor says they have diabetes, they will question you too.

Q: I’m the coordinator of a hospital program in Baltimore. I know Maryland is different as far as payment, but can you speak to using telehealth and how that can be billed? We bill a facility fee in the office. Can you bill a facility fee because you’re providing it form the office?

Ms. Telgener: There are a whole set of archaic regulations for telehealth. DSMT and MNT are listed as approved services via telehealth. First of all, the patient has to be eligible and live in an understaffed area based on number of physicians per population. How that works is the physician, or whoever is providing DSME, bills the G codes, and they are billed just as if it were face to face.

Q: When doing telehealth, the RD can provide it but RN can’t. Is that true?

Ms. Telgener: I understand that you have to have a two-way video conference.

Q: Can you use Skype?

Audience member: No. Skype is not HIPAA.

Q: We have been a recognized program long enough to have repeat patients.  Can we use the initial hours if a person leaves for a long time and then comes back?

Ms. Telgener: If I understand your question, they have the one-time initial benefit and then they have the follow-up appointments. Those are lifetime benefits; you don't get to restart with initial hours again.

Q:  If they go from Medicare to Medicare Advantage, does the Medicare Advantage plan track their education hours?

Ms. Telgener: The Medicare Advantage plans can go outside that window of maximum hours, because they are getting paid per patient per month by Medicare. They cannot go below Medicare’s hours but they can go above.

Q: With the new changes, I’m a fish out of water. I haven’t done diabetes education since I left Kaiser per se, but I’m a pharmacist. With the changes in mail order, I’ve done an increasingly large amount of counseling for patients. I do 500 prescriptions per day, so I don’t have the time for that. We just hired five dieticians in my chain (Giant groceries) – so for you guys here, get your MPIs! We’re going to be coming to hire you soon because I have my job and you have yours. This process you all have here [for accreditation] is taking too long and is too cumbersome. It shouldn’t be that long and cumbersome to get certification or licensing for something that’s really needed. People are losing their insurance, they’re losing test strips. If you don’t make it easier, someone else is going to take over soon.

Ms. Kolb: We need to send you to Washington.

Comment: With regards to the slide you had on competitive bidding. Medicare beneficiaries can now go to a pharmacy but that script has to be a written order, it cannot be called in. We have had patient since July who are physically going to a pharmacy and then it typically should be provided but there is a learning curve here.

Ms. Telgener: Especially for the first time because it is a new provider.

Comment:  Right, they had previously picked it up through a DME. Drugs can be called in but they need a physical script for the testing supplies.

Q: All of the stuff we are talking about is for straight Medicare. Not these combo private/public Medicare plans right?

Ms. Telgener: Correct; some of those Advantage plans can act differently. They can offer more, they can offer differently, but they have to offer DSMT at least 10-hours initial and a two-hours of follow up.

Q: My largest referral source is a family practice program affiliated w/ local hospital so I have to be careful not to make them mad. Unfortunately, because they’re using an EMR I’m getting flak about my referral form. I’m getting it back, and it’s not signed. The docs are putting the foot down because they want to use the form on their EMR. I’ve been taking it and keeping both of those forms together, but I’m not really comfortable taking it because my form is the one with all of the specific elements of my DSMT program. But those two pieces of paper together probably aren’t going to fly with Medicare. What do you think?

Ms. Telgener: It has to have the number of hours on it, and if I wanted to see the lab work I would want access to that. It doesn’t have to be in the same referral form, it just has to be on that chart. It doesn’t have to be on a certain referral form.

Comment: Medicare may not pay for prediabetes but if the patient is obese, Medicare is going to start paying for obesity.

Ms. Telgener: The coverage for that obesity counseling is a separate benefit and has different coverage criteria than DMST.

 

6. Education, Diabetes Prevention, and Self-Management

Keynotes

HOW TO CHANGE HUMAN BEHAVIOR

BJ Fogg, PhD (Stanford University, Stanford, CA)

Behavioral science expert Dr. BJ Fogg gave AADE’s final keynote address – this was an outstanding presentation and one of our favorites at the conference. His command of the material, use of stories and examples, engaging slides, and incredible branding (his twitter handle @bjfogg on every slide; an informative handout/business card passed out at the end of his session) were terrific examples to see from a very marketing-savvy, outstanding presenter. Dr. Fogg provided a whirlwind tour of human behavior and how to change it – literally thousands of attendees were copiously taking pictures, notes, and videos of the Fogg Behavior Model (behavior = motivation + ability + a trigger); the Fogg Behavior Grid; (a matrix of the 15 different types of behavior change); the concept of “success momentum” (small wins that build confidence over time); how to change long-term behavior (make it easy, change environments, and use baby steps); and how to build new habits (use an existing routine to trigger a new behavior). Dr. Fogg concluded his presentation with three challenges of what AADE can do in this arena: 1) teach how behavior works (especially habits); 2) give guidance on redesigning home environments for health (“no one is doing this well”); and 3) curate innovations (e.g., apps, technologies) so members get the best stuff.

  • “Behavior happens when motivation, ability, and trigger come together at the same moment. If any one of these is missing, the behavior won’t occur.” Dr. Fogg discussed each aspect throughout his presentation. He recommends troubleshooting behavior problems in the following order: 1) Did we trigger the behavior? 2) Was it easy enough to do? 3) Was there motivation to do the behavior? He emphasized that this is the opposite of received wisdom – most people try to attack motivation first. Dr. Fogg illustrated this concept with a very useful graphic; see www.behaviormodel.org.
    • “No behavior happens without a trigger.” A trigger is a call to action via a prompt, cue, or reminder: “Walk” at a traffic light; a Costco employee offering you a sample; a “Rate Pinterest” pop up on your phone; a blue hyperlink in a text message from the Red Cross; the triangle play button in the center of a YouTube video. Dr. Fogg explained how he missed his Zumba class even though it was on his calendar, he was motivated to go, and had the ability to do it. The missing piece was no popup or trigger reminding him to go.  Triggers are a particularly critical component of diabetes care and one where best practices can be developed: triggering someone to test their blood sugar, avoiding unwanted triggers that cue eating certain foods, triggering exercise, etc.
    • “In behavior change, ability matters more than motivation. The ROI on simplifying things is much bigger than trying to sustain motivation.” Dr. Fogg encouraged the audience to work on simplicity, an area is especially critical in diabetes technology and mHealth; right now, things still aren’t quite easy enough to get massive numbers of patients on pumps, CGMs, regularly downloading their own data, and using apps. Using an example from one his own students’ creations, Instagram, Dr. Fogg highlighted that the product “won because it was so simple. They had the discipline not to keep adding stuff.” Prophetic words…
  • “To lump all of behavior change into one pot is messy.” Dr. Fogg reviewed his Fogg Behavior Grid, a matrix of the 15 different types of behavior change – what great work here. He divides behavior change into three time lengths: 1) a one time behavior change (“DOT”); 2) a fixed duration behavior change (“SPAN”); and 3) a behavior change from now on (“PATH”). The matrix also delineates five types of change: 1) do a new behavior (GREEN); 2) do a familiar behavior (BLUE); 3) increase the duration/intensity of a behavior (PURPLE); 4) decrease the duration or intensity of a behavior (GRAY); and 5) stop doing a behavior (BLACK). A picture is at www.behaviorgrid.org.
    • For instance, an exercise challenge is a “PURPLE SPAN” behavior, while watching less TV forever would be a “GRAY PATH” behavior. Dr. Fogg has developed a Behavior Wizard (www.behaviorwizard.org) with unique persuasion strategies for each behavior type. We found it particularly notable to hear that there are different strategies for each of the behavior changes – in our view (and we think Dr. Fogg would agree), this speaks to the importance of excellent and targeted product design to achieve behavior change, especially with technology.
    • If you want to instill a new habit (a PATH behavior change), Dr. Fogg advocates starting with a SPAN behavior change – an example is a goal of “walking every day for five days.” Said Dr. Fogg, “There is a psychological power that comes from SPAN that can take people to PATH.” This is in contrast to initially phrasing the goal as, “Walk 30 minutes per day from now on.” That phrases the goal as a PATH behavior change, but doesn’t give the same psychological power that can build habits, sustain the behavior, and lead to a long-lasting change over time.
  • “I am really convinced that in the health arena, we need to be designing for success momentum.” Success momentum is the concept of small wins that subsequently build up confidence. Dr. Fogg described reactions like, “I feel awesome,” “I feel empowered,” and “I feel great.” He believes this type of momentum is critical for overcoming the inevitable roadblocks that arise. To illustrate his point, he shared an example: a monkey and frog decide they’re going to get strong. The frog decides to lift 10 lb kettle bells for five easy reps per day. Conversely, the monkey decides to lift 50 lbs for three sets of 10 per day. At the end of six months, the frog is stronger. This is success momentum in action – the frog achieved small wins along the way and kept upping the level of difficulty.
  • “The secret to habits is ‘after’…Your existing routine can trigger a new behavior.” If your goal is to start flossing, one way to make it a habit is to consistently do it after an existing routine. For example, flossing (a new routine) would always follow brushing one’s teeth (an existing routine). And if you are not flossing right now, Dr. Fogg recommends starting simple: floss just one tooth to start! The formula for creating new habits is then as follows: 1) After I [existing routine], 2) I will [new tiny behavior]. 3) Then, celebrate your tiny successes! The latter is “really important,” as it fires off positive emotions associated with the behavior. The formation of these small habits then often ripples out into other aspects of peoples’ lives.
    • Dr. Fogg described how he would do two pushups (a new tiny behavior) after peeing (an existing routine). He would then say, “Awesome!” and fist pump to celebrate his small win. He has now built up to 12 pushups after his trips to the bathroom. When he is busy, he scales back to only a few pushups, but he doesn’t feel guilty about it; rather, he celebrates “Keeping the Habit Alive.”
  • There are two ways to get people to change their behavior long term: 1) create habits that grow over time and 2) change one’s environment. Dr. Fogg emphasized that lots of behaviors contribute to health outcomes, and the key is to create a whole bunch of habits that endure. He distinguished these from choices or decisions; habits, by contrast, are automatic and do not require thinking. For instance, as a vegan for ten years. Dr. Fogg looks at a restaurant menu and “Does not even see the meat options.” “The more we’re deciding,” he said, “the weaker the habit. The more automatically we do it, the stronger the habit.”
  • “What works is helping people do what they already want to do.” Dr. Fogg highlighted that there is a big difference between want vs. should, and those who want to do things are more successful. “When you look at the landscape, if people need to be active to be healthy, getting them on the treadmill and forcing them to run – there’s not a lot of potential there.” To us, this reinforces the importance of shared-decision making, individualizing therapy, and considerate HCP-patient interactions.

 

LEADING THE CHARGE

Phil Southerland (CEO, Team Novo Nordisk, Atlanta, GA)

In an inspiring keynote, Mr. Phil Southerland used his personal story to demonstrate the power of exercise and that while “diabetes will never hold you back…mismanagement of it can.” Mr. Southerland was diagnosed with type 1 diabetes at the age of only seven months. At the time, doctors told his mother he would likely not live past his 25th birthday and that he would probably be blind or in renal failure before then. Triumphantly and humorously, Mr. Southerland announced “I’m not dead yet!” In so many ways, Mr. Southerland has reset expectations for what a person with diabetes can do. Throughout his keynote, Mr. Southerland underscored the critical role exercise played in his life and diabetes management. When Mr. Southerland was 12 years old he began cycling and gradually learned that exercise is the “billion-dollar drug that doesn't get prescribed enough” – initially, he realized that it enabled him to eat candy bars and control his blood glucose levels. Reflecting on his cycling success, Mr. Southerland noted that when he had good blood sugar levels, he “could compete with the best.” The problem was when he was too high or too low. Thus, he concluded that he “didn’t fail because of diabetes. [He] failed because [he] didn't manage [his] diabetes properly.” Fortunately and unsurprisingly, Mr. Southerland has been very successful – Team Novo Nordisk’s goal is to compete in the Tour de France in 2021, the hundredth anniversary of the discovery of insulin.

  • With a $400 donation to buy t-shirts and business cards, Mr. Southerland founded Team Type 1. Today, Team Novo Nordisk is comprised of 101 athletes from 13 countries, all of whom have diabetes. It also has a team of 35 staff members. Additionally, Team Novo Nordisk conducts research into the effects of exercise on blood glucose levels and runs a diabetes camp to teach diabetes self-management to children.
  • Mr. Southerland urged diabetes educators to inform people with diabetes and their family members about the importance of exercise. He emphasized that a person with diabetes cannot be the only person in a family exercising.

 

GUIDED IMAGERY AND THE NEW MIND-BODY BREAKTHROUGHS IN DIABETES CARE

Belleruth Naparstek, LISW, BCD (Health Journeys, Cleveland, OH)

The Friday morning AADE 2013 General Session on relaxation and diabetes replaced the previously scheduled keynote address by the prohibitively controversial Ms. Paula Deen – we were extremely glad that AADE made this replacement. Calling diabetes “one moody sucker of a disease,” Ms. Belleruth Naparstek based her address on the notion that influencing a patient’s behavior is predicated on building a strong relationship. She defined guided imagery as an immersive, hypnotic audio intervention, consisting of calming words, soothing music, and positive images. It is designed to structure a relaxing, healing experience that targets specific health goals. Because guided imagery can be spoken by a practitioner or self-administered by a recording, some call it the “lazy man’s meditation.” According to Ms. Naparstek, guided imagery has been used by Kaiser Permanente, Blue Shield of California, United Healthcare, the American Red Cross, Oxford Health Plan, the Mayo Clinic, the Cleveland Clinic, the US Army, and the US Marine Corps. Ms. Naparstek then brought calm to the massive exhibition hall audience as she led the group through a sample session in guided imagery. We’d tell you how long the sample session was; however, we found ourselves relaxing so much we didn’t notice! After reviewing an array of studies validating the health benefits of guided imagery and similar therapies, she provided a series of practical tips for the audience to begin using immediately with their patients and on their own.

  • Guided imagery holds a number of general benefits to patients. These include enhanced relaxation, reduced stress and anxiety, countered depression, lowered cholesterol, improved blood pressure, improved focus and concentration (including with developmentally disabled adults), improved athletic performance, improved sleep, enhanced energy, increased self-esteem, improved surgical outcomes, and decreased treatment side effects. Guided imagery also has a wide, user-friendly application due to its “press play” operation, and it is relatively simple to transition onto. Guided imagery can be introduced in the hospital setting and then immediately brought home.
  • A number of small studies have demonstrated the efficacy of guided imagery and similar therapies for patients with diabetes. The most notable of these include a small randomized control trial of 39 patients with type 2 diabetes were sorted into either ten sessions of biofeedback and relaxation therapy or three sessions of standard patient education (McGinnis, et. al., Diabetes Care 2005). The biofeedback and relaxation therapy group achieved significant decreases in average levels of blood glucose, A1c, and muscle tension compared to controls (these results were sustained at the three-month follow-up). Additionally, Ms. Naparstek indicated that guided imagery can decrease neuropathy, enhance feelings of empowerment, elevate self-care, and reduce anxiety-based behaviors like compulsive eating, drinking, and smoking.
  • Ms. Naparstek shared practical tips to help people get started with guided imagery. She encouraged the audience to put guided imagery audio clips on their hospital phone lines for patients to dial in to. Alternatively, they could upload clips to patients’ smart phones or MP3 players. If certain patients are severely technologically-challenged, Ms. Naparstek suggested attendees might consider ordering Playaways, a pre-loaded audio player, which she indicated is easy to use. Furthermore, according to Ms. Naparstek, guided imagery doesn’t compete with other treatments. Instead, she believes it supports patients’ treatment regimes., Ms. Naparstek encouraged the audience to also give their patients a guided imagery download when putting patients on a new medication.

 

Breakout Session: Implementing Findings from the NDEP National Diabetes Survey Results Where Do We Go From Here?

NDEP NATIONAL DIABETES SURVEY (NNDS) RESULTS

Linda Siminerio, PhD, RN, CDE (University of Pittsburgh, Pittsburgh, PA)

The National Diabetes Education Program (NDEP) National Diabetes Survey (NNDS) characterized trends in Americans’ awareness, knowledge, and attitudes about diabetes prevention and control – the results revealed both encouraging and startlingly disappointing findings. Dr. Linda Siminerio presented the results and identified gaps in the general population’s knowledge that diabetes educators in the audience could help bridge. This survey has been conducted three times: in 2006, 2008, and 2011. It was conducted over the phone, and the latest 2011 survey yielded >2,000 completed interviews.  Notable findings included the discouraging statistic that only 25% of high risk individuals (BMI >25 kg/m2 or history of gestational diabetes) reported feeling at risk for diabetes. Additionally, CDEs in the audience were shocked that so few people recognized the severity of cardiovascular disease (CVD) as a major diabetes complication (<10% of people with diabetes identified CVD as the most serious complication associated with diabetes). Less than half of people with diabetes surveyed reported receiving any type of instruction from a diabetes educator. Nonetheless, general awareness of diabetes in the overall population appears to be on the rise with more people in 2011 aware that diabetes could be prevented than in 2006. During the group discussion following the presentations, audience members were encouraged to offer suggestions for improving the upcoming 2013-14 survey. A theme that cropped up was that usually the biggest barrier to education is cost and lack of reimbursement.

  • General awareness of diabetes in the overall population appears to be increasing: from 2006 to 2011, an increasing proportion of people had heard of an A1c test, were aware that diabetes could be prevented, and had heard of prediabetes. Roughly 80-90% of people think diabetes is a “very serious” disease, though this number has trended slightly downwards since 2006 – Dr. Siminerio emphasized that this was an important message for educators to continue helping patients take the disease seriously.
  • Most people identified blindness as the most serious complication associated with diabetes (70% in 2006 and ~50% in 2011), and an increasing number of people identified kidney disease as the most serious diabetes complication (18% in 2006 and 28% in 2011). Dr. Siminerio pointed out that <10% of people identified CVD as the most serious complication associated with diabetes and suggested that that this perhaps means that educators could do a better job of communicating the relationship between diabetes and CVD.
  • A startlingly low percentage of people (25%) at high risk (BMI >25 kg/m2 or history of gestational diabetes) felt that they were at risk for diabetes. Dr. Siminerio emphasized the importance of raising awareness in this population and conveying the message that people can prevent or delay type 2 diabetes.
  • Amongst people with diabetes, disappointingly few report having an “excellent understanding” of several self-management strategies. Less than half felt they had an “excellent understanding” of blood glucose monitoring (<50%), prevention and treatment of high blood sugar (<50%), prevention and treatment of low blood sugar (30-31%), and preventing complications (44-50%). Dr. Siminerio conjectured that educators focus on training for people on insulin but may not emphasize such training for people on oral agents.
  • Finally, less than half people with diabetes reported receiving any type of instruction from a diabetes educator (49%), suggesting that access to CDEs and CDE availability needs to be improved.

 

NNDS RESULTS: USING RESULTS FOR PROGRAM CHANGE -- EXAMPLES

Joanne Gallivan, MS, RD (NIH, Bethesda, MD)

Ms. Joanne Gallivan jumped right into a discussion of how the NDEP is translating the results of its survey into action. She reiterated that patients’ blood sugar testing frequency, recording of their blood sugar measurements, and adherence to medication regimens have not improved since 2006. The “Managing Diabetes” campaign, which aims to communicate the importance of diabetes management, was developed as a result. The Family History campaign was created in response to the finding that many individuals do not associate their family history of diabetes with their perception of their own risk for the disease. Ms. Gallivan next discussed the shocking lack of awareness of the association between diabetes and cardiovascular disease. To place the issue on peoples’ radar, the NDEP is deploying the D-CVD Campaign and has developed a Diabetes and Heart Health online resource. Ms. Gallivan stated that initially, the NDEP’s focus was on expanding diabetes awareness, but that NDEP leaders are increasingly aware of the importance of providing patients and providers with the proper information. She highlighted the Diabetes HealthSense resource, which was created in collaboration with CDEs and features a wealth of helpful videos. We are glad to see that the NDEP is so vigorously translating the results of its study into action, and will be interested to hear feedback on its new set of campaigns and patient resources.

 

PANEL DISCUSSION

Joanne Gallivan, MS, RD (NIH, Bethesda, MD); Linda Siminerio, PhD, RN, CDE (University of Pittsburgh, Pittsburgh, PA)

Q: One of the things that I think is great with videos is that they are great for health literacy. Maybe there is some way that we can gauge health literacy through a survey? How, for example, do people understand the words “diabetes” and “prediabetes”?

Ms. Gallivan: I think you’re right, and one thing we do is that when we develop new materials, we pretest them. We understand that health literacy is a huge issue, and plan on working with health literacy experts.

Q: Since so much is changing in the world of insurance and coverage, maybe in the next survey you could ask some questions about whether they know what resources their insurance has? We need to have a groundswell of demand for coverage, so that has to happen from both providers and maybe the population, because that has to be put on the table.

Ms. Gallivan: Right, everything is changing.

Dr. Siminerio: I don’t think people realize that prevention isn’t paid for, so I think that’s a very good question.

Q: On the slide that showed that the frequency of patient self-monitoring has decreased, could that be because so many offices now download meters directly, and patients no longer need to record their own results?

Dr. Siminerio: I think that another question could be whether patients understand the link between their results and their self-management. It would be an interesting thing to figure out from a survey.

Q: There’s one area that I don’t see much data in that is of great interest to me – I am a nurse educator and type 1 diabetic. In my personal experience and anecdotally, there is an incredible power of a diabetes community with support groups, group classes, group events. I think questions as to the availability, use, and impact of those groups would be great to include. The hardest part is funding because there’s no numbers to cite to say, “See, it works.” I think the low impact we’re seeing from behavioral change from professionals kind of points to that. It’s the community that actually pushes behavioral change on the accountability and empowerment that one finds in a group of like individuals.

A: Thank you

Q: I think that this should have been a general session - I think, this information was incredible. The lack of a perceived link between diabetes and CV risk is astounding. And Linda, could you talk about nontraditional methods of reaching patients?

Dr. Siminerio: I think that we need to start deploying our educators to primary care. I have a network of primary care providers; we go out and identify practices with a high volume of diabetes patients and we send educators out there, and the providers know that they are there.

Q: A lesson I learned early on is on the use of churches in the community. I wanted to report and invite anyone to get a hold of me later to give me your insights. I’m working in Minnesota, and my Lutheran church is going to launch a 15-year-old empowerment program in May that includes goal setting, problem solving, coping with life with diabetes, mobilizing support on your own behalf, and maintaining hope. I’m very excited, and I’m making a plea to corner me later if you can and tell me what insights you might have for use of churches.

Dr. Siminerio: I consider the patient-centered medical home also as part of the community, but you’re right that that’s where we need to be. Places like churches, or any other community facility, we absolutely have to start looking at those things.

Ms. Gallivan: Whether faith-based, or a senior center, please go to the NDEP website. We have many partners since we can’t do it all. HealthSense is a tool that collects what our partners have done and what has worked well in their communities.  

Q: Out of the less than fifty percent of people who have had instruction from diabetes educators, do we know how many have access issues?

Ms. Gallivan: It’s not a question we have asked, but we are interested in knowing that.

Dr. Siminerio: I don’t think that it should ever be interpreted that we are not doing our job – it’s really an access issue. And if you look at the national surveys, you see that referrals are poor. The way our system works now, even if the physician remembers to refer to us, the patients sometimes forget.

Q: I really like the idea that minority groups have been oversampled. I’m wondering for the next survey if Asian Americans/Pacific Islanders will be represented as well.

Ms. Gallivan: It depends on the number of people we’d need to get to get a large enough sample size. We are looking into that, so thank you. We are looking into other ways to get information too. Whether we can go online and do online surveys as well is another option.

Q: On affordability: for a lot of patients, the reason that they don’t know this information is because copays are going higher and higher. We also know that patient results are closely related to blood glucose monitoring, but patients are finding it harder to afford their testing strips. I’ve had some people who have told me that in their local hospital, their copay is $1250. They are getting the referrals and being told to go to a class, but then they get told that there is a copay and they walk out. Another thing to ask on a survey would be whether it is an affordability issue.

Dr. Siminerio: I remember seeing the presentation of a survey that reaffirmed what you said – people are criticized for being noncompliant, but the biggest reason for not attending educational events and monitoring their blood glucose was the cost.

Q: It’s very interesting – I’ve had a very large education program for 20 years and watched the progress of this. Since 2007, I’ve had to lay staff off three different times because the reimbursement is no longer there. Medicare will pay well over $400 for somebody to come to group class, but for all of these insurance plans they have a $500 or $1,000 deductible. No one in this world will attend diabetes education classes for $1,000. Referrals are steady, but attendance keeps dropping. There’s been record closings of outpatient programs, and despite foundation support to help pay for co-pays, there’s going to continue to be closings. I don’t know if there’s a way to look at, in the survey, it’s wonderful for people to have access to a CDE, but you can’t cover everything in an hour if you have only one access point. They may get to see somebody on education, but less of it is comprehensive education. Even my own PCP doesn’t refer to my program. She sends them to the Panera down the street since a company does a free two-hour class.

Dr. Siminerio: I think we’re in a movement of consumers being made more aware of what things cost. Hopefully over time, not while I’m alive, but maybe in the future people will start to see the cost of education visits vs. other things. I know they’re starting to market in my community that the heart surgery at this hospital costs this much vs. that hospital. We should do something that says, over time, here is a preventative measure you can take that costs this much vs. taking four diabetes medications. I did a study in one of our communities where the referrals for diabetes happened after people had four comorbidities. I would like to be able to show that my preventative efforts were cost savings.

Q: If you don’t make the connection that if you get diabetes, you get heart disease then people just have a lack of perceived benefit for diabetes prevention. We make programs absolutely free, and they still don’t come. All supplies for our employees are totally free, yet they’ll drop out of the program. Even if it’s free.

Q: In the doctor’s waiting rooms you could show the NDEP videos on diabetes. You can get them from YouTube?

Ms. Gallivan: Yes

Dr. Siminerio: The information is valid, accurate, up-to-date, reviewed and based on all the recent studies, so you can feel comfortable using them as educational materials.

Comment: Access to insurance is the elephant in the room – it’s what prevents our patients from having proper access. Telehealth, since 2006, has significantly reduced the A1cs of many of our patients. Telehealth has great proven effectiveness, and I think these results need to spur the legislation to grant reimbursement for these services. 

 

Breakout Session: Strike the Spike: Strategies for Managing Postprandial Hyperglycemia

STRIKE THE SPIKE: STRATEGIES FOR MANAGING POSTPRANDIAL HYPERGLYCEMIA

Gary Scheiner, MS, CDE (Integrated Diabetes Services LLC, Wynnewood, PA)

Mr. Gary Scheiner, our highly valued diaTribe contributor, columnist for “Thinking Like a Pancreas”, and AADE’s Diabetes Educator of the year for 2013 addressed a fully packed hall to speak about a common predicament for patients with diabetes: managing postprandial glucose spikes. He began by sharing a personal anecdote from yesterday’s lunch when he forgot to bolus, and was forced to dash about the conference center in search of the men’s restroom. His post-meal blood glucose was in the 300s, a common occurrence for patients with diabetes that do not appropriately time their bolus. The majority of his session discussed management strategies for controlling postprandial glucose spikes. These management strategies fell under two main categories: slowing the rate of digestion (and thus the uptake of glucose), and speeding up the insulin response. For many of the strategies, Mr. Scheiner shared detailed case studies, data from scientific literature, and even some humorous lines about his perspectives on these management strategies.

  • Mr. Scheiner set realistic definitions for ideal postprandial blood glucose levels based on clinical experience and achievable results for children, adults, and pregnant women. Despite different definitions of postprandial hyperglycemia between the ADA, European Diabetes Policy Group, AACE, and other organizations, Mr. Scheiner offered his own benchmarks for postprandial glucose goals. His goal range for children was <200-240 mg/dl at peak levels (<100 mg/dl rise from fasting); for adults < 180-200 mg/dl at peak (<80 mg/dl rise from fasting); for pregnancy <140-160 at peak (<60 mg/dl rise from fasting). In comparison, the ADA recommended <180 mg/dl 1-2 hours after the start of the meal, the AACE recommended a peak of <140 mg/dl, and the European Diabetes Policy Group set the recommended peak at <165 mg/dl – all highly unrealistic goals according to Mr. Scheiner. In reality, despite the <200 mg/dl goal set by him, the average peak blood glucose in a study of children with diabetes was 293, 291, and 280 mg/dl after breakfast, lunch, and dinner respectively (Boland et al., Diabetes Care 2001). According to ADA goals, less than 10% of children met this goal, and as much as 46% of children in the study were over 300 mg/dl.
  • In addition to setting benchmarks, Mr. Scheiner highlighted the risks of postprandial hyperglycemia – both immediate to long-term effects. A study of Australian children with type 1 diabetes found that 68% of the participants reported negative impacts on thinking. Furthermore, postprandial glucose above 200 were linked to an almost 50% increase in cardiovascular disease mortality. CDEs in the audience noted that postprandial glucose had a direct effect on fetal development and growth, for patients with gestational diabetes. In addition, it was not uncommon for patients with diabetes of all types to have fasting blood glucose in the normal range, but still have high A1C, a discrepancy that is attributable to high post-meal glucose. Most importantly, it seems that there is a very high association of risk for complications – particularly for cardiovascular disease.
  • In order to manage postprandial glucose spikes, Mr. Scheiner offered two synergistic methods – slowing down the rate of digestion and speeding up the insulin response. More specifically, to slow down the rate of digestion, he recommended food choice-oriented solutions such as eating food with low glycemic index, saving a portion of a full meal for an hour to 90 minutes later, and sequencing meals by eating vegetables before other portions and designating lunch as the higher-carb meal. In addition to the solutions involving food choice, he mentioned physical activity after meals, and adding acidity to these meals through vinegar. Citing a study, he noted that adding acidity such as vinegar to meals was shown to reduce 60-minute glucose response by up to 55%. Finally, he also offered medicinal approaches, in particular beta-glucosidase inhibitors, GLP-1 agonists, and especially pramlintide. Mr. Scheiner believed that pramlintide was the most potent medication for improving postprandial glucose for both type 1 and type 2 diabetes patients, and cited a study with significantly lower postprandial glucose over a 6-hour time frame. (p=0.005 for type 2, p<0.001 for type 1; Fineman et al. 2002).
  • In order to speed up the insulin response, he provided insulin dosage techniques, and lifestyle habits to supplement the slower digestive process. He encouraged patients to use rapid analog insulin, choose an appropriate insulin program, and engage in post-meal physical activity to stimulate insulin response. Mr. Scheiner also recommended heating the site of injection in order to speed the delivery of insulin. He shared information about an experimental device called “Insupatch”, a heating element in the pump infusion site to fit this purpose. Another proposed method of speeding delivery was to “liquefy” the site, and a pre-market mixture called Hylenex was under development to break down barriers in subcutaneous fat to insulin delivery. Furthermore, Mr. Scheiner laid out a chart for timing of bolus insulin based on the glycemic index of the meal and blood glucose before the meal. Timing of bolus demonstrably improved A1C levels by 0.4% compared to a baseline of bolus timed with the meal instead of before (Duran-Valdez et al., 2012).

Questions and Answers

Q: Why does anybody check the 2-hour postprandial glucose rather than the 1-hour interval? Doesn’t postprandial glucose peak at about an hour and a half?

A: You’re preaching to the choir here. [Laughter from audience] I always thought reading 2 hour post-meal glucose is like going skiing, going halfway down the slope, and then deciding whether you are going to ski or not. [More laughter from audience] If you want to find the peak check after an hour, and if you want to know whether your dose is correct, check at three to four hours.

Q: Do you have any thoughts on the use of psyllium fiber to slow down the postprandial glucose uptake?

A: Psyllium fiber use has been shown to have some effect on slowing the rate of digestion. My question is – how do you find a way to get more psyllium into your diet? It seems supplementing is the only way to do so as of now.

Q: Do you have any comments or experience on the use of Victoza in type 1 patients?

A: Lots. A lot of people with type 1 diabetes use Victoza successfully. It will have some effect on postprandial glucose, and a more pronounced effect on appetite. Victoza won’t be as effective as Symlin [pramlintide] in directly targeting postprandial glucose.

Q: Are there any specifics details on the effect of vinegar in slowing digestion?

A: The study that was done used the equivalent of two tablespoons of vinegar.

 

Breakout Session: Mentorship: A Strategy to Improve Clinical Skills

MENTORSHIP: A STRATEGY TO IMPROVE CLINICAL SKILLS

Davida Kruger, MSN, APN-BC, BC, ADM (Henry Ford Health System, Detroit, MI); Virginia Valentine, APRN-CNS, BC-ADM, CDE, FAADE (Northside Family Medicine, Albuquerque, New Mexico)

With the increasingly complicated landscape of diabetes treatment options, Ms. Davida Kruger and Ms. Virginia Valentine described the importance of mentorship and formal preceptorship training programs in improving HCPs’ clinical skills. Specifically, Ms. Kruger described how her practice used this training model to enhance clinicians’ diabetes management skills with regard to combination pramlintide (BMS/AZ’s Symlin, an amylin analog) and basal insulin treatment. In writing the grant for this project, Ms. Kruger noted her deliberate decision to make her project CME-based so that mentors could to talk about “real issues” and answer questions that they might not be able to in other settings; she emphasized that the mentorship process is critical given that healthcare professionals often find it difficult to get the answers they really need with the increasingly stringent FDA restrictions on what can be said in promotion of different drugs. She also noted that it is important to identify chair people, other experts, and clinics that will be champions for the cause. By having these cornerstones in the process, the ability to teach non-experts becomes much easier. Ms. Kruger conducted a small study in which HCPs participated in a CME-based preceptorship program to learn about the multiple hormones involved in postprandial glucose control, the benefits of amylin therapy in insulin-requiring patients, and developing individualized treatment strategies using amylin as an adjunct to insulin (n=24 patients under the care of HCPs participating in the study). She remarked that at the end of the study, these HCPs patients (with both type 1 and type 2 diabetes) saw a reduction in postprandial hyperglycemia, A1c (an average reduction of 3.7%, though p=0.075), and overall weight (an average of 2.45%, p<0.001). Learning how to use pramlintide under the mentorship model not only created a new generation of experts and improved patient outcomes, but fostered a sense of group learning that encouraged the team to ask questions and work as a group, exactly what it means to be a mentor.

Question and Answers:

Comment: There are some patients who give themselves more shots of insulin than are really necessary; they give a shot of insulin at dinner and then again two hours later. So, many patients find that they give more shots when they are on insulin than when they are off, say, taking pramlintide.

Ms. Kruger: A lot of time the extra injections may be because patients are frustrated with a post-prandial rise they are seeing; they might be frustrated because their basal is fine, but they are still spiking. What is nice about pramlintide is that it prevents spiking, so many of my patients who were taking seven or eight injections and began taking pramlintide found that they were taking fewer overall injections; they were not chasing their glucose levels.

Q: I have been the mentor to several people. I am wondering what you would do differently with technology and mentorship. Some interesting technologies have recently come up – how would you integrate these into your guidance?

Ms. Kruger: I would use more CGMs so patients could see what was happening before and after they ate, took insulin, or did anything else.

Ms. Valentine: Technology really opens communication between the mentee and mentor. There is an immediacy with texting and email.

Ms. Kruger: Or even Skype or FaceTime. I think we did more than 500 professional uses of CGM. We were thinking: our practice just roles with it. We have had 15 CGM starts this week. The start is not as bad as the interpretation. We have maybe 50 patients who send their results in on their own on a regular basis. I look at that these readings after 30 years in practice, and I feel like I was blind for the first 25 years. Now all of this data is in front of me, and patients can see what I am talking about. Patients understand what you are talking about so much faster when you are able to show it to them.

 

Breakout Session: Diabetes Education and Weight Management Programs: An Ideal Partnership for the Future

DIABETES EDUCATION AND WEIGHT MANAGEMENT PROGRAMS: AN IDEAL PARTNERSHIP FOR THE FUTURE

Kendall Smith, MPH, RD, CDE (Phoenix Children’s Hospital, Phoenix, AZ); Christine Roberts, PhD, MBA (Phoenix Children’s Hospital, Phoenix, AZ)

In one of the first talks of AADE 2013, Ms. Kendall Smith and Dr. Christine Roberts used the example of their collaborative intervention for children with type 1 and type 2 diabetes to reflect on some best practices for improving treatment accessibility and coordinating care. Ms. Smith began by describing the challenges of providing diabetes self-management education at the Phoenix Children’s Hospital. The hospital serves an expansive metropolitan area that many children and families (for whom Spanish is their primary language) must travel several hours to reach. The program serves a total of 1,336 children with type 1 diabetes and 69 children with type 2 diabetes. Ms. Smith explained that the diabetes education program used the process for establishing ADA Program Recognition to overhaul their approach, which allowed them to move away from one-on-one patient-care-provider interactions to group interactions. The Phoenix Children’s Hospital weight management program CARE (Cardiometabolic Assessment, Research and Education) was described by Dr. Roberts, who highlighted their research registry, capacity to undertake clinical trials, translation services (the facility runs a Spanish-language DPP program), and education services that rely heavily on nutrition and healthy lifestyle education. The partnership between the diabetes education and weight management program focuses on providing non-disease specific healthy lifestyle education to CDEs, and supporting a rotating clinical structure where a healthcare team consisting of a physician, CDE, psychologist, research coordinator and CARE program personnel all rotate around a patient for 30 minutes each. This structure is meant to make the most of a patient’s time at the clinic. We found it interesting that a key feature of the diabetes education program is to teach patients and their families the difference between child diabetes and adult diabetes, as most of the children will have a close family member with diabetes as well.

  • Program outcomes demonstrate increased exposure to AADE 7 Behaviors. Before the program collaboration, tracking indicated that patients were exposed to an average of three behaviors. With the collaboration in place, patients now see an average of six behaviors, between three with the physician, four with the CDE and four with behavioral health groups. The most heavily covered topics between these three HCPs were Eating, Being Active, and Healthy Coping.
  • Coordinating services has allowed the program to triage care and save CDE hours. Having more classes help cut down on educator work, giving them time to work on program development and working with remedial kids. In 2012 all pump education was done by educators and took 87 hours. By May-July 2013, when the collaboration initiated pump classes, the same number of families (23) was taught, but using only nine hours of educator time.
  • The chief lesson learned was that communication and buy-in are key. The speakers noted there was staff resistance to changes that came with program redesign, in part because change can be seen as criticism. Challenges also incurred from moving from one-on-one sessions to a class model. Patients also need to be informed of changes, as they’re sometime used to seeing the same providers over years. Upper administration support was critical.

Questions and Answers

Q: Is there a way we could get access to neutral disease management tools?

Ms. Smith: I think that is a goal. We are looking at a revision of our website, with a potential of an existing grant to focus on adding diabetes applications where we can host our education materials online.

Q: When you provide intensive coaching, do you bill for phone call and emails after the coaching?

Ms. Smith: No we do not; this is an idea that came from the educators themselves at the Kaizen event. They felt it was extra work, and better for the patients not to. We assign kids two educators, and each educator can have a maximum number of kids.

Q: How long is a patient in the T2 clinic, and how many can you see in a morning?

Dr. Roberts: The visit is an 1.5 hours, with 30 minutes in the clinic visits. We see six patients in a morning. Three patients come in at the same time and the providers rotate around them.

Q: How do you mandate post-pump after pre-pump. Nobody comes to our post-pumps.

Dr. Roberts: We really emphasize building relationships in person. Then on the phone we remind them of labs and appointments.

Ms. Smith: That has been a major paradigm shift. Our program doesn’t have an administrative assistant, so we’re making all those phone calls. We let them know from the outset, if you want to go on a pump, here’s exactly what you need to do. We let them know post-pump is a benefit. When they interact with other families, that’s when a lot of learning happens.

Q: I work with people with multiple comorbidities, but you can only bill the top 4 diagnoses.

Ms. Smith: You can’t bill DSMT and MNT on the same day. Our education is not assessment, so we’re very strict about that with regards to billing.

 

Breakout Sessions: Novel Nutrition Interventions for the Prediabetic State: Specific Dietary Components Prevent Diabetes

NOVEL NUTRITION INTERVENTIONS FOR THE PREDIABETIC STATE: SPECIFIC DIETARY COMPONENTS (PRELIMINARY RESULTS)

Shelley Mesznik, MA, RD, (Columbia University, New York, NY), Patricia Davidson, MS, RD, CDE, (St. Clare’s Health System, Denville, NJ)

Ms. Shelley Mesznik and Ms. Patricia Davidson detailed novel nutrition interventions in prediabetes and metabolic syndrome. They began by outlining the objectives used to define the diagnostic components and the pathogenesis of prediabetes (PreDM) and metabolic syndrome (MetS). The focus on the nutrition guidelines for prevention of type 2 diabetes poses the question as to whether there is a diet that can reduce risk for type 2 diabetes, independent of weight loss. According to Ms. Mesznik the novel aspect of this approach is its analysis of clinical outcomes with respect to dietary treatment for metabolic/anthropometric parameters of the prediabetes state to reduce the risk, not the outcome of developing type 2 diabetes. The PreDM and MetS populations were considered separately. To define prediabetes, literature including both metabolic syndrome and prediabetes were analyzed due to disparities in international definitions. Recommendations for prevention of type 2 diabetes were independent of weight loss and included medical nutrition therapy (MNT), macronutrient distribution, weight loss, glycemic index/glycemic load (GI/GL), protein type, fat type, carbohydrate load, and physical activity. It was recommended that MNT, macronutrient distribution, and weight loss should always be prescribed concurrently, but specifically to the individual. The results of this meta-analysis used to make recommendations lacked specificity and were too vague to be used as strict guidelines. It seems that we should wait until concrete research that specifically targets these questions are published before attempting to make generalizations on recommendations for patients to prevent their diabetes.

  • The recommendations for Medical Nutrition Therapy are to provide MNT and increase the frequency of encounters between the patient and RDN to optimize outcomes in individuals who are at high risk for type 2 diabetes. The analysis of 7 studies all presented different definitions of macronutrient distribution in diets, which rendered analysis insignificant. The project concluded that the RDN should individualize the nutrition composition based on DRI requirements.
  • Weight loss was found to be a key cofactor in several behavioral recommendations: for those with PreDM who were also overweight or obese, just a 2.6-7.1 kg weight loss significantly decreased waist circumference, fasting blood glucose, triglycerides, and blood pressure. In the MetS population, weight loss range from 1.1-13 kg was associated with significant improvements in A1c, triglycerides, waist circumference and systolic blood pressure.
  • Reduction of GI/GL from load and without weight loss improved postprandial blood glucose levels, however, the results were not significant. Limited research has been done on both adults with MetS and individuals with PreDM.
  • In analyzing type of protein, no studies were found that looked at a true vegetable protein diet versus an animal protein inclusive diet. It seems that this diet consisting of only vegetable proteins cannot hurt, but research on this would be helpful in determining a conclusive recommendation. Without weight loss, the effect of unsaturated fat was found to have either no or inconsistent effects; the type of fat alone is not enough to produce health effects.
  • In MetS, modern intensity of physical activity at 135-180 minutes per week, independent of weight loss, reported significant improvements in triglycerides, waist circumference, and blood pressure (systolic and diastolic). In those with PreDM physical activity was not found to improve health measures alone, but did when combined with weight loss.

Questions and Answers

Q: With AJ [the case study patient], would you have considered adding metformin as a prediabetes medication?

A: Yes, we did recommend that. Because of the fasting blood glucose level and A1c we did, but his dose is only 500 mg.

Q: Just wanted to clarify, did I correctly understand that when you met with the patient, you analyzed his diet, determined his nutrient distribution, and then altered distribution (tried to keep carbs, protein between this and this percent)—is that the recommendation you gave the patient? Or just how you chart it?

A: Good question. Because this was over 6 months and weight loss was gradual, we tried to make changes very slowly. We talked about food changes rather than percentages to try to make him understand rather than telling him to measure percentages.

A: But I’m moving him in directions to use that as a goal, focus on the foods that are driving percentages higher.

Q: You said you followed the patient for over 6 months, how many sessions did you have, and how long were those sessions?

A: Every 6 weeks, 30-40 minutes

Q: Related to weight loss, would you recommend percentage of weight loss, or by pounds?

A: When I’m working with patients, it depends on if the patient is asking. If they say knowing a target number will help, we’ll do that. If they’re not asking that, we look more at trends; you want to know things are trending downwards and going in the right direction, because you’re looking at the behavior more specifically.

A: As little as two kilograms of weight loss can cause significant changes, so we don’t use X amounts unless the patients want us too.

A: Some other times, they’re already within range, so that doesn’t work.

Q: I wanted to ask about the composition of macronutrients—I’m not sure I’m understanding it. Your case study improved parameters due to weight loss, but regarding the shift of macronutrients, this weight loss wasn’t necessarily because he changed his dietary composition.

A: We can’t say the change [in parameters] is there because of the diet, we can say the change is there because of the weight loss.

A: We cannot say for certain the change is there because of the macronutrient distribution; there were synergistic effects

Q: So we don’t know if we cut the calories, but kept the same percentage of macronutrients, if he would have improved his parameters?

A: Right, yes. That’s what we can’t determine. If we lower the calories, you’re going to lose the weight, but based on our recommendations, we can’t say that just because we changed the percentage of macronutrients or shifted from refined to complex carbs that makes a difference. That is why we have our recommendation that whatever weight loss is possible, that is what we want to focus towards. Changing the macronutrient composition is great, but weight loss in general is more important.

Q: With physical activity, if the person stays the same weight, eats the same, but moves more often, it doesn’t really change any parameters?

A: The glycemic levels weren’t significantly changed.

Q: The presentation said 30% of prediabetes will go on for type 2 in Europe, but you said 50% in America?

A: Yes, that’s generally what you find.

Q: Any plans to do something similar for pediatrics?

A: Good question. We debated this. But metabolic syndrome isn’t really there in children because of development differences.

A: We did include children in Q/A on prediabetes, but there weren’t many.

Q: There was a question that DPP4 talks about prevention projects, and their stats were 58%, just trying to understand and clarify because you say 30% of people prediabetes go on to develop type 2 diabetes.

A: 30% stay with prediabetes, and 30% go on to type 2 diabetes, so overall 60% don’t have normoglycemia.

A: Part of the issue is that DPP4 is international, which would drive the numbers differently. Does that make sense?

Q: I guess. The presentation goes quickly through a lot of information, so I think I need to reread it. There’s a lot going on here, so what’s happening is that we’re talking about different studies and different parameters. The part that I’m getting is that you separate it independent of weight loss, but then you say weight loss has to happen. I don’t really understand what you’re trying to say.

A: Weight loss is the key thing that we found that is consistent where if it happens, we see improvement in these parameters. But if you see weight loss out of the picture, and you look at basic components of the diet, that itself doesn’t seem to show. The research is so isolated in looking at specific types of fat, types of diet, that the real takeaway is that this population needs to be studied more to see more of what it is we can do to help them.

Q: If you have someone coming to your practice where weight loss is not appropriate (normal or low weight) but they do have prediabetes, where would you go?

A: Do an assessment of their diet based on their macronutrient balance. Perhaps their diet is still off balance so you can really help them and get them to start a better diet.

A: That’s why the recommendation for weight loss needs to be personalized. We may need to look at different populations—whether its changes in weight circumference, visceral fat, etc. Mixed results are very difficult to report. It’s not that it wasn’t there, it’s that they were significant enough across the board.

A: Yes, a lot of the skinny diabetics I see are older, and they weren’t heavily included.

Q: Are you going to try to pitch this information to insurance? I have a RD that consults my practice, and I can’t get them to pay the money to do this. So is this part of your plan?

A: The academy is working on that. It is the information we take to them.

 

Breakout Session: Get Your Clients to Achieve Weight Loss at Your Healthcare Facility or Place of Employment

GET YOUR CLIENTS TO ACHIEVE WEIGHT LOSS AT YOUR HEALTHCARE FACILITY OR PLACE OF EMPLOYMENT

Nessie Ferguson, MS, RD, CDE; Kristina Volkmer, MPH, ACSM, CES (The Nebraska Medical Center, Omaha, NE)

Ms. Nessie Ferguson and Ms. Kristina Volkmer presented an in-depth description and analysis of their program “Eat, Walk, Talk,” implemented at the Nebraska Medical Center. They provided a brief background on the current state of health in Nebraska: in 2009, less than a quarter of Nebraskan adults consumed five or more servings of fruit and vegetables; primary diet consisted of beef and potatoes; only 20% of Nebraskan adults reported getting 150 minutes of exercise a week. They outlined the key components of the program and explained how to make it effective and sustainable. They reported successful results from the program as evidenced by reported and/or observed sustained weight loss and management, exercise regimen adherence, and group support. The objectives of the program were to explore effective aspects of weight management, identify target client populations to implement a successful weight loss program and demonstrate effective partnerships with employee wellness departments. The top four health characteristics targeted were hypertension, hyperlipidemia, diabetes, and stress management. Employee participation was proven to improve fitness and motivation. Participant evaluations showed high recommendations of the course overall, and some were quoted describing it as “excellent”. The primary take-home messages of the course were to stay committed, maintain a positive upbeat-attitude, remain current, have fun, and collaborate with the healthcare team.

  • The program included a full spectrum of medical care physicians and specialists, including exercise specialists. The corporate track program costs $100 per participant for eight weeks of session, and the corporations offered their employees incentives to participate. In-house track sessions cost $70 per participant for six weeks with weekly private weigh-ins.
  • The Eat component of the program consisted of an individualized structured, meal plan between 1200-1600 calories. The plan included two meal replacements per day, a weekly shopping guide, recipes, and a diabetes-specific cookbook. Calorieking.com and myplate.gov were used to track food and determine appropriate serving sizes, respectively. Mindfulness, in combination with the hunger scale, were emphasized to prevent overeating and excessive snacking. The Eat segment sought to implement behavior change and environmental control to assist in sustaining the new diet. Nutrition lessons were provided on various aspects such as the benefits of unsaturated fats and omega EPA and DHA, ancient grains, sugar substitutes, probiotics, calcium and fruits and vegetables.
  • The Walk component highly emphasized walking and provided pedometers or accelerometers to be used for measuring and tracking steps. 10,000 steps per day were recommended, not including exercise. Myfitnesspal.com was recommended to track all exercise. Resistance training was encouraged by incorporating hikes to local trails. Flexibility and stress management were also stressed and motivation was constantly a difficult challenge to overcome.
  • The Talk component focused on group support, discussions, sharing of insights and tips, incorporating relevant topics, and managing stress. Evaluation was a continuous process and group members were asked “Where are you now? What are your goals” to be held accountable by each other.

Questions and Answers

Q: How long are the sessions? How do you make it so affordable?

Ms. Volkmer: They are 45-60 minutes and all topics are covered. We have new management

Q: What kind of participation numbers did you have? Did they stay?

Ms. Volkmer: I think, because can go where they are, and accessibility is one of our features that works well for us, people stayed. But, I do not know the answer to that specific question; however, the power of the group was high. They brought their pedometers with them and were held accountable by their partners. Very rarely did people drop out though. Because $60-70 is expensive to some, they see value in and commitment to the course and, they like us.

Q: What are the statistics for keeping the weight off?

Ms. Ferguson: On average, they lose 2lbs/week if they stay with the menu plan, but we didn’t do research to determine this. In the corporate program, we do not weight them; we just rely on their personal testimonials. We only track weight in our own clinic and had great success, but I cannot give you statistics on the corporate programs.

Q: I have trouble helping people follow through where I work. Do you use Power Point slides and do you do walking together?

Ms. Ferguson: We never use Power Point slides and walking is done on their own. They report to us on their exercise regimens.

 

Breakout Session: The Role of Promotores de Salud in Primary Prevention of Diabetes

THE ROLE OF PROMOTORES DE SALUD IN PRIMARY PREVENTION OF DIABETES

Betsy J. Rodriguez, RN (National Diabetes Education Program Centers for Disease Control and Prevention, Atlanta, GA)

Ms. Betsy Rodriguez spoke about the significance of Community Health Workers (CWH) and implementation of the Road To Health toolkit (RTH) on improving diabetes outcomes among low-income and racial and ethnic minority patients. The CHW is a frontline public health worker who is a trusted member of the community with which he/she is involved. She emphasized that close relations to the community facilitate trust and access to services used to improve the quality and cultural competence of service delivery. The interventions by CHWs have been found to be a promising strategy for improving diabetes outcomes. Ms. Rodriguez’s passion as she discussed improving prediabetes care to underserved and/or migrant areas not only made hear choke up, but inspired another member of the audience to stand up and, with tears in her eyes, express her appreciation for Ms. Rodriguez’s work. This was yet another example of the incredible passion that so many educators have for their work and the populations they help – we were incredibly moved by this talk.

  • In 2010, funding was authorized by Affordable Care Act to bring a new arena to include CHW into the healthcare team. The estimated annual cost savings using CHWs in the community was $2,000/medical patient with diabetes. The Wake Forest Baptist Study on Diabetes Prevention Program led by CHWs concluded it is effective in reducing blood glucose of patients at risk. Ms. Rodriguez explained that the purpose was to take this intervention out to people in the community rather than having them come to a clinical setting; this study shows an effective means for providing care and inspiring change.
  • The Road To Health toolkit (RTH), a toolkit on primary prevention of type 2 diabetes, was developed as a tool to be used by CHWs. The RTH toolkit encourages healthy food choices, increases in physical activity, and promotes moderate weight loss for those who are overweight. Events involving the community were hosted and activities were provided that incorporated the RTH toolkit. Users gave overwhelmingly positive feedback and thought it was easy to use. Reflecting on her lessons learned, Ms. Rodriguez concluded that the best curriculum is one based on the patient and focused on preventing diabetes within the context of their stories and their experiences. CHW/Promotores can improve access to diabetes prevention education and the RTH offers an effective alternative approach for providing group or individual diabetes primary prevention education to underserved individuals with low health literacy.

Questions and Answers

Q: How are the areas that are promoting CHW being identified?

A: As one example, the migrant health promotion works mostly with the Latino population in the border states and is one of the oldest organizations using CHWs.

 

Breakout Session: Improving the Diabetes Knowledge in Primary Care Nurses Using Innovative Tools

IMPROVING THE DIABETES KNOWLEDGE IN PRIMARY CARE NURSES USING INNOVATIVE TOOLS

Kimberly Joy Lopez Carney, DNP, APRN (VA Medical Center, Fayetteville, AR)

Dr. Kimberly Joy Lopez Carney presented results from her study examining the impact of a US diabetes Conversation Map to improve diabetes management in the veteran population in the Veterans Health Care System of the Ozarks (VHSO). The US diabetes conversation map is a town map that is used to start conversations about how much to eat, when to eat, and how people feel about food, among other topics using game cards as discussion points. The aim of the project, she remarked, was to increase the diabetes knowledge in primary care nurses in the VA system. From the literature review conducted before the study, Dr. Carney remarked that there is evidence that the Conversation Map is an effective tool for nurses to gain knowledge they currently lack. The 46 volunteer primary care nurses received four hours of diabetes educational intervention, taking a diabetes basic knowledge test (DBKT) before and after the intervention. Consistent with previous research, the study that Dr. Carney presented demonstrated that the use of conversation maps at the VHSO significantly improved diabetes knowledge in primary care nurses (p <0.05 for scores >80% on the DBKT before and after map use). Because of the improvements in knowledge, the program at VHSO will continue to be offered for three hours on a monthly basis for two years. Dr. Carney noted that future studies plan to examine the impact of this improved nurse knowledge on patient outcomes in the VHSO. We appreciate this increased emphasis on nurse education, especially as, like Dr. Carney emphasized, the prevalence of diabetes continues to rise. We hope that other institutions will follow the lead of VHSO and find methods to increase nurses knowledge of diabetes, and we look forward to hearing how these increases in education impact patient outcomes.

 

Breakout Session: The Adequacy of Insulin Knowledge of Staff Nurses at a Major Academic Medical Center

THE ADEQUACY OF INSULIN KNOWLEDGE OF STAFF NURSES AT A MAJOR ACADEMIC MEDICAL CENTER

Regina Bonnette, MS, RD, LD, CDE, BCADM (Nurtur Health, Dallas, TX)
Nancy Drobycki, MSN, RN, CDE (UT Southwestern Medical Center, Dallas, TX)

Ms. Regina Bonnette and Ms. Nancy Drobycki began by noting that insulin is increasingly being used instead of oral agents to achieve glycemic control in the inpatient setting. However, there may be gaps in knowledge regarding insulin use among nurses who graduated more than ten years ago, as many new types of insulin have been introduced in the past decade. Accordingly, the presenters conducted a study that assessed current understanding of insulin knowledge and protocols at the UT Southwestern Medical Center. 132 RNs were asked to take a brief insulin knowledge assessment. The mean rate of correct answers to the assessment was 67.4%. Notably, education, degree, staffing unit, or years of experience did not impact the number of correct answers. For questions on treating hypoglycemia in conscious patients, defining split mixes, syringe mixes, and premeal insulin, over 80% of nurses chose the correct answer. Questions regarding Novolog onset and peak, scaled use, NPO insulin, and pumps, however garnered correct responses less than 60% of the time. Perhaps most surprisingly, questions on pump use had an average correct rate of merely 30%. After the baseline knowledge assessment, an online training module was implemented as an educational intervention  A post-test was then administered to assess the efficacy of the module, which used the same questions as the pre-test. The intervention overall showed 5% improvement, with individual questions ranging from -3% to 15% increase in percentage of correct answers. The results from this study imply that there is a heavy need for ongoing insulin education for inpatient nursing staff, particularly as pumps become more widely available and new insulin formulations are marked. Such education could feasibly be delivered through either interactive online or classroom methods.

Questions and Answers

Q: I was looking at a study that examined cardiac inpatient units that help facilitate [glucose control]. I’m fascinated with your notion of keeping a nurse in the room for 15 minutes after insulin infusion. How were you able to convince nurses and administration around this mechanism, etc.?

A: It’s actually not the nurse that has to stay in the room, it’s the patient care technician. We talked a lot about scope of practice, and the nurse can delegate that task. Obviously the nurse is responsible for the treatment of hyperglycemia, but the patient care technician can do the point of care blood glucose testing. We’re not leaving the patient alone, and if their symptoms worsen, someone will be there. If we leave and come back and they’re worse or unconscious it’s bad. That’s why we leave the patient care technician there.

Q: As someone living with type 1 diabetes, I am thrilled to see any educational effort that helps providers work better with insulin. I have a multi-pronged question. I have diabetes, and one of my biggest fears is ending up in the hospital. It’s not about why I end up in the hospital, but rather what’s going to happen to me and my diabetes while I’m in the hospital. My understanding is that people in hospitals typically want to keep blood sugar quite high out of fear of patient going low. As someone with tight control, that makes me nervous. Is there any attention being put on maybe not keeping people quite as high?

A: I’ll be happy to answer that. At UT Southwestern, our patient goal 140-180 for patients not in the ICU; keep in mind this is individualized in our facility. We have certain patients for whom, if they’re normally under 140, and that is the patient/physician decision, we will individualize our blood glucose targets. If someone has type 1 diabetes and is very insulin sensitive, we’re going to be very conscious to try and not drop them. But generally when you’re ill and in the hospital, you’re going to be very high. We want to make sure we’re following the insulin regimen you follow at home as close as possible—that is something we try to address.

Q: Is there a patient bill of rights? Can I say I will manage my own diabetes, or how should I talk to the nurse to get her on my team as opposed to this being adversarial issue?

A: We do hand out a patient bill of rights, and we actually have something called a “Speak Up” brochure in Spanish or English.  If a patient has any concerns about their care, we do encourage them to speak up. Having said that, we’ve found that that is really an ice breaker, that if a patient has a concern about their care they are free to speak up. I have yet to come across a nurse in my facility who does whatever they want to do without first consulting with a provider.  We have had issues in the past, and they have been dealt with seriously. One of the big culture changes in nursing (been a nurse for 31 years) is that a patient is really the expert in their diabetes. They know it better than I do, and better than you do. One other thing you brought to mind is we do have an inpatient diabetes management team, who are spearheaded by our endocrinology group. Two nurse practitioners are CDEs, two on their way to CDE. Patients on U500 receive a consult

Q: I’m curious as to what sources of carbohydrates you keep in the patient’s room in case of hypoglycemia? I find lots of times in my hospital the tray comes in and the whole family eats off it, so it’s difficult to keep food in patients’ rooms.

A: We’ll put juice and apple sauce in there. We put a note by them that says it’s potential treatment for them. The nurses explain that to the family and the patient, and usually the family is used to having the patient have low blood sugar at home, so they will generally leave it at home. We will take glucose gel and lock in our patient’s room, but the preference is to just use the food and juice.

Q: I was wondering how you were able to keep your classes going, and pull nurses away during the day? Where I work they tend to tell us that they don’t have the time and they’re too busy for this sort of education program.

A: Great question. I actually survey the nurses what time is the best time they could attend a resource/infusion class. I usually do that at 7:30 in the morning on a couple different days. I try to alternate days. I do the same with the diabetes nurse resource class. They are paid for the time, and they generally aren’t working on the ICU at the time, because the class is mandatory to do once every 2 years. One of the other things too is that when I do this class, I survey them for topics of interest they would like to see presented in the annual diabetes day in November, as well as what I need to emphasize in the course. This is very important because I need to teach to relevance.

Q: Could you address what you’re using for your severe hypoglycemia, since D50 is currently very scarce right now?

A: As long as they’re conscious, and able to take their treatment p.o., we double their oral treatment.

Q: I’m talking about when they’re not conscious?

A: We use D50 for our unconscious patients. The pharmacy has rigged up some syringes for us. So far we’ve been okay, and haven’t run out of D50. We don’t get very many unconscious lows. But yes, it’s been a big concern. We are very careful when we put gel in our formulary to remind people that’s really not the treatment for unconscious patients. The pharmacy initially thought “oh good we can just use these [on unconscious patients],” when D50 supplies are running short. That’s wrong.

Q: Do you use glucagon?

A: We do. We have to warn patients that glucagon doesn’t always work, but it is on our protocol. We haven’t had to do that for so long, we’ve had to retrain ourselves. It’s amazing what that D50 shortage has done to tighten up our policies, since we realize we really can’t take that risk of having that severe an episode of hyperglycemia.

 

Breakout Session: American Association of Diabetes Educators Diabetes Prevention Program (AADE DPP)

AADE DPP PART OF THE NATIONAL DPP IN PARTNERSHIP WITH CDC

Joanna Craver, MNM (Diabetes Prevention Program Manager, AADE, Chicago, IL)

Ms. Joanna Craver reviewed the rationale and results of the NIH’s landmark DPP study and how this evidence has informed the development of the National Diabetes Prevention Program (NDPP). Working with the Diabetes Training and Technical Assistance Center (DTTAC), AADE has been training diabetes educators in a three-day training program to implement the NDPP curriculum. The AADE DPP is in its first year and is currently being implemented in Alabama, Florida, Kentucky, Louisiana, Michigan, Mississippi, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, and West Virginia. With a goal of enrolling at least 300 participants in the first year, over 400 have already enrolled.

 

Breakout Session: Patient Centered Outcomes Research and Comparative Effectiveness Research for Diabetes Educators

PATIENT CENTERED OUTCOMES RESEARCH (PCOR) DISSEMINATION BY HEALTH PROFESSIONAL ASSOCIATES

Ruth Lipman, PhD (Chief Scientific and Practice Officer, AADE, Chicago, IL)

Dr. Ruth Lipman reviewed the concepts of comparative effectiveness research and patient-centered outcomes research and provided attendees with resources to access such information. As an example for how badly patients and providers need tools to help cut through the noise of “evidence,” Dr. Lipman cited a recent article in the popular media claiming that avocado seeds could cure diabetes. In a PubMed search of “avocado seed” and diabetes, she found one article stating that it had identified a bioactive phytochemical in avocado seeds that increased glucose uptake in muscle cells in culture – a far stretch from curing diabetes. She pointed to the Patient Centered Outcomes Research Institute (PCORI) as an ACA-funded initiative that will fund evidence-based research to help patients better understand the value of prevention, treatment, and available care options. Additionally, she suggested that the NIH-funded GRADE study would be instrumental in giving prescribers the confidence to tell patients and their families how different second-line therapy options compare head-to-head. She provided a hierarchy of study-designs to help audience members assess the evidence base – at the top she placed systematic reviews, followed by RCTs, cohort studies, case-control studies, case reports, and expert opinion. Finally, she directed audience members to PubMed, Cochrane Reviews, association evidence-based guidelines (e.g., the ADA/EASD or AACE guidelines), AHRQ, the CDC, and AADE.

Questions and Answers

Q:  It feels like CER is foundational to tools being created. Is there any effort to be transparent in the use of such research to create the tools? Will AADE be a leader in that so that when we find these types of tools out there we can have a sense of where the information came from?

A: It’s always good to question where materials come from. I would say that anything AADE puts out there will have a bibliography with it so you can look and see where the information comes from. So if it all comes from a drug company – and sometimes the research by a drug company is really the best that is out there – but you at least know and can take that into consideration when putting the information into context.

 

Workshop: Culturally Sensitive Diabetes Education in Minority Populations: Strategies to Success

DIABETES IN AFRICAN AMERICANS: URGENCY FOR CULTURAL COMPETENCE IN EDUCATION AND TREATMENT

James Gavin III, MD, PhD (Emory University School of Medicine, Atlanta, GA)

We always love getting to hear from charismatic speaker Dr. James Gavin III (Emory University School of Medicine, Atlanta, GA). In a valuable talk on the importance and urgency of cultural competency, Dr. Gavin emphasized understanding the foundational problems of health disparity in order to comprehend the true significance of cultural inequalities and their effects on healthcare outcomes. He stressed how the combination of socioeconomic factors and inadequate lifestyle and thrifty genes may contribute to beta cell dysfunction, defects in incretin function, insulin resistance and abdominal obesity.  Wow. Very dispiriting. These propensities may be further exacerbated by biological and cultural factors that lead to frequent complications and increased mortality rates. Dr. Gavin recommended tailored approaches that are straightforward and easy to understand for high adherence, noting the weight and thought that should be put into cultural congruence. He concluded that a team approach aimed at improving outcomes and creating empowered patients is highly necessary, especially considering demographic trends towards increasing diabetes prevalence in minority populations. Many in the audience verbalized that such a remarkable presentation should certainly have been given a more ‘prime’ time slot – presumably conference organizers placed him in the last time slot to encourage more attendees to stay until the very end. Nonetheless, we certainly wish many more had been able to attend Dr. Gavin’s noteworthy presentation. 

  • “Diabetes favors minorities.” Dr. Gavin presented several slides expounding on biological differences among ethnic groups that act as contributors and explanations to healthcare disparities. He cited a study by Chiu, et al. (2000) demonstrating differences in insulin sensitivity in nonwhite Hispanics, Blacks, Asians, and Mexican Americans, noting that in analyses of young, lean populations, these differences represent legitimate biological differences and inherent genetic resistance or susceptibility. End stage renal disease, as well as higher A1c levels, have a higher prevalence in communities of color. As Dr. Gavin suggests, there is a growing body of data to suggest the genetic, environmental, and sociocultural factors that so irrevocably contribute to the prevalence, development, and course of diabetes in minority groups.
  • Differences in quality, access, and, exposure to preventive or curative services, and physiological stress create huge disparities in healthcare. Fighting these disparities, whether they result from race, socioeconomic status, sexual orientation, gender or geographic location is necessary. More important than initial differences are the subsequent gaps that arise even with proper attention. Differences in rates of recommended services (A1c testing, eye exams, foot exams, to say nothing of valuable technology like CGM or even syringes vs. insulin pens) are significant between populations when comparing race, income, and education. Dr. Gavin also highlighted several barriers to better health outcomes including emotional issues, lack of trust, and elements of cultural congruence. Patterns for chronic disease detection and management are influenced by different understandings of obesity and healthy body frames, unaddressed emotional issues, and educational exposure which leads to differences in clinical decision making, pursuit of clarity on confusing issues, treatment and follow up adherence, and importance placed on preventive care.
  • “Focus on blue jeans, not biological genes.” Dr. Gavin advocated prioritizing strategies that could cause significant change. Concerns of nomadic existences, lack of resources, anxiety and clinical depression, lack of confidence, and absence of cultural congruence were among the issues he listed as the most important barriers to be addressed. He stressed strategies of healthcare reform and insurance coverage to increase access, promoting racial diversity among HCPs, and creating opportunities for community outreach efforts and patient participation to implement change. In addition, focusing on specific ethnic issues and intercultural communication that acknowledges language discordance, health literacy, cultural believes, and administrative complexity can make steps towards improving cultural congruence.
  • Developed models of cultural competency education tailored toward improving patient satisfaction, decreasing costs, and improving outcomes in high-risk patients are necessary and urgent. Dr. Gavin pointed to demographic changes and trends as a further press for developing paradigms to improve outcomes and create empowered patients. Culturally congruent models representing local solutions to the global problem of healthcare disparity are much needed and should garner heavy attention and focus.

 

PANEL DISCUSSION

James Gavin III, MD, PhD (Emory University School of Medicine, Atlanta, GA)
Lenore Coleman, PharmD, CDE (Healing Our Village, Inc., Washington, DC)

Q: What are some of the best ways to build trust with patients?

Dr. Gavin: The issue of building trust has no easy answer. There are different thresholds for different people. But there are some things we try to teach, especially as part of cultural congruence. We encourage our people not take liberties with peoples’ names and titles. Someone is “Ms.” or “Mr.” until they give you permission to use their first name. There are circumstances where people in their community settings may be called Doctor, Reverend, or Deacon, even if they aren’t necessarily, that’s what they’re called, and that’s what you call them. There are some communities where firm handshakes are not the norm, and our attempt to establish trust and bond with a rigorous handshake is not the norm. I had a situation where we had lots of patients from Iraq. If they see the soles of your feet, that’s an insult. A trainee crossed his legs in a manner where they saw the soles of his feet, then didn’t understand why things deteriorated from there. It’s really about a series of integrations. Sitting down, instead of standing up, when you talk to a patient. Eye to eye contact is becoming a thing of the past (we’re looking at their charts on the computer), but it’s important. These are basic principles to help people see you as sensitive and worthy of a trusting relationship.

Dr. Coleman: Most of our Latino patients and African American patients like to chitchat. They like to talk. This is a simple thing that you may not have thought about, but don’t schedule them at the end of the day. If you get to four o’clock and have four or six patients left, you’re going to rush through them. Those are the folks that need to sit down, and they can’t be rushed. We will carve out 20 minutes, 30 minutes, that’s a lot, and ease into he conversation. Remember what they said on the last visit, and start by asking them about it.

Q: You never let me down, Dr. Gavin. Do you ever include physicians in your education when you come into an office? Sometimes they’ve made my work a lot harder by saying, “You never skip your insulin, you always check your blood sugar, don’t you?” I feel like there’s always mistrust because they can’t be honest.

Dr. Gavin: Do we ever. It’s something we insist upon. These patients that we work with never become our patients. We work with their providers. We go in with the idea that what we want to do is change their behavior in a way that will change the numbers on the board. We want to leave methods that allow that to be sustainable. And that begins with everybody changing. Especially you. We’ve had some pretty tough discussions where folks don’t want to step up and say what they’ve been doing has been short of optimal. Because this is a socially contentious issue, we have to get buy in from senior management.

Q: Just last week, I’m a CDE, and someone was admitted by alcoholism. I’m the CDE and I’m the only one to bring it up.

Dr. Gavin: Sometimes we can’t referee those things and have to retreat to a posture of a third neutral party when what we really want to say is “You got some funky stuff going on. This can’t continue.”

Dr. Coleman: A medical director at one of the biggest clinics wouldn’t allow us to go in because he did not want anyone looking at his charts. He asked, “What are they going to do?” We told them we’ll be looking at the charts and providing recommendations. [Shakes head no.]

Q: This is my first time at AADE annual meeting. Although you were the last session, this is one of the best I’ve been to all week.

Dr. Gavin: Make sure you tell them that.

Q: I was a little overwhelmed by how many attendees were women were here. I’m wondering if you have special training or tips, since a lot of women are taking care of your population. What can you pass on to us?

Dr. Coleman: As much as I can, I try to hire guys. But over the last three years, I see a lot more males going into nursing. This trend may shift. We’ll see. What I do with my female educators is really get them comfortable about conversations about impotence. I have to be comfortable talking to an African American male with hypertension about this. No hedging. You have to be frank and direct. We do a lot of teaming, and by osmosis we learn about football and basketball and stuff that helps with male patients and getting them to talk about their hobbies, which soften some of the barriers. We teach some of our educators to do that as well. To be able to talk to and relate to people of all genders, socioeconomic status, sexual orientation, I mean you have to. I hire people who are open and embracing.

Comment: My experience is that guys like when you can throw it back at them a little bit. When you’re the normal polite healthcare provider they tend to say “yeah, yeah, yeah.” I’ve had experience that they want a little ‘tiger in a tank’ to prove to them it’s worth it to spend time with you. 

Dr. Coleman: Yes. No one had ever challenged [one of my previous patients] but you have to get them to change. You have to be comfortable enough to develop techniques.

Dr. Gavin: As a slight footnote to that, especially regarding the issues on impotence and sexual issues, sometimes its an opportunity to establish a unique kind of communication level, because you’re trying to get permission to talk about something you recognize is sensitive.  You can say, ”This is something that I’m uncomfortable talking about as well, but with your medication and your treatments we have to talk about them. There are things we can do about it.” This opens up pathways around a lot of other things that they might not otherwise want to talk to you about, like issues with work or family. But by getting into these leads you can find out a lot of things that will help you.

Q: We’re doing a health disparities project in Texas. You’ve mentioned cities, but have you worked in rural areas where there is less access to care, literacy issues, and minority populations?

Dr. Gavin: We’ve focused pretty much in cities, but more because of opportunity than anything else. We’ve worked hard in developing what we think would be useful strategies in areas where the populations are more dispersed. You can do so many things now virtually. It can’t all be virtual. We fundamentally believe that at some point there needs to be some face time if you really want to benefit and form a relationship. In terms of education and awareness and monitoring changes, there’s a lot that you can do by using the platforms we’ve alluded to. We think there are ways to do it. We just haven’t gotten those opportunities.

Q: With the fact that there is disparity in minority healthcare providers, when you’re hiring and finding people, are you focusing on ethnicity to match them up? Because there’s not enough people. How are you meeting that gap? Or are you hiring anyone based on professional background?

Dr. Coleman: We try to get a raw cross section of races and ethnicities, but to piggy back, let’s say we got a contract from a rural health plan. We hire coaches from the local area, so they become Healing our Village contractors, because we believe that we need to have that cultural congruence. Language is a big deal. We need dialect. Often these people live and work together in the same communities. The local on the ground folks are generally from this area.

Dr. Gavin: Also, these people also know the geography. We don’t have time to be getting lost all the time.

Comment: Thank you for this. This was an awesome presentation. The person who did say how can I connect with my patients, I want people to be genuine. People can feel when you’re real. People can feel if you don’t like them or believe in them. Keep in mind that you might not like them, you might not say that, but you shouldn’t pretend to be false or phony. Patients say, “I don’t care if they like me, I just need to know what they know.” Someone said something about being a woman. Men like being asked questions by women. That’s helpful.

Comment: I also greatly appreciate the presentation. I’d also like to address a couple questions. Something that I found works well with women is realizing that the first thing out of my mouth is not going to be “I have a raging yeast infection.” They don’t know what I mean when I say yeast. I know patients who had yeast infections back to back, and it was causing problems in their marriage. Another thing that I do with my people is that I found someone that has made a successful change, and I call them a diabetes missionary. People are going to see how you used to look and now how you’re feeling, and they’re going to know what happened to you. You’re going to see people in bad shape and say, “You can be like me.” That gets the buy in to make even more changes.

Dr. Gavin: Very important, thank you.

Dr. Coleman: So glad you mentioned that. We’re looking for health champions to interview on our radio show. So if you have people like that, those are the kinds of people we’d love to interview.

Q: I think I have become a fan of Dr. Gavin. But we are so happy to have both of you. You are something worthwhile to wait for. We thank you so much for coming. The one thing that’s been bothering me—I’ve been certified for over 23 years—my question is about mixed information given patients. It bothers me when you work with a patient and you know you have all your ducks in a row, and they go to the new intern and everything is shattered and when they come back they don’t know what to believe. Has anyone ever experienced that?

Dr. Gavin: I think we all have. The controls we try to exercise include that our team is always reading from the same script. It gets to be a bigger problem when they’ve gotten information from someone they’ve been seeing—their provider, someone on their care team, and now you’ve got to assume a posture that seems to be discrediting to people that they’ve had. That’s when it helps for you to have tools, like diabetes self care, and some other items of information that you can share with people so it doesn’t become your opinion, or doesn’t carry the perception of being your opinion. You can say, “You know there is some information that speaks to this kind of information. Here’s a source that that talks about he latest thinking on this issue.” That way you can get away from this is my opinion versus the opinion of that idiot you’ve been talking to. This is a delicate balance—you don’t want to burn bridges between you and your patients, nor destroy the bridge of the people you’re working with.

Q: We’re doing a diabetes education in East Texas. Our problem is how to convince them to come to class without driving them. I’m a subcontractor for a government contract in Texas.

Dr. Coleman: What I’ve done is, I use my sponsor’s facilities, whoever my sponsor is. A hospital system has cafeterias, and a lot of cafeterias have food left over from the hospital during the day, and we have them bring the trays to feed folks. You don’t know how big a deal that is to folks. That’s one trick I’ve used, as well as gift cards and the big TV giveaways. All that stuff got us to about 70%. For the other 30%, I’m taking the van to their house.

Dr. Gavin: If you have any leverage with the local community leaders, they can give voice of the fact that this is going to be happening and it’s important.

Q: To piggy back off what Dr. Coleman said about medication, and talk to you about what they’re actually taking versus what they’re being prescribed. If they have a long list, talk to them about pillboxes, and ask them if they’re having trouble taking it. You know, 50% of people on metformin get diarrhea or stomach problems from it. You can ask them if they’ve been experiencing that. And when using the community health works and wellness coaches, how do you ensure that they’re giving the proper information? How do you work with someone not trained as a health professional?

Dr. Coleman: We use medical assistants. We don’t use lay workers, and we really keep them on script. They have some healthcare training, and then we give them the diabetes knowledge they need, and then we give them some tools, and then if certain questions they can’t answer come up they refer them to the pharmacists or the CDEs. Then we will do some random follow up phone calls to see how it went.

Dr. Gavin: We intentionally use medical assistants because they need to be qualified to draw blood. 

 

Workshop: Diabetes Meal Planning: What Should Patients Eat?

DIABETES MEAL PLANNING: WHAT SHOULD PATIENTS EAT?

Marion Franz, MS, RD, LD, CDE (Nutrition Concepts by Franz, Inc., Minneapolis, MN)

Ms. Marion Franz opened the session in front of a full-capacity room, and began by stating that patients with diabetes receive many mixed messages about dietary guidelines from many sources. Citing the UKPDS results, she argued that nutritional intervention did indeed provide long-term benefits to patients’ A1c regulation. From a baseline A1c of 9.0% for both groups, the conventional and intensive therapy groups saw A1cs reduced to 7.5% and 7.0% respectively. In addition, she said weight loss was not necessarily a factor for effective nutrition therapy for patients with type 2 diabetes, based on a retrospective meta-analysis of 19 studies. Of the 19 weight loss intervention arms, only 8 of them reported improvement of A1c over 1 year. The ones with most improvement (0.6-1.2% reduction) came from a combination of frequent physical activity, and surprisingly, 11 of the studies reported no improvement in A1c over one year. Similarly, no single combination of macronutrients offered an advantage in A1c reduction. In summary, the best nutrition therapy was not purely a nutrition therapy – for patients with type 2 diabetes, a mixture of portion control, weight loss, physical activity, and frequent contact with physicians led to the most lasting glycemic control.

Questions and Answers

Comment: I think you have to remember we have a lot of people who live long healthy lives who are not eating plant based diets. It’s really up to the individual, and I think still comes down to consumers choice.

Q: Do you have any further comment on vegetarian versus non-vegetarian diets in patients with diabetes?

Ms. Franz: We have to remember that many people who live very long healthy lives are not vegetarians so it’s really up to you individually. A lot of the evidence of health benefits for a particular diet obviously comes from observational studies.

Q: Is there a role for the glycemic index (GI) or even using glycemic load in dietary guidelines? We’ll get the occasional patient that wants information on GI and a lot of participants become confused about things such as ice cream and watermelon.

Ms. Levin: Our diet recommendations take care of the ice cream problem. We don’t make people follow GI recommendations religiously because we know it’s confusing and we know our diet is clean enough.

Ms. Boucher: I will say that we are working on the ADA’s new nutrition guidelines. We did look at GI and included information on that in our review. Most of the evidence is C-level, so there is very modest impact on glycemic control and it might be an additional tool in carb counting.

Q: Although vegan diets claim to be nutritionally balanced, they do need B12 supplementation. Do you have any comments on B12 deficiency in these diets?

Ms. Levin: Vegans are not any more deficient in B12 than any other group; in fact it’s the elderly that manifest B12 deficiency the most. I can’t speculate why there isn’t enough in the plant sources. I don’t believe it’s strong enough to say we should be eating meat to supplement B12. I recommend taking a B12 supplement, and since you only need 2.4 micrograms a day a supplement three times a week is sufficient.

Q: The plant-based diet is so different form the ADA diet we teach; how do you get patients on board?

Ms. Levin: I don’t work in a clinical setting; the only people I encounter day to day are those in our clinical trials, who know what they’re getting into. We do have a nurse practitioner and a dietician, and I know when they work with their patients they make the decision to go on a plant based diet with their patients. It’s the patient’s choice, but it’s the information they have

Ms. Franz: Be careful when you talk about that ADA diet, because as we all know, there is no “ADA diet”.  [Applause]

Q: Adventist has its own version of a vegan program called CHIP – Complete Health Improvement Program. When I went out to my training session for a CHIP-approved meal, I found rice pilaf, beans, and very few vegetable options. Since all these foods are high carb how do we reconcile that?

Ms. Levin: I would like to have heard there was a more colorful selection of vegetables.

Ms. Franz: I would like to make a comment of concern about the high carb meal – when you read the literature, what matters is not macronutrient composition. For example, when people go on a low carb diet what do they eat? Saturated fats. We do see that in people who do not have diabetes that high saturated fats contribute to insulin resistance, but we do not know about people with diabetes.

Q: I always thought we were supposed to give our patients 35 grams of fiber, so I’m wondering where that 40 grams came from? I just don’t think my patients will be able to leave the house if I recommend that that. [Laughter]

Ms. Levin: Our diet is going to be at least 40% of fiber, when you look at plants, vegetables, etc. I probably eat 60 grams of fiber a day, when I sit down and calculate it.

Q: Is the 40 grams appropriate though?

Ms. Boucher: I think that is a little high, but if you look at what she had in there: lentils, greens, beans, it’s going to add up quickly. But agree, 40 is hard for the average American to achieve.

Ms. Franz: In the studies on hyperglycemic effect, people had to go up to about 40 grams of fiber to see any difference. People who only went up to 2- or 25 didn’t see a real affect.

Q: Usually vegans are very vitamin D deficient and vitamin D has been seen as having anti-cancer and anti-inflammatory effects. Any comment on how to meet vitamin D needs?

Ms. Levin: The only dietary source of vitamin D is through supplements. 

Ms. Franz: Almost all studies about vitamin D deficiency are observational. Controlled supplement studies are almost nonexistent. However, there is currently a large trial on vitamin D conducted by Harvard. Hopefully we will have a more definitive answer in a few years. The issue we are seeing now is very similar to the whole issue of antioxidants.

 

Poster

THE BIG BLUE TEST: IMMEDIATE IMPACT OF EXERCISE ON BLOOD GLUCOSE IN PEOPLE WITH DIABETES

Sheri Colberg, PhD (Old Dominion University, Norfolk, VA); Manny Hernandez, (Diabetes Hands Foundation, Berkeley, CA); Fatima Shahzad (Johns Hopkins University, Baltimore, MD)

The authors of this valuable poster and the Diabetes Hands Foundation deserve big congratulations for being selected as the first place poster by the AADE staff. This study, conducted by the Diabetes Hands Foundation’s Big Blue Test Program, assessed the immediate effects of exercise on blood glucose levels. The organization is an online submission-driven initiative where participants checked their blood glucose, engaged in physical activity for at least 14 minutes, and tested their blood glucose afterwards. From a total of 7,157 paired data points of participants with diabetes, the results of Big Blue Test determined that with all levels, all types, and all intensities of physical activity, participants observed an average 31 mg/dl reduction of blood glucose, with 75.8% of participants observing a decrease. Mr. Hernandez, one of the authors of the study, noted that it wasn’t only participants’ blood glucose that benefitted during this study – there was a collective incentive in participating in Big Blue Test, because a total a 20,000 person participation rate in the 2013 iteration of the study would result in $100,000 of funding to be allocated to centers and organizations that advocate physical activity as a means of lowering blood sugar.

  • The study collected results from the 2012 Big Blue Test (BBT), where participants anonymously entered a total of 7,157 paired data points through BigBlueTest.org, or via the BBT iPhone app. These participants entered their diabetes status, type of activity, intensity, duration, time since most recent meal, and blood glucose readings before and after physical activity. Activity choices were given as walking, running/jogging, cycling, conditioning, dancing, or other (unspecified). Exercise intensity was given as moderate or vigorous, and duration increments were <10 minutes, 11-19 minutes, 20-29 minutes, or >30 minutes. Elapsed time since the last meal was given as 30 minutes, 1 hour, 2 hours, or more than 3 hours.
  • The authors of the study found that out of 7,157 paired data points, mean blood glucose levels decreased after all exercise levels, with regards to type of exercise, duration, and intensity (-31.3±47.1 mg/dl, 16.8%). Overall, 75.8% of participants had a decrease in blood sugar after exercise of all types and time intervals. Longer exercise times resulted in greater decreases in blood glucose levels (p<0.05). The largest decrease in blood glucose levels took place after 30 or more minutes of either intensity of exercise, after 1-2 hours following the most recent meal (-49 mg/dl to -46.4 mg/dl).

 

Product Theater: A 360 (Degree) View of Diabetes: Findings from the DAWN2 Study (Sponsored by Novo Nordisk)

A 360 (DEGREE) VIEW OF DIABETES: FINDINGS FROM THE DAWN2 STUDY (SPONSORED BY NOVO NORDISK)

Melissa Magwire, RN, CDE (Shawnee Mission Medical Center, Shawnee Mission, KS); Stephen Brunton, MD (University of North Carolina, Chapel Hill, NC); Steven Edelman, MD (University of California at San Diego, San Diego, CA)

This product theater served primarily as an overview of the findings of the DAWN2 study, and included discussions on the emotional and psychosocial aspects of diabetes, the concept of the “family with diabetes,” and the communication and interaction between people with diabetes and their healthcare team. Ms. Melissa Magwire gave the introduction and led the discussion, with Dr. Steven Edelman and Dr. Stephen Brunton contributing as panelists throughout. The DAWN2 study spanned 17 countries and involved 16,100 respondents. Of these respondents, 9,040 had diabetes, 2,160 were the family members of someone with diabetes, and 4,900 were healthcare providers. Participants with diabetes had to be 18 years old or older to respond. The primary objectives of the study were to assess potential barriers and facilitators of active and successful management of diabetes amongst patients, their family members, and healthcare providers. The secondary goals of the study were to establish national benchmarks for health status, quality of life, access to self-management education, and to assess access and use of support teams, family, and friends in living with diabetes.

  • The first portion of the discussion explored the emotional and psychosocial aspects of diabetes, and compared the audience response to DAWN2 results. When asked by Ms. Magwire, 40% of audience members indicated that they would describe 51%-75% of their diabetes patients as distressed by their diabetes, and 29% said they would describe 76%-100% of their patients as distressed by their diabetes. Ms. Magwire then revealed that 45% of DAWN2 participants reported high levels of diabetes distress. The audience was subsequently asked how many of their patients they believed commonly experienced symptoms of depression, and the vast majority of them (87%) answered the number was between 25% and 100% of their patients. Though DAWN2 found that only 14% of patients reported depression, Dr. Edelman speculated that patients suffering from this condition would be less likely to participate in DAWN2, and Ms. Magwire noted that there might be cultural differences in the understanding of depression. She concluded with several other results of DAWN2, stating that 62% of respondents with diabetes reported reduced health as a result of their diabetes, and 21% said it impacted their relationships with family and friends. The panelists then broke for their first discussion.

Panel Discussion:

Ms. Magwire: Do you feel healthcare providers consider “diabetes distress” when forming treatment plans for their patients?

Dr. Brunton: I think sometimes patients can just become numbers to healthcare providers.

Dr. Edelman: When you’re a healthcare provider, you do have to be so focused on so many different factors that are required to “complete” the visit, it’s hard to address this important issue.  But I agree most caregivers are unfamiliar with “diabetes distress.”

Ms. Magwire: Is our idea of distress different to the patients?

Dr. Brunton: There’s no question we don’t really understand what’s going on with the patients. I used to teach in a hospital where we would admit interns as patients anonymously, so they would feel the experience from the patient’s perspective. Our system is oriented toward the healthcare practitioners in general. I think you shouldn’t be a practitioner until you’ve had two or three chronic diseases.

Dr. Edelman: I think many doctors see distress and label it as noncompliant.

Ms. Magwire: At my clinic, using the term “noncompliance” means you have to place a quarter in the “noncompliance jar.”

Dr. Brunton: Even the term adherence still implies a top-down approach. The British use the term “accordance,” which implies that theirs is a team effort between the doctor and the patient.

  • The next portion of the session was devoted to discussing the “family with diabetes.” When asked, the majority of audience members agreed that between 26% and 75% of their patients’ family members would report feeling distressed or burdened by their loved one’s diabetes. DAWN2 found that 40% of family participants reported this feeling, but the numbers varied a great deal by country. In France, 60% of family members answered that they felt distressed or burdened by diabetes, whereas only 19% of Indian participants did so. Interestingly, the audience response was more split when asked to predict how many of their patients’ family members would like to be involved in helping with their loved one’s diabetes management. 30% of audience members predicted that less than 26% of their patients family members would feel this way, 45% predicted that 26-50% of their patients families would agree, 21% put the number between 50% and 75%, and only 4% thought that 75% to 100% of their patients families would report feeling this way. DAWN2 found that 39% of respondents wanted to be involved in the diabetes care of their family member, and 46% wanted to help their loved ones deal with feelings.

Panel Discussion:

Dr. Brunton: My daughter was diagnosed with type 1 several months ago, and when your child has it, there’s such a feeling of being out of control. She was very brave, she injected herself from the first day, but it was overwhelming. And we already knew about diabetes.

Dr. Edelman: Families worry like crazy. They all love their family members dearly, but they can hover over people and become the diabetic police. With type 2, people can be accusatory, saying they ate themselves into diabetes, and will point out when they’re “cheating.”

Dr. Brunton: There is not the support for type 2 that there is for type 1.

Dr. Edelman: Some of the most successful patients I’ve seen have supportive partners.  But if there isn’t individualized education, a loving concern can become haranguing.

Ms. Magwire: Dr. Edelman, does it surprise you that families want to be more involved?

Dr. Edelman: Being in practice myself, I think an easy first fix is to get the family to come in with the patient. They’re a second set of ears, and it allows them to ask questions, and to get involved in leading to better discussion. I once had a patient ask if could videotape our discussion for his wife to watch later.

Ms. Magwire: Dr. Brunton, as someone living with type 2 diabetes, and someone with a child with diabetes, and a diabetes educator, how is it important to recognize the family’s need?

Dr. Brunton: For my own diabetes, I really think of myself as a patient. When my daughter got diabetes, it was different. My ex-wife didn’t know a lot about diabetes and she was very overwhelmed. We had resources with the JDRF and others, and there were two other girls in my daughter’s class who had diabetes, which made it less unusual in the school, but it was still overwhelming.

Dr. Edelman: Sometimes at the Veterans Association we have people who bring their grandchildren in with them.

Dr. Brunton: You know, we’re mostly talking about parents, but my daughter has siblings, and they need to be included in the discussions too, so it doesn’t become “we can have ice cream, you can’t.”

  • The last portion of the presentation featured a discussion in how to improve interactions between healthcare providers and their patients. Audience members were asked what percentage of their patients they  estimate had been assessed for psychological issues, and 77% replied less than 25%. DAWN2 found that only 32% of patients said someone on their healthcare team asked about their feelings of anxiety or depression. Ms. Magwire began the discussion by reporting that 24.4% of patient participants reported that their healthcare providers asked them how their diabetes impacts their life, but conversely, 52% of healthcare providers claimed to ask their patients that question.

Panel Discussion:

Dr. Brunton: I think the first question [what percentage of patients were assessed for psychological issues] is almost a “don’t ask, don’t tell” question. Practitioners are worried that if they ask they’ll get overwhelmed with information, and think if patients don’t volunteer the information, it can’t be that big a deal. I think patients worry their doctors are too busy to bother with that information.

Dr. Edelman: I think caregivers are over reporting how many of them ask how diabetes impacts their patients’ lives, because that number is just too high. In some of these countries more people than you would expect were asked about their depression, most of those countries were ones with socialized medicine. In Sweden, for instance, asking about mental health is right there in their protocol.

Dr. Brunton: It’s encouraging to think a quarter of patients are being asked. But as you know, as healthcare providers, when we ask patients, “Are you taking their meds?” they always say yes. Patients may forget, because there is so much going on, but then the question is how specific was the question in the manner the healthcare provider asked it.

Dr. Edelman: Every practitioner that sees patients with diabetes really needs to think about redefining their diabetes visit. I would encourage every provider to open up their visit to say hello and ask, “What are the biggest issues preventing you from taking control of your diabetes?” It can really open the discussion, and get to the root of their issues. Try to fill out all the little check boxes you have to do while asking that question. Certainly not every patient needs it, but some patients, especially ones with consistently high A1c, do. I really believe stress affects how you take care of your diabetes.

Questions and Answers

Q: I work with veterans, where depression is a big issue. I often have people say they’re tired of being diabetic. How do you suggest I address this?

Dr. Edelman: You have to give them some degree of empathy. People with diabetes are asked to do so many things to help keep their diabetes under control. It’s also important to out what things they can do that can help control their diabetes they are willing to do. For instance, for someone struggling with home glucose monitoring, you might develop a system wherein they only have to test x number of times a day, at different times. Veterans are one set of patients, they are often men, and often older, with PTSD or some depression, but some of those factors are definitely present across the board.

Dr. Brunton: I think for a lot of our patients, diabetes is just one of the issues they have. So a lot of their treatment is aligning your goals as a practitioner with theirs. Our goal may be to get the A1c down; their goal may be to lose ten points.

Dr. Edelman: I always say it’s not a sprint, it’s a marathon. It’s not about getting them where we want as fast as possible, but making adjustments they can stick to.

Q: How have you been able to incorporate families into the treatment process?

Dr. Brunton: I have an advantage being in a family practice. We encourage patients to bring family in, especially spouses. Trying to make a lifestyle change with one person just doesn’t work. I think that’s when work with our diabetes educators works very well, because it gives them a chance to talk about what some dietary modifications we can make that still fit in with your lifestyle are.

Dr. Edelman: We’ve had support groups just for family members. When we have all the workshops at Taking Control of Your Diabetes in the afternoon it is really impressive. Everyone just opens up. It should be moderated by someone who has a good feel for that area or it gets out of control. But when you open up that area where people are really connecting over loving people with diabetes, you’ll get a lot out of it.

Ms. Magwire: I was at one of those sessions with the DAWN study, and you could really see family members relax as they began hearing that others had had common experience.

Dr. Brunton: It can also help patients feel less isolated, when they hear that their family members share some of their fears and worries.

Q:  Many of my patients seem stressed or depressed, but they refuse appointments with a mental health counselor. What can you do in a situation like that?

Ms. Magwire: A lot of that comes down to the patient’s perspective of what depression means. I often tell patients that depression doesn’t mean that they are just sitting in a corner rocking back and forth. I tell them its okay, and all chronic illnesses have some select of depression or anxiety. It’s tough, but it is about helping them realize that those appointments are just another tool in their box.

Dr. Edelman: Since I can prescribe drugs, if I feel there’s a depression issue I may offer to prescribe a selective serotonin reuptake inhibitor (SSRI). Then after three months, we can see how they’re doing. It’s not for everyone.

Dr. Brunton: Talk therapy is also very good. In your situation, I would encourage them to talk, if not to a mental health provider, at least to their physician.

Q: In a large practice, how can we assist primary care physicians to have an open dialogue with their patients?

Dr. Brunton: I think the DAWN Study provides a good starting off point to show how great an effect this sort of distress an have. I think diabetes care is a team effort, you’re members of that team, and giving feedback to your other members is a part of that. For example, mentioning to a physician, “Mrs. Jones may be depressed, how can we help that?” I think PCPs often feel like they have to do it all, so if you can help them feel supported, that may be better.

Ms. Magwire: sometimes patients will open up more freely to the assistant, and then they can report back to the physician to see what they should hone in on.

Dr. Edelman: I agree with both of you. Education has to start early, and it has to start in medical school, or nurse practitioner school. I heard a statistic that for medical students, 2% of their time is spent on diabetes, yet a third of their patients they will see will have diabetes. That may not be why they’re there, but it’s a factor.

Q: What should you do with a family member who wants to help, but the patient is not ready to change?

Dr. Edelman: They have to be educated, just like anyone else. They also have to be educated on what not to do. They have to not be the diabetes police, but to come in slowly, and be ready to help make gradual changes.

Dr. Brunton: You have to give control back to the patient. I would want to look at what dietary changes the patient can make. Patients are human, and they have conditions and desires, and after finding out what they feel they can do, show them the small changes they can make. Like Steve said, it’s a marathon, not a race. If my daughter is watching her siblings eat ice cream and is feeling deprived, I will give her that ice cream and adjust her insulin, rather than have her feel deprived and eat ice cream behind my back.

Dr. Edelman: That’s true. People will sometimes say things to me like, “You can’t eat that chocolate cake, you’re diabetic,” and I always want to say, “Watch m

 

7. Inpatient Diabetes Management

Breakout Session: Inpatient Glycemic Management: From Culture Shock to Culture Change

INPATIENT DIABETES MANAGEMENT PART ONE

Jane Seley, DNP, MPH, BC-ADM, CDE, CDTC (New York-Presbyterian/Weill Cornell Medical Center, New York, NY)

Dr. Jane Seley outlined the policies that she believes have been key to improving glycemic control in her inpatient diabetes program, from changes in meal tray delivery to implementing written protocols outlining how to treat patients who are using insulin pumps. Along with improving glucose monitoring, insulin and meal timing, Dr. Seley also remarked that educating the staff on carbohydrate counting and serving sizes has helped patients make better mealtime decisions in the hospital and at home. Turning to insulin pens, Dr. Seley discussed how insulin pens should be used in inpatient care, specifically emphasizing the “be aware, don’t share” campaign in hospitals. One great initiative Dr. Seley has been spearheading is working to assign personalized barcodes to pens so that when a pen is scanned, it comes up with the patient name (very critical, we think, especially after hearing from Dr. Seley that hospitals have been advised by the Institute for Safe Medication Practices (ISMP) to stop using insulin pens after patient pen-sharing was identified as a problem). Dr. Seley also highlighted strategies to improve blood glucose meter accuracy and shared the new ISO standards (<15 mg/dl deviation from the lab value when the blood sugar is less than 100 mg/dl, and within 15% of the lab value if the blood sugar is above 100 mg/dl). Transitioning to treating blood glucose levels, Dr. Seley highlighted the usefulness of point of care testing data, highlighting the need for data to be shared with the right people so that hyper- or hypoglycemic rates can be lowered through targeted educational efforts. Along the same lines, Dr. Seley also noted that it is crucial to have  a written protocol in place that delineates hypoglycemic treatment; she urged the use of glucose gels rather than  food in acutely ill patients. She stated that it is fine for the patient to treat with food at home, but at the hospital” she does not believe in the use of food to treat hypoglycemia because it takes longer to work and it is not a one to one conversion.

  • Dr. Seley remarked that ensuring that meals are delivered first to all patients with diabetes reduces the variation in insulin timing. She remarked, “What a difference it makes” giving insulin anywhere between fifteen minutes before and after the first bite of the meal. If insulin is given outside of this range, it may lead to preventable hypo or hyperglycemia. Dr. Seley also highlighted that blood glucose should be checked no longer than one hour before the tray is delivered, which is especially difficult for the morning meal because of the change of shift from nights to days; according Dr. Seley’s data, 30% of inpatient blood sugar testing was done before 6 AM on half the units monitored, and, she noted, if the blood sugar is tested at 5 AM, nurses are going to be tempted to give insulin for high blood sugars instead of waiting until the meal is delivered several hours later.
  • Dr. Seley opined, “If there is no one available to assess patient competency with their insulin pump, I do not think that pumps should be allowed in a hospital.” She believes that pumps should require a written policy with a bedside flow-sheet for the patient to document carbohydrates eaten and boluses given. She also emphasized the need for a mandatory diabetes consult to evaluate how patients use their pumps.
  • “No one is going to think about the patient’s comfort except for the diabetes expert.” We think this point is especially important, and sometimes overlooked. Dr. Seley highlighted that HCPs need to ensure that insulin injections are as comfortable as possible, and they need to use the equipment that is going to support the patient in the best way. She made the critical point that if the patient’s hospital experience is utterly uncomfortable, patients will not be able to translate their treatment to home use. It is important that the experience at the hospital is as positive as possible.
  • Dr. Seley remarked that the 2012 Umpierrez ADA abstract that addressed transition guidelines based on A1c helps determine which treatment regimen to use at the time of discharge from the hospital. For example, Dr. Seley explained, she may send a patient home with an A1c between 7-9% on one-half of their inpatient basal dose. If patients have an A1c above 9%, she considers whether the patient can calculate mealtime boluses, or if they need to remain at a fixed dose. One trick that Dr. Seley suggested is for patients who are not ready to go home on mealtime insulin, to have them start practicing dosing based on current blood glucose and meal size with an oral glinide medication. They will need these skills when they go on insulin.

 

PANEL DISCUSSION

Jane Seley, DNP, MPH, BC-ADM, CDE, CDTC (New York-Presbyterian/Weill Cornell, New York, NY); Donna Jornsay, RN, BSN, CPNP, CDE (Long Island Jewish Medical Center, New Hyde Park, NY)

Q: This question is coming out of frustration. The nurses at the bedside take ownership with working with patients and do not rely on educator, or they wait until the last minute, or they wait to teach patients about until the last day. Do you have any creative ideas on how to get others to help with these tasks?

Dr. Seley: This is an issue we all struggle with. Diabetes educators know more about training the patient. There is something to be said about expertise, but we cannot train every single patient who needs training about how to check their blood sugar or give themselves insulin. I find that many nurses find this to be a rewarding part of their job, but they find it hard to find the time, or they just don’t prioritize it. I think that having one expert on each unit that steps up to the plate really helps.

Ms. Jornsay: There needs to be several point people. I think the critical mass is to have four to six champions on every unit. The nurses are working 12 hours.  Patients with A1c >9% who are started on insulin, or anyone we know who is going to be started on insulin, we order insulin and pens for. We give the pens to the nurse, and they find it easier to train the patient using the pen instead of the syringe. I also have a little vignette that speaks to the importance of doing this early. We had one patient who, early in admission, would use a pen. He was discharged with a reasonably good blood sugar and was in good control during hospitalization. Ten days later, he was readmitted. There is 48.4% re-admittance rate for people with diabetes. I asked him, have you been taking your insulin? He said, religiously. I handed him a Lantus pen and a pen needle and I said show me what you are doing. He did a two unit air shot, and then shot the insulin into his mouth! He saw the nurses using a vial and syringe, and he thought that the pen was halfway between oral medication and the syringe. We need to make sure we observe our patients taking a self-administered dose of insulin.

Comment: It is so great to hear that everybody has the same problems our hospital is having. It is very reassuring. I worked in an outpatient setting for a long time, so the inpatient is new to me in the last six months. I also wanted to mention the pump policy that our hospital has. We have had a really great pump policy since 2009. However, we were still having trouble with this policy. What we ended up doing was involving IT and making our policy more rigorous. The nurse’s admission sheet has a place to check if the patient has a pump, and if that box is checked, I get an email. This helps with communication so that we are all on the same page. There are also rules that delivers a pop-up to a physician reminding him to order insulin if he discontinues the pump. We also have a hard stop that does not allow the patient to receive insulin [Editor’s note: we believe this refers to injectable insulin]. and a pump at the same time. These are new changes, and I am going to track it and see if it helps to improve the quality at our hospital. We are hoping to use technology to make the patient safer.

Dr. Seley: I think what you are doing is great, but I would just like to point out that for safety reasons, our endocrine team has made the decision to sometimes give basal insulin even when the type 1 patient has a pump or an insulin drip. For example, if the patient is going to the OR, sometimes we will give some basal insulin while the patient is still wearing the pump just in case the pump is inadvertently removed during surgery.

Comment: With everything, we have an override decision that the prescriber can make.

Q: I want to make a plea about reading the statement from the PRIDE inpatient group of endocrinologists in the July issue of Diabetes Care. The term sliding scale is used off-and on. I think the term needs to die [applause and agreement from audience]. Everybody else has no idea what that means. The few that do know have no interest in going into what in the world it means at different points and different times. Please call it something else, such as “correctional insulin.” One term with multiple meanings always causes problems.

Ms. Jornsay: Thank you for your comment.

Q: I recently developed a nurse resource committee, and I would love to also develop a champion program. However, we have a small community, and I was wondering if you could talk a little about teaching nurses survival skills and explain how the program looks?

Ms. Jornsay: The program is not necessarily about teaching other nurses’ patients on the unit, although I have a couple units with a smaller patient to nurse ratio and the nurse manager has been my biggest champion since I came to the hospital. I have sent nurses through and reassigned my other nurses so that they can take care of other patients who have diabetes – but this has not been done in other areas. We have been incorporating ‘survival skill’ information into their conversations when the patients come in for something else: “Have you been having hypoglycemia? What would you do if you had hypoglycemia at home?” This doesn’t take a long time. It is all about getting patients to think outside of the box. This is all about little, small interventions throughout the course, and seeing the patients throughout the shift.

Dr. Seley: We also use resource nurses for other conditions such as wound care. Our nurses exchange services. For example, a wound care nurse can ask the diabetes nurse to cover his/her patients while teaching the patient, and the diabetes nurse can do the same with the wound care nurse later.

Ms. Jornsay: I do not have the following plan in place yet, but I have a chief nursing officer who I am proposing will not have a patient load on a daily basis so that that nurse will have more hours to work toward the CDE. This would involve having one extra nursing salary per day so that there is a rotation so that all nurses who want to pursue the CDE could have extra hours to study. 

Q: I was interested about how you were able to calculate that the money that you saved on pens was $75,000. How else did you save, and how did you demonstrate this importance to administrators?

Ms. Jornsay: What got me to go from a team of one to a team of four was a business plan. What I did was find the average cost per day of the entire facility, and then I looked at the total number of admissions for the previous year, about 16,000, and CPG for diabetes, and cost out the readmission rates. It all added up to $81 plus million dollars in lost revenue. When I presented that to senior leadership, they were literally dumbfounded, and this was just a 5-page business plan. You have to show them where the costs are. If you can hit any healthcare system now in their pocketbook, you can really make them pay attention.

Q:  If insulin is given more than 15 minutes after the meal, why do you give only half the dose?

A: Because I am afraid of hypoglycemia.

Comment: Usually giving half a dose is not adequate at our hospital.

A: Come see me after, and we will discuss.

Q: You had a target for hyper- and hypoglycemia. We have been trying to come up with our own rates in our hospital. What is your benchmark?

Dr. Seley: There is no published benchmark for rates of hypo and hyperglycemia. The Society of Hospital Medicine is working on this. For now, lowering your current rates is a great goal.

Ms. Jornsay: It is arbitrary. It went to us trying to get joint commission. We do not care so much about reaching benchmarks, but about moving in the direction of improvement. We set our own numbers Vis-à-vis the work we are doing.

Q: I have a question about insulin pens. We toss a lot of dispensable insulin pens, and there are a lot of regulatory issues involved. What we are getting is that these can help us relate better to patient use. How do you get around the regulations?

Ms. Jornsay: New York cannot be the final word for all states. But we have strict regulations for anything that can be relabeled and sold.

Dr. Seley: You can also Google “multidose medication dispensing for discharge.” There is a website. You can click on your state and see your regulations. Additionally you can also go to your state pharmacy board for guidance.

Q: I vote that instead of using sliding scale we use “base meal coverage.” Secondly, when you’re trying to dose insulin at mealtime, how do you deal with restaurant-style meals?

Ms. Jornsay: We don’t serve restaurant-style meals at our facility, so we’ve never had to deal with this issue.

Comment: I have a comment about how our room deals with the hyperglycemia protocol about pumps. The emergency room boluses several times for pumps when they need to follow hyperglycemia protocol. They unhook the cannulae and put on a new set with the new model of insulin. 

Q: Is there any type of incentive for being nurse champion? Secondly, how often do you offer the classes hosted by your organization? Could you share the curriculum?

Ms. Jornsay: I don’t know that I can share it [the curriculum] because it is a collaborative effort. We offer the core class 4 times a year, and then we offer the insulin pump policy class 6 times a year. We offered the pregnancy and the adolescent course 2 times a year. We’re open to additional suggestions such as motivational interviewing, and if we see a need for classes such as carb cutting from the perspective of nurse practitioners, then we try to meet the demand. Vis-à-vis compensation is something that the nurses don’t have yet. Every single one of these nurses volunteered to become diabetes champions. They are motivated because they have family, kids, etc. with diabetes. Often, my best champions are ones that have immediate family members with diabetes. If they take the certification exam and pass, they will get the fee waived, and they also receive an additional $1,500 in annual pay. We are trying to find additional methods of compensation. I am pushing this to the administration but I cannot say whether it can be successful.

 

Breakout Session: Improving Inpatient Diabetes Care: Accelerating Change with a Pay for Performance Initiative

IMPROVING INPATIENT DIABETES CARE: ACCELERATING CHANGE WITH A PAY FOR PERFORMANCE INITIATIVE

Mary Ellen O’Connell, MSN, MBA, RN; Joyce Najarian, MSN, RN, CDE (Lehigh Valley Health Network, Allentown, PA)

Speakers Ms. Mary Ellen O’Connell and Ms. Joyce Najarian presented the implementation and successes of a pay for performance diabetes care initiative at their Lehigh Valley Health Network, which is currently in its third year. At the beginning of the discussion Ms. O’Connell gave a brief financial background of the costs of patients with diabetes admitted to hospitals. She noted that 43% of the $245 billion spent in the US on diabetes care in the last year was spent on inpatient care, making it the largest expense area in diabetes care – and of course, a very preventable one. Ms. O’Connell then went on to discuss the aspects of the program they implemented in the Lehigh Valley Health Network at their three different hospital locations. The program was funded by an insurer (Ms. O’Connell did not specify which insurer) and contained three elements: adapting a value based care plan in the hospital setting, redesigning how care was delivered, and reducing the costs associated with inpatient care. The study had two large clinical goals.  The first was to reduce the number of days patients had one or more blood glucose level above 180 mg/dl, below 70 mg/dl, and below 40 mg/dl. Patients who had two or more instances of a blood glucose above 180 mg/dl, or one instance of hypoglycemia (blood glucose below <70 mg/dl), were designated as being “not well controlled.” The second clinical goal was to measure the A1c of all patients upon admission, with the exception of those who had had their A1c tested within the past 90 days. 

Ms. O’Connell and Ms. Najarian spent the bulk of their presentation discussing in great detail how they implemented changing the standard for patient care delivery. In an anecdotal manner they recounted issues of getting healthcare providers to take an online training program, training them to be more precise in insulin dosing, and spoke frankly about the difficulties in getting hospital staff to take the initiative seriously. The discussion ended on a moving note when Ms. O’Connell took a moment at the end to dedicate the presentation to her mother, who had passed away in the early morning. Momentarily losing her composure, Ms. O’Connell explained that her mother had dedicated her life to helping people, and she thought she would have wanted her to give the presentation that morning despite the loss, so that it could help the people the room. Multiple audience members grew teary as Ms. O’Connell finished, and we were incredibly moved at this dedication.

  • The initiative successfully implemented a near universal policy of testing a diabetic patients A1c upon admission. Ms. O’Connell stated early in the discussion that when the program began on their Muhlenberg campus, a baseline study showed that only 48.9% of diabetes patients had an A1c performed upon admittance. The most recent data showed that approximately 100% of patients have an A1c test performed upon their arrival, or have had one performed in the 90 days before they arrive. In implementing this as a system wide policy, the Lehigh Health Network internal computer system was modified so that any time a doctor prescribed insulin for a patient, the records were automatically searched for an A1c test.  If no record of an A1c test in the past 90 days appeared, a test was automatically ordered.
  • Over the course of the initiative, the number of patients categorized as having their blood glucose “not well controlled” decreased significantly. In 2012 (the first year the program was initiated at all three hospitals in the Lehigh Valley Network), the number of admitted patients who were “well controlled” was 1,534 and in 2013 it increased to 2,033. Conversely, the number of admitted patients defined as being “poorly controlled decreased from 998 in 2012 to 549 in 2013.

Questions and Answers

Q: I’ve been a diabetes care coordinator for nine years, and this is fantastic.  Our problem is always getting the patient data organized.  We know we’re doing great things, but it’s hard to get the data.  How did you get the physicians to record it properly?

Ms. O’Connell: After the charts are coded as belonging to patients with diabetes, they are automatically pulled that show us how many patients with diabetes were in the hospital that month, and that then shows us how many days we had patients with diabetes. Then our data is configured by taking the number of days (in the thousands) patients were admitted and compared to the number of days patients were well controlled or poorly controlled.

Q: What is you definition of well controlled versus poorly controlled?

Ms. O’Connell: I define it a little differently than the insurance companies. We define anyone well controlled who had more than two blood glucose readings over 180mg/dl in a single day, or one instance of a blood glucose of below 70mg/dl a day, as being poorly controlled.

Q: Are you thinking of cataloguing the journey so that outsiders can read about it?

Ms. O’Connell: That is one of my 2014 goals.

Q: What role to do your pharmacists play in this initiative?

Ms. O’Connell: They are not as involved as I would like.  They are very helpful with the order sets, and they do education with their own team.  They’re very busy, and to be honest sometimes I’m a little disappointed that they don’t question some of the orders that come through.

 

 

Breakout Session: Critical Care Glycemic Management: Pearls of Success

CRITICAL CARE GLYCEMIC MANAGEMENT: PEARLS OF SUCCESS

Jenny Simpson, RN, MSN (Cone Health,
Greensboro, NC); Crystal Dodson, PhD, RN, MSN (Cone Health,
Greensboro, NC)

Ms. Jenny Simpson and Dr. Crystal Dodson discussed their initiative to reduce instances of hypoglycemia in ICU patients at the Cone Health hospital system. The two began by briefly giving some background on the Cone Health hospital system, which contains five campuses and 987 beds, before outlining some key features of ICU glycemic management. They then narrowed in on the specific issue of hypoglycemia occurring in patients receiving subcutaneous insulin and with high doses of basal insulin. To try and reduce hypoglycemic events, they adjusted their ICU hyperglycemia protocol to include a reduction in once-a-day basal insulin dosing and addition of bolus insulin to cover enteral feeds. With this adjustment in place, the revised ICU protocol called for intravenous insulin to be given to patients who had one or two CBGs over 250 mg/dl. At a point at which IV insulin infusion rate was <4 units/hour, enteral feeds were at goal, and the patient had stabilized with 6 CBGs of <180 mg/dl, bolus insulin was added to cover enteral feeds. The adjusted protocol was tested in a 16-bed MICU over the course of two months. Of the 42 patients the MICU received in this time, 44% received the enteral feed coverage. After two months, 73.1% of all blood glucose tests from these patients were between 70 and 180 mg/dl, results the speakers deemed “remarkably low.” The results of the pilot were presented to the Critical Care Protocol Committee, and the revised protocol was then implemented throughout the hospital system in all intensive care units. Despite these successes, Ms. Dodson shared ongoing challenges with the program, such as compliance with protocol from MDs and RNs alike. In addition, computerized order entries and specialty populations of renal dysfunction and corticosteroid utilization presented additional challenges to the program.

 

8. Exhibit Hall

  • AADE:  The large exhibit booth for the American Association of Diabetes Educators occupied the center of the hall. The layout of the space sat atop a plush carpet that raised the space noticeably above the surrounding ground. Unifying the many sections of the space was the persistent use of the AADE's soft orange and grey color scheme. The space could be thought of as having three sections. First, a number of service-station kiosks with computers and AADE staff popped up like mushrooms in the south end of the space. These stations provided real-time assistance for Membership, Distance Education, DEAP/BC-ASM/AADE 7 Systems, Advocacy, and the AADE 2013 tablet. Much of the AADE space was occupied by the bookstore, which by the time we came to it on Friday, was nearly out-of-stock. Indeed, a number of speakers referenced this store in their talks, recalling the books they purchased at previous annual meetings. Surrounding the book store and much of the exhibit space were pamphlets providing information and next-steps for nearly every function of the AADE you could think of. Finally, flanking the side of the space was a raised stage and seating area devoted to a series of live trainings for each day the Exhibit Hall was open. On the day we stopped by, the day's agenda included a AADE HealthSlate Tablet Demonstration, Book and CD signing for keynote speaker Ms. Belleruth Naparstek, a session on Licensure from an Educator's Perspective, AADE's new outreach campaign, and a session on the Yellowhawk Tribal Health Center (an AADE DEAP Tribal Health Center). Taken together, the service stations, bookstore, training area, and pamphlets provided an appropriately educational space for an organization intent on walking the walk.
  • Abbott: We were excited to see Abbott back on the exhibit hall floor after its absence from ADA’s. Indeed, it made a big impression, standing in the middle of the hall with signature-Abbott-yellow panels of information and large, bright yellow circles reaching above the heads of the other booths. Additionally, all of the sales representatives were in bright yellow shirts. Together, the booth was impossible to miss. Approximately half of the booth was taken up by a game show testing attendees’ knowledge of the FreeStyle; there were four podiums stationed in front of a large screen and an announcer with a microphone so that questions could be heard booths away.  The screen faced outward so that anyone walking by could stop and learn about the Abbott products (which some people did). The center of the exhibit provided information about the FreeStyle meters, with information handouts and example meters across a bench. On each corner opposite the game show, representatives were ready to inform visitors how CMS’ competitive bidding would affect patients’ health plans. Representatives were equipped with handouts and were ready to provide background on competitive bidding and how it could affect patients’ choice. They highlighted that Abbott test strips would still be covered by Medicare part B. Talking to representatives, it was evident they understood the extent to which competitive bidding would impact the strip market and that they were knowledgeable about both competitive bidding and Medicare services.
  • ADA: This year’s ADA exhibit was very reminiscent of the previous year’s exhibit, featuring an extensive library of pamphlets, fact sheets, and books catering to all types of patients and healthcare providers. We noted the increase in Spanish-language materials in an effort to reach out to the Spanish-speaking community – this was great to see. In addition to Spanish-speaking community outreach materials, the booth also featured more on prediabetes and nutrition guidelines, reflecting the clear and pressing need to give educators educational materials on this topic.
  • Alere: Towards one of the hall’s back corners, Alere’s booth had a sleek white backdrop with “Alere” printed on it. In the middle of the booth were two, white podiums standing side by side. The letters on each podium were bright green and purple, calling attention to the brochures and information available for reference. One of the stands highlighted the past, present, and future of hypoglycemia, while the other emphasized Alere’s relationship with JDRF. We found the idea behind the booth was fascinating: stop, look, listen encouraged attendees to stop at Alere’s booth, look at the Insulin Dosing System used with over 100,000 ICU patients, and listen to Dr. Nicole Saur present on Thursday, August 8. Additionally, Alere promised to donate $25 to JDRF for anyone who does attend. Alere also publicized this presentation on their website, noting that there is limited seating at Dr. Saur’s Thursday talk, so it is prudent to sign up on their form (which can be found at http://www.alere-is.com/events.html#sign). The website also encourages attendees to visit Alere’s booth to see how the ICU is replacing paper protocols with the GlucoStabilizer Insulin Management System, and how the GlucoStabilizer decreases glycemic variability in critically ill patients. We think Alere’s stop, look, and listen idea, as well as its charitable promotion, is clever, as it both  draws visitors to Alere’s booth and helps raise money for a great cause.
  • ArkrayThe Arkray exhibit was certainly eye-catching with its American themed panels and Uncle Sam pointing at the attendees proclaiming: “We want YOU to help make our health team.” The booth focused on two major components of Arkray’s diabetes care business: its Glucocard blood glucose meter and the complementary ARK Care cloud network app that allows people to transfer meter readings to an online database. On the other side of the massive Uncle Sam were columns set up featuring the Glucocard meters with representatives ready to tell attendees about its features, including the auto-enabled blood glucose monitoring system for audio test results. Additionally, throughout the exhibit, there were flat screen monitors set up with examples of how to use the ARK Care system and additional representatives ready to walk attendees through the diabetes management system.  We were excited to sign up for a chance to win a free conference ticket to EASD 2014, a perk that drew many attendees to listen to the exhibit.
  • Bayer: Following Bayer’s absence from ADA’s Exhibit Hall, we were happy to see a Bayer booth. Sitting near the center of the exhibit hall, Bayer appeared to be appealing to a variety of individuals. The overall coloring of the booth was darker than most, with a brown carpet, mostly dark wooden interior walls, and black seating. What we were most struck by at first was the A1c test at the booth; a representative on the side was ready with forms for attendees to fill out in order to test their A1c levels, and the waiting line was demarcated by que line divider winding its way across half of the exhibit to a counter where about five representatives were testing A1c levels. Seeing this, we were particularly reminded of previous Novo Nordisk booths (such as at ADA 2013) that performed similar tests. Like Novo Nordisk’s previous booths, the draw of the A1c test proved to be appealing, and there was usually a line of at least five people. On the other side of the A1c test, there was a smoothie bar where attendees could sample different flavors of smoothie; each smoothie came with its own umbrella, and the representatives were dressed in Hawaiian shirts (the colorful details really provided a spark to the booth, we think). Adjacent to the smoothie bar was a lounge space, equipped with a long couch, a few chairs, and a coffee table, providing fatigued attendees a location to relax, check their email, or hold a conversation. The lounge was cut off from the noise of the exhibit hall by a large wall, and on the other side of the wall, facing outward, was a large poster with photos of the Bayer Contour Next and Contour Next EZ meter. Information on Bayer’s products, although not as prominent as some of the booth’s extra features, were scattered throughout the floor.
  • BD: BD’s booth was located toward the side of the exhibit hall. Similar to their booth at ADA, it included a demonstration of the BD Nano 4 mm pen, a presentation on lipohypertrophy and hypoglycemia, and an area for distributing water and apple slices for the booth visitors. There were also stations on either side of the booth that allowed visitors to review recent research articles and data. The “wow demo” was highlighted in the booth, with representatives pointing the way to the demonstration. During the demonstration, the machine placed five pounds of force on an insulin pen loaded with 60 units of insulin, and allowed attendees to observe the time difference between the 4 mm EasyFlow technology needle and a needle without EasyFlow technology; the EasyFlow technology allowed the insulin to exit the needle in only four seconds while the other needle required 7.5 seconds. A representative was also nearby to guide attendees through a video presentation on hypoglycemia, which involved attendee participation for guessing how much faster insulin is absorbed during muscular injection compared to subcutaneous injection. The video also highlighted that the 4 mm needle reduced the number of intra-muscular injections. Just as at ADA, the focus of the booth was on improved insulin injection technique.
  • BMS/AZ: BMS/AZ had two booths in separate back corners of the exhibit hall. The main booth was much smaller than the one they brought to ADA – it channeled a sophisticated living room-like feel with cream and beige carpets and a spiky blue chandelier. The booth was sparsely populated, with only one simple screen each dedicated to displaying label information for Byetta (exenatide), Bydureon (exenatide extended-release), Onglyza (saxagliptin), Kombiglyze (saxagliptin/metformin), and Symlin (pramlintide) in very small print. The rest of the floor space was bare and housed four white couches. The Byetta panel promoted its use in combination with long-acting insulin. BMS/AZ also had a satellite booth on the opposite end of the exhibit hall where visitors could learn about insulin-independent mechanisms of glycemic control, with a focus on the kidney. This very small booth featured a touch-screen animation focusing on the SGLT-2 inhibition mechanism.
  • Centers of Medicare and Medicaid Services: The exhibit hall booth for the Centers of Medicare and Medicaid Services (CMS) was  hidden amongst booths lined with food options, jewelry, and hand creams. Its location was difficult to find and its banner consisted of a single 8.5 x 11 white piece of paper printed in black Arial font. The takeaway leaflets were neatly lined up on tables, but were all general information sheets on Medicare and Medicaid—there were no materials specific to diabetes or diabetes technology reimbursement. Along such lines, the exhibit hall representative was unable to answer any questions on Medicare’s competitive bidding program and subsequent concerns of BGM testing strip quality. When prompted on CGM reimbursement, the spokesperson was again unable to provide any information or details on the topic. For an organization so deeply involved in the access and culture of diabetes care, we certainly had hoped to see and learn more. We’re hoping that this was largely a product of this being the CMS’ first year with an exhibition booth at AADE.
  • ConAgra: The ConAgra booth was located near other food related companies and toward the back left of the exhibit hall. The backdrop display had an array of ConAgra food packages, including some of their Healthy Choice meal boxes, diced tomato cans, and PAM spray. Two representatives managed their table, which had a presentation of one Healthy Choice meal box, a glass of milk, and a bowl of lettuce and cucumbers neatly situated on a tray. The representatives administered surveys, asking individuals to guess the caloric, sodium, carbohydrate, and saturated fat content of the entire meal. Once we submitted our answers, they demonstrated that their Healthy Choice frozen microwaveable meals are lower in calories, saturated fat and sodium that one presupposes. They provided us with measuring cups, a very in-depth packet of all their products, and the advantages of serving size control, and other information on how monitoring serving sizes by buying meals with predetermined food portions can be advantageous to someone with diabetes or prediabetes.
  • Daiichi Sankyo: Daiichi Sankyo’s medium-sized, centrally-located booth was dedicated to Welchol (colesevelam), its second-generation bile acid sequestrant indicated for type 2 diabetes and hypercholesterolemia. The booth was planned with its target audience (diabetes educators) in mind: visitors could create their own educational handout for diabetes patients, choosing between topics such as hypoglycemia, the importance of blood glucose monitoring, or lifestyle changes. One notable handout illustrated the do-s and don’t-s of diabetes care with a picture of an overweight man smoking and eating a pizza while sitting on an armchair and watching television. After creating their handout, visitors could view presentation screens to learn more about Welchol. Sales representatives noted that colesevelam features in the ACE/AACE Glycemic Control Algorithm as a potential add-on to metformin. They also highlighted study results demonstrating that colesevelam added to metformin therapy led to a mean 0.5% decrease in A1c (Bays et al., Archives of Internal Medicine 2008). Before leaving, visitors could enjoy a glass of iced tea or lemonade.
  • Dexcom: Dexcom’s smaller booth was nestled in the corner of the exhibit hall, with an open design that offered attendees ample seating room. Dexcom Share was prominently featured at the booth’s front table, albeit under a plexi-glass case with a handwritten “Investigational Use Only” label. Still, it was great to see Dexcom showing this next-gen product in what is normally a very conservative exhibit hall for companies. We learned in Dexcom’s earnings call yesterday that a PMA supplement for Share was submitted to the FDA at the end of July; launch is expected in 2014. The focus of Dexcom’s AADE booth was on educating educators about CGM broadly and the G4 Platinum specifically, primarily through handouts on the device’s accuracy and the Detect & Direct campaign. As a reminder, the laminated Detect & Direct wheel shows how the addition of trend information to glucose values can affect real-time treatment decisions. In the back of the booth, a sleek marketing video from Dexcom’s website showcased the many improvements with the G4 Platinum. In talking with the rep about the device’s reception here at AADE, she said, “G4 Platinum is turning a lot of heads.”
  • dLifeThe dLife booth had a clear commitment to providing diabetes educators with tools and resources to pass on to their patients for healthy at-home education. The exhibit was covered in colorful patient pamphlets with tag lines such as “What Can I Eat?” and “Join the #1 Diabetes Community.” Perhaps the biggest takeaway was more information on their “Eat Well, Test Well” initiative in collaboration with Bayer (http://www.eatwell-testwell.com). The free six-week program gives patients a Bayer Contour Next meter and personalized tips, nutrition advice, and support to better understand blood glucose management. dLife’s exhibit hall reps were quick to comment on the excitement and positive reception towards their program. We walked away with a handful of fun patient leaflets, including our very own diaTribe postcard!
  • Eisai: In the front and center of the Exhibit Hall, Eisai’s coral, navy blue, and white booth told diabetes educators that Eisai/Arena’s anti-obesity medication, Belviq (lorcaserin) is “now available.” Compared to neighboring Medtronic and J&J busy booths, the Eisai booth seemed to have relatively fewer attendees and no apparent giveaways on the couple occasions when we walked by. Flower arrangements were scattered throughout the booth, which seemed to allude to the names of Belviq’s phase 3 trials: BLOOM, BLOOM-DM, and BLOSSOM. There were white desk chairs at which people could sit and view the obesity rates in their state on a screen. The representative we spoke to emphasized that Belviq is an adjunct to diet and exercise and that it should be prescribed to motivated patients who are willing to make lifestyle changes but need to see more short-term positive feedback than the average person typically sees from lifestyle changes. The medical information team told us that Eisai is working on an analysis to more robustly determine Belviq’s impact on the prevention of type 2 diabetes. In the BLOOM and BLOSSOM trials, according to the medical information personnel, patients on Belviq were about 1.6-fold less likely to develop type 2 diabetes during the trials than people on placebo (p<0.05).
  • FDA/CFSAN (Nutrition): Located toward the back of the exhibit hall, the FDA table was not very easy to find and lacked colorful or creative décor (this of course is driven by their budget – they are very careful with resources, and comparisons to industry are not useful). Their table was covered in numerous pamphlets and brochures about food safety on topics ranging from how long to cook various foods, to types of pathogens in specific foods, how to avoid them, and how to stay safe with your food choices.
  • Genentech: Genentech’s small booth tucked away on the outskirts of the exhibit hall urged visitors to “Lead the way against the leading cause of blindness.” The diabetic macular edema drug Lucentis was not directly mentioned. The booth showcased its awareness campaign to educate people on how to prevent diabetes vision loss, and representatives emphasized the sometimes-asymptomatic nature of diabetic retinopathy and relayed that having a retinal eye exam is often the only way to detect damage. iPads displayed the site DiabetesEyeCheck.org – the campaign’s accompanying website where visitors could learn about the relationship between diabetes and eye disease and preventative efforts. Finally, visitors could have their pictures taken by a professional cameraman in front of a green screen to be Photoshopped onto a poster promoting eye disease awareness.
  • Glooko: The small Glooko booth had an elegant blue-and-white-themed design, marketing the company’s big news of the day: FDA submission of a special 510(k) for the Android version of the Glooko app and universal MeterSync cable (the system is currently only available for Apple iPhones). We immediately asked how long approval would take – the rep could not say, but for comparison, the company’s first 510(k) took less than 60 days and the second one took only 29 days. Notably, Glooko can now download 19 meters for Android (the new cable opens up micro-USB and mini-USB meters) and 19 meters for iOS – there is some but not complete overlap. The Android submission is a particularly notable one, since roughly 50% of the US market uses a phone with this software, and according to the rep, 65% of the EU market and 90% of the Chinese market. Glooko’s booth prominently displayed the three major groups the company’s universal data management system is intended to benefit: patients, professionals, and payers. We were also excited to see a prototype of Glooko’s next-gen product on display: a Bluetooth Low Energy connector. This small plastic adapter will plug into a glucose meter and turn it into a Bluetooth-enabled device that sends the data straight to the Glooko app. Nice! As we understand it, the goal is to submit the Bluetooth adapter to the FDA by the end of the year.
  • GSK: The company’s modestly-sized booth focused on its non-branded Care Management resources, which include Care Management Central (for healthcare professionals; CareManagementCentral.com) and HealthCoach4Me (for consumers; HealthCoach4Me.com). Representatives at the booth noted that the set of initiatives provide touch-points for providers and patients along the continuum of diabetes care. We were not surprised that GSK’s booth didn’t feature explicit product mentions, given that GSK’s only diabetes product available in the US is Avandia. If Eperzan (albiglutide) is approved next year, we certainly expect that GSK will invest in a larger presence at US conference exhibit halls.  
  • Intuity Medical: Intuity Medical’s booth was located toward the side of this year’s hall and was adorned in bright colors and patterns. The Pogo logo dominated the four pillars of the booth along with the catchphrase “Press. Test. Go,” with the company name in much smaller print near the bottom of the stands. The representatives were eager to demonstrate the all-in-one blood glucose meter, emphasizing the ease of use and the convenience of having the lancets and strips in a cartridge contained in the device. The representative was also quick to highlight that the test requires only 0.25 ml blood, less than Abbott’s FreeStyle, and that the needles are 30 gauge. The presentation also included a walk-through of their web-based program, which has a user-friendly interface and patients can choose to share their data with a HCP. The device can be easily uploaded onto a computer using a regular USB cable, which we think is very convenient. The web-based program allowed the patient or HCP to observe patterns visually, or in a list-like logbook. Similar to the booth at ADA 2013, attendees could enter to win a Kindle by selecting their five favorite Pogo meter designs, and the booth also gave away free fans that display, “Pogo… So Hot It’s Cool.”
  • Insulet: Insulet’s booth, identical in design to its ADA offering, was tucked between Tandem and Dexcom in the AADE hall. The can’t miss slogans advertising the second-gen pod were noticeable from across the hall: “Now 34% smaller” and “Now with updated PDM.” The booth’s newest offering definitely won the award for most unique marketing campaign of the day: an educational solid chocolate second-gen OmniPod to emphasize the importance of using extended boluses for high fat meals – the “Edupod” came in both milk chocolate and dark chocolate flavors. Each Edupod came with an enclosed booklet containing nutrition facts, a review of the PDM’s new insulin-on-board calculator, a discussion of how to extended bolus on the PDM, and the tagline, “Bolus with confidence and ease.” Each chocolate pod was 26 g of carbs (21 and 24 grams of sugar) and had 16g of fat (10 g saturated) – while we cannot commend Insulet for choosing a healthy high fat option (e.g., peanut butter and an apple might have been a better choice!), the company is sure to get some buzz with the campaign among educators. In talking with reps about the second-gen pod launch, they emphasized that demand is “huge” (long hold times on the phone), “crazy, crazy,” and patients “are coming out of the walls.” The rep we spoke to talked about the cut-the-cord program ($199 for an in-warranty durable pumper to switch to the OmniPod), the benefits of continuous insulin infusion (“Would you remove your pancreas for 15 minutes a day?”), and the 90-minute post-pod change blood glucose reminder on the new PDM.
  • Janssen: The Janssen both took up about a quarter of the very lively Johnson & Johnson booth – one of the largest booths at AADE 2013, featuring their family of “J&J Diabetes Solutions Companies.” Invokana, Janssen’s new SGLT-2 inhibitor, was featured prominently, and many people were curious about the new mechanism. Sales representatives, who flowed seamlessly between the LifeScan/Animas and Janssen sections of the booth, had broad knowledge of both J&J’s diabetes device portfolio and Invokana. They enthusiastically emphasized the myriad possibilities for combination therapy with Invokana. One representative reassured us that mechanistically, Invokana should not be expected to harm the kidneys any more than they would already be harmed by hyperglycemia since the SGLT-2 inhibition takes place in the proximal tubule after the blood has already traversed the glomerulus. Strings of light streamed down the center of the Invokana booth, suggestive of streams of glucose raining down from the ceiling. As at ADA, the Invokana section featured six paint-by-number easels that attendees could help paint. The six canvases will be assembled together into a mural to be donated to the Foundation for Hospital Art.
  • JDRF: The JDRF booth contained a familiar motif – the words “Cure. Treat. Prevent” featured prominently as a header, accompanied by images of JDRF cyclists, families, and researchers. The booth was packed with information, including a very valuable fact sheet – “Top 10 Advances of FY2013” – that summarized key innovations in research areas such as complications and the artificial pancreas.
  • J&J Diabetes Institute: JJDI occupied half a booth situated near the front-facing corner of the Exhibit Hall within the larger J&J space. The fully-subsidized program offers diabetes-focused training to healthcare providers in California’s Silicon Valley. Each course is limited to 25 students, and thousands have moved through the program since it began in 2008. In addition to classroom instruction JJDI also offers an online community for diabetes learning that is fully stocked with lectures, webinars, message boards, and other educational resources. We were told the web portal has engaged 10,000 HCPs since the program’s inception. Much of their outreach efforts are undertaken by way of their partnership with AADE, as well as by positive word-of-mouth from their program participants.
  • Kellogg: The Kellogg table was located near a few other food vendors toward the center and back end of the exhibit hall. The focus of this table was two of their newer products: high fiber cereal and high fiber bars. These were promoted as healthy foods for people with diabetes and prediabetes. Per ¾ cup serving, the high fiber cereal contains 7g of sugar and 9g of fiber. The bars contain 9g of sugar, 7g of fiber, and 10g of protein. Representatives gave away individual cups of the dry cereal and individual fiber bars to anyone interested attendees.
  • LifeScan/Animas: The familiar bowtie shaped J&J booth made an appearance at AADE, encompassing both LifeScan/Animas as well as Janssen. Toward the front of the hall, J&J was situated slightly to the side and one row ahead of Abbott. The LifeScan/Animas booths were contained to one half of J&J’s booth. The Verio Sync was demonstrated with an emphasis on its simplicity. As a reminder, the Verio Sync sends blood glucose data via Bluetooth to the OneTouch Reveal Diabetes Management Application. The device received FDA clearance in early February (to learn more, read our report at http://www.closeconcerns.com/knowledgebase/r/4f5547c3). Representatives were excited about the return of the Verio IQ “after AADE.” This was similar to the response at ADA of “fairly soon.” On one end of the booth were two counters featuring the waterproof OneTouch Ping, each of which had a narrow, bubbling tube of water with a pump turning in the small currents. Keeping in the aqua themes, J&J chose a dolphin as their stuffed animal of choice this year (as a reminder, J&J Animas choses a different animal as a giveaway each year). In the J&J booth there was also a table presenting their all-natural, no calorie sweetener, Nectresse. We also saw the product last year at AADE after it was launched in July 2012 by McNeil Nutritionals, LLC (a subsidiary of J&J). Separating LifeScan/Animas from Janssen was J&J’s espresso bar, which was popular throughout the day.
  • Lilly: Lilly’s signature red circular display reading “Personal Solutions for Everyday Life” was certainly one of the largest in the Exhibit Hall, though foot traffic was low when we visited. Just as at ADA, the exhibit was modeled after a home, with a different product or theme featured in each room of the house. Humalog was prominently featured in the “kitchen” of the Lilly house, where Humalog pen devices were displayed under glass casing (like cupcakes on a cake stand). The outdoor patio featured a grill with tips on healthy eating. A final “room” in the exhibit was a children’s elementary school classroom complete with cubbyholes, lunchboxes, and crayons, with a traditional glucagon rescue kit interspersed amongst these more familiar childhood props. This room provided educational materials on hypoglycemia. Tradjenta did not receive as much fanfare as it did at ADA, as BI did not have its own separate booth. A purple awning over a large window next to a newspaper stand displayed the Tradjenta logo. Replacing the space that Byetta and Bydureon used to occupy, Lilly added a stand on Humulin-R U-500; the stand used a picture of a mega-syringe to demonstrate how patients could reduce their insulin volume by 80%. Finally, Lilly continued to feature its innovative partnership with Disney and its resources for children and teens.
  • Medtronic: The expansive Medtronic booth was bustling when we arrived, with attendees taking in the company’s full suite of insulin delivery products. We immediately noticed the new “future technologies” pillar, which for the first time, showed the MiniMed 530G threshold suspend insulin pump. It was of course not labeled as such (we even checked the back of the pump!), but there was no mistaking what we were looking at – a Paradigm-based pump (identical looking to the Revel), an Enlite sensor and inserter, and an instructional iPad with a graph showing how threshold suspend works. Kudos to Medtronic for finally showing this in an exhibit hall, though it was also discouraging to read, “As of August 2013, this feature and products embodying it ware investigational only and not approved for sale in the US.” Sigh. The other news of the booth was Medtronic’s new Start Right program, which is designed to ease the first six months of transition for patients new to CGM and/or insulin pumping. Patients are paired with a Start Right representative, who proactively calls the patient at various milestones over a six-month period (e.g., going through the box, following up on training, etc.). The rep emphasized that Start Right augments what Medtronic already does with in-person training and educational materials. We think the program is a good idea and wonder how many patients will take advantage of it. The rep would not say how many patients typically quite pumping or using CGM after six months (we tried!), nor did we find out how many Start Right reps Medtronic has. The company started the program because it noticed that the first six months were a particularly hard time for many patients.
  • Merck: Merck’s simple and understated booth was directly in front of one of the hall’s main entrances and was serving vanilla and chocolate frozen yogurt. Merck’s product signage included stands emphasizing the diversity of type 2 diabetes patient needs and the importance of individualizing care. The information stands featured “patient” characters that attendees could “meet” (e.g., at the Januvia stand, we met “Steve,” a man with type 2 diabetes who was not achieving optimal glucose control on metformin alone). We noted that Merck strongly positioned sitagliptin as an adjunct to metformin, rather than an alternative for the average patient. Characters generally were either already on metformin or were newly diagnosed requiring more than metformin monotherapy. Notably, Janumet (sitagliptin/metformin) and Janumet XR (sitagliptin/metformin extended release) appeared to be featured more prominently than Januvia ­– an observation a Merck representative reaffirmed. She noted that since most people on sitagliptin are also on metformin, they would likely find Janumet more convenient. We note that Janumet had a strong 2Q13 with worldwide sales totaling $474 million (the agent’s highest ever revenue), up 15% from 2Q12 and 16% from 1Q13 (for more details on Janumet and the entire Januvia franchise’s 2Q13 results, please see our Merck 2Q13 report at http://www.closeconcerns.com/knowledgebase/r/8ac8afbc).
  • Nipro Diagnostics: Nipro Diagnostics showcased its TRUE2go, TRUEresult, and TRUEtrack products in a fairly large exhibition space towards the side of the hall. Representatives highlighted the portability and convenience of the TRUE2go device, which contains a meter, strip container, and lancing device in a pocket-sized package. Interestingly, a representative stated that the company should fare well in the aftermath of CMS’ new competitive bidding policy for blood glucose testing equipment. They noted that, through their close partnership with retail pharmacies such as CVS/Caremark, they have been able to ensure that their meters are offered at a price point that will be fully covered by Medicare.
  • Nova Diabetes Care: The blue and yellow Nova Diabetes Care booth was located off to the side. The exhibit highlighted the partnership with Medtronic, advertising their strips as “for the Medtronic pump.” Panels advertised Nova Diabetes Care’s five-second glucose results, and 10-second ketone test. The booth also offered a “Diabetes Nutrition Placemat” for attendees, with exercise activities, portion size suggestions, and food suggestions. We were slightly disappointed, however, to see that diet sodas were listed as “free food” with “unlimited servings.” As a reminder, at the end of July, Nova Diabetes Care voluntarily recalled 21 lots of glucose tests strips (read the press release at http://www.novacares.com/news/nova-max-recall.php?source=govdelivery), however, neither the booth nor representatives made any mention of the recall.
  • Novo Nordisk: The company featured a large booth (though not the largest) towards the side of the exhibition hall. It followed the company’s usual style, with white panels and brightly lit presentation screens. As with Novo Nordisk’s booths at previous conferences, half the space was dedicated to Victoza (liraglutide), while the other half was dedicated to the company’s insulin products. The Victoza half followed the now-familiar “Grab type 2 diabetes by the roots” theme. Visitors were encouraged to play a Victoza quiz on an iPad, which involved tilting the screen to roll a ball towards the correct answer choice. Quiz questions highlighted that Victoza has reached 600,000 prescriptions and acts on a wide range of organs. When questioned about pancreatitis fears, a sales representative noted that diabetes itself leads to an increase in pancreatitis, and that all the relevant information is clearly noted on the drug label. The representative also proudly noted that Victoza recently hit blockbuster status, and that (as a result) much Novo Nordisk’s US team is being invited to the company headquarters in Denmark for their annual meeting. The insulin section of the booth featured the NovoLog pen – representatives spoke at length about the thin and convenient NovoTwist pen needles, and provided demonstrations of the pen’s operation. Visitors to the booth could also get an A1c test done. A representative noted that each day, every time a visitor scans in to the insulin, Victoza, or Victoza iPad game section of the booth, Novo Nordisk will donate $10 to AADE. This means that, over the course of the conference, a single individual could help Novo Nordisk contribute $90 of donations to AADE.
  • PepsiCoThe PepsiCo booth was nestled in near the back of the exhibit hall, surrounded by colorful glasses of their reduced sugar and diet beverages. A good number of healthy options were on display, including Quaker oatmeal products and Trop50—a half-calorie line of juices. Exhibit hall employees mentioned PepsiCo’s nutrition team, which they explain continually tries to slash calories and sugar, but keep “great taste” to provide “options for everyone” including those that would fit inside a healthy diabetes plan.
  • Philosys: Despite its somewhat secluded location, Philosys attracted a significant amount of traffic and never seemed to have an empty table. The company had a table set up with its current and new products neatly displayed.  Their current product on display, the Gmate VOICE, is a blood glucose monitoring system about the size of an iPhone 4 with a large and easy to read display that produces fast results. Three representatives were demonstrating the new device, the Gmate SMART, on their iPhones. It is currently the world’s smallest blood glucose meter, about the size of a quarter, but thick, square and black. This little device is iPhone, iPad, iPod and Android compatible and plugs right into the headphone jack. The Gmate SMART works directly with the phone application, Gmate SMART, to read and record results. Once inserted into the phone, the test strip is simply attached to the exterior, a sample is applied, and nearly instantly the results are uploaded to the app as well as an online. The beauty in this device is its small size and the ability to access results anywhere you have internet and then export them to your physician in real-time. Philosys was very excited about its new product and is waiting for FDA approval. It has already received the CE Mark, so Philosys will soon be allowed to market it in the EU. As a thank you for stopping by their booth, representatives generously gave away free lancing devices.
  • Roche: Roche’s stylish booth grabbed our attention with blue arches above a wooden walkway curving through one half of the booth. The arches appeared to be held up by blue, stick-figure-esque people. The main message of the booth was the same as that at ADA 2013: “Brining It All Together.” When attendees entered the booth, they received a “With a Splash of Color!” card. As they traveled along the walkway, they visited five different stations, collecting stamps for every station they visited. As the card pointed out, this was a nice way for the conference attendees to learn how all the products fit together into a care system for the patient. The five stations were 1) blood glucose systems, 2) insulin delivery systems, 3) clinical corner, 4) hospital information, and 5) information management solutions. After attendees finished traveling along the pathway, they could head to “prize redemption” and show what they had learned to earn a prize, which is to be different each day (Wednesday the prize was frozen ice drinks and an Accu-Chek FastClix lancing device). On the booth’s outside wall there was an area for visitors to quickly stop by and learn how patients, physicians, and products can work together. We appreciate Roche’s efforts to get conference attendees to see the bigger picture (it is sometimes easy to focus on one specific product). We think that Roche also did a nice job targeting their information towards educators; representatives were prepared and eager to show healthcare providers how to upload and work with data on the computer. Additionally, Roche had on display Rufus, the bear with diabetes, as well as the book starring Rufus, a nice reminder of Roche’s partnership with JDRF.
  • Sanofi: The maker of the highest-selling product in diabetes (Lantus) had a medium-sized booth towards the side of the hall. The layout was uncluttered, with white exhibit structures on an off-white carpet. A central wall divided the space into thirds; one dedicated to Lantus (insulin glargine), one dedicated to Apidra (insulin glulisine), and one dedicated to the A1C Champions Program. The exhibit’s most prominent features were man- (or woman) sized models of two SoloStar pens (one for Apidra and one for Lantus). A handout highlighted that Lantus SoloStar pens are compatible with BD Ultra-Fine pen needles. Representatives were also distributing brightly colored booklets (“Make Mealtime More Manageable”) with tips for meals and information on Apidra. A significant portion of the space was dedicated to the A1C Champions Program, a team of 70 diabetes patients that travels across the country to give free presentations. A member of the team from the group who was present at the booth highlighted that the program provides a combination of education and camaraderie that is very beneficial for patients.
  • T1D Exchange: The T1D Exchange had a booth promoting Glu (www.myglu.org), a type 1 diabetes online community, whose website the representative described as having undergone a “facelift.” She explained that Glu now accepts people who are “close supporters” of people with type 1 diabetes, in addition to people with type 1 diabetes and their caretakers. Additionally, Glu now supports private groups for people or topics wanting more privacy. Material the booth was distributing, explained to HCPs that by being a “Glu Clinic” they will help patients access Glu, where they can give and receive support, empowerment, and education between office visits. Glu provides “Glu Clinics” with material on Glu’s benefits for patient education.
  • Tandem: The San Diego-based company reprised its modern, clean booth from ADA, showcasing the t:slim and its touchscreen sleekness. The booth’s clear hit was registration for Tandem’s “Dancing Among the Stars” event, which included celebs from the showing Dancing with the Stars: Cheryl Burke and Tony Dovolani (Mark Ballas was supposed to attend but an unavoidable family matter came up). When we visited the booth in the morning, we learned that over 900 educators had registered – wow! In a very smart marketing move, rep handed registrants a Tandem-branded lanyard and VIP pass with a map to walk to the venue (complete with the info that walking there would burn 50 calories – nice!). The booth showed off the new colors for the Myabetic protective t:slim cases (green, teal, and orange), which in Tandem fashion, were chosen based on market research and a company-wide vote. A dedicated kiosk showed off the web-based t:connect software, though all the educators in the booth seemed more interested in registering for the evening’s dancing event.
  • Telcare: Toward the back-right of the hall, Telcare’s booth rose above its smaller neighbors and informed visitors about its cellular-enabled meter. Pictures of the meter in the booth consistently featured positive messages such as “GOOD JOB! Your reading was in range.” A rep walked us through its Telcare’s physician portal, handing us a brochure with “Connected care is here” on the cover. In particular, she emphasized the technology’s ability to help HCPs see how their practice’s patients are doing overall and how particular individuals are fairing. If an HCP would like to contact a patient, they can send a message to the person’s Telcare BGM, a feature the rep noted is especially useful for patients who do not have a smart phone. Similar to Telcare’s booth at ADA, the booth was adorned with several signs for the Gluco-Share program (www.gluco-share.org), which had the tagline, “Turn Your Readings into Rewards.” The free iPhone app (also on Facebook) helps patients set goals and challenges, allows them to enter blood glucose readings and to interact with friends and family, and gives tangible rewards for good behavior and habits (>800 to choose from and some partner companies include Lego and Hasbro). Patients using the Telcare meter will be able to enter their blood glucose values into Gluco-Share using the meter’s wireless transmission. According to the representative, Telcare’s link to Gluco-Share is to launch in two weeks. Gluco-Share was started by John Madden’s son, Joe, and it is intended to “gamify” diabetes. The booth had a fun giveaway: attendees could have an electronic caricature drawn and printed of them, during which representatives would discuss Telcare and Gluco Share. While getting our caricature done, we asked about the impact competitive bidding and competition form Walmart’s ReliOn is having on Telcare. The representative explained that such competition caused Telcare to adopt the strategy of targeting self-insured markets, such as employers, who might be more responsive to their employee’s needs.
  • Valeritas: Though the booth for Valeritas was situated near the back end of the Exhibit Hall, the structure advertising the insulin delivery device V-Go was very vertically visible. The device is constructed to deliver a continuous preset basal rate of insulin, as well as bolus dosing at the push of a button. Much like its presence at the ADA Exhibit Hall, the V-Go spire stood out in its bright green coloring. The booth itself had a great deal of content between pamphlets, signage, and several video screens that all worked to frame V-Go as an easy, eminently convenient treatment for Type 2 patients. Frequently seen were posters of regular Joe’s and Jane’s shown on-the-go with their V-Go patch. The video screens played testimonials that spoke to the device’s ease of use. When asked what reaction or feedback surprised them the most about the product since its launch one year ago, both the sales representatives and the folks from Valeritas’ Medical Affairs division told us about initial disbelief by HCPs that the product was so simple to use. This booth was very well attended by passersby, so much so that it was difficult to find a representative free to speak with us.
  • Vivus: Vivus’ signature purple, light blue, and white booth featured a notable addition to its ADA booth: a large panel proclaiming that Qsymia is now available in retail pharmacies. As a reminder, Qsymia became available at more than 8,000 retail pharmacies on July 1, 2013 (for details on the rollout, please see our July 10, 2013 Closer Look at http://www.closeconcerns.com/knowledgebase/r/22838b02). One of the representatives told us that the retail-rollout has had a noticeable impact on sales; according to the representative, weekly Qsymia script sales have grown ~65% since the shift in distribution. When we asked if the representative has noticed a difference in Vivus’ approach since the new CEO Tony Zook and board began to serve Vivus, the representative frankly responded that while it has not impacted his daily activities yet, he thinks it will be a positive change (for details on the management change, please see our July 24, 2013 Closer Look at http://www.closeconcerns.com/knowledgebase/r/5116a9ab). He felt that the Qsymia launch will benefit from the new leadership’s experience in drug commercialization. He painted the former leadership team as having a stronger “background in research” and as being “in over their heads” with Qsymia’s commercialization). The representative noted that Vivus is a small company with ~150 sales representatives. As a result, he remarked, his territory is two New England states rather than the 50-mile radius he was responsible for with the previous pharma companies he worked for. Vivus has previously noted that many of its representatives held prior positions as companies like Takeda, Sanofi, Novartis, and BMS.
  • Walmart: The Walmart booth was dedicated to its ReliOn diabetes care products. When we approached the booth the two representatives warmly launched into an explanation of how inexpensive the ReliOn products are; a 50-count box of ReliOn Prime strips costs $9. They became defensive, however, when we asked the representatives what they would say to patients about the Strip Safely campaign (http://www.stripsafely.com/) or those who have concerns that inexpensive strips might be inaccurate. Both representatives underscored that the ReliOn products have to meet the same FDA standards as others and  one remarked that the theory of inexpensive strips being inaccurate was “put forth by industry” charging people “three to four times more.” The other representative urged, “Walmart would not puts its name on a product that is not high quality” – an assertion we are uncertain all patients would find reassuring. She continued to note that blood glucose monitoring is “so critical to daily life” and that ReliOn “would not mess with something so important.”
  • ZamzeeThe company had a booth towards the far corner of the hall focused on its sole product, the Zamzee — a two-part solution involving a kid-friendly clip-on accelerometer and a website where users can download and track the accelerometer data. The Zamzee is the product of a collaboration between Hope Labs (which develops health games for children) and the Robert Wood Johnson Foundation (a key player in obesity research). A randomized control trial of the Zamzee presented at the Obesity Society’s 2012 meeting demonstrated that device users engaged in significantly more vigorous exercise per week and experienced a modest but statistically significant improvement in A1c and LDL cholesterol. The representative at Zamzee’s booth stated that the company is looking to partner with large healthcare groups such as Kaiser Permanente to test the Zamzee with large, targeted groups of children. We will be excited to monitor the Zamzee’s future progress, as health games present an exciting and affordable potential solution for the growing childhood obesity and diabetes epidemics.

 

-- by Adam Brown, Hannah Deming, Jessica Dong, Samiul Haque, Hannah Martin, Rajiv Narayan, Phaedra Randolph, Jennifer Tsai, Lisa Vance, Manu Venkat, and Kelly Close