August 6-9, 2014; Orlando, FL; Full Report - Memorable Talks - Draft

Executive Highlights

This report contains what we consider the most memorable talks from AADE 2014, including thoughts from KOLs on the future of CGM, critical commentary on sulfonylureas, and how healthcare reform is impacting diabetes educators.

On the diabetes technology side, Dr. Irl Hirsch (University of Washington, Seattle, WA) discussed the past year’s state-of-the-art technology, proclaiming that “CGM is going to out-enroll pumps” in the near future. Asante CEO Mr. David Thrower (Asante, Sunnyvale, CA) announced a series of pipeline updates at a festive customer appreciation event (featuring the Blue Man Group) where he highlighted the recent launch of the MySnap program and hinted at potential artificial pancreas development plans. In addition, a star-studded panel including Mr. Jeff Hitchcock (Children with Diabetes, West Chester, OH), Ms. Kerri Sparling (SixUntilMe.com), and Mr. Bennett Dunlap (StripSafely and Your Diabetes May Vary, Philadelphia, PA) discussed the role of social media in diabetes management.

Regarding drugs, Dr. James Gavin (Emory University, Atlanta, GA) characterized hypoglycemia and weight gain as the “Achilles heel” of treatment adherence and called out the high hypoglycemia rates of the sulfonylurea class. The conference also included several notable product theaters: Ms. Davida Kruger (Henry Form Health Systems, Detroit, MI) discussed the potential of SGLT-2 inhibitors at Janssen’s presentation and AstraZeneca featured the first public demonstration of its new Bydureon (once weekly exenatide) pen.

Notably, health policy and reimbursement was a significant focus this year, as AADE President Ms. Joan Bardsley (MedStar Health Research Institute, Hyattsville, MD) opened the conference by advocating for better reimbursement for educators. In addition, political scientist Dr. Jonathan Oberlander (University of North Carolina – Chapel Hill, Chapel Hill, NC) presented a keynote address on the goals and challenges of the Affordable Care Act, commenting that healthcare reform is built on an imperfect system.

The titles of all of these talks are highlighted in yellow in our full report.

Diabetes Technology

Corporate Symposium: Diabetes Technology Comes of Age: Practical Strategies for Optimizing Integrated Insulin Pump Therapy and Continuous Glucose Monitoring (Supported by an Unrestricted Educational Grant from Medtronic-Bayer Alliance)

State-of-the-Art Diabetes Technology in 2014

Irl Hirsch, MD (University of Washington, Seattle, WA)

Dr. Irl Hirsch’s presentation focused on current SMBG accuracy standards and CGM/pump use in the T1D Exchange. He stated that the 2013 ISO and 2014 FDA proposed accuracy standards for home use of meters are “doable,” though the FDA proposed point-of-care (POC) accuracy standards are unrealistic – indeed, he emphasized that the latter leaves “zero tolerance for statistical outliers” and even YSI cannot meet them. He predicted that changes will be made to the guidance before final publication. Dr. Hirsch also shared unpublished data from the T1D Exchange on insulin pump and CGM penetration (used by 59% and 9% of type 1 patients, respectively) – despite the disparity, Dr. Hirsch reiterated his prediction from ENDO 2014 that “in the next three to five years CGM is going to out-enroll pumps.” In particular, he pointed to what he considers the unjustifiably high frequency of severe hypoglycemia in the current US population (as high as ~20%/year in patients with a duration of diabetes >40 years), noting that hypoglycemia “is the reason we fight for CGM.”

• Dr. Hirsch characterized current 2013 ISO and 2014 FDA proposed accuracy standards for home use of meters as “doable,” noting that Roche’s Accu-Chek Aviva Plus and Bayer’s Contour Next Link currently meet these guidelines. However, he was critical of offshore strip brands, none of which meet either the 2013 ISO or 2014 FDA proposed standards – this is of course cause for concern, as patients and payers frequently turn to offshore brands in order to cut costs.
  
  • Dr. Hirsch was incensed over the FDA proposed point-of-care (POC) accuracy standards. As a reminder, these guidelines call for 99% of measured values to be within ±10% of reference for >70 mg/dl and within ±7 mg/dl for <70 mg/dl. Additionally, 100% of individual results are expected to fall within ±20% of the reference method for samples >70 mg/dl or ±15 mg/dl for <70 mg/dl. Echoing sentiments we have heard since the January publication of the document, Dr. Hirsch noted that there is “zero tolerance for statistical outliers” and that even YSI cannot achieve these standards. That said, he did express confidence that “common sense will prevail” – he predicted that significant changes would be made to the FDA guidelines before final publication.

Table 1: Insulin Pump Use by Age in the T1D Exchange

*Not defined in Dr. Hirsch’s presentation, though we assume this means over the last five years.

Table 2: CGM Use by Age in the T1D Exchange

*Not defined in Dr. Hirsch’s presentation, though we assume this means over the last five years.

• Dr. Hirsch shared unpublished data from the T1D Exchange on insulin pump and CGM use by age. Though certainly not representative of the whole US type 1 population, the data reveal the gradually increasing penetration of CGM and insulin pumps in the type 1 population over the last several years (currently used by 9% and 59% of Exchange participants, up from 6% and 54% at the time patients were enrolled – the latter was not defined). Use of pumps in pediatric patients <12 years has increased quite substantially over time, rising from 31% to 51% in those <6 years and 47% to 62% in those 6-12 years. A similar pattern has been observed in CGM penetration; the prevalence of use in the youngest age groups has tripled (<6 years) and doubled (6-12 years), albeit from very small bases. It was disappointing to see the limited uptake of CGM (5%) in the young adult population (ages 18-25), a number that has not increased. One might expect comparable, if not greater, penetration relative to the other adult age groups, given the familiarity with new technology; we wonder if this stems from insurance and/or income constraints, as out of pocket costs of using CGM can sometimes be quite high.  
• Dr. Hirsch also shared T1D Exchange data on the relationship between mean A1c and insulin pump and CGM use. Unsurprisingly, pump users had a lower average A1c relative to those on MDI, and CGM users had a lower average A1c relative to non-CGM users (see below).

Table 3: Mean A1c – Insulin Pump Therapy vs. Injection in the T1D Exchange

Table 4: Mean A1c – CGM Users vs. Non-CGM Users in the T1D Exchange

• Despite the disparity in CGM vs. pump penetration, Dr. Hirsch projected that “in the next three to five years CGM is going to out-enroll pumps” – a prediction we heard most recently at ENDO 2014. As evidence, he pointed to what he considers the unjustifiably high frequency of severe hypoglycemia in the US population; according to a recent study (Weinstock et al., Journal of Clinical Endocrinology and Metabolism 2013), the frequency of severe hypoglycemia is as high as 20% per year in patients who have had diabetes for over 40 years (regardless of age) and does not drop lower than ~7% for patients whose duration of diabetes is < 20 years (regardless of age). Dr. Hirsch emphasized that hypoglycemia “is the reason we fight for CGM,” noting that these devices can change “these horrible numbers.”

Customer Appreciation Event

Snap to the Beat! Blue Man Group at Universal Orlando Resort

David Thrower, MBA (CEO, Asante, Sunnyvale, CA)

A series of pipeline updates headlined Asante CEO Mr. David Thrower’s presentation at the company’s late night even featuring the Blue Man Group. In front of an enthusiastic crowd at Universal Studios, Mr. Thrower opened his presentation by highlighting the recent launch of the MySnap program; this service will allow users to customize the color of the face, frame, and accent of Snap pumps in an effort to promote patient individualization. Mr. Thrower also detailed plans for a next-generation, wireless Snap pump (launch scheduled for “next year”) that will be cloud-enabled and will feed into an Asante smartphone app – creatively called the “SnapCoach.” According to Mr. Thrower, the app will allow users to bolus from the smartphone app itself – that would represent a major convenience advantage for patients, though we wonder how long the regulatory path would be. This mobile platform will also precede the integration of Asante Snap pump data into Dexcom’s Gen 5 mobile platform (also announced at AADE), as Asante seeks to provide new innovation “every year” in the foreseeable future. Mr. Thrower also highlighted Asante’s Simple Upgrade program, which allows patients to move to the newest product for $99 dollars. Intriguingly, Mr. Thrower also hinted that the company has plans to become involved in closed-loop technology, stating, “We’ll have much more to say about an artificial pancreas later this year.”

• Asante took the unusual approach of forgoing an exhibit hall booth in favor of a more extravagant, high-profile event. The decision appears to have paid off from a public relations perspective, as we overheard multiple attendees eagerly anticipating the event throughout the conference. Those who attended are unlikely to forget Asante soon – the impressive display (which took place at Universal Studios, a short bus ride away from the conference center) featured an open bar, a finger-food buffet, and, of course, an energetic performance by the Blue Man Group.
• Mr. Thrower opened his presentation by highlighting the national launch of the “world’s most person-friendly” insulin pump, Asante’s Snap. As a reminder, Asante began a controlled launch in the Northeastern US (New England, Philly, Pittsburgh, and Baltimore/Washington, DC) in April 2013. Mr. Thrower cited data indicating that patients trained on the Snap once can use the pump correctly on their second attempt 99.4% of the time. The pump is the only one on the market with a prefilled insulin cartridges (300 units of Humalog, up to seven days), which Asante claims will save the user roughly eight hours over the course of four years (or, as their clever – and touching – promotional video noted “59,500 warm fuzzy hugs”). Emotional appeals aside, we think the Snap’s focus on ease of use and prefilled cartridges could help expand the market for insulin pumps by appealing to patients on MDI therapy who are eager for a low-hassle alternative to injections. See diaTribe’s test drive of the Snap for more information.
  
  • Mr. Thrower highlighted Asante’s four-week risk-free trial program, something that is highly unique in the pump industry. We are big fans of this marketing strategy, as a permanent switch to pump therapy can be a very daunting decision for patients. Given that only ~30% type 1 patients are currently pump users, we hope – and Asante is certainly convinced – that more might be persuaded to make the leap if they could simply try pump therapy for just a few weeks.
• Mr. Thrower highlighted the recent launch of Asante’s MySnap program, which will allow users to choose custom colors for the face, frame, and accent of their pumps in an effort to promote individualization – Snap is currently the only insulin pump to offer this feature, similar to what Nike did with its NikeID program. According to Asante’s press release, the company will begin shipping MySnap pumps on November 24th of this year; anyone who purchases a Snap pump between now and then will also receive a free MySnap pump upgrade.
  
  • Mr. Thrower highlighted Asante’s $99 Simple Upgrade program, which will allow Snap users to upgrade to “every single innovation [Asante] introduce[s] for $99 dollars.” We believe this program will apply to most, if not all, of Asante’s upcoming innovations; we know for certain that it will apply to the MySnap program and the next-gen Bluetooth-enabled pump.
• Mr. Thrower detailed plans for a next-generation, wireless Snap pump (launch scheduled for “next year”) that will feed into a new Asante smartphone app. The pump will be cloud enabled, featuring a new screen and new look, while the app – creatively called the “SnapCoach” – will allow users to bolus from the app itself and will eventually integrate data from Dexcom’s Gen 5 CGM. Though Mr. Thrower provided little granularity on either front, the announcement offered our first concrete glimpse of the company’s robust pipeline. We are fans of Asante’s Silicon Valley approach to product development and willingness to try new things; in particular, we see the move to mobile-bolusing as a huge win for patients, though the regulatory path is a major unknown.
  
  • According to a timeline on the accompanying slide deck, the next-gen pump will precede the integration of Snap pump data into Dexcom’s Gen 5 mobile platform that was also announced during AADE. The relative timeline of platform development was previously unclear. As a reminder, FDA submission of Dexcom’s Gen 5 platform is expected by the end of 2014/1Q15. A formal timeline for the Gen 5 launch depends on how fast the regulatory process goes – we assume it will take at least 12 months.
• “We’ll have much more to say about an artificial pancreas later this year.” This announcement was certainly the highlight of Mr. Thrower’s pipeline updates, though he was otherwise coy on details. Given Asante’s new CGM integration partnership with Dexcom, we assume it would build its own predictive low glucose suspend or treat-to-range system.  Dexcom already has existing CGM integration partnerships with Animas and Tandem, though neither company has moved very quickly on automating insulin delivery.

Diabetes Drugs

Master Class Session: Medications Update – New and Emerging Therapies

Insulin

Curtis Triplitt, PharmD, CDE (University of Texas Health Science Center, San Antonio, TX)

Given that drug-related presentations at AADE often focus on how to best use already-available therapies, we were glad to see a session dedicated to drugs that are not yet approved in the US. Dr. Curtis Triplitt provided a comprehensive presentation on emerging insulins, giving the room a reason to be excited about the products on the horizon. He covered the complex ongoing regulatory journey of Novo Nordisk’s Tresiba (insulin degludec), attempted to pronounce Sanofi’s “Toujeo” (U300 insulin glargine), reviewed the clinical profile of Lilly’s peglispro, and concluded with an in-depth discussion of MannKind/Sanofi’s inhaled insulin Afrezza – the couple minutes of Q&A at the end of the session were dominated by questions about Afrezza.

• Novo Nordisk’s Tresiba (insulin degludec): Dr. Triplitt noted that Tresiba was the victim of a slightly “backhanded” move by the FDA, which applied its CV Guidance (originally not intended to apply to insulin) to the candidate. Examining the clinical data on Tresiba, Dr. Triplitt characterized it as a good basal insulin that (from most trials) appears to have a hypoglycemia advantage over Lantus (insulin glargine).
• Sanofi’s Toujeo (insulin glargine U300): Introducing the candidate’s name with a French accent, Dr. Triplitt highlighted that Toujeo appears to have a hypoglycemia benefit in type 2 diabetes patients but perhaps not in type 1 diabetes patients (at least not to the same extent). Concentrated insulins that are already available (such as Lilly’s Humulin U500 vials) require some tricky math, but Dr. Triplitt suggested that Toujeo will be available in a pen that will make dosing simpler for patients. 
• Lilly’s Peglispro: Dr. Triplitt focused on the flat PK/PD profile and long half-life (~36 hours) of Lilly’s novel basal insulin, characterizing it as a step up from currently available basal insulins.
• MannKind/Sanofi’s Afrezza: This was the only emerging prandial insulin Dr. Triplitt covered; he gave it a very thorough overview. He covered both the established benefits (a PK/PD profile comparable to IV insulin), safety concerns (pulmonary function, patients with lung disease), and the ideal patients for the product. In Dr. Triplitt’s view, the lack of dosing precision means that Afrezza is much more useful for type 2 diabetes patients than type 1 diabetes patients – in fact, during Q&A, Dr. Triplitt and his co-presenter Dr. Joshua Neumiller (see below) could not recall whether the drug had even been approved for type 1 diabetes. Dr. Triplitt believes that the dose conversion required for Afrezza is quite complex, especially considering that the product has demonstrated a non-linear dose response at higher doses.

Breakout Sessions

Hypoglycemia and Weight Gain: The “Achilles Heel” in the Treatment of Patients with Type 2 Diabetes

James Gavin, MD, PhD (Emory University, Atlanta, GA)

In front of a very receptive audience, Dr. James Gavin asked why, in an era with so many treatment options for type 2 diabetes, the field has not been more successful in improving patients’ long-term outcomes. He named several factors that have contributed to the problem, including clinical inertia and the failure to take advantage of combination therapies earlier in the disease progression. However, Dr. Gavin pointed to insufficient adherence to treatment as one of the most vexing obstacles, which he attributed to unacceptable rates of weight gain and hypoglycemia with many diabetes drugs. Given the well-documented link between improved glycemic control and a reduced risk of microvascular complications, Dr. Gavin argued that improving treatment adherence must be a top priority for providers, and therefore weight gain and hypoglycemia need to be more strongly considered when prescribing medications for type 2 diabetes. For him, the high hypoglycemia rates associated with sulfonylureas make the drug class much less cost-effective than many providers think, as reduced adherence, lower quality of life, and increased risk of complications and hospital visits all contribute to the real “cost” of the drug along with the price itself. Reviewing results from numerous clinical trials, Dr. Gavin demonstrated the more favorable profile of incretin-based therapies (which he called “21st century secretagogues”) and SGLT-2 inhibitors, and he repeatedly urged educators to prioritize these agents whenever possible in their type 2 diabetes treatment algorithms.

Questions and Answers

Q: Can you comment on hypoglycemia in the post-bariatric surgery patient?

A: Frankly, I don’t know. It’s a complex issue. We need to find out what is the frequency and what is the mechanism. When you’ve done that much rewiring and re-plumbing, changing hormonal profiles that profoundly, and depending on the type of surgery, changing emptying rates and the presentation of nutrients to beta cells, all bets are off in terms of understanding the nature of hypoglycemia by any models we have for drug-induced hypoglycemia or underutilization of calories. It’s a very different and complicated subject, and I wouldn’t presume to give an answer with real clarity.

Q: The data showed that more women had hypoglycemia. Do you think there was a correlation with menopause?

A: I don’t know if that’s the reason. I’m not aware of the data. On the face of it, women get pregnant, and that’s an insulin-resistant period, which lowers the likelihood of hypoglycemia. Women have more fat relative to muscle, which would also tend to confer more protection. I’m not sure if it’s the tissue distribution, hormonal profiles, or the demographics of treated diabetes. Men may be just as successful but they tend to be more trifling in terms of getting treated.

Product Theater: Advancing Paradigm Changes in Type 2 Diabetes Management (Sponsored by Janssen)

Advancing Paradigm Changes in Type 2 Diabetes Management

Davida Kruger, MSN, APN-BC, BC, ADM (Henry Ford Health Systems, Detroit, MI)

In a product theater focused on J&J’s Invokana (canagliflozin), Ms. Davida Kruger called on diabetes educators to “wrap their heads around this new idea” of SGLT-2 inhibitors. She began her talk by providing a high-level overview of the role of the kidney in glucose homeostasis, walking educators through Invokana’s mechanism of action. Addressing concerns about the drug’s harmful effect on kidney function, Ms. Kruger pointed to data from a study comparing Invokana to Merck’s Januvia (sitagliptin) demonstrating no difference in eGFR changes between the two treatment groups. Ms. Kruger emphasized that “you can use Invokana again at any point in a patient’s therapy and can expect benefit,” as a variety of treatment regimens (including mono, dual, and triple therapy) have led to substantial A1c reductions. In discussing the drug’s safety profile, she acknowledged the increased risk of genital mycotic infections but downplayed them, stating that “patients usually only get one.” She also advised patients to stay hydrated, as increased urinary frequency is a common side effect in the first month of treatment.

• “This is the new idea we have to wrap our heads around after we grew up thinking, ‘No glucose in the urine,’” highlighted Ms. Kruger in her overview of Invokana’s mechanism of action. She explained that the drug lowers the renal threshold for glucose excretion, thus increasing the amount of glucose in the urine, which many older educators have been taught to avoid.
• Ms. Kruger cited female genital mycotic infections, urinary tract infections, and increased urination as the most common adverse reactions to treatment with SGLT-2 inhibitors. However, she suggested that such infections are not cause for too much concern given that “only 20%” of women experience a second infection. With respect to men, she noted that infections are more frequent in individuals who are uncircumcised. Such comments are similar to those of Dr. Anne Peters (University of Southern California, Los Angeles, CA) at CWD/FFL this past July, where she offered tips and tricks to avoid these infections.
• Ms. Kruger noted that treatment with Invokana leads to weight loss and cardiovascular benefit. Presenting the comparison between Invokana vs. sitagliptin, she pointed out that while sitagliptin is weight neutral, Invokana can lead to a five-pound weight loss. Similarly, she showed that Invokana had a greater systolic blood pressure reduction (-5.1 mm Hg) compared to sitagliptin (+0.9 mm Hg).

Questions and Answers

Q: How often do you see mycotic infections?

A: I’ve only seen them in the first couple weeks to a month. Twenty percent of women will have a second one. One lady I worked with said that she took a probiotic and hasn’t had a yeast infection since. But honestly, I’m not sure if probiotics make a difference. You can also prescribe diflucan.

Q: Why do you start at the 100 mg dose and not the 300 mg dose?

A: As with any medication, go low and slow and see how the medication responds. Keep the patient on the 100 mg for 4-8 weeks, recheck GFR, and then increase to 300 mg. You want to make sure that the drug is agreeable. This also helps prevent side effects.

Q: With increased sugar in the urine, does it change the odor?

A: I haven’t heard any reports of changed odor. And my patients would tell me if it did.

Q: I’ve heard that two-thirds of patients reported increased hunger.

A: I have not seen that at all. It may be due to a slight SGLT-2 blockage. But I don’t know of any other mechanisms otherwise. It’s possible that patients see the scales go down and are motivated to work on dieting, but this wasn’t reported in studies.

Q: Is there any UTI data in women older than 65 or 75?

A: There was no difference across all age groups. 

Product Theater: The Critical Role GLP-1 Receptor Agonists Play in Addressing the Treatment Goals of Adult Patients with Type 2 Diabetes (Sponsored by AstraZeneca)

The Critical Role GLP-1 Receptor Agonists Play in Addressing the Treatment Goals of Adult Patients with Type 2 Diabetes

AstraZeneca’s product theater (held in its massive booth) featured the first public demonstration we’ve seen of the new Bydureon (once weekly exenatide) pen. As a reminder, the dual-chambered pen, which encapsulates the entire reconstitution process within one device, was approved by the FDA in March and recently received a positive CHMP opinion in Europe, paving the way for a likely European approval within the next few months. The “twist, tap, twist” procedure demonstrated by the AZ representative looked significantly more user-friendly than the old vial-syringe reconstitution process, though it is of course not quite as convenient as a “ready-to-use” device like those for Novo Nordisk’s Victoza or Sanofi’s Lyxumia. Device and administration continues to be a significant point of differentiation between various once-weekly GLP-1 agonists, and AZ is certainly taking positive steps in a more patient-friendly direction. The company plans to submit a Bydureon ready-to-use suspension formulation device in both the US and EU in 2015.

Mobile Health and Social Media

Breakout Sessions

The DOC Rx: The Role of Social Media in Managing Type 1 & 2 Diabetes

Jeff Hitchcock (Children with Diabetes, West Chester, OH); Ms. Kerri Sparling (SixUntilMe.com); Mr. Bennett Dunlap, BS (StripSafely and Your Diabetes May Vary, Philadelphia, PA); Ms. Jennifer Block, RN, CDE (Stanford University, Stanford, CA); Dr. Jill Weissberg-Benchell, PhD (Northwestern University Feinberg School of Medicine, Chicago, IL)

An intense and at times emotional panel discussion addressed the positive role that the diabetes online community (DOC) can have in enhancing diabetes management. Moderated by the well-respected Mr. Jeff Hitchcock, the star-studded panel featured Ms. Kerri Sparling, Mr. Bennett Dunlap, Ms. Jennifer Block, and Dr. Jill Weissberg-Benchell. The panel opened with a discussion of the guilt (“the worst complication of diabetes”) and fear associated with diabetes, including the burden of carrying stress 24/7 without a break and the impossible task of trying to explain that burden to family, friends, and providers. In particular, panelists found consensus in discussing the more sympathetic perspective educators and providers need to take when advising patients on diabetes management. The presenters also spoke very positively about the diabetes online community as a resource for patients, families, and providers; they all agreed that the benefits of sharing the burden of the disease with other patients outweigh the risks of misinformation and harassment and can provide an avenue for owning the disease more fully.

Panel Discussion

Mr. Jeff Hitchcock (Children with Diabetes, West Chester, OH): Let’s begin by talking about the shame, guilt, and fear associated with diabetes.

Ms. Kerri Sparling (SixUntilMe.com): I think one of the most challenging things about diabetes is that you don’t get time off for good behavior. You can spend a whole day doing all the things right, and what’s the reward: You have do it again. You have to go and do the same thing, and it wears you out. I think even my family has trouble understanding this sense of being burned out. I get burned out doing the right thing. It’s a psychosocial burden as much as a physical one. I have trouble having people understand that. Because at the same time, I don’t want to sound like a pity party – that isn’t fun.

Mr. Bennett Dunlap (StripSafely and Your Diabetes May Vary, Philadelphia, PA): The stress that Kerri just spoke about is different for a parent. We were just talking right before this session. The fear of hypoglycemia is a real psychological burden for parents. It’s not the hypoglycemia itself. It’s the fear of hypoglycemia. I think that’s a function of the 24/7 nature of diabetes. But that’s part of living with diabetes, and I hope it becomes recognized as part of the clinical visit.

Ms. Jennifer Block (Stanford University, Stanford, CA): As a provider, I used to approach diabetes differently than I approached it myself. I used to feel as if I had to put up a front that I could do this every day without being burdened. But it was the online community that I learned from. And what I learned is that I’m not perfect at this, and it’s OK to admit that this is hard to do. And by admitting that, as providers, we’re empowering people. As a provider, I can teach people about diabetes; that part of my job is easy and fun. The challenge is how to support others through this process. Many of my patients are adolescents who are overwhelmed by diabetes. There are few things better for them than when they meet someone else with diabetes. That said, I’m not going home with them. But their computer is at their fingertips 24 hours a day. And that community can support them in a really positive way.

Dr. Jill Weissberg-Benchell (Northwestern University Feinberg School of Medicine, Chicago, IL): For parents, I think the question is whether they’re doing enough for their child, enough for their child’s health and safety. As health care providers, it’s important to think about what contributions we might be making to the fear and guilt. Yesterday, I talked to a mom who shared a story about the stress of taking her child to the endocrinologist. They had had a bad day managing blood glucose values the day before the visit – because of a bad vial of insulin – and she was afraid to take her child to the endocrinologist. She felt he was likely going to hyper-focus on yesterday, despite it just being a bad vial of insulin, and ignore the previous weeks of success. As HCPs, we need to think about that. We need to partner with patients and families, so that we don’t promote these feelings of shame and guilt and fear. And to Jen’s point, for teenagers, the feeling of a shared experience through the online community is something so powerful and life changing. And for loved ones to see what other people are thinking and feeling, the online community is incredibly powerful too. And for people like Kerri, who are able to express on paper what others are unable to – that ability is an incredible gift.

Ms. Sparling: Thank you. And you’re right in speaking about this stress of visiting your provider. If my A1c is out of range, I hear ‘What did you do?’ Out of the gate, emotions are assigned. I find that stressful. I don’t want to be judged. That’s a sticking point. I want to be a good girl, and I’m trying. So there are emotions automatically assigned to values even though it’s just one statistic. I want my CDE to understand that diabetes is occurring within the context of my normal life. I’m trying and I don’t want to disappoint you. I want my CDE to know I’m a good girl. That’s what everyone wants. Do you want to be a good girl, Bennett?

Mr. Dunlap: Yes.

Ms. Block: To me, every single time that things work out, I want you to celebrate it. But when things don’t work out, accept that it is just diabetes. I think we need to be really humble in our approach with people. I think we’re all here because we want to help our patients. But I’m not sure how we help them when we’re making them feel guilty.

Mr. Hitchcock: There’s this overwhelming fear of the complications of diabetes. But what we’ve learned is that if you stay engaged in managing your diabetes, that’s a path you need not see. My guidance is to echo this: Do the best you can every day. What we really want every day are the coaches that teach us how to play the game well. Sometimes we’re going to drop the ball, run toward the wrong goal, but with you as our coaches, that gives us the strength to go back every day.

Mr. Dunlap: “Control” is a loaded word. Someone was talking about a few years ago, and I was seething. He talked about taking energy from something stressful, like diabetes, and moving it over to something else that isn’t a problem. I would encourage providers to understand that there are unique emotions and stress associated with diabetes. But where can we transfer it? You don’t get a get-well card for diabetes. And you don’t get the reward of feeling better. So it’s hard to move that anxiety to something else. But when I go on the online community, I can find inspiration. I have a friend who I get inspiration from. He’s a biker and whenever I’m down, I see pictures of him biking and get back on my own bike. So people should get online and help each other out.

Ms. Sparling: It struck me when you [Jeff Hitchcock] said you try your best every day. But I don’t try my best every day. I would be lying my face off if I said that. I need to be honest with my doctors about where I’m struggling. I don’t want to be judged for saying that I didn’t check my blood sugar in the morning or that I didn’t respond to a blood sugar over 200 mg/dl. I need to be honest with my health care professional, so that I feel comfortable to share that.

Mr. Hitchcock: Doing your best sometimes means saying, “I’m not going to check my blood sugar this morning,” and taking a break.

Ms. Block: I often don’t have the right answers to diabetes management as a provider, but sometimes the parents and families I work with do. And by having open conversations, we can make changes. Because if I’m the only one making a decision, it’s not going to be as effective. So as a patient, you’ve got to open the door. I’m not living with your diabetes. You are.

Mr. Dunlap: A week ago, I found that in giving a peer support for type 2, I owned mine much more. Someone came to me and said that I have diabetes. She said she doesn’t know how this works. I sat down, and we went through how to check her blood sugar, and she kept getting error 5. I kept laughing and she was getting frustrated. And I said, I have a friend whose license plate is Error 5. And we talked about the conversation she should have with her doctor. This person was my sister. And I was empowered by this interaction. And I get empowered by working with other people.

Dr. Weissberg-Benchell: Honestly, I think the online community is equally as powerful as going to camp or going to Children with Diabetes. I think sometimes, especially with the use of different technologies that give you better control over your diabetes, management can be isolating. After all, nobody in middle school wants other people to ask about it. I’ve had people tell me that substitute teachers have pulled a pump out of a kid’s hands, saying, “You’re not allowed to have a cell phone.” And the kid saying, “Uh no, that’s attached to me…” How do you have those conversations and deal with that? Those online conversations are important.

Ms. Block: Even as a provider, I openly go to the online community. When one of my patients was having trouble waking up to her alarms, I went to the Diabetes Online Community (DOC) and saw Kerri’s advice to put the CGM in a glass cup. I got that from the DOC. And I don’t know if you’ve heard about Glu. Glu has actually conducted clinical trials online. And in their first trial, in 48 hours, they got responses from over 200 patients. These online blogs can be very insightful. This is where we are going to learn about our diabetes in the future.

Q: I don’t want to mislead any of my patients. And there is a lot of misinformation out there. What kinds of regulation or oversight can there be?

Ms. Block: I actually think there is a role for educators with that. Insulin is a very dangerous drug, and who do we trust with it? Our patients. So I think we owe it to our patients to prepare them to sort through that information, especially because this information isn’t just online. It also comes from the people we meet who give us advice. So misinformation isn’t just on the Internet; it’s everywhere. I think patients need to be savvy consumers. As providers, you need to say, “I know you’re going to get information from the Internet and if it tells you to change something significant about your medical management, let’s have a conversation about it.” You should say that it is OK to learn and look around. But let’s just have a conversation about it.

Dr. Weissberg-Benchell: I think we should also trust the family and patients to be able to sift through that information as well. Like Jen said, they are savvy consumers. To an extent, they will be able to figure it out.

Mr. Hitchcock: Almost every human in the world who has a computer searches online for something related to healthcare. So people with diabetes naturally go online and search for diabetes and get millions of hits. And most of those are misinformation. So I would encourage you to encourage people to use the Internet, but to print information out and bring it with them into the clinic to have a conversation about it.

Ms. Sparling: That’s true. But let’s also remember that there is a lot of good information online, too. How many people in the room have blogs on diabetes or share your story online? [~10% of audience raises a hand]. See, these weirdos from the Internet are here, too. You can meet them here. Talk to one of these people to get a sense for the good content that is online. And also, when you’re online, feel free to speak up when you see something that’s incorrect.

Mr. Hitchcock: Speaking of going online, let’s talk about rules of engagement. You’ve got to remember the “Five Ws.”

(i) Who runs/funds the website? – If you can’t find that, don’t’ trust it;

(ii) What does the site say? Do they have citations for the science to back it up?;

(iii) When was the information posted or reviewed? Is it up-to-date?;

(iv) Where did the information come from? Do they have good science to back their claims?;

(v) Why does the site exist? Is it selling something?

Ms. Block: When you [providers] open that door and look online, you learn so much. You learn what your patients are looking at.

Q: Glu is looking to partner with all of you [providers]. We ask a question every day. I’m sure you have questions that you’d like answered by thousands of respondents. And we self-report and police ourselves, so if anyone sees something inappropriate, we remove it immediately. We’ve only had to remove two posts in two years.

Mr. Hitchcock: I would caution everyone though. Some adults resort to seventh grade behavior online. When people hide behind a screen name, immature behaviors come out. Remind families that they are going to meet bullies online. If you introduce yourself online, and someone gets mad at you for using the wrong language, don’t let it bother you. They’re not real. They’re just a screen name. You will hear about that. Don’t be surprised.

Ms. Block: These things happen because you’re hiding behind that wall. But because they are behind a wall, people also say things that they’re uncomfortable saying in person. So we have to take into account that there are some incredibly good things that come out of this anonymity in addition to the bad. We should appreciate that."

Dr. Weissberg-Benchell: You can offer families sites that you trust. They are going to look for you for advice.

Mr. Hitchcock: How many of you go online and look around? [80% of audience raises a hand]. How many of you are anxious and have reservations about it? [10% response]. I just want to remind you that if you’re uncomfortable putting your name out there, you can lie. You don’t have to give your real name if you want protection.

Q: When I go online, I have a different screen name, but list that I’m a diabetes educator. And sometimes, I correct things. I make people think about things twice if I think there’s bad advice out there.

Mr. Hitchcock: I think very few people are out there trying to cause problems or lead people astray.

Mr. Dunlap: My website is called Your Diabetes May Vary. I coined that because of the number of people I heard giving strict advice. I’ve often heard people comment that a particular treatment is bad or that something must be done a certain way. And I would always say, “your diabetes may vary.”

Mr. Hitchcock: Today there is literally an explosion of online opportunity for people with diabetes. Whether you run triathlons or snowboard…if you have a certain passion in your life, there will be someone out there who’s done it before and can chart out that path for you. The greatest fear we have is this feeling of being alone. And the online community is there to show you that you are not alone.

Q: For 20 years, I ran a support group for people with diabetes. But when I moved recently, I couldn’t get that started up again. Do you think that the online community is sapping that personal, face-to-face support and moving it online?

Ms. Block: I think that’s an incredibly challenging issue. There’s a huge benefit to face-to-face interaction. However, there are a lot of patients who are incredibly busy. Life has gotten incredibly busy. But I feel like the online community has broken down some of the barriers to that access. The truth is that we’re not doing as well as we wish we were in diabetes management. So everything we can do to improve management is a good thing.

Mr. Hitchcock: CWD has a chat room. And during the conference, you can see at one in the morning, moms who get up to check their child’s blood sugar, and it’s high but they are not sure whether to treat. And they would get online and receive reassurance from families in Hawaii and others who were awake. At that exact moment, the online community provided exactly what she needed. And we need that.

Q: In the community, we are in a tough spot when we have important, valid questions, such as how much do I need to bolus for this cake? These are real-time decisions, but we don’t want to bother HCPs, because that’s not fair, and it’s not an emergency. So the online community can provides this real-time feedback. What do you think about that?

Ms. Sparling: I personally feel uncomfortable telling people how much insulin to take. That’s something I step away from. However, if someone wants to talk about emotional or psychosocial issues, I’m comfortable talking about that. But not so much telling people how much to bolus.

Mr. Dunlap: I’m also not happy giving out my ratios. However, I’m happy to say how I figure out my ratios.

Ms. Block: One of the things I use the online community for is that I see what people are asking about and incorporate that into my practice. I can understand what questions they have, and it can help us adapt more efficiently.

Dr. Weissberg-Benchell: I just want to point out that if you don’t feel comfortable asking your diabetes educator or nurse a question at two in the morning, you need to switch to someone else. Because that’s what we’re here for. If you need to contact us, you need to feel comfortable doing that. We’re here to support you.

Q: I live by myself. And I don’t have CGM. And two months ago, I had a super high blood sugar before going to bed. And I was up until three in the morning because I didn’t feel safe going to bed. I went onto Twitter, because I wanted the support. Not for advice. But while I was waiting for my unexplained blood sugar to go down, I needed and wanted that support. That’s what Twitter was there for – it was the community.

[Ms. Block puts a green Children with Diabetes Friends for Life (FFL) bracelet on her wrist.]

Mr. Hitchcock: Just to explain that green bracelet, it’s something that started at FFL. Someone said they couldn’t distinguish between people with and without diabetes. So they decided to give everyone with diabetes green bracelets and those without diabetes orange bracelets. And it was originally intended to distinguish people, but it really came to mean so much more.

Ms. Block: It came to mean that you’re not alone.

Mr. Hitchcock: I remember my daughter had to leave FFL early one year and said, “I feel like I’m leaving my home.”

Ms. Block: Speaking about support, I have lots of thoughts about the words we use. Why does it have to be that the words we use often are taken to reflect our number? As a patient, we have personal wants. Maybe I don’t want to ever be low in front of my friends. I don’t want to go low on a date. I would rather be up around 200 and 300 than around 60. You have to take into account a patient’s preferences.

Mr. Dunlap: I love Jen.

Comment: Thank you so much! As a nurse, I always tell my patients, “You will teach me more than I will teach you.” I’ve started on Facebook, and I’ve got a Twitter account and I identify myself as a diabetes educator. I also run a radio show that was picked up by three new radio stations yesterday. What happened is that I’ve tied in Twitter and Facebook to the radio show. What I’ve heard on the show is that everyone is overwhelmed by diabetes. “How do I manage diabetes? Can you recommend a safe way to manage this? How do you stop it from consuming you?” Those are the questions I get.

Ms. Sparling: What is the name of your show?

Comment: The Health and Humor Show. I do corporate comedy. I was invited to speak at a fundraiser, and I was invited to speak to add some humor to these situations. Kerri, what you said was so true about doing well and the reward just being getting to do it again. I have so many people that are only told to go home, stick themselves a couple times a day, and come back in a week. So to hear this amazing feedback from all of you, my soul is happy.

Q: You talked about the guilt and shame and fear of diabetes. You talked about easing those emotions. Next month, I will celebrate my 50th year with diabetes. I’m applying for the Lilly and Joslin awards and when I walk around people are going to think I’m an Olympian [applause]. Earlier this conference, at the talk on erectile dysfunction, we heard that within 20-30 years of being diagnosed, you suffer from sexual dysfunction. I would encourage you to keep duration of disease in your mind. I think as providers we get way too caught up in what the numbers are. We forget that this person has neuropathy, etc. because this person has been carrying this disease for 40 years. The fact that this person still has some bowel function, some brain cells left, is reason to be celebrated!

Mr. Hitchcock: You’re right. What Benno Schmidt said was, “I suffered in silence.” And that’s unacceptable. What’s great about the online community is that people can feel comfortable to come out and share. And I just want to read this last bullet point. Many words are used in clinical practice because they are clinically appropriate. But that doesn’t mean that’s right. My personal pet peeve is the word “compliant.” It just doesn’t work.

Q: I have a Twitter account that’s in my name, and I enjoy it. And the online community appreciates my words as an educator. And I’ve learned so much from the community as well. I went in at my quarterly visit and my A1c was 5.8%, which is too high for me. My next one was 6.9%, and it was because of a lot of the challenges that we face. And I think as educators, it’s important to keep that in mind.

Ms. Sparling: I had a friend who was trying to get to an A1c of 6.1%. She got to 6.1%, but she was sobbing because she had been hypoglycemic all the time. And she was sobbing because that’s what it took for her to get there, and she would rather have been at 7% and not have all that hypoglycemia. And the doctor didn’t understand that.

Dr. Weissberg-Benchell: I celebrate any teenager whose A1c is not double digits [applause].

Q: Are there any online resources specifically for type 2 patients?

Mr. Dunlap: There is a website called The Type 2 Experience. It’s a wonderful place to start and branch out from. TuDiabetes is also a great resource. So is DiabetesSisters – they focus on all types of diabetes, including gestational.

Dr. Weissberg-Benchell: There’s so much guilt and shame for type 2s. There’s a stigma that you brought this on yourself. There is so much judgment that if only you hadn’t eaten all those Twinkies and Frosted Flakes, you wouldn’t have diabetes.

Ms. Sparling: As people with type 1, we need to get those with type 2 to bring their stories online and share them.

Q: I’m an educator and, in my third visit with a patient, he told me he’s a drug addict. He’s been in rehab. I got him on a pump and a meter, but I’m the only outside visit he’s allowed, and I want him to get on the online community. I think it would really help him as he’s by himself and trying to get rid of his other demons as well. I want him to see that diabetes can be empowering. Where should I start him?

Mr. Hitchcock: I would say TuDiabetes.org.

Mr. Hitchcock: Just to wrap up, I want to bring attention to a couple final points. A couple of years ago we were trying to think of something we could do as a group. We came up with Spare a Rose, Save a Child. The idea encourages people to buy 11 roses and donate the money for a 12th to diabetes. This year, we’ve raised $27,000. And it wasn’t one person dropping a lot of money. There was an average contribution of $30. That’s the power of social media to impact diabetes. It’s going to keep over 400 kids alive for a year. We’d love for you to take this back to your office. Please join us.

Ms. Sparling: Have you guys heard of CGM in the Cloud? Essentially, I’m a grown woman with a family and I travel a lot. My husband and mother want to see the CGM data from my pump off my Dexcom receiver. We’re waiting for that data to be available but regulatory regulations stop us from doing this. Given these regulations, CGM in the Cloud is a group of parents with kids with diabetes who hacked their CGMs and put this data in the cloud to allow them to follow CGM data from their loved ones. So my family can now see my blood sugars in real time because people with diabetes were tired of waiting for these regulatory hurdles to be cleared. So if you want to find these people, the CGM in the Cloud group is there for you. There’s a lot of focus on pediatrics, but this applies to everyone. Adults need the same support that kids need. Just because I’m a 35-year-old women doesn’t mean that my mother doesn’t care if I don’t wake up in the morning.

Health Policy, Reimbursement, and Healthcare Models

Introduction

Opening Remarks

Joan Bardsley, MBA, BSN, RN, CDE (MedStar Health Research Institute, Hyattsville, MD)

AADE President Ms. Joan Bardsley opened the conference with a rousing call to action, advocating for diabetes educators to “effectively communicate our impact in order to get properly reimbursed.” Despite educators’ well-documented effectiveness in improving outcomes and reducing costs, many patients remain unaware of the importance of the educator’s role and reimbursement consistently falls short of what it should be. Ms. Bardsley cited a lack of primary care physicians’ referrals to educators as “one of the biggest obstacles” facing diabetes educators today. We wonder how this could change and if a direct-to-patient campaign from patients who have benefited from educators may help. Although educators focus on individual patients in their day-to-day work, Ms. Bardsley urged educators to also think at a macro level and strive to communicate with key healthcare decision makers – this was most valuable from our view since educators have significant expertise in direct patient care. Regarding efforts to increase reimbursement, Ms. Bardsley discussed recent state licensure initiatives that aim to expand educators’ legal scope of practice. In addition, she highlighted the AADE’s national promotional campaign, which encompasses both media relations efforts and collaborations with larger organizations like the American Academy of Family Physicians and the AARP.

Keynote Addresses

The Future of Healthcare Reform

Jonathan Oberlander, PhD (University of North Carolina – Chapel Hill, Chapel Hill, NC)

In a keynote address on US healthcare reform, political scientist Dr. Jonathan Oberlander stressed that “we can’t judge healthcare policy solely by cost control.” He reviewed the goals and challenges of the Affordable Care Act, emphasizing the fact that policy makers chose to build on an imperfect system rather than “wipe the slate clean” when crafting the law. He pointed out that although this was likely a smart approach politically, it has presented challenges for implementation. He also cited intense political opposition to “Obamacare” as a major obstacle to the law’s success, as analysts had not expected so many (mostly Republican-led) states to opt out of setting up their own insurance exchanges or expanding Medicaid. Dr. Oberlander highlighted several up-and-coming developments to watch including ongoing legal challenges, the debate over Medicaid expansion (“this is not an ideological issue, this is an issue of health”), and how the 2014 and 2016 election results could affect implementation. Regarding accountable care organizations (ACOs), he suggested that the verdict is still out on their effectiveness, commenting that although the model is sound in theory, “an ACO [alone] can’t provide compassionate, quality, effective care; it’s the people in it” who are crucial for success. He emphasized that despite the importance of bending the healthcare cost curve, improving health often requires investments that do not directly save costs, and that “allowing people with diabetes to live longer and better lives” is worth the investment. We wholeheartedly agree, and are sometimes frustrated by the expectation of cost savings with diabetes therapies while other disease areas do not face similar expectations.

A Decade of Progress Towards a New DAWN

Martha Funnell, MS, RN, CDE (University of Michigan, Ann Arbor, MI)

In front of a packed audience, Ms. Martha Funnell (University of Michigan, Ann Arbor, MI) shared data from the second iteration of the Diabetes Attitudes, Wishes, and Needs Study (DAWN2); the main take-home message from the study was the widespread need for greater appreciation of the psychosocial burden of diabetes. Ms. Funnell reported distressing data regarding the impact of diabetes on quality of life for both patients and family members (see below), illustrating the need for support systems that go beyond brief office visits and handing patients a prescription. The study also concluded that discrimination remains a significant issue for people with diabetes and provided a new breakdown of self-management behaviors by ethnicity. Specific results and analysis of the study are presented below.

• DAWN2 (n=15,438) revealed the detrimental effects of diabetes on quality of life for people with diabetes (PWD) and their family members (FM) – sizable percentages of both groups reported that diabetes had a negative impact on their physical health (62% PWD; 26.7% FM), emotional well being (46% PWD; 45% FM), finances (44% PWD; 35% FM), leisure activities (38% PWD; 31% FM), work/studies (35% PWD; 23% FM), and relationships with family, friends, and peers (20% PWD; 20% FM). Ms. Funnell criticized traditional treatment plans, which she said often devalue the psychosocial burden of diabetes (“the problem”) and focus only on suboptimal self-management (“the symptom”) of the disease.
• There is currently a great unmet need for care that effectively addresses the psychosocial and behavioral dimensions of diabetes. Only 24% of DAWN2 respondents said that their healthcare provider had asked them how diabetes affects their lives, which Ms. Funnell believes is the single most important question a provider can ask. The study also revealed that 38% of family members wanted to be more involved in diabetes care, while 27% said they did not know how best to help. Ms. Funnell urged providers to emphasize psychosocial education over unnecessarily technical lessons about disease mechanisms, saying that it is one of the best opportunities to help patients improve their disease management. 
  
  • 81% of patients and 72% of family members who participated in education programs reported fewer psychological problems and enhanced self-management. The data suggest that health care providers recognize this need as well – ~60% of HCPs surveyed felt that there is a need for greater access to diabetes self-management education and that this education will improve the burden of diabetes. We hope that the documented benefits of education for patients and the acknowledgement by HCPs that the status quo is unacceptable will help persuade payers of the need for greater reimbursement for diabetes education and enabling technologies.
• A substantial number of respondents with diabetes (~20%) reported experiencing diabetes-related discrimination – we were actually surprised that this number was not higher. According to market research by our colleagues at dQ&A, a recent survey of diabetes patients demonstrated that 76% of type 1 patients and a 52% of type 2 patients believe that diabetes comes with social stigma.
• Ms. Funnell also shared data from a smaller study (n=1,055) within DAWN2 evaluating diabetes management among minority groups. Patients in minority groups (African Americans, Hispanics, and Chinese Americans) reported experiencing more diabetes distress compared to non-Hispanic whites (p <0.05). Interestingly, this finding is inconsistent with other DAWN2 data indicating that African Americans with diabetes reported the highest psychological well-being, quality of life, and diabetes empowerment of all groups examined. Given this conflict, we await further details regarding the scoring system used to assess these variables. Regardless of the ambiguity, Ms. Funnell highlighted the findings as a reminder that providers must be cognizant of cultural considerations when treating patients from different demographics.
  
  • Data on ethnic differences in the resources used to manage diabetes were quite revealing. As summarized in the table below, non-Hispanic whites seek very little information to supplement in-clinic care. Though Ms. Funnell did not speculate on the reasons for this discrepancy, we wonder whether minority groups are, perhaps, less satisfied with their in-clinic care or do not have frequent access to in-clinic care. On the other hand, the discrepancy may reflect underlying cultural differences in the way patients receive information from a perceived authority figure. Regardless, the question speaks to the need for further research in this area.

Table 1: Whom do patients rely on to help manage their diabetes?

• In closing, Ms. Funnell stressed that people with diabetes, not providers, are the foremost experts on themselves. She encouraged providers to help patients identify problems as opposed to focusing on superficial behaviors. The message of DAWN2 is not simply that patient-centered care has long been misunderstood but that patient, family, and provider education regarding psychological aspects of disease management can enhance treatment and lead to better outcomes.

Master Class Session

Current State of DSMT Reimbursement and Healthcare Reform

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

Ms. Patty Telgener discussed the impact of healthcare reform on diabetes education and reviewed reimbursement guidelines for educators. She highlighted the benefits of the Affordable Care Act (ACA) for diabetes patients, and applauded accountable care organizations (ACOs) for aligning incentives with the use of diabetes education. She pointed out that diabetes educators are necessary components of successful ACOs, as care coordination and health education all lie within their expertise. Ms. Telgener was critical of competitive bidding in SMBG, explaining that while out-of-pocket costs have been reduced, patients have been left with significantly fewer options. In reviewing reimbursement guidelines, she expressed frustration with Medicare’s “antiquated” definition of diabetes and how nurses and CDEs are not labeled as “DSMT Certified Providers.” However, Ms. Telgener ended on a positive note, concluding that with the current direction of healthcare, “you [diabetes educators] are all here at the right time and place.”

• Ms. Telgener shared a positive perspective regarding the ACA’s impact on diabetes. She highlighted the elimination of the pre-existing conditions exclusion and lifetime limits on benefits. She applauded the fact that some preventative services will now be free of co-pays and deductibles and that premiums can no longer be based on diabetes or other chronic disease. However, she also acknowledged that flaws, such as unaffordable premiums, remain.
• With respect to competitive bidding in SMBG, Ms. Telgener noted that “manufacturers have been hit hard and patients have fewer options.” She explained that competitive bidding has hit mail-order diabetes supplies and that the program is expanding to more Metropolitan Areas. While the program has reduced out-of-pocket expenses, she recounted stories of patients being forced to switch manufacturers and losing options.
• Ms. Telgener is “not real optimistic about the timing” of the current legislation efforts to recognize CDEs as Diabetes Self-Management Training (DSMT) certified providers under Medicare. Notably, DSMT services are only covered by Medicare in the case of a referral from a certified provider. As such, the lack of recognition for CDEs represents a real reimbursement challenge for patients.
• Ms. Telgener labeled Medicare’s definition of diabetes as “antiquated,” as its criteria do not include A1c level. The current criteria are: i) a fasting blood sugar greater than or equal to 126 mg/dl on two different occasions; ii) a two-hour post glucose challenge greater than or equal to 200 mg/dl on two different occasions; and iii) random glucose test over 200 mg/dl for a person with symptoms of uncontrolled diabetes. Ms. Telgener also pointed out that Medicare does not currently cover prediabetes, noting that expansion of coverage is an important initiative for AADE.

Questions and Answers

Q: I’m seeing a lot of outpatient diabetes education programs, yet no reimbursement on the inpatient side. It’s supposed to be more about prevention. Can you comment on these trends? Will they eventually pay for inpatient diabetes education?

A: I’m seeing financial restraints everywhere. As far as getting paid for inpatient care, most payers pay the hospital. I would expect inpatient to continue to be bundled.

Q: I do a lot of CGM training and I wanted to clarify the billing code, 95250. As an RD, can I use that billing code?

A: For Medicare, it will not necessarily allow an RD to. But some of the commercial plans may allow the RD to bill it. You need to make sure it’s part of your contract. The physician can bill it even though you’re doing the training.

Q: Do our patients need to use up their MNT hours before we can bill for DSMT?

A: No, those are two different benefits. Some patients may not even have referrals for both.

Snap Learning Session

AADE Diabetes Prevention Program

Joanna Craver, BS, MNM (AADE, Chicago, IL)

Ms. Joanna Craver presented encouraging early data from the AADE Diabetes Prevention Program (DPP). The analysis encompassed 12-month results from the majority of AADE’s 30 DPP sites, where participants implemented intensive lifestyle changes while attending regular support sessions with trained facilitators (sessions took place once weekly for the first four months and once monthly for the remainder of the year). Results showed that participants who attended more than four sessions had an average weight loss of 5.9% in the “core” phase (16 weekly sessions) and 6.5% in the “post-core” phase (monthly sessions for the remainder of the year) – this is of course a best-case completer analysis, which would show stronger results than an intention-to-treat analysis. The average number of core sessions attended was 14, and as Ms. Craver put it, “if they’re coming more than four times, they’re coming, and they’re successful.” As promising as these numbers are, Ms. Craver cautioned that AADE will need to find more sustainable sources of reimbursement if the program is to continue beyond 2016 (when its CDC funding expires). AADE is working to convince third-party payers that investing in the DPP will prove to be cost-effective over time and that AADE’s infrastructure and clinical expertise makes it uniquely well-positioned to implement a high-quality program.

• Ms. Craver outlined several key goals for the AADE DPP in the coming year, most of which are focused on reimbursement. AADE aims to launch several DPP sites in partnership with employer groups, with the goal of demonstrating that the program can be a reimbursable model. The organization is also engaging with health department officials in the few states (Kentucky, Washington, and Colorado) where the DPP is a reimbursable benefit for state employees; AADE hopes to better understand which strategies were successful in those states and encourage other state health departments to follow suit.
• The AADE-run programs have cost $565/patient/year on average, only slightly above the CDC’s recommendation of $500/patient/year. As such, Ms. Craver pushed back against the claim that AADE’s use of CDEs and registered DSME sites will lead to unnecessary costs. There is tension with the YMCA and certain payers that have argued the DPP should be run by lay facilitators in order to keep costs down. Ms. Craver said, “We’re not that much more expensive and we offer that much more quality,” thanks to the greater clinical expertise of diabetes educators and the greater access to physicians and other healthcare services from the AADE’s existing DSME infrastructure.

Questions and Answers

Q: We’re running a weight loss program that started as a 12-month program and had considerable dropout. Now we’re running six-week sessions that just give people tools. How do you keep 82% of participants going?

A: The sites set it up as a yearlong program and people sign waivers. We ask people, “Are you ready for this commitment?” If not, we say “let’s talk about other programs.” A lot happens in between sessions – e-mailing, Facebook groups, lots of communication. Once people attend four sessions, they’re hooked in. These are the sorts of things we discuss in forums.

Q: As AADE members, do we have access to your forums?

A: We’re setting that up in the next year. They’re currently just for our grant sites.

Q: I work for a hospital with a DPP that’s based out of the NIH and the CDC, and the people are trained in Pittsburgh. If we want to partner with the AADE, should we talk to you?

A: Yes, the AADE accepts the University of Pittsburgh curriculum.

Q: Is there data on the participation of men vs. women? We have an ongoing program and it seems that the females are there and the males aren’t.

A: The DPP is generally female-dominated. We have about 200 males out of 1,000 participants. The CDC is troubleshooting that to see how to get more men in. Women tend to be the caretakers, so they care about health from a different perspective. There’s research being done and tools we can offer. We’re talking to other groups that have had men and seeing why they signed up, and getting answers from the men who are there.

Q: We have a DPP associated with our medical office group, and patients have been pulled into our practice from the program. I think some of the nutrition content in the curriculum is outdated – they’re counting fat grams but they’re drinking sugary beverages and not counting carbs.

A: Some things are counterintuitive. CDEs are working with the program, and there are some questions about whether it’s outdated, but the program was based on the national study.

Comment: There are more current evidence-based guidelines now.

A: We’re looking at the standards – the new standards are supposed to be out in September – and we’re looking at things like that raised by our educators during a comment period. We tell sites that this is the curriculum, but if you have knowledge exceeding that, you can add as much as you want. You could have a guest speaker come in and talk about sugar. That definitely enhances our programs.

Q: So as of October, the curriculum might be updated?

A: I don’t know what they’re doing with the comments; they don’t want to alter the evidence-based curriculum too much. But our CDEs have expertise that others don’t, and we encourage them to use it.

Q: I’m in a rural area. Does the program depend on having community resources for exercise and diet?

A: Existing sites have teamed up with local fitness centers and offered coupons or free months; some sites have personal trainers come in. We encourage groups to meet outside the classroom – some groups have walking groups that meet before our weekly meeting. It depends on the site. I would reach out to existing sites in a similar area to see what they do.

Comment: As a PSA for AADE members waiting to join forums, there’s a Diabetes Prevention Community of Interest that has resources online.

A: Great. If you ask a question, maybe we haven’t heard it, and now we know that’s an issue. Communication is key.

Q: Is the curriculum fixed? Is it the same group every week or is there rolling admission?

A: The curriculum is fixed, and there is a core group. It really becomes a support group, so it unsettles the dynamic if people come in and out. We discourage people from entering after the first session, though we can do makeup sessions. We want a group dynamic and a yearlong commitment.

Q: So you’re devoting that year to eight to ten people?

A: Yes.

Q: I work with uninsured patients in a free clinic. There are lots of high-risk patients in that setting, 30-40% of my patients are Hispanic – how can we implement the program in that setting?

A: We want to work where there’s reimbursement potential but also elsewhere. The CDC is working to get programs covered by Medicaid; it’s currently covered in Montana. We’re not tackling everything at once so we’re not spearheading that effort, but we’re having conversations. Go to the discussion group and pose those questions.

Q: I’m from Washington, and there’s no recognized program within 75-100 miles. What kinds of opportunities are there? Is there any collaboration with the YMCA?

A: There is collaboration – we realize there aren’t DSME sites everywhere. We’re looking at what we can do. There’s no solution yet, but if you want to help us find one, that’s what we need to do: reach out to members. There has been some collaboration with YMCAs helping them to implement the program.

Q: I’m from Florida, I’m a CDE and RN, and when I sought out information from local YMCAs, I got tremendous pushback against joining the team as a lifestyle coach. I was told that our knowledge level would “veer off the set guidelines.” In light of not being welcomed into the YMCA setting, are there other avenues or trainings? The community needs more prevention, but the YMCA is the only organization offering this. There’s nothing in the hospitals.

A: Florida Blue is covering the program for YMCAs but not in our DSME setting. We’re working with insurance groups to change that and working with the YMCA from the top. We want to know what’s going on, so write that in an email so we can troubleshoot. The YMCAs spearheaded the DPP, the CDC wants it to be available in a setting where it’s taught by lay professionals, and we don’t want to disrupt that by saying our educators are better. But if our costs are similar and we have good, if not better, results, it shows that collaboration is good. We’re trying to show that. It’s not that the YMCAs aren’t doing a good job. There’s room for everyone in the space – with 86 million people [with prediabetes], we don’t have to worry about stepping on each other’s toes. We want to create our own space, and if there’s room for collaboration, that’s great.

Q: We felt a pushback; it was quite obvious. They wanted their own YMCA lay staff. They even pushed back medical residents who wanted to start their own program and build a patient load.

A: I would love to talk more about this. If we can look more closely at the reasons why, we can find solutions for other groups.

Breakout Session

The Role of Shared Decision Making in Diabetes: Considering the Patient’s Preferences

Anna Vannelli, MS, CDE (International Diabetes Center, Minneapolis, MN)

Speaking to a packed auditorium, Ms. Anne Vannelli highlighted the utility of the Mayo Clinic Diabetes Decision Aid tool in facilitating shared decision-making. Ms. Vannelli believes that traditional evidence-based, “directive” approaches to care drive patients to non-adherence by making assumptions about their personal preferences and values. In contrast, the Mayo Clinic tool invites patients to participate in the decision-making process by providing them with a convenient and simple interface that facilitates education and allows patients to make deliberate choices regarding treatment options. According to Ms. Vannelli, this process leads to cognitive investment in the decision, thereby enhancing ownership of the therapy and improving adherence, often the biggest factor limiting treatment efficacy in practice. She acknowledged that shared decision-making is not a tool that will “make money” or dramatically lower A1c, but she said it represents a commitment to a patient-centered approach, and “that is what’s important.”

• “When we want your opinion, we’ll give it to you” – according to Ms. Vannelli, this hierarchical, directive school of thought has traditionally defined the patient-provider relationship. She suggested that this lack of consultation with patients and families is a major factor behind the high rates of non-adherence that currently plague the US health care system: data from IMS Health indicates that only 53% of type 2 patients fill their prescriptions within three months of the written date, only 38% fill their prescriptions within 12 months of the written date, and ~25% do not fill their prescriptions at all.
  
  • Citing a recent study (Cutler and Everett, NEJM 2010), Ms. Vannelli noted that the lack of adherence to medication regimens leads to costs of ~$100 billion annually due to avoidable hospitalizations; we hope that such overwhelming figures will convince payers and policy makers of the need for a more collaborative approach to care that can hopefully encourage greater patient adherence. Certainly, improved medication that don’t cause hypoglycemia and improve weight also stand to improve adherence.
• Ms. Vannelli characterized shared decision-making as a method of incorporating a more patient-centered focus into the traditional, evidence-based approach to healthcare. Ms. Vannelli stressed that patients are the experts in their own lives; only they can weigh the financial tradeoffs or the cultural perceptions regarding medications that ultimately impact adherence. She cited multiple studies demonstrating that engaging and educating patients increases their confidence in treatment decisions, thereby improving adherence.
• Ms. Vannelli highlighted the utility of the Mayo Clinic Diabetes Decision Aid in facilitating shared decision-making. The tool consists of color-coded handouts that allow patients to evaluate common type 2 diabetes medications across seven categories: weight change, A1c reduction, daily routine, low blood sugar, cost, daily sugar testing, and other considerations. For example, a patient whose foremost concern regarding medications is weight gain can look at the corresponding card that summarizes the effects of various drug classes on weight (insulin: 4-6 lb gain; liraglutide/exenatide: 3-6 lb loss; sulfonylureas: 2-3 lb gain; metformin: neutral; SGLT-2 inhibitors: 3-4 lb loss; etc.). We found the Decision Aid interface to be quite intuitive and user-friendly, and we think it would be readily applicable to a real-world clinical setting.
  
  • Educators seemed impressed by the simplicity of the Decision Aid, and several asked where they could access the cards. The cards are available free of charge online, allowing patients to access them outside the clinic as well. diaTribe has also developed a similar, but more general download to help providers and patients share decision making – see www.diaTribe.org/patientguide for more information.
  • Ms. Vannelli shared preliminary data from the TRICEP (Translating Information on Comparative Effectiveness Into Practice) study (n=342), indicating that patients using the Mayo Clinic Decision Aid expressed greater satisfaction and understanding of their treatment relative to those not using the tool (94% vs. 86% and 52% vs. 45%, respectively). The question, of course, is to what extent the higher satisfaction and understanding results in better adherence and improved outcomes.
• Shared-decision making is “a manifestation of your commitment to your patient.” Ms. Vannelli acknowledged that it is not a tool that will “make money” or dramatically lower A1c but said it represents a commitment to a patient-centered approach, and that “that is what’s important” – we imagine that in certain patients, A1c could be dramatically lowered given a significant bump in adherence.

Questions and Answers

Q: Is the Decision Aid available in Spanish?

A: Yes. And they’re working on a couple other languages as well. On the main page, you should be able to select Spanish.

[Comment]: I just want to point out that similar decision aids are available at a variety of clinics (Isenberg, etc.) across the country.

A: Thank you.

Q: Can you talk about the literacy level requirements for using the cards? What happens when we see patients whose level of understanding is at a third or fourth grade level?

A: I can’t fully answer the question about what reading level is necessary for use, because I wasn’t involve in making the cards, but I know it was considered. You could certainly contact someone on the website.

Q: And can you address cultural barriers? How would we work with these cards?

A: In the TRICEP study, we only took people who were English-speaking, but everyone was able to use the cards. In terms of cultural decision-making, some people actually want physicians to make decisions. Others want to be really involved. Maybe the cards are the way to do that, but in some cases, it may be better to ask them outright: What is most important to you? In other cases, the key may be having a conversation and to figure out what’s important to them. And so, my point is that this tool may not be perfect, and you may have to figure out something different that’s appropriate for the cultural groups you work with. However, we are working on it. For example, with the Native American population, we are involved in discussions about how to develop shared decision-making tools that are appropriate for them.

[Comment]: This website has really transformed the discussions I have with patients. If they speak Spanish, I use the Spanish version of the instructions. Patients actually get more engaged and are not as fearful of therapy. And with the [Mayo Clinic] statin decision-aid tool, you put in their personal information – If they are a smoker, etc. – and it gives you data on the likelihood of a heart attack. Patients are used to getting a pill thrown at them, but with this tool, they feel like they have a choice. Just a note: It would be great if we could order them instead of having to print them out online. I just wanted to thank you, because it’s made a big difference in my clinic.

A: Thank you.

Q: Is access to the Decision Aid free?

A: Yes.

Q: How do I get a physician to agree to sign a decision that agrees with a patient? What if the physician doesn’t agree with the treatment?

A: This has happened to me. Whether it’s because the chosen medication is new or because the physician doesn’t agree, sometimes you’ll have trouble getting everyone on board. You can talk to physician in person about the fact that it’s a patient’s decision, not theirs. Of course, you have to back it up with reasoning and feeling. One other solution is coming up with two options when you talk with a patient. Tell them that their first choice is a new medication and that the doctor may not agree to prescribe it. Ask them what their second option would be? We’ll often make that decision early, so that we have a backup option. But you’re right, sometimes the doctor may just not agree.

Q: If the clear decision is insulin, how do you use shared decision-making?

A: During the study that we did [TRICEP], we actually had some people who were on three oral medications and who probably needed to go onto insulin. So that’s kind of where your expertise meets patients’ values. Maybe still involve the patient in choosing what insulin regimen to go for. That’s a way to develop another shared decision-making conversation. That’s where patient shared decision-making values meet your knowledge. It’s all about having a conversation. Some organizations have a pamphlet on insulin that can help with that decision.

Additional Topics

Breakout Session

What PWD Wish Their HCP/CDE Knew About Diabetes

Connie Chitwood-Vu, MS, RD, LD, CDE, BC-ADM and Lyndsay Wright, MA, RD, LD, CDE (Insulet Corporation, Bedford, MA)

Ms. Connie Chitwood-Vu and Ms. Lyndsay Wright presented results from an online survey sponsored by Insulet on patient preferences regarding their educators and other HCPs. The survey asked people with diabetes to name the most important lessons they had learned from their providers as well as a “wish list” of items they wished their providers understood more fully. The population that completed the survey (n=317) was split fairly evenly in terms of gender (57% female) and type of diabetes (53% type 1); the average age was ~40 years and the average duration of diabetes was ~18 years. The survey found that the specific messages patients valued the most related to the ability to live a normal life with diabetes, practical advice for blood sugar control, information about pump therapy benefits, and the assurance that difficulty managing their diabetes did not constitute a personal failure. Only 20% of participants said there was something they wished their provider knew more fully about diabetes; among that group, common responses included the sheer number of variables that can affect blood sugar, the emotional impact of diabetes on patients’ loved ones, and what it is truly like to live with diabetes 24/7/365. In addition, survey results showed that many participants preferred to learn about diabetes through one-on-one meetings with providers (67%) and online support groups.

Questions and Answers

Q: When patients answered how they want to learn about diabetes, one-on-one sessions were at the top and groups were at the bottom. We’ve been hearing so much about how great group education is, so how do we balance that?

Ms. Chitwood-Vu: We’ve gotten feedback elsewhere about learning more from others in a group setting. The majority of the survey population had type 1 diabetes, and I’m just speculating, but many people may already be participating in other support groups. The question was specifically “How do you like to learn from a healthcare provider or CDE?” Many people haven’t done group visits with a provider. But we could definitely explore this more.

Q: What’s your opinion on educators who have diabetes sharing that information with the group?

Ms. Chitwood-Vu: I don’t know how many educators have diabetes. I do, and I share it the majority of the time because no matter what the patient is experiencing, chances are I probably have too – not being perfect, having blood sugars that aren’t perfect. I absolutely share that. Especially when people are really struggling, I say that I understand it’s hard, that not every day is a great diabetes day. The vast majority of us that have diabetes went into diabetes to help other people. I’m impressed with all the CDEs who don’t have diabetes that put up with us.

Ms. Wright: I don’t have diabetes, and I’ve had patients say to me, “do you live with diabetes every day?” I lose a little credibility with them. So if you’re comfortable, I say, let patients know; you guys can really relate.

-- by Melissa An, Varun Iyengar, Emily Regier, Manu Venkat, and Kelly Close