This report features our full coverage from the American Association of Diabetes Educators 43rd Annual Meeting (AADE 2016) held in San Diego, CA from August 12-15 that drew in 3,600 attendees from all 50 states, and a bustling and bigger-than-ever exhibit hall. Each year, we find ourselves impressed by the practical, real-world perspectives at this meeting, and this year was no exception.
Below, we have divided our coverage into five categories: (i) Themes; (ii) Diabetes Technology; (iii) Diabetes Drugs; (iv) Additional Topics; and (v) Exhibit Hall.
We noticed an even bigger emphasis on diabetes technology this year at AADE, including very positive commentary on automated insulin delivery (but there are expectations and training challenges as systems come to market), tremendous enthusiasm for CGM (though still underpenetrated), and encouraging movement on app-enabled diabetes coaching platforms. Technology in diabetes has never moved this fast and educators were all over it from what we could see.
In diabetes drugs, we observed enthusiasm for the quickly-growing GLP-1 agonist class, though this excitement was somewhat tempered by concerns over the rising cost of diabetes care. Several sessions discussed the ins and outs of reimbursement and drug pricing – highly concerning issues, especially given that the often prohibitive cost of diabetes care is a strong contributor to the low patient engagement.
Big picture, we heard about the need to move beyond A1c alone, a greater focus on prediabetes and prevention (a full day on Sunday), lots of interest in the microbiome, and several fascinating talks on the psychology of diabetes (including stigma and poor language). In obesity, many speakers encouraged providers to be more open-minded about suggesting drugs as a viable therapeutic option.
- Executive Highlights
- Diabetes Technology
- Diabetes Drugs
- Additional Topics
- Diabetes Technology
- Breakout Sessions
- Anticipating the Availability of Artificial Pancreas Systems: What to Expect in the Clinic?
- Closed Loop Automated Insulin Delivery Systems: From DIY to FDA Approved
- The Diabetes Technology Revolution: Utilizing Tools and Technology Data to Maximize their Use and Improve Patient Outcomes
- CGM Before CSII Initiation: Reverse Your Thinking
- The Art & Science of Safe and Effective Insulin Injections: What We Learned at the FITTER Congress in Rome
- FDA Guidance and an Educator's Perspective on the Avalanche of Apps
- The Value of Retrospective CGM Data in Shared Decision Making
- Hypoglycemia in 2016: Detection, Consequences, and Prevention
- Insulin Therapy and Delivery Today and Tomorrow
- Josh Guffey, PharmD (Carolinas Health Care System, Charlotte, NC); Theresa Pearson (Innovative Health Care Designs; Minneapolis, MN); Jill Schramm (Uniformed Services University, Bethesda, MD); Evan Sisson, PharmD (VCU School of Pharmacy, Richmond, VA); Nathan Painter, Pharm D (VCU School of Pharmacy, Richmond, VA)
- Diabetes Wheel of Fortune: Help People Choose the Best Mobile Health Solutions for Them
- Optmizing Insulin Therapy Through Applied CGM
- Insulin Pump Therapy Management: The Collaborative Art and Science of Supporting an Adult “Pumper”
- Help Clients Overcome Diabetes Data Smog: Perspectives from a CEO with DIabetes
- Special Symposia
- Corporate Symposia
- Product Theater
- Breakout Sessions
- Diabetes Drugs
- Breakout Sessions
- Pre-Conference Events
- Corporate Symposia
- GLP-1 Across the Continuum: From Metformin to Basal Insulin (Sponsored by Novo Nordisk)
- Achieving Partnerships and Improving Outcomes in Your Diabetes Patients (Sponsored by AZ)
- Constructing an Open and Shut Case for the Practical Application of New Insulin Formulations in Type 2 Diabetes (Sponsored by Novo Nordisk)
- Product Theater
- The Role of a Once-Weekly GLP-1 RA Therapy in Improving Glucose Control (Sponsored by AstraZeneca)
- Meet Basaglar (Sponsored by Lilly/BI)
- Going Further with Invokana: A Leading Option After Metformin
- The Importance of Utilizing a Comprehensive Approach when Managing Patients with Type 2 Diabetes
- Additional Topics
- Patient Engagement and Access
- Looking Beyond A1c as the Gold Standard Diabetes Outcome
- Maximize Medication Adherence by Minimizing Barriers
- Sharing Evidence-Based Hope with Your Clients
- Mastering the "Why?", "Whether To?" and "How?" of Successful Behavior Change in Diabetes Care
- Diabetes Management and Education in the Era of Healthcare Transformation – An Optimist’s View
- The e-community: How eHealth Can Engage People and Providers
- The e-community: How eHealth Can Engage People and Providers
- Tailoring Treatment Plans and DSME for Food Insecure People with Diabetes
- Diabetes Prevention Program
- Current State of DSMT Reimbursement and Healthcare Reform
- What Will it Take Prevent or Delay Type 1 and Type 2 Diabetes?
- The National Diabetes Prevention Program and AADE's Diabetes Prevention Program
- Aligning Payment Models with Effective Diabetes Program Management
- Psychology of Diabetes
- Diabetes Stigma: Who Feels It, What’s the Impact, and What Can We Do About It?
- Helping Individuals Deal with Diabetes Stigma and Guilt
- Type WE: The Positive Power of Life Partners in Diabetes Self-Management
- Obesity Management in Diabetes Care and Education: Exlore Our Current and Future Armamentarium
- Weight Loss Medications in Prediabetes and Type 2 Diabetes: Who, When, How?
- No Guts No Glory: Microbiota and Diabetes
- Obesity, INsulin Resistance, and Gut Microbiota
- What do Diabetes Educators Need to Know about NAFLD and NASH?
- Facilitating Healthy Behaviors to Prevent and Manage Diabetes: Results of the NDEP & AADE Diabetes HealthSense Study
- Developing a Safe and Effective Exercise Program for People with Prediabetes and Type 2 Diabetes
- Exhibit Hall
Automated Insulin Delivery is Coming – What to Expect?
- JDRF’s Dr. Aaron Kowalski and FDA’s Dr. Courtney Lias both gave very valuable talks on automated insulin delivery (AID), highlighting the progress in the field and key challenges (e.g., training and unrealistic expectations) as systems come to market. Dr. Courtney Lias expected “we will see an explosion” of AID systems in the “next couple of years,” a point echoed in Dr. Kowalski’s pipeline slide. Dr. Lias highlighted the Agency’s commitment to efficient regulatory pathways, shared a slide on the “extremely exciting” MiniMed 670G pivotal data, expressed concern over training requirements (a major point of discussion with companies), touched on insurance coverage (companies need to start earlier), maintained high enthusiasm for device interoperability and component AID systems, and offered balanced thoughts on do-it-yourself (DIY) systems like OpenAPS (regulation should move faster so patients don’t feel compelled to do this). Dr. Kowalski was equally enthusiastic, though his list of challenges as systems come on the market was the highlight of the talk in our view. For patients, he echoed what we heard at ADA: unrealistic expectations is the biggest concern for the field. For HCPs, Dr. Kowalski explained that with hybrid closed loop (basal modulation), care will shift to focus on meal times, and more patients on pumps might add administrative and reimbursement hassles. The payer challenges seemed especially daunting, though something JDRF is extremely focused on. Dr. Kowalski emphasized that form factor will be critical to expand AID adoption in the future, pointing to examples like Abbott’s FreeStyle Libre and Dexcom/Verily’s work to improve wearability. Dr. Lias’ vision of the future centers on device interoperability, standardized device communication protocols, and component AID systems – enabling faster time to market, more patient choice, and quicker innovation (components instead of systems). Based on the most recent timing, the MiniMed 670G is expected to be on the US market well before AADE 2017 (by April) – we wonder how the initial experience will inform the discussion next year?
CGM Is a Gamechanger, but Not Enough Use it. Will it improve?
- A number of well-known educators and doctors championed CGM, encouraging educators to get more of their patients on the gamechanging technology. Many kept returning to the latest T1D Exchange data, suggesting only ~15% of type 1s are on the technology, a shortcoming that Dr. Steve Edelman partially attributed to providers “not knowing about it.” In a well-attended session entitled “A Beginner’s Guide to Continuous Glucose Monitoring,” Ms. Patricia Gaye Knutsen told the audience “You have to get caught up in the magic of this. In my career, this is the most magical thing that’s happened.” In the same session, Mr. Gary Scheiner added that CGM data is the ultimate teaching tool for an educator. The final Keynote panel also had strong praise for CGM: Dr. Steve Edelman said that if he had to go back to NPH and Regular in order to keep his Dexcom, he would do it. Dr. Edelman strongly recommends CGM for all his type 1 patients. Ms. Martha Funnell echoed Mr. Scheiner’s sentiment that, while CGM can increase work for the educator, it also facilitates patient education. Dr. James Gavin III offered yet another perspective on the benefit of CGM, suggesting that it helps doctors assess the efficacy of therapies and even help to diagnosis diabetes in at-risk individuals.
- We believe CGM has only matured as a technology in the past couple of years. Now that the accuracy and reliability has improved, more needs to be done on real-world translation, best practices, awareness, prescribing hassles, and cost. Medicine has a very long adoption lag time, so with only a few years of “real” CGM, it’s no surprising that adoption is so low (particularly because spinning up reimbursement took time). It’s hopefully a matter of “when” and not “if” CGM will become standard of care in type 1 (and perhaps professional CGM for type 2). Of course, the devices still need to get cheaper, easier to use (factory calibrated, approved for insulin dosing), smaller on the body, and more actionable. Still, when CGM is roughly the price of a few fingersticks per day, but adds a lot more clinical value in a low-burden package, it should be a no brainer for the system, for educators, and for patients. How long will it take?
Digital Health – Coaching + A Zoo of Diabetes Apps
- A new care model, app-enabled remote CDE coaching, was a big theme of the meeting. We wonder whether teams of tech-enabled educators within small or big companies might provide more diabetes care over time. Spearheading the charge are diabetes apps like mySugr and OneDrop and platforms like Livongo (cellular-enabled meter + coaching) and Glooko (Population Tracker). Both mySugr and OneDrop had announcements at AADE, sharing the first details on their own direct-to-consumer coaching products. A limited launch of mySugr’s coaching platform occurred just after AADE, costing $19.99 initially ($39.99 thereafter), and piloting the services of powerhouse educators Gary Scheiner, Jennifer Smith, and Lisa Foster-McNulty. OneDrop’s CDE coaching platform, One Drop Experts (seeking CDE applicants!) expects to launch in October and aims to provide on-demand, 24/7 in-app support. Educators will see all data patients enter into the app, collected automatically (Bluetooth-enabled BGM integration, HealthKit, other devices) or manually inputted (e.g., insulin doses). The scalability of these coaching approaches has always been an open question, but we love the idea of accountability to a human coach, more diabetes data to inform decision making, and IT-enabled care that is far more scalable than current face-to-face models. Will these catch on in the coming years? What product will drive the most change, and where can partnerships take these products further?
- With over 1,200 mHealth apps in diabetes alone (and that number growing rapidly), it is crucial that providers learn how to discern high- and low-quality apps. The lack of a standardized assessment, combined with the vast quantity of apps that would require assessing, places the burden of on clinicians, for now. TypeZero’s Molly McElwee-Malloy highlighted the dangers of unregulated bolus calculator apps like RapidCalc, InSpark’s Ms. Laura Fuqua checklists for providers to use when deciding if an app is worthwhile, and FDA’s Dr. Courtney Lias shared the Agency’s risk-based approach to apps and offered some optimism for using apps in AID devices.
- TypeZero’s Molly McElwee-Malloy noted that 83 unregulated apps currently offer insulin dosing advice, but call themselves “wellness apps,” and are thus illegally marketed. She urged educators to do their homework: Go to the app store, download any diabetes app, and see if you can spot any problems. Do you understand how to use it? When in use, do you consider the advice sound for your patients? What value does this bring to your patients and your practice?
- InSpark’s Ms. Fuqua proposed six critical criteria to look for in an app: (i) clinical trials/research behind claims; (ii) usability testing with real patients; (iii) approved by FDA or developed under a Design Control System; (iv) diabetes KOL endorsement; (v) diabetes experts involved in development/design; and (vi) meets security standards. Tracking down this data is impossible for most apps in our view, so we preferred her suggestion that CDEs become mHealth experts and work with patients to assess the quality of an app: Does it improve the patient-provider relationship? Does it have measurable outcomes? Does it improve patient engagement and quality of life? Does it impact cost of care? Is there data to back up the claims?
Pricing Woes and the High Cost of Diabetes Management
- The rising cost of diabetes care was a prevailing theme at this year’s AADE, with ongoing discussion of reimbursement difficulties and high drug prices. This issue was at the forefront of a Novo Nordisk-sponsored corporate symposium. While the presenters discussed the benefits of newer insulin formulations and first line insulin/GLP-1 combination therapies for patients with type 2 diabetes, several audience members commented that these newer pharmacotherapies, though exciting from a scientific perspective, are completely out of reach for the majority of their patients. Panelist John Sink (Jones Center for Diabetes and Endocrine Wellness, Macon, GA), a CDE himself, sympathized with this frustration, but noted that it is the duty of health care professionals to “get up, pull your pants up, and figure out how to get your patients on the drugs they need” – usually via a series of calls to the patient’s insurance company. “As an educator, I want what the patient needs,” he declared, “Not what the PBM thinks they need.”
- Beyond the woes of reimbursement, Dr. Sunny Smith (University of California, San Diego, CA) and Mr. Morgan Smith (Feeding America, San Diego, CA) cogently reminded us that the price of diabetes management is not limited to drugs and lifestyle management programs: among low-income people with diabetes, 49% report difficulty following a diabetes-friendly diet (this statistic rises to 64% for people with diabetes experiencing food insecurity). Mr. Leslie Jebson (SIU School of Medicine, Springfield, IL) summarized the issue well, noting that the high, often prohibitive cost of diabetes care is a strong contributor to the low patient engagement that so frustrates health care professionals. On a hopeful note, he forecasted that cost pressures in the pharmaceutical industry will eventually lead to pricing for medications along a sliding scale (a trend that device manufacturers have begun to adopt), which should hopefully translate into more affordable options for patients.
Buzz Surrounding GLP-1 Agonists
- Several sessions throughout the meeting underscored the positive view and immense interest in GLP-1 agonists among diabetes educators and other conference attendees. A standing-room-only AZ-sponsored product theater on GLP-1 agonist Bydureon (exenatide once-weekly) was completely packed and standing-room-only (indeed, our team at Close Concerns only just barely made it in ourselves!) While the content of the product theater was not particularly notable or new, the sheer volume of attendees is a testament to the massive and growing interest in the use of GLP-1 agonist therapy. In the session, Dr. Robert Busch (Endocrine Group, Albany, NY) emphasized the benefits of Bydureon on A1c reduction, glycemic variability, and weight loss, reviewing several clinical trials of Bydureon with CGM, head-to-head with basal insulin, and compared to twice-daily Byetta (exenatide). The session also featured a video of a diabetes educator demonstrating the (rather complex) dose administration process for Bydureon – we expect this administration will be simplified once the Bydureon suspension formulation is available. On the way out of the session, each attendee was handed a Bydureon training pen for use at home. Indeed, in an earlier session on various pharmacotherapy considerations in patients with chronic kidney disease, there was clear overwhelming support for the initiation of GLP-1 agonists over most other diabetes drug classes. The session involved several case studies as a patient progressed through worsening levels of renal function and asked the audience which of the many available pharmacotherapies they would prefer to apply to the patient. At each opportunity to recommend a therapy within the cases, the room overwhelmingly voted in favor of GLP-1 agonist use.
Outcomes Beyond A1c
- Calls for outcome metrics beyond A1c are becoming the norm at diabetes meetings. This AADE, acclaimed physician-scientists Drs. James Gavin III and Robert Vigersky led the charge. Dr. Gavin delivered a couple of memorable quotes during the final day’s Keynote panel, characterizing the problem in the context of a conversation on CGM: (i) “We make [diabetes] diagnosis on one metric alone, which is static in nature. And that’s not nature. We need something that can capture moment to moment variations...we have a tool”; and (ii) “We are prisoners of static measurements – there are a lot of paths to an average, and that’s what A1c is. To be able to see whether people are in or near range, a concept made possible by CGM, changes everything when it comes to determining if medicines are doing what they are designed to do.” We applaud Dr. Gavin for bringing the issue to attention in one of the best-attended forums at the conference, but it was Dr. Vigersky, in a talk two days prior, who continued his quest to explore (and incite others to explore) what form a better metric would take and how to convince all of the relevant players (payers, the FDA). He described A1c as “woefully inadequate”, neglecting crucial health indicators (especially hypoglycemia) and not providing real-time feedback to reinforce behavioral change. As in the past, he put forth a number of alternate composite outcome measures that have been previously suggested – he wasn’t necessarily arguing that they are perfect, but he masterfully explained their pros and cons, how to manipulate them to be “better”, and gave attendees an idea of what form a future metric might take. Dr. Vigersky also briefly touched on the million-dollar question: How do we get data to support a proposed replacement metric’s correlation with positive short- and long-term outcomes? He believes that a modern-day DCCT would be too costly and time-consuming – instead, we should be able to leverage big data, retrospectively applying the metrics to the vast quantity of existing clinical data. The movement is gaining momentum – now let’s all hope for some meaningful action in the near future – we hope AADE keeps a close eye on this.
- The FDA just hosted an encouraging public workshop, “Diabetes Outcome Measures Beyond Hemoglobin A1c.” We left the meeting with cautious optimism – the FDA was more receptive and positive than we expected, and there were calls for the 2008 drug guidance to evolve based on two more meetings in the next nine months from a broad group of stakeholders. See our report for our top 10 highlights from the day.
- While Sunday marked AADE’s first ever dedicated prediabetes day, we also heard much more about diabetes prevention throughout the entirety of this year’s meeting, with added emphasis on reimbursement and weight loss. Ms. Joanna DiBenedetto (AADE, Chicago, IL) shared findings from a 2015 survey of AADE members in which 81% of respondents reported that they treat people with prediabetes. She used this to demonstrate great interest in diabetes prevention, compounding great need (86 million Americans are living with prediabetes, while nine out of 10 don’t realize it). A Friday morning session on Diabetes HealthSense underscored that the online resource, which facilitates behavior change and provides psychosocial support, is just as useful for people with prediabetes as it is for patients with type 2 diabetes. Multiple sessions featured data on the power of the National Diabetes Prevention Program (DPP) to reduce the rate of new-onset type 2 diabetes. While metformin alone lowers incidence of type 2 diabetes by 31%, the DPP lowers incidence by 58%. And while metformin decreases an individual’s chances of developing type 2 diabetes by 8% and delays progression by an average of 3.3 years, the DPP decreases an individual’s chances by 20% and delays progression by an average of 11 years. Many renowned leaders in the field advocated for the DPP throughout the meeting, including ADA’s Dr. Robert Ratner, Dr. Sandra Bollinger (Health Priorities, Sikeston, MO), and obesity expert Ms. Donna Ryan (Pennington Biomedical Research Center, Baton Rouge, LA) in her Sunday morning keynote to kick-off prediabetes day. The National DPP consists of 16 sessions of core curriculum covering diet, exercise, and other lifestyle modifications. The uptick in discussion about diabetes prevention was timely considering Medicare’s proposed plans to reimburse the DPP by January 2018 and the AMA’s new policy urging all private payers to cover the DPP as well.
- A recurring message at AADE 2016 encouraged people to submit feedback to the Centers for Medicare & Medicaid Services (CMS) by September 6 on the proposed expansion of Medicare reimbursement to cover the DPP. We heard this call-to-action repeatedly, from annual AADE favorite Ms. Patty Telgener (Emerson Consultants, Excelsior, MN), Ms. DiBenedetto, Dr. Bollinger, and Dr. Ryan, among others. As Ms. DiBenedetto put it, “Once CMS creates a ruling, it’s really hard to change, so let’s get this right the first time!” We’re so glad that the gravity of this reimbursement decision is being clearly and broadly communicated. As healthcare economics expert Mr. Leslie Jebson (SIU School of Medicine, Springfield, IL) put it, “as Medicare goes, often, so do the other insurers.” We certainly hope this is true, especially since earlier this summer the AMA adopted a policy urging all commercial payers to reimburse this effective prevention program.
- Looking ahead to the rest of 2016 and 2017, AADE plans to do even more in diabetes prevention. Ms. DiBenedetto outlined the organization’s priorities: Medicare reimbursement, a cost analysis for all DPP programs within its network, tools to help programs maintain CDC recognition and get reimbursed at the highest capacity, and a database for performance management. AADE will also be exploring online/virtual add-ons to its in-person DPP sessions and hopes to stand up new AADE DPP sites, according to Ms. DiBenedetto. Lastly, she mentioned a potential project on getting Medicaid reimbursement for DPP. Overall, we were thrilled to notice greater emphasis on prediabetes and type 2 diabetes prevention, and we were so happy to hear AADE’s concrete ideas to expand its prevention focus moving forward. That said, this has been one of the very hardest areas to move the ball on in the past, so … hopes are high but the challenge is enormous.
- Obesity management was framed as an important strategy in diabetes prevention, with many speakers encouraging HCPs to be open-minded about suggesting obesity drugs as a viable therapeutic option. Dr. Donna Ryan was vocal on this point. While she acknowledged that for many in the diabetes field, medical management of obesity falls outside their “comfort zone,” she asserted that it’s high-time for this resistance to go, given the “armamentarium” of obesity drugs now at our disposal. Prescriptions and sales of obesity medications reflect marketplace challenges, which we assume stem from continued reluctance from patients, educators, and providers to duly consider pharmacotherapies for weight loss. That said, Novo Nordisk’s Saxenda (liraglutide 3.0 mg), relatively new to the obesity market, seems to be doing very well (see 2Q16). In any case, we hope that more commentary from respected leaders in the field will soon tackle the stigma plaguing obesity treatment.
- Several speakers reminded us that modest, ~5-10% weight loss is enough to yield health benefits in most cases. Dr. Ryan shared evidence that a 5% drop from baseline weight is enough to achieve maximum benefits to adipose tissue insulin sensitivity and liver insulin sensitivity, arguably two of the more relevant benefits for people with or at risk for type 2 diabetes. Empirical investigations of the DPP show that all major health benefits occur in the first 5 kg (~11 lbs) of weight loss and that there are no accumulating benefits after 10 kg (~22 lbs) of weight loss. In a session focused on fatty liver disease and nonalcoholic steatohepatitis (NASH), a comorbidity of type 2 diabetes, Dr. Jamie Wolosin (Sharp Rees Stealy Medical Group, San Diego, CA) stated that ~10-15 lbs of weight loss is sufficient to mitigate NASH in most patients. Importantly, modest weight loss goals make long-term maintenance more realistic. We’ve seen from follow-up on The Biggest Loser how dramatic weight loss is exceptionally difficult to sustain in the long run. Dr. Ryan wanted audience members to recognize and spread the message that “modest weight loss means major health benefits.”
- Two p-a-c-k-e-d (standing-room-only!) lectures on the gut microbiome illustrated the continued massive interest in the mysterious relationship between gut bacteria and diabetes and obesity. Ms. Meghan Jardine (Physicians Committee for Responsible Medicine, Dallas, TX) delivered an informative and humorous overview of the existing literature on the role of the microbiota in diabetes and obesity, repeatedly emphasizing nutritional intervention as a very feasible way to optimize one’s microbial and therefore metabolic profile. Her message was resoundingly encouraging for physicians and CDEs hoping to counsel their patients about the importance of healthy eating: “There’s something we can do right now. We do it three times a day. It’s what’s on our plate.” To complement this, we also heard from Dr. Kristina Martinez (University of Chicago, Chicago, IL) in an equally highly-attended session. Dr. Martinez presented original research demonstrating the power of dietary prebiotics to promote a metabolically-beneficial microbiome. As demonstrated by the lively Q&A session, this message clearly struck a chord with the audience, who were extremely curious to learn more about these preliminary insights on how diet alters the microbiome, and by extension metabolism.
Psychology of diabetes
- A talk featuring our very own Adam Brown and the Behavioral Diabetes Institute’s Dr. Susan Guzman highlighted the insidious and seldom-addressed issue of diabetes stigma, which affects a disturbingly high percentage of people with diabetes (52% of type 2s, 76% of type 1s) and is highest in the patients who need the most help.
- Adam shared data on the prevalence and forms of stigma from diabetes market research company dQ&A – the data was originally a late-breaker at ADA 2014, and you can watch the 17-minute talk here and download the slides here. dQ&A surveyed a patient panel of 12,000 people with diabetes, asking them ‘Does diabetes come with social stigma?’: 52% of type 2s responded yes (n=3,850), as compared to 76% of type 1s (n=1,572). Why, given all the discussion on stigma in type 2 diabetes, do people with type 1 feel more stigma? Adam suggested that this is an issue of therapeutic visibility. Stigma stems from deviance from cultural norms, and type 1 diabetes is an extremely visible disease, involving wearable devices, more frequent blood sugar measurements, and insulin injections/pump therapy. To this point, the dQ&A data suggested that among respondents with type 2 diabetes, stigma increases as therapy intensity (and therefore visibility) rises: 49% of type 2s on orals, 55% of type 2s on insulin, and 61% of type 2s on intensive insulin – the latter almost reaching the level seen in type 1 diabetes. Tragically, across both diabetes types, those most in need of help were also the most negatively impacted by diabetes stigma (higher A1cs (>9% vs. <6%), higher BMIs (>35 vs. <25), and those who self-reported as being in poor control).
- To complement the exploration of who feels stigma the most, BDI’s Dr. Susan Guzman, one of the country’s few diabetes psychologists, shared five lessons for HCPs to replace the negative messaging surrounding diabetes with facts and empathy (download her slides here). A large part of this, she explained, is simply realizing the negative impact of stigma on patient outcomes. Psychologists have long understood that labeling someone as a “failure” is a self-fulfilling prophecy, so individuals who feel stigma will likely be disengaged from seeking the education, treatment, and support required to effectively manage their diabetes. Dr. Guzman emphasized the importance of acknowledging the constant decision making and mental gymnastics that makes diabetes such hard work, and focused extensively on language. Words like “non-compliant,” “unmotivated,” and “failure,” are discouraging, unhelpful, and do not appreciate how difficult diabetes is. An overarching theme throughout both Adam’s and Dr. Guzman’s presentations was the key responsibility that diabetes educators and physicians (and to that we would industry) hold in shifting the dialogue on diabetes in their communities into a conversation that asks “How can I help you?” instead of “what did you do wrong?”
- Behavioral Diabetes Institute’s Dr. Bill Polonsky similarly emphasized the importance of language in talking to patients about adherence, imploring HCPs to stop using the term “non-adherence.” Dr. Polonsky articulated why terms like “non-adherence” and “compliance” – words we still hear far, far too often – are harmful in chronic disease management. He presented “non-adherence” as a serious pet peeve: “Please, never use that term. You can perhaps say ‘poor’ medication adherence, but suggesting that people do nothing is never true and it leads us to work against each other.” Instead, as Dr. Polonsky put it, providers and diabetes educators should be aligning themselves with patients to (i) set shared goals; (ii) make invisible facets of diabetes visible to their patients; and (iii) understand where a patient’s “poor adherence” may be coming from. Terms like “compliant” and “non-adherent” can be off-putting, creating distance between patient and provider or patient and educator when in reality, all parties in diabetes care have the same end goals. While we see “adherence” as a step up from the word “compliance,” we wonder if there are better alternatives still (“engaged”?).
- Building on the message that words matter, Dr. Polonsky also suggested that we present A1c as “safe vs. unsafe” instead of “good vs. bad.” Given that diabetes is a chronic disease in which high glucose scores aren’t associated with pain, it’s understandable that patients don’t always feel a strong sense of urgency and can’t always see the long-term implications of uncontrolled glycemia, Dr. Polonsky explained. Helping patients grasp what glycemic control means for their long-term health by highlighting “safe” and “unsafe” A1c is one way to make the invisible, visible. Moreover, Dr. Polonsky pointed out a key issue that people miss when they say their patients are “non-adherent” – patients quit medications because they’re actually trying to be healthy, and a complicated schedule of drugs is seen as a sign of disease. He underscored that we already have the tools to change these notions, starting with the language we use.
Anticipating the Availability of Artificial Pancreas Systems: What to Expect in the Clinic?
Aaron Kowalski, PhD (JDRF, New York, NY)
JDRF’s Dr. Aaron Kowalski packed the house with a terrific talk on automated insulin delivery (AID), highlighting the state of the field and key challenges as systems move into the clinic over the next couple of years. His slide on the competitive landscape mostly aligned with our most updated version in Closer Look, showing Medtronic out in the lead (expected April 2017 launch) and a slew of companies planning for 2017-2018 launches (Animas, Beta Bionics, Bigfoot, Insulet, Tandem). More interesting was his list of challenges as systems come on the market, summarized in the table below. For patients, he echoed what we heard loud and clear from Dr. Trang Ly at ADA: unrealistic expectations is the biggest concern for the field. For HCPs, Dr. Kowalski explained that with hybrid closed loop (basal modulation), care will shift to focus on meal times, and more patients on pumps might add administrative and reimbursement hassles. The payer challenges seemed especially daunting, though something JDRF is extremely focused on. Dr. Kowalski showed the modal day plots from the MiniMed 670G pivotal trial (see our ADA coverage), calling the data “dramatic” and noting the strong overnight control and stellar results in adolescents. We were glad to see him give a shout-out to the OpenAPS poster presented at ADA, using it as evidence that AID works, even in highly motivated patients! He also noted the strong sleep improvements in the poster, something that is often overlooked or undervalued. Dr. Kowalski emphasized that form factor will be critical to expand AID adoption in the future, pointing to examples like Abbott’s FreeStyle Libre and Dexcom/Verily’s work to improve wearability. Regarding JDRF’s important T1D Outcomes Program, he said the committee is close to consensus on glycemic outcomes, and the white paper will be published next year.
Key challenges for AID
- Dr. Kowalski was mixed on glucagon, noting that it “may add value in an AP, but more research is needed.” Still, he critiqued the BU/MGH group’s aggressive use of the hormone (a concern if the glucagon infusion set fails), noted the higher cost of adding glucagon into AID systems (this is somewhat theoretical since pricing hasn’t been decided), and pointed out no clinically meaningful and significant hypoglycemia advantage over insulin alone thus far (“the field is not tenable if you don’t get less hypoglycemia”). We think it will be positive for many options to exist for patients; while glucagon definitely has a ways to go and much to prove at this stage in that chronic use hasn’t been proven, we suspect there’s a very real chance that both less hypoglycemia as well as less hyperglycemia may be used. We look forward to more direct head-to-head data on patient preferences for commercial systems – glucagon may enable some user experience advantages, though clinical data will be needed to convince payers of the value.
Closed Loop Automated Insulin Delivery Systems: From DIY to FDA Approved
Courtney Lias, PhD (FDA, Silver Spring, MD)
FDA’s enthusiastic Dr. Courtney Lias expected “we will see an explosion” of automated insulin delivery (AID) systems in the “next couple of years.” She highlighted the Agency’s commitment to efficient regulatory pathways, shared a slide on the “extremely exciting” MiniMed 670G pivotal data, expressed concern over training requirements (a major point of discussion with companies), touched on insurance coverage (companies need to start earlier), maintained high enthusiasm for device interoperability and component AID systems, and offered balanced thoughts on do-it-yourself (DIY) systems like OpenAPS (regulation should move faster so patients don’t feel compelled to do this). Dr. Lias called training one of the “most significant challenges” the AID field will face: “How many of you know what happens when the 670G gets kicked out of closed loop control? Will newly diagnosed patients that start on an AID system understand how to use insulin when the device fails?” This is now a big point of discussion with companies and we’ll be interested to see what the 670G materials look like. Who will have the easiest AID system to train and use in the coming years? Notably, Dr. Lias deliberately used the term “automated insulin delivery (AID)” noting that “artificial pancreas” sets unrealistic patient expectations. We completely agree and love how flexible she is; we hope the entire field changes the terminology too. Looking to the future, Dr. Lias maintained her enthusiasm for device interoperability, standardized device communication protocols, and component AID systems, mirroring her highly positive talks at the NIH Workshop in July, at ADA in mid-June, and at the June 2 Live Q&A Webinar. More from this terrific talk below, which again reinforced our confidence in and admiration for Dr. Lias and the CDRH team working on CGM and AID.
- Regarding the MiniMed 670G, Dr. Lias highlighted the pivotal’s encouraging 0.5% A1c reduction alongside the impressive 44% hypoglycemia improvement (presented at ADA). She did not give an approval timeline, even though an attendee asked if it would launch by Medtronic’s stated goal of April 2017. The FDA’s commitment and continued enthusiasm for this device seems encouraging, although regulatory reviews are always hard to predict.
- Dr. Lias called training one of the “most significant challenges” the AID field will face: “How many of you know what happens when the 670G gets kicked out of closed loop control? Will newly diagnosed patients that start on an AID system understand how to use insulin when the device fails?” Dr. Lias said there is not yet enough discussion about training requirements, and the FDA is actively talking to manufacturers about it. We were not surprised to hear this after leaving the Dexcom-FDA meeting in July; the Agency is clearly and understandably concerned about provider and patient education for tech that moves into the realm of insulin dosing.
- Dr. Lias deliberately used “automated insulin delivery (AID)” throughout her talk, noting, “The term artificial pancreas is going out of vogue.” She rightly noted that “artificial pancreas” sets the wrong patient expectations (e.g., “An ‘artificial pancreas’ device is a cure,” “I don’t have to do anything with an artificial pancreas,” etc.). Dr. Lias said that the field is moving to “automated insulin delivery” or “AID,” and we were glad to see this reflected in her talk’s title. David Panzirer has been a strong advocate of “AID” for a long time, and we see this as a positive move for patients and HCPs. We learned in a fascinating ADA poster that nearly half (42%) of patients think “artificial pancreas” refers to an organ graft; clearly there is a lot of education to do and terminology to define.
- Dr. Lias was clear about access challenges and insurance coverage: the FDA encourages manufacturers to think about this early, but they often don’t do it. Dr. Lias said the studies to support coverage are “typically sufficient for FDA as well.” Unfortunately, “Most companies put this off until after FDA approval.” We wonder if the problem is not one of prioritization, but speed: the studies payers want to see may be too time-consuming and costly to run pre-market. We hope companies work with the FDA and payers to find a good middle ground solution – products should ideally have reimbursement in place right when they launch. We hope AID can learn from CGM; certainly there is more published literature at this stage of the field, though there won’t be major outcomes studies once the 670G launches.
- “People are doing [DIY, OpenAPS] because they feel they need to do it. We recognize the need for smooth and efficient regulatory pathways to market, including efficient clinical trials. Let’s create a situation so patients don’t feel compelled to do this.” We thought this was an outstanding takeaway on a tricky issue, and is exactly the Nightscout group did with remote monitoring of CGM – push companies and the FDA to move fast and approve safe and effective commercial products. Dr. Lias otherwise reiterated what she has said previously: these home-built products do technically fall under FDA’s regulation as Class III devices, but the Agency will enforce based on risks to the public. Right now the risks of OpenAPS are somewhat low, since the systems require technical know-how to build, and are typically built by highly motivated individuals for personal use (or by a parent for a child). Of course, “distribution” takes many forms (not just selling a device), which is why distributing open source software code moves into regulatory gray area.
- “How should you handle patients who come to you with DIY AID devices?” Dr. Lias advised providers in the audience to ask patients the following questions: Do you understand exactly what algorithm is being used? Is it right for you? Have you checked the code to ensure it implements the algorithm correctly? Have you double checked? When new modified versions of code are shared, have you re-validated your entire system before implementing it? Etc.
- We think these are equally instructive questions for commercial automated insulin delivery devices. Will patients and providers understand how the algorithms work? Will they be simple to explain and setup? Like all technology, AID will improve over time, and the first systems like the 670G will err closer to traditional pump therapy – requiring setup and pretty far from plug-and-play.
- Dana Lewis wrote an outstanding article on this topic here, “Our take on how to DIY closed loop, safely.” The piece highlights things to consider before starting DIY closed loop (e.g., it is not a cure!) and getting started with DIY closed loop (e.g., understand how it works!). It’s a great read, even for companies developing these products and patients that go on the soon-to-be commercialized devices.
- “How should you handle patients who come to you with DIY AID devices?” Dr. Lias advised providers in the audience to ask patients the following questions: Do you understand exactly what algorithm is being used? Is it right for you? Have you checked the code to ensure it implements the algorithm correctly? Have you double checked? When new modified versions of code are shared, have you re-validated your entire system before implementing it? Etc.
- Aside from the 670G, Dr. Lias also showed data from BU/MGH’s bihormonal Bionic Pancreas. She noted the strong mean glucose and hypoglycemia results, but cited the lack of an approved glucagon as key challenge for commercialization. Dr. Damiano’s plan, as a reminder, is to get the insulin-only system approved first (pivotal to start 2Q17, PMA submission expected by end of 2017), followed by a longer process to get glucagon approved in the device (longer pivotal starting in mid-2017 to gather chronic exposure data, PMA submission perhaps by early 2019).
- Echoing her talks at the at the NIH Workshop in July and at ADA in June, Dr. Lias admitted that the current regulatory process will hamper AID innovation – it is suboptimal for devices requiring different manufacturers (e.g., Dexcom/Tandem). The Agency is “working on policies to foster innovation,” and ideally, drive toward component AID systems. The ultimate vision is an ecosystem of devices and algorithms that can talk to each other, but not require approval for every combination. Patients would be able to swap different sensors, algorithms, and pumps in and out as they please (more choice, more innovation), while companies won’t be hampered by legal contracts and lengthy PMA submissions. Dr. Lias shared some of the challenges that must be ironed out:
- Standardized communication between devices. She cited the interoperability example of viewing digital pictures on any device from any manufacturer – it just works. [Top of the hat to Tidepool’s Howard Look for sharing this at the FDA Workshop in November 2014, and clearly, influencing the Agency’s thinking.] We hope the FDA can strongly encourage companies to adopt the device communication standards developed in Toronto (Dr. Joe Cafazzo and Melanie Yeung).
- Device failure – who is responsible? When something goes wrong in a component system, is the algorithm developer, CGM developer, pump developer, or no one responsible? The regulatory expectations have to be defined on this question. This does sound like a solvable problem to us.
- Device modifications. The slide showed a picture of the iPhone 3 vs. iPhone 4 adaptor change. Device standards, said Dr. Lias, will help identify methods and criteria to validate modifications – and presumably, to integrate them quickly into devices. (We’d point to the iPhone adaptor change as a great example of a device modification that killed an innovative product like AgaMatrix’s iBGStar.) We hope this becomes easier with Bluetooth devices that don’t require hardware connections. Still, this will be a concern for AID as CGM continues to rapidly evolve, as algorithms improve, and as pumps change – where will the FDA set the regulatory bar for device changes and updates? How can companies ensure safety, but not need a lengthy PMA submission for every update? How can the FDA promote innovation, but ensure the updated product components are safe and work together well?
- What type of data should be used? Sensor values? Glucose concentrations? Etc.
Aimee Jose (Palo Alto Medical Foundation, Palo Alto, CA), Gary Scheiner (Integrated Diabetes Services, Wynnewood, PA), and Toby Smithson (Livongo, Mountain View, CA), Amy Tenderich, MA (Diabetes Mine, Palo Alto, CA)
Following optimistic, rapid-fire presentations from Diasend, mySugr, Glooko, OneDrop, and Tidepool, an honest CDE panel discussion weighed in on the very mixed – and somewhat depressing – state of diabetes data. Gary Scheiner (Integrated Diabetes Services), Aimee Jose (Palo Alto Medical Foundation), and Toby Smithson (Livongo) reminded us that while some clinicians experience the benefits of using the latest digital health tools, others face significant organizational hurdles to implementing any new technology. There couldn’t have been a starker contrast than that between Mr. Scheiner’s experience at a small private clinic and Ms. Jose’s experience at a large health system. Mr. Scheiner uses data management tools extensively (he specifically praised Glooko’s insights, but uses all available tools), while Ms. Jose has been stymied by a close-minded administration in the heart of Silicon Valley – she gets “limited” access to the web-based diasend and Tidepool platforms, and Glooko has been in the works “for a long time.” Ms. Jose frustratingly described having to be a detective every day, figuring out how to view the data her patients took the time to upload (a woman commiserated during Q&A that she is unable to access “anything web-based whatsoever” at her practice). The audience gasped audibly when Ms. Jose added that she can’t even accept email attachments – what?! She said the issue is mainly around privacy and HIPAA, which strikes us as absurd – we thought all these systems are made with those in mind. (As an aside, HIPAA is in need of an overhaul – it came out in 1996, when cellphones looked like this). Ms. Jose finds workarounds, such as having the patient upload the data at home on diasend, looking at data on their device with them, or having them log data by hand. As the field talks about making data actionable, it’s clear that the precursor step – making data available – is still lacking for some clinicians, even those in Silicon Valley. See below for more from this session – comments on CDE time, reimbursement, and key takeaways from the rapid-fire industry talks.
- Noted Mr. Scheiner, “The wrong people are being paid to treat and care for diabetes.” The panelists and audience members lamented that CDEs are not paid nearly enough for analyzing diabetes data. Mr. Scheiner’s organization now works on a retainer basis – clients, instead of paying per session, pay for three or six months of care. In this way, educators are paid up front for phone time, text time, and data interpretation.
- The conversation on the panel made us wonder whether teams of educators within industry will provide more and more diabetes care over time. In ten years, will more educators be employed at companies and paid a salary to provide contacted patient care/coaching? It feels sort of inevitable that companies will have to pick up the slack for patient care, given the trends in patients vs. providers. Medtronic is building out a whole diabetes service and solutions arm (e.g., acquiring the Diabeter Clinic), while smaller players like Livongo, mySugr, and One Drop are building coaching businesses to leverage technology.
- Ms. Jose noted a lot of time is still wasted downloading data – in some cases 20-40 minutes per one-hour appointment! Mr. Scheiner did not agree, noting that most downloads happen pretty quickly. We do think the breadth of experiences will continue to improve with auto-upload cloud-connected devices, but data is still siloed, rarely flows into EMRs (though Glooko has integration), and reimbursement for analysis is still poor. It is key for educators more broadly to hear from experts that the user experience has improved substantially – sometimes HCPs are working on old data.
- The session opened with brief speeches from five diabetes data management companies. Here’s what we learned:
- Diasend (President Mr. Richard Laurits): Aside from its vast device compatibility (140+ devices!), the company is working on an “exciting” mobile app update that will allow direct upload from NFC/Bluetooth compatible devices (the slide showed Roche’s Accu-Chek Connect BGM). “Project Type 2” is also in the works – the platform ambitiously aims to estimate “in a few seconds” what kind of needs a given type 2 patient has. [Subsequent to AADE, Diasend and Glooko announced they are merging; read more here.]
- mySugr (COO Anton Kittelberger): The beautifully designed presentation highlighted the limited US launch of mySugr Coaching in September – watch the intro video here, featuring Gary Scheiner. The product will have an introductory price of $19.99 per month ($39.99 ongoing), leverage the world’s most popular diabetes app (Logbook; 770,000+ registered users), and add a killer iPad Pro interface for educators. See our exhibit hall coverage below for more details.
- Glooko (CEO Rick Altinger): Glooko is now used in 1,300 health systems in the US, an impressive testament to the success of the Insulet partnership. The company is making progress on its compelling next-gen work to optimize insulin dosing: the DreaMed MD Logic Pump Advisor partnership (study starting later this year) and its Mobile Insulin Dosing System for type 2s (studies in 2H16; launch in 2017). Medtronic integration is in final testing and expected to launch within the next month, just slightly behind the expectation of July given at ADA. [Subsequent to AADE, Diasend and Glooko announced they are merging; read more here.]
- OneDrop (CEO Jeff Dachis): Mr. Dachis announced the upcoming launch of One Drop Premium: an impressive ~$30-40 per month cash pay for unlimited test strips, a Bluetooth-enabled BGM, 24/7 in-app CDE coaching, and a “digital therapeutics program” (AADE/ADA-based) in the One Drop app. The meter is currently under FDA review. The Premium service is expected to ship in October. See our exhibit hall coverage below for more details
- Tidepool (CEO Howard Look): The Tidepool Uploader now supports all major pumps in the US (with the recent addition of Animas), and with the Blip Notes app, users can now upload data from Apple Health (e.g., Dexcom G5) straight from their iPhone. The mealtime bolus app, Nutshell is in beta testing – we are very excited for this one and believe it will help many patients unpack the nuances of bolusing for meals out. Mr. Look also showed a remote monitoring population app for automated insulin delivery (showing a group of patients’ real-time data on one screen) and an app that mashes CGM data and a city map.
CGM Before CSII Initiation: Reverse Your Thinking
Aimee Jose and Ruth Spirakis (Palo Alto Medical Foundation, CA)
Educators Aimee Jose and Ruth Spirakis argued fervently that “CGM first, pump second” is far easier for patients, less costly at startup, makes providers’ lives easier, and simplifies insulin dose titration. They bluntly characterized the current model of “pump first, CGM second” as “putting the cart before the horse.” The DIaMonD study was not discussed, but they did run through several real-world advantages of starting CGM first: (i) lower startup costs for patients; (ii) CGM is an easier technology to learn first (it is self-started, while pumps require face-to-face training and multiple sessions); (iii) CGM allows improved overnight basal testing: more comprehensive data, more sleep, reduced patient burnout; (iv) CGM requires fewer fingersticks = less work; and (v) CGM enables greater and sooner use of advanced pump features. A series of examples showed how “CGM first, pump second” also helps optimize pump settings with less burden. A CGM-based basal evaluation requires 57% fewer fingersticks (7 vs. 3) and offers 94% more data (120 data points vs. 7 points) than when using fingersticks to drive pump settings in the traditional “pump first” model. In Q&A, Ms. Jose reiterated what we seem to be hearing more and more – having a pump is a personal/lifestyle choice, but sensors should be given to everyone willing to wear them. “When you introduce a patient to CGM, it’s amazing what can happen. As long as they are getting insulin, I don’t care what method they use to deliver it.” It will be interesting to see if this perspective changes once automated insulin delivery is available.
- Dexcom talked in its 2Q16 call about the “CGM first” message starting to resonate – now ~60% of its new starts are from MDI, an uptick from its historical ~40%, and more in line with the general type 1 population (~70% on MDI).
Jane Jeffrie Seley, DNP (New York-Presbyterian Hospital/Weill Cornell Medicine New York, NY); Donna Jornsay (Long Island Jewish Medical Center, New York, NY); Donna Tomky (ABQ Health Partners, Albuquerque, NM)
An enthusiastic trio of experts on all things injection-related, Dr. Jane Jeffrie Seley, Ms. Donna Jornsay, and Ms. Donna Tomky, shared their learnings from the recent FITTER (Forum for Injection Technique and Therapy: Expert Recommendations) Congress in Rome, presenting compelling evidence that our current insulin delivery practices need to be better refined. See our coverage here of the subsequent Mayo Clinic Proceedings papers The panel focused on three major aspects of insulin delivery: (i) subcutaneous injection technique; (ii) prevention of lipohypertrophy; and (iii) best practices insulin pump use. Insulin delivery is such a fundamental aspect of diabetes care that it often escapes our notice. An ongoing theme was that optimizing insulin delivery with these simple recommendations has the potential to improve patient comfort, thus promoting greater engagement and better outcomes.
- Dr. Seley explained that despite the prevalence of 12 mm needles, the shortest available needles (4mm pen needles or 6mm syringes) are recommended to avoid intramuscular injections and the associated risk of hypoglycemia. Skin thickness ranges from 1.25-3.25 mm, so these are safe and effective for all subcutaneous injections, even in people who are overweight. Ms. Jornsay later described falling rates of hypoglycemia incidence in their institutions after 12 mm needles were replaced with smaller ones, and the hope that the impending publication will drive awareness of this issue forward. BD has talked about this concern for years now, but overthrowing the conventional wisdom always takes time. Fortunately, long needles (12.7mm) are used by only 1% of people taking insulin (per a global insulin technique questionnaire (ITQ)), so they are certainly on the way out
- Ms. Jornsay described the “dramatically neglected epidemic” of injection site lipohypertrophy (LH), which can cause greatly reduced insulin absorption. This swelling or induration of fat tissue surrounding injection sites occurs in 49%-64% of insulin users, more so in people with type 1 diabetes and those who inject insulin more frequently. Ms. Jornsay noted that 40% of people regularly inject insulin into LH-affected tissue – a suboptimal practice given the results of a recent study demonstrating that insulin absorption is reduced by 34% in such sites (Famulla et al., Diabetes Care 2016). By injecting insulin into LH-affected tissue, people are not getting the full benefit of their insulin dose (associated with a 0.5% higher A1c) and consequently increase the size of their subsequent doses. Besides being expensive, Ms. Jornsay explained that this practice is potentially dangerous: if the patient injects this now-larger dose into “virgin territory” not affected by LH, there is an increased risk of hypoglycemia.
- Lipohypertrophy is exacerbated with suboptimal practices, and can be minimized with patient education. LH is highly correlated with avoidable practices such as needle re-use (p=0.004) and failure to rotate injection sites (p=0.004). Few patients realize these risks or receive counseling from their health care providers about what lipohypertrophy is, let alone how to prevent it. In fact, only 39% of patients have ever been checked for LH in their lifetime. Ms. Jornsay recommends that patients be screened for LH at every appointment, and educated about the danger of injecting insulin into an LH-affected site and the importance of rotating injections across broader areas (alternating through a “W” or “X” pattern across the stomach can help with this).
- All currently available insulins are associated with LH, although there may be differences in the extent to which different insulins are associated with it. There have been anecdotal accounts that insulin aspart (Novolog) minimizes LH compared to insulin lispro (Humalog), but this has yet to be rigorously investigated. Injectable GLP-1 agonists may also carry the risk of LH, but according to Ms. Jornsay there is no data on this to date.
- Ms. Tomky explained that infusion sets are the “Achilles’ heel” of insulin pump technology, in terms of dermatological challenges and insulin occlusions. Children with type 1 diabetes using an insulin pump suffer from high rates of dermatological complications, including micro-scarring (94%), erythema (66%), and lipohypertrophy (44%), and the onset of bruising, itching, and pain often begins before the device manufacturer’s recommendation that the infusion set should be changed. Ms. Tomky surmised that the current recommendations for infusion set use are rather arbitrary, advocating that user guidelines should be based on scientific investigations of why and when these skin issues occur. Another problem is kinking and blockage of the infusion set – an issue so prevalent that 1 in 10 patients report changing an infusion set early due to hyperglycemia.
- Innovations such as BD’s FlowSmart technology may reduce silent occlusions. With broad launch expected in roughly October-December 2016, this new infusion is unique insofar as it allows insulin to flow out of two places: the bottom (like current infusion sets) and the side (a new innovation). The result, as was shown in a human study at ATTD, is significantly more reliable insulin delivery. Compared to Medtronic’s Quick-set, the BD set reduced the occurrence of flow interruptions by 75% and silent occlusions by 91%.
- Infusion set innovation is only becoming more critical as automated insulin delivery comes to market. Systems will show much greater benefit as infusion sets improve. Many longstanding pumpers we know report problems with insulin absorption (patients tends to use the same areas of the body) and we’ll be interested to see how quickly innovation in this area moves. BD has certainly done amazing work with FlowSmart, and better products in this area is a clear JDRF priority.
Questions and Answers:
Q: Once you see a patient with profound lipohypertrophy and you know that moving the site will increase the insulin absorption, how do you counsel them about dose?
Ms. Jornsay: I decrease the dose by 20% and do additional monitoring. And this is completely anecdotally based!
Q: What about that hard crusty tissue?
Ms. Jornsay: That is an abnormality of the fat caused by over-injection. It gets lumpy and hard in some people, but not others. One of my pediatric colleagues has seen this kind of lipohypertrophy in kids who have been on insulin for only 2 years! We are really not sure what contributes to it. There may be some genetic component to this that we just don’t understand yet.
Q: We see a lot of lipohypertrophy in kids. What do I do with it? It seems like it never heals, and we are running out of spots!
Ms. Jornsay: That’s a problem. Unfortunately, we can’t advise them to grow new geography! I wish I had a solution.
Ms. Tomky: I saw lipohypertrophy in an adult patient of mine. We switched from insulin lispro to insulin aspart and it got better.
Q: I see a lot of patients with lipohypertrophy. How long does it take for that to recover? Can it recover?
Ms. Jornsay: For some people it will resolve after 3-6 months of non-use. But I have sites on my abdomen that haven’t resolved for 25 years!
Q: Is lipohypertrophy related to the volume of the insulin dose?
Dr. Seley: I don’t think we have the evidence to support that right now. I wish I had more answers.
Q: Can you advise on how to troubleshoot when patients have bruising at the site of pen injections?
Ms. Tomky: Applying pressure after the injection seems to help sometimes.
Ms. Jornsay: I have people inject, and then make a “V” with their fingers around the sight, and then pull out the needle. That helps with the bruising.
Dr. Seley: I’ve noticed that some people who have bruising tend to have a very aggressive injection technique – like throwing a dart! It is important to observe their injection techniques.
Q: Does anyone have experience with using Flonase (fluticasone) for injection site irritation?
Ms. Tomky: One of my friends uses this for her Dexcom CGM and it seems to work. [Editor’s Note: We wonder how much Dexcom next-gen inserter will solve some of these pain issues; FDA submission is expected this quarter (3Q16).]
Q: Many big hospitals are still using 12 mm needles, despite the new data on the benefit of smaller needles. How can we encourage these big institutions to change?
Dr. Seley: Hopefully when our paper comes out you can show it to them! It’s a fight we need to fight.
Ms. Jornsay: We made the switch almost one year ago at my health center to the 6 mm needle. We had to do extensive in-servicing to train the staff about this, but our hypoglycemia incidence, system-wide, has gone down. This goes to show often these injections with the 12 mm needles were intramuscular.
FDA Guidance and an Educator's Perspective on the Avalanche of Apps
Molly McElwee-Malloy (TypeZero, Charlottesville, VA) and Courtney Lias, PhD (FDA, Silver Springs, MD)
A session on mobile apps was a mixed bag: TypeZero’s Molly McElwee-Malloy highlighted the dangers of unregulated bolus calculator apps like RapidCalc, while FDA’s Dr. Courtney Lias shared the Agency’s risk-based approach to apps and offered some optimism for using apps in AID devices. Ms. McElwee-Malloy noted that 83 unregulated apps currently offer insulin dosing advice, but call themselves “wellness apps,” and are thus illegally marketed. Running through screenshots of RapidCalc (a free bolus calculator), she noted some pretty dangerous stuff: defaulting to mmol/l (changing the setting is really buried) and absurd checkboxes that are confusing or not clinically valid (“BG not measured/extra carbs” are the same check box; “Over 2 units of alcohol in last 4 hours” is confusing – what is a unit of alcohol?). She noted there are only “two” FDA-cleared bolus calculator apps, displaying pictures of Roche’s Accu-Chek Connect and J&J’s OneTouch Reveal app – we’d note that LifeScan’s current OneTouch Reveal app does not have a bolus calculator. WellDoc’s BlueStar does have a bolus calculator, and she was probably referring to the future planned integration of these apps. [Companion Medical’s just cleared InPen also has a bolus calculator in the paired app, though it won’t launch until 2017.] Ms. McElwee-Malloy asked educators to do some homework: Go to the app store, download any diabetes app, and see if you can spot any problems. Do you understand how to use it? When in use, do you consider the advice sound for your patients? What value does this bring to your patients and your practice? We thought this was reasonable advice, though her discussion was fairly negative and absent any app recommendations. There are certainly many unregulated logging apps like mySugr and Glooko that patients DO find useful, and the coming years will undoubtedly see more FDA approved apps that do offer valid dosing advice and treatment recommendations.
- Dr. Courtney Lias followed with a balanced review of the FDA’s risk-based approach to mobile app regulation, sharing some optimism for AID. She explained that most apps are unregulated (e.g., logging and tracking, wellness), and regulation focuses on the slice of diabetes apps that communicate with regulated medical devices (e.g., a CGM display app) or provide treatment advice (e.g., a bolus calculator). Regarding automated insulin delivery, Dr. Lias shared that these devices “should be developed with apps in mind” – echoing previous comments from the NIH Workshop. However, remaining technical challenges must be overcome, such as operating system updates, critical functions, and alarms. Dr. Lias called operating system updates “very challenging for manufacturers, particularly for Android devices” where a variety of manufacturers exist, and they do not give developers advanced notice like Apple. Regarding critical functions, companies must determine what happens with mobile medical apps in certain situations: apps running in the background, phone calls interrupting processes, etc. The phone mute button is a particularly difficult challenge – what happens when the phone is on silent and a critical alarm (low CGM) doesn’t sound? Dexcom has talked about updating its app to incorporate this mute override feature, but it is certainly not easy and presumably requires working directly with Apple. We think all of this solvable and salute the FDA for sorting through this very difficult and quickly moving field. The risk-based approach is right on the mark in our view, and we’ll be interested to see how quickly more valuable apps get through the FDA.
The Value of Retrospective CGM Data in Shared Decision Making
Davida Kruger (Henry Ford Health System, Detroit, MI) and Virginia Valentine (Northside Family Medicine, Albuquerque, NM)
Ms. Davida Kruger and Ms. Virginia Valentine, two dynamos of the CDE world, championed Dr. Rich Bergenstal and colleagues’ one-page, standardized Ambulatory Glucose Profile (AGP), declaring that it is (or at least should be) the new standard of care for interpreting glucose data. Under the current standard, they noted, fingersticks result in inconsistent testing and recording, inadequate pattern-detection during office visits, varying meters/displays, and an oversimplified representation of a patient’s blood glucose profile. In short, it’s a total nightmare, and other areas of medicine like cardiology have figured this out. The AGP provides a digestible, unabridged picture of 14 days of blood glucose data – both graphed and sorted into key statistics (see our deep dive from the JDST/DT&T publication two years ago here). Ms. Kruger and Ms. Valentine talked about how easy it is to dive into AGP data, identify trends, and pull out actionable insights – and many times, patients love problem solving in tandem and figuring out where they can improve their regimens. We look forward to seeing how this session evolves once FreeStyle Libre Pro is approved (still pending PMA approval; submitted over one year ago in 2Q15).
- We would love to see even more companies adopt AGP. Abbott paved the way by including it with the FreeStyle Libre download software, and at ADA, we learned that Roche, Diasend, and Glooko signed agreements to add it. As of June, Dr. Bergenstal told us three other device companies and aggregators were expected to sign similar agreements in “the next month” – the big glucose monitoring players that have not signed on yet include Ascensia, Dexcom, J&J/LifeScan, and Medtronic.
Hypoglycemia in 2016: Detection, Consequences, and Prevention
Anthony McCall, MD (University of Virginia, Charlottesville, VA)
In a talk heavily focused on nocturnal hypoglycemia (because half or more of severe hypoglycemia occurs at night), Dr. Anthony McCall (University of Virginia, Charlottesville, VA) pointed to BeAM score (and also basal-bolus balance) as valuable but often-overlooked metrics for nighttime hypoglycemia risk. BeAM calculates the difference between blood glucose at bedtime and breakfast, with a larger difference/higher score indicating that the individual’s glucose has dropped more significantly throughout the night. Paying attention to this score will thus send a clear, direct signal to a providers and diabetes educators if their patient is at risk for nocturnal hypoglycemia, Dr. McCall explained, as regular large BeAM scores suggest the risk of potential overnight lows. Despite this seemingly intuitive method of assessing the likelihood of overnight lows, very few people in the audience responded that they had heard of BeAM before. We first heard about it at this year’s Keystone conference, where the illustrious Dr. Bruce Bode (Atlanta Diabetes Association, GA) presented BeAM as a useful way to quantify whether or not a new therapy is working for a patient. We’re certainly intrigued by this measurement, especially given its low-cost and easy calculation (patients simply have to subtract two values that they would typically be measuring in any case via fingersticks. Of course, CGM would give a deeper dive in when lows are occurring, but since so few are on it, BeAM has a place. We wonder if we’ll start to see it used more often in evaluating diabetes care, especially in the context of basal insulin. Dr. McCall went on to summarize data on how CGM affects the magnitude and frequency of hypoglycemia both during waking and sleeping hours. He highlighted the “big ray of sunshine” DIaMonD trial presented at ADA 2016, which reported a 79% lower risk of nocturnal hypoglycemia for Dexcom CGM users vs. standard of care (p=0.005), alongside improvements in A1c, time in range, and overall frequency of hypoglycemia. Looking ahead, Dr. McCall suggested that insulin pumps and artificial pancreas devices will be the optimal way to minimize hypoglycemia and especially nocturnal hypoglycemia, expressing early enthusiasm for Medtronic’s just approved MiniMed 630G (threshold suspend on the new pump platform) and the 670G under FDA review.
- “We thought the artificial pancreas was ‘around the corner’ 40 years ago, and it’s actually very close now!” Following a detailed discussion of all the complicated factors that make nocturnal hypoglycemia difficult to diagnose and treat, Dr. McCall ended his talk on an optimistic note, reminding the audience that an artificial pancreas device – Medtronic’s MiniMed 670G/Enlite 3 hybrid closed loop – will potentially be commercially available by 2017 (submitted in June).
Questions and Answers
Q: What about a person who works the night shift, sleeping during the day and working at night? This skews circadian rhythms. Does this patient face the same risks for nocturnal hypoglycemia?
A: Fragmented sleep often causes patients to be more insulin-resistant. I find myself writing letters to employers to get my patients on a standard shift to help with their glycemic control. Do you know which employers I struggle with the most? Hospitals.
Comment: I’m mostly talking about nonprofessionals, people who may not have any flexibility in their working hours. With the job market as it is…
A: In that case, I simply have patients shift the way they take their insulin, timing it with their “day.” Strategies using CGM, AP, model predictive control – these things are also going to help. I’m hoping that CGM will be approved and reimbursed by Medicare. Please?
Diabetes Technology: the Hype, the Hope, and the Harvest
Jennifer Schneider, MD (Livongo, Mountain View, CA)
Livongo’s Chief Medical Officer Dr. Jennifer Schneider explained why people are so excited about the digital health revolution and outlined the early lessons and outcomes from seven aspects of the remote monitoring and connected healthcare world. The promise of remote connected health, she began, is the vision of a world where we can passively collect all of the data on people with diabetes that really matter, without manually uploading a device, without regulating or checking or calibrating, and without having to carefully track things manually. The appeal cannot be understated – modern technology has the potential to bring life with diabetes closer and closer to the experience of life without diabetes. But historically, we would note, diabetes tech has added burden to patients’ lives. Dr. Schneider moved on to a pro/con analysis, presented in tabular form below, of seven recent trends in the field: (i) Wireless sensor technology; (ii) Meaningful data; (iii) Data sharing; (iv) Real time intervention; (v) Gamification; (vi) Instant access to health information; and (vii) Diabetes prevention. We particularly like that she included cons, such as access and data overload – it is too easy to get wrapped up in the excitement of technology and ignore potential pitfalls. Dr. Schneider concluded by reminding the audience that digitalization is still a very young process, and as such, we all have the power to influence its development from whatever vantage point we have.
Trends in remote monitoring and the connected healthcare world – early outcomes and lessons
Wireless sensor technology (e.g. Fitbit, wearables, Abbott FreeStyle Libre, Propeller)
Breaks in connection
Getting less savvy populations comfortable with technology
Meaningful data (e.g. mySugr, Livongo)
Immediate real-time advice and support
Actionable insights and graphs
What is “meaningful”?
How much data (data dump not helpful)?
Entire care team (family, friends, providers) can have access and provide support
Difficult to access
Who gets what?
Real time intervention (e.g. Nighscout, Livongo alerts)
Intervene when people need it most
Leads to healthy, positive behaviors
Less struggle to achieve behavior change
How to use it?
Digital divide for elderly or lower income?
Instant access to health information (e.g. Fooducate, myfitnesspal)
Better information = better treatment
Reduce risks of prescription conflicts and approaches
Very difficult to integrate at the EHR level
Getting the data to the right place at the right time
Technology can help scale programs like DPP
Ensuring the quality of the program
Insulin Therapy and Delivery Today and Tomorrow
After a series of speakers reviewed commercially-available insulin products, including next-generation basals and new insulin pens, Ms. Jill Schramm (Uniformed Services University, Bethesda, MD) zoomed in on three simple infusers – Valeritas’ V-Go, CeQur’s PaQ, and J&J’s OneTouch Via. She highlighted a retrospective study published in June that showed V-Go to be both clinically and cost-effective – she especially emphasized this latter point, arguing that contrary to popular belief, costs don’t have to increase when patients rely on simple infusers instead of multiple daily injections (MDI). The study found that diabetes-related direct pharmacy costs were significantly lower for V-Go users (n=56) vs. MDI users (n=60). For every 1% reduction in A1c, V-Go cost ~$119 while MDI cost ~$217, a substantial $98 margin (p=0.013). Reductions in A1c were also greater for the V-Go group, with an average decline of 1.98% vs. 1.34% with MDI (p=0.02). In addition, V-Go users dosed significantly less insulin across 27 weeks, using an average of 56 units/day vs. 78 units/day for the MDI group (p<0.001). Ms. Schramm presented these results in support of simple infusers from a health standpoint as well as an economic one. She listed other benefits to simple infusers, including discrete delivery, reduced injection burden, and greater adherence to insulin therapy. Ms. Schramm also mentioned expected 2017 releases of PaQ and OneTouch Via (the latter in early 2017 in the US based on timing we heard at ADA).
Diabetes Wheel of Fortune: Help People Choose the Best Mobile Health Solutions for Them
Laurel Fuqua (InSpark Technologies, Oceanside, CA/USA)
InSpark’s Ms. Laurel Fuqua said what many believe about mobile health apps: “There’s a lot of junk out there” – many claim to give medical advice, but a large portion were developed by under-qualified groups. With the widespread adoption of smartphones and >165,000 mHealth apps comprising a $26 billion industry (>1,200 in diabetes alone), she argued there needs to be a standardized system to evaluate apps’ efficacy and appropriateness, or at least a strategy for providers to do so. Currently, people refer to App store ratings, word of mouth, and social media, all of which are hugely subject to bias, to navigate the “mHealth Minefield.” Ms. Fuqua proposed six critical criteria to look for in an app: (i) clinical trials/research behind claims; (ii) usability testing with real patients; (iii) approved by FDA or developed under a Design Control System; (iv) diabetes KOL endorsement; (v) diabetes experts involved in development/design; and (vi) meets security standards. While we agree that a check mark in each of these boxes would probably be a good indicator that an app is worthwhile, it would be preposterous to try to track down all of this information for most apps. We preferred her suggestion that CDEs should become mHealth experts and work with patients to assess the quality of an app: Does it improve the patient-provider relationship? Does it have measurable outcomes? Does it improve patient engagement and quality of life? Does it impact cost of care? And, above all, is there data to back up the claims? We think market forces will take care of some of this over time, but we hope lame apps don’t give the entire field a bad name.
- There is still no official assessment for mHealth apps, and even if there were, FDA and other assessors (for logging, tracking, wellness apps) would be tremendously overburdened by the sheer magnitude of options. A number of organizations (JAMA, FDA, CCH) have published app assessments and there are a few mHealth curation resources (Hacking Medicine Institute, iMedicalApps, IMS Institute for Healthcare Informatics, Social Wellth, and Edify Health), but nothing has been universally adopted. We believe people with diabetes will continue to rely on app store ratings, “trying it” (a nice part of apps), and their healthcare providers.
Optmizing Insulin Therapy Through Applied CGM
Gary Scheiner (Integrated Diabetes Services, Philadelphia, PA); Davida Kruger (Henry Ford Health System, Detroit, MI); Patricia Knutsen (Washington University School of Medicine, St. Louis, MO)
In a standing-room-only ballroom, a dynamic trio – Mr. Gary Scheiner (Integrated Diabetes Services, Philadelphia, PA), Ms. Davida Kruger (Henry Ford Health System, Detroit, MI), and Ms. Patricia Gaye Knutsen (Washington University, St. Louis, MO) – sounded off on the latest and greatest in CGM. Mr. Scheiner highlighted the threshold suspend feature of Medtronic’s 530G/Enlite (and recently FDA-approved MiniMed 630G pump). He pointed to findings from the ASPIRE in-home study that threshold suspend reduces “area under the curve” by 40%, which takes into account time spent in a low blood sugar range as well as magnitude of the low. Ms. Knutsen discussed various options for downloading CGM reports and explained how the field is moving toward simplicity with ambulatory glucose profiles (AGP). “Get used to looking at AGP,” she asserted. “It cuts your time in half.” We would certainly love to see greater use of AGP and more companies adopting it (Medtronic and Dexcom especially). Ms. Knutsen also expressed fierce opposition to blinded CGM reports, arguing that HCPs should be reviewing reports alongside their patients to facilitate patient learning and enhance their sense of self-efficacy. Lastly, Ms. Kruger emphasized asking the right questions so that patients experience the maximum possible benefits from CGM. Reports should be personalized, she remarked, providing information that is meaningful to that particular patient.
Insulin Pump Therapy Management: The Collaborative Art and Science of Supporting an Adult “Pumper”
Ellie Feddersen (Northshore University Health Systems, Chicago, IL)
Ms. Ellie Feddersen (Northshore University Health Systems, Chicago, IL) delivered a comprehensive talk on the psychosocial side of how to help patients optimize their insulin pump therapy, dividing tips into “science” and “art.” While we discuss the science often (or at least, more often), Ms. Feddersen highlighted the art – the collaborative process of working with patients and personalizing care. She shared findings from a small survey (n=37) probing for what patients want from their healthcare providers and diabetes educators in initiating and managing pump therapy. Accessibility, approach to teaching, attitude of educator, and psychological support were all common responses, Ms. Feddersen explained. She added that patients should have ample opportunity to ask questions and receive nonjudgmental, non-condescending answers. Downloading and reviewing data from the pump together is also a key component of care according to Ms. Feddersen. This was a recurring comment at this year’s conference, with Ms. Patricia Gaye Knutsen (Washington University, St. Louis, MO) also advocating strongly for sharing CGM reports with patients and going over data together.
Help Clients Overcome Diabetes Data Smog: Perspectives from a CEO with DIabetes
Erik Otto (President and Co-Founder, InSpark Technologies, Charlottesville, VA)
With 20 years of experience with type 1 diabetes and a career dedicated to diabetes data analysis technology, Erik Otto passionately described a core problem in diabetes management: the ‘diabetes data smog.’ 25 billion blood glucose data points are collected annually, but most people do not have the time or clinical acumen to make sense of the data, and most analysis tools act as mere repositories of data, doing little to add insight. This problem is exacerbated by issues of what Mr. Otto calls ‘data disintegration’ – lack of standardization for meter downloading, lack of data on external factors like food intake and activity, and the inconvenience of logging data. More critically, most software fails to provide useful and timely clinical insight into important questions, like when there is hypoglycemia risk, or where there are persistent daily patterns that could improve glycemic control if mitigated. Mr. Otto expressed confidence in a future where technology acts as a therapy, once glucose monitoring software is able to reliably and easily generate such insights for patients. He advised his audience of diabetes educators that so-called “smog-busting” technologies with this potential will be characterized by (i) glanceable insights that are automatically apparent without any calculations or analysis on the user’s part (like a weather app); (ii) strong predictive power for alerting the user about adverse events, without excessive false alarms; and (iii) discreet and low-hassle. We would add that diabetes technologies should also strive for accessibility and affordability. In Mr. Otto’s view, the development of such technologies will progress along a continuum, where over time more work will be done by the software and less by the user, resulting in better insight, thus better glycemic control, and thus better diabetes outcomes.
- Mr. Otto’s company InSpark is combatting the diabetes data smog with its blood glucose pattern recognition app Vigilant, although he did not explicitly discuss this in his talk. Compatible with both Android and iOS, the app notifies BGM users when it detects a risk of severe hypoglycemia in the next 24 hours, and provides automatic glucose pattern notifications. The app launched freely available to the public, but now requires a code. Vigilant pairs directly with Roche’s Accu-Chek Connect meter but can also accept manually entered blood glucose values. Its automatic glucose pattern detection is based on technology developed at UVA. In our initial review of the app, the user interface was in need of improvement, though we liked the concept.
Questions and Answers
Q: I felt like I had an epiphany when you were presenting this. The word “context” is really key. No patient lives a robotic life, so context is so important. The problem is that once we have context (the person’s food, activity, medications, etc.) it takes forever to analyze. So having software that will prompt us or provide useable insight for clinical decisions will be extremely useful. How do we propel industry, whether its device manufacturers or software developers, to develop pattern recognition based on context and lifestyle events? That’s ultimately what we need, software that shows cause and effect relationships.
A: To draw everyone in and show that this is what we need to do, we will have to show the outcome benefit of these technologies. People will realize how much this technology will change the game if we can show with these solutions that: (i) we improve clinical outcomes; and (ii) we get people engaged using the software. We need to advocate to manufacturers that this is what we want.
Q: You suggested that standard deviation isn’t a good measure of blood glucose variability. What’s an alternative?
A: We have a tool called risk range, which measures the percentage of time spent in and out of range. I would recommend you look at a Diabetes Care paper from 2006 where they compare different measures of glucose variability and how predictive they are.
Q: As these technologies move along this continuum, can you comment on how the people using these technologies can grow to feel confident to use it as intended, and how we as educators can help them?
A: Getting people to realize the utility of these new technologies is critical. People are jaded by the thousands of software packages out there that are really just data repositories. This is a huge turn-off. Again, it comes down to outcomes. We need to show people that this software improves outcomes – A1cs, the prevalence of severe hypos. We hope people will view the technology as a kind of therapy that can improve their treatment. We want technology to be more like a diabetes management companion, not a repository of data. Once people get started on these tools, hopefully they’ll see that.
BD Thought Leader Summit
We were fortunate enough to attend the 2nd annual BD-hosted summit, where the medical, marketing, and management teams shared recommendations for insulin injection protocols and picked the brains of ~14 diabetes thought leaders – the majority of which have type 1 diabetes and exert their tremendous influences through blogs and social media. Topics of conversation involved patient engagement, patient and provider education, and the upcoming MiniMed Pro-Set launch. Attendees also had the opportunity to demo the MiniMed Pro-Set with BD FlowSmart technology, which is slated for a limited (at least 1,000 patient) launch in the US and France soon to collect user feedback, followed by a full-scale, global launch around October-December, per BD’s August call. As a reminder, the MiniMed Pro-Set has a unique form factor featuring a dual-opening cannula, thinnest insertion needle (30G) compared to the leading sets, multi-position connector, and safety shield that covers the needle after insertion as well as connectivity with insulin pumps and reservoirs that use luer-lock and MiniMed connections, including Medtronic, Animas, Tandem, and Roche. BD demoed the set for AADE attendees in the exhibit hall.
- The first major discussion point of the day was injection/infusion technique, a crucial yet often overlooked factor necessary for proper diabetes management. We believe many patients have not been trained in technique and hope that the just-published FITTER recommendations change this! Dr. Thomas Fillman provided a recap of last October’s Forum for Injection Technique & Therapy Expert Recommendations (FITTER), which sought to achieve consensus on a set of recommendations for injection technique, insulin safety, and infusion based on clinical evidence and results from a >13,000-participant global survey. Hundreds of diabetes experts participated (many remote from various regions of the world like Brazil and China). Relative to previously accepted guidelines, FITTER brings improved insulin injection technique recommendations, consensus on proper insulin safety and infusion protocols, and enhanced strategies for communicating recommendations – we think healthcare providers will very much benefit, as should patients, as long as the education happens. For a deeper dive, see www.fitter4diabetes.com and our coverage of the Mayo Clinic Proceedings publications.
- The long-awaited publications will hopefully address a number of education hurdles that the group returned to multiple times:
- In this tech-centric world, people often forget about the basics of insulin delivery (site rotation, choosing the proper needle length, disposing of needles appropriately, etc.), which we were reminded is anything but trivial (we certainly agree);
- The most visible patients are those who are most engaged and most likely to follow protocols, but many patients are not so lucky to be engaged due in part to a range of social and cultural determinants – they can benefit from particular focus; and
- People are creatures of habit – it is very difficult to alter an established behavior, so proper practices must be instilled early in both clinicians and patients. We were glad to hear clinicians should be a focus – it was raised in the #DSMA Twitter chat at AADE how important various language is and that a range of clinicians could benefit from education on this front.
- Regarding the MiniMed Pro-Set launch, attendees were unwavering in their support for a “test drive” model where patients can try the product before committing to and paying for a 10-infusion-set box. They also suggested that, to make the value of the MiniMed Pro-Set with BD FlowSmart technology more evident and increase the number of patients throwing away their old sets, the marketing division should leverage various social media platforms to highlight the clinically-demonstrated benefits of the BD FlowSmart technology. The attendees also recommended that if patients receive new sets, they also should make sure to share unused old sets to the extent allowed. We applaud BD for allowing patients’ and advocates’ voices to be heard early in the process where they can still have a material impact. We hope the test drive recommendation will be instituted across all diabetes tech – it remains too hard to try technology before you buy.
A Beginners Guide to Continuous Glucose Monitoring
Gary Scheiner (Integrated Diabetes Services, Wynnewood, PA), Patricia Gaye Knutsen (Washington University School of Medicine, Saint Louis, MO), Davida Kruger (Henry Ford Health System, Detroit, MI)
This standing room-only symposium offered attendees a fairly comprehensive introduction to CGM technology – primarily how CGMs work and how they strengthen treatment regimens. The presentations were informative and engaging, but the fact that such a session was necessary speaks to how much education is still needed. We were not surprised when Wash U’s Ms. Patricia Gaye Knutsen quizzed the audience on BGM/CGM lag, and 32% said that BGM lags behind CGM (in reality, the CGM signal typically lags behind that of BGM by 5-6 minutes). While some may have been confused by the question’s wording, it does speak to the gap in educators’ knowledge of CGM! As Dr. David Rodbard pointed out in a special January issue of Diabetes Technology and Therapeutics, a major barrier to widespread CGM implementation is poor training for healthcare providers. There needs to be a better system in place to ensure that providers are equipped to give their patients the tools to efficiently self-manage their diabetes, because CGM does just that. Mr. Gary Scheiner (Integrated Diabetes Service, Wynnewood, PA) called it “an investment that is worthwhile” and noted that CGM data is the ultimate teaching tool for an educator. Ms. Davida Kruger (Henry Ford Health System, Detroit, MI) echoed that sentiment in her talk, claiming that, with CGM, she does more education because she has the data to convince patients that behavioral change is necessary. Ms. Knutsen raved that CGM is the “most magical thing that’s happened” in her career, telling attendees that they will “fall in love” with the technology. We think this will inevitably improve as the products get better, as studies with modern devices show the real benefits of the technology, and the companies invest more in educating the field. To date, CGM has needed technical improvement, and now that the accuracy and reliability has improved, more needs to be done on real-world translation.
Integrating Diabetes Technology into Daily Life with Accu-Chek Connect (sponsored by Roche)
Anne Peters, MD (USC Keck School of Medicine, Los Angeles, CA)
According to the T1D Exchange registry, 65% of meter users never upload their SMBG data into the cloud for their clinicians to analyze. To Dr. Anne Peters, this is representative of the disconnect between expectations for how technology should improve lives and its actual impact – if patients found uploading their data worthwhile, they would do it. Dr. Peters shared a litany of issues that prevent technology from improving outcomes: (i) Access to providers – as more patients get access to care, they require guidance, shifting the demand curve for providers up, while supply dwindles; (ii) Device and data overload; (iii) poor EMR integration of devices (“Everyone hates EMRs”); (iv) Lack of understanding of what both patients and providers need for data interpretation; (v) Lack of report standardization; (vi) Lack of reimbursement for providers for data interpretation; (vii) Need to keep data protected; and more. This makes success with technology highly uncertain, but Dr. Peters said there is too much potential for enhanced communication, therapy, and cost to give up hope. She outlined five recommendations that would begin to address the issues presented above: (i) devices that make it easy for patients to communicate all kinds of data to clinicians (e.g., cloud-connected via cellular or Bluetooth to a phone); (ii) Give patients immediate feedback on how to make a therapeutic decision (e.g., real-time CGM data, and eventually, decision support); (iii) Positively reinforce healthy decisions (we like Dexcom Clarity’s “best glucose day” report); (iv) Enable wireless integration into a variety of software and support groups; and (v) Standardize reports – every time Dr. Peters’ brain has to shift to a different report, she’s afraid she is going to miss something. Ultimately, she concluded, it is the provider’s responsibility to establish that patients know how to use and understand the value of a given technology so they remain adherent.
- “We need apps that addict our patients. We need gamification. We need it to be fun … The hardest part is getting people from knowledge to action. The app has to do that.” Dr. Peters noted that patients often use diabetes apps for short periods of time and then stop because they require too much data entry and don’t give proximal feedback or reinforcement – in short, not enough benefit relative to the burden of use. Pokemon Go and the Fitbit craze have shown that gamification and social apps can get people to move – how can that translate to diabetes? Gamification could help explain the success of mySugr (770,000+ registered users worldwide), which uses challenges and a points system to encourages diabetes logging.
- For more on this idea, see an updated May 2016 version of Adam’s ADA 2015 talk on how a Device Becomes a Device. We hope there is lot more companies can do to make devices so useful and addicting, patients cannot live without them. To us, it all comes down to benefit vs. burden tradeoff.
- Dr. Peters said there are two adoption curves to overcome before people with diabetes benefit from an app: the patient’s and the provider’s. Tidepool’s blip presents a case study. Providers are stretched so thin that they commonly don’t have the time to sit down and learn a new technology. Dr. Peters told the story of how Tidepool’s blip used to “annoy” her but when her CDE/clinical researcher husband forced her to use it (as part of the T1D Exchange’s REPLACE BG study), she came to appreciate the product and the way it “helps her think through data better.” Of course, few to none of her patients were using this valuable data management platform until she accepted it herself.
The Impact of Blood Glucose Monitoring System Accuracy on Diabetes Management (sponsored by Ascensia)
Gary Scheiner (Integrated Diabetes Services, Wynnewood, PA)
2014 AADE Educator of the Year Gary Scheiner spoke to the importance of using accurate BGMs (within 10% of reference), such as those of the Ascensia NEXT portfolio. He began with an analogy to illustrate ideal glycemic control: At the Grand Canyon, you have to get up close to get a good view, but not so close you fall in. People with diabetes face the same conundrum – they want to achieve tight glycemic control, but without frequent or severe hypoglycemia. The problem with this strategy today, Mr. Scheiner continued, is that current official FDA regulations (2003 guidance) are too relaxed, allowing ±20% error (>70 mg/dl) or ±20 mg/dl (<70 mg/dl). Even with the proposed 15% error threshold vs. YSI (2014 draft guidance), a blood sugar of 320 mg/dl could read anywhere from 272 mg/dl to 368 mg/dl. If that wasn’t enough, the 15% error neglects systematic and user errors such as inter- and intra-meter variability, test strip under-filling, alternate site testing, competing blood substrates (e.g. acetaminophen), patient technique, dirty hands, etc. At the end of the day, the reading from a meter can be misleading and lead to potentially dangerous therapeutic decisions. Mr. Scheiner left the audience with the take-home message that it doesn’t matter how many “buzzers and whistles” your meter has if it’s not accurate. Then he proudly displayed his DIY all-in-one (BGM, lancet, strips) “device” that was held together by rubber bands, demonstrating that patients can have cool features and accuracy at the same time, even if the company didn’t design it that way. His talk was yet another reminder that “fingersticks” are probably less accurate in the real world than is widely appreciated, which emerged as a big theme of the July 21 FDA-Dexcom meeting. We hope more and more clinicians understand the comprehensive risk-benefit profile of both CGM and fingersticks – both have their strengths and weaknesses!
- Mr. Scheiner, who uses the Contour NEXT USB, said the Ascensia Contour NEXT BGM suite is the most accurate on the market, with 99% of readings within 10% of lab values. Ascensia attributes the accuracy to the supreme specificity of the proprietary mediator, the agent that extracts the glucose from the enzyme and carries it to the electrode. This allows for an electric current to pass through all of, and only, the glucose from the sample.
- As an aside, we’ve been impressed with Ascensia’s Contour Next strips cash-pay pricing on Amazon – ~$19 for 100 strips is remarkably inexpensive for a branded offering, particularly one of the most (if not the most) accurate meters on the market. For the most intensively managed patients testing 10 times per day, $57 for 300 strips (cash-pay) is roughly comparable to the $50 co-pay patients with insurance often have these days.
Selected Questions and Answers
Q: What do you recommend for patients whose insurance only covers poor accuracy sensors?
A: Fighting the system is never easy. They’ll approve things if you can send data their way. They just want to see that there’s a medical reason that the device is needed. You have to appeal every insurance plan – they have preferred formulary meters, but you can appeal if you can show there’s a medical need. They’re usually flexible with those things.
Upsides and Downsides of SGLT2s
Anne Peters, MD (USC Keck School of Medicine, Los Angeles, CA)
The great Dr. Anne Peters presented a very positive view of the SGLT-2 inhibitor class overall, though she acknowledged the non-minimal risks of DKA and genital infections associated with the drugs. Dr. Peters emphasized that diabetes is not just about hyperglycemia and glucose control and is associated with multiple comorbidities, including cardiovascular disease. She pointed out that now, for the first time, we have diabetes drugs that we know can mitigate the risks of diabetes comorbidities in more than one way, as demonstrated by the cardioprotective benefits of Lilly/BI’s SGLT-2 inhibitor Jardiance (empagliflozin) in the EMPA-REG OUTCOME trial. She characterized this as a huge positive for patients and for the diabetes field. She also acknowledged that some data (like the renal outcomes from EMPA-REG OUTCOME) suggest that SGLT-2 inhibitors may be nephroprotective in the long-term. From a glucose perspective, Dr. Peters shared numerous stories of her patients with type 1 diabetes who experienced weight loss and remarkable improvements in glycemic variability with SGLT-2 inhibitor use and begged to remain on them (sometimes even after experiencing severe DKA). We’ve previously heard one of her patients with type 1 diabetes speak powerfully on her own very positive experience with the class in person and it’s clear that Dr. Peters is not being hyperbolic in describing her patients’ enthusiasm for the therapy. Along with the benefits, Dr. Peters heavily underscored the need for substantial patient education on the risks associated with SGLT-2 inhibitors. In particular, she outlined an intensive risk management strategy she employs to avoid DKA in her patients with type 1 diabetes that involves regular ketone testing before initiation, very low doses of the SGLT- 2 inhibitor (even cutting up pills), ensuring that patients eat at least 100 g of carbs per day, and intensive education on various situations in which to temporarily stop the SGLT-2 inhibitor. Dr. Peters also highlighted the extensive patient education she conducts surrounding genital infections for both women and men – an oft-overlooked and largely dismissed adverse event for the class. Ultimately, Dr. Peters emphasized that the drawbacks of SGLT-2 inhibitors are manageable and asserted that they are a “wonderful addition to our ability to treat diabetes in both type 1 and type 2.” Dr. Peters has been one of the most vocal supporters of SGLT-2 inhibitor use in type 1 diabetes (and in type 2 diabetes for that matter) and her presentation at AADE certainly continued on that theme.
Is Glucagon Ready for Prime Time?
George Grunberger, MD (Grunberger Diabetes Institute, Bloomfield Hills, MI)
In a comprehensive overview of the role of glucagon in diabetes, AACE immediate past president Dr. George Grunberger (Grunberger Diabetes Institute, Bloomfield Hills, MI) highlighted hot-off-the-press topline phase 2 results for Zealand’s liquid-stable glucagon analog dasiglucagon (formerly known as ZP4207) for hypoglycemia. Zealand shared the topline results from the single-center, randomized, double-blind trial just last Thursday. The trial (n=58 participants with type 1 diabetes) compared four doses of dasiglucagon to native glucagon, demonstrating that the three highest doses of dasiglucagon, like native glucagon, were able to achieve a blood glucose concentration of 70 mg/dl within 30 minutes of administration to patients following an insulin-induced hypoglycemia event. The three highest dose groups were also able to raise plasma glucose by a clinically meaningful 20 mg/dl in 9-10 minutes, similar to the time it takes native glucagon to achieve the same. Dr. Grunberger and the press release both noted that dasiglucagon is safe and well tolerated. Dr. Grunberger was optimistic that next-generation glucagon products such as dasiglucagon can offer promising alternatives to the current error-prone native glucagon kits that require a complex nine-step process for reconstitution. We certainly look forward to learning more details in the full results, particularly regarding whether dasiglucagon offers any clinical advantages beyond the potential for an auto-injector pen administration – that’s a big one in our view! Other exciting next-generation glucagon candidates in the pipeline highlighted by Dr. Grunberger included Xeris’ line of G-Pen glucagon auto-injector (phase 3) and G-Pump products and Lilly/Locemia’s intranasal glucagon (phase 3) – Dr. Grunberger was particularly optimistic on the latter’s potential to simplify glucagon administration in emergency settings. Both products reported impressive human factors study results in the last year (at ATTD 2016 and EASD 2015, respectively), demonstrating their ease-of-use in comparison to traditional glucagon.
Pharmacology Boot Camp
Susan Cornell, PharmD (Midwestern University, Chicago, IL)
In another outstanding pharmacology bootcamp (a reprisal of last year’s AADE), Dr. Susan Cornell (Midwestern University, Chicago, IL) characterized GLP-1 agonists as the future first-line therapy and shared her stance that metformin and sulfonylureas should soon become a thing of the past. Dr. Cornell argued that GLP-1 agonists fix at least four of the organs in the “ominous octet” of organs underlying the pathophysiology in type 2 diabetes:
- acting on the liver to lower endogenous glucose release;
- (ii) enhancing secretion of insulin and amylin from the pancreas;
- (iii) increasing satiety by sending more amylin to the brain; and
- (iv) slowing gastric emptying from the GI tract.
In comparison, Dr. Cornell pointed out that metformin only acts on the liver. Dr. Cornell also expressed a staunchly negative view on sulfonylureas, explaining that they are inconvenient for patients, cause weight gain, and introduce high hypoglycemia risk. As part of her comprehensive rundown on all of the drug classes available for the treatment of diabetes, she also touched upon the tremendous weight loss benefit of SGLT-2 inhibitors and the exciting promise of combination therapies, including GLP-1 agonists with basal insulin (like Novo Nordisk’s Xultophy) and GLP-1 agonists with SGLT-2 inhibitors. Dr. Cornell also highlighted four drugs that have thus far been used effectively as an intervention for prediabetes – alpha glucosidase inhibitors (AGIs), metformin, TZDs, and GLP-1 agonists – and like us, said she’s looking forward to AADE’s first ever dedicated prediabetes day on Sunday.
- “To be honest, I don’t think it’s going to be first-line therapy much longer.” Dr. Cornell argued that with more effective options on the market, especially GLP-1 agonists with their quadruple action, metformin is losing its pull as the preferred first-line therapy. That said, she emphasized that metformin is one of three type 2 drugs that has been used off-label successfully in type 1 patients, the others being GLP-1 agonists and SGLT-2 inhibitors. This role of type 2 drugs in treating type 1 diabetes is nontrivial, given the lack of indicated options beyond insulin and the need for better adjunct therapies. Dr. Cornell attributed the efficacy of these drugs in type 1 diabetes to their weight loss effect, noting that the line between type 1 and type 2 diabetes is growing fuzzy – she even elicited a gasp from the audience when she shared that nearly 50% of type 1 patients today present with insulin resistance, usually due to obesity. We’ve heard similar commentary on the dwindling rationale for metformin use from University of Miami’s Dr. Jay Skyler at Keystone 2016. While it’s certainly true that newer drug classes offer greater efficacy, it’s difficult to argue with the benign safety and tolerability profile of the old standby and the easy, cheap access to the drug. That said, we look forward ultimately to seeing GLP-1 agonists or SGLT-2 inhibitors eventually achieve affordable access – once that happens, SFUs will ideally be completely off the radar screen.
- On sulfonylureas, Dr. Cornell stated simply, “it’s time for them to go.” She emphasized that these agents can have a dangerously long half-life, that they significantly increase hypoglycemia risk, and that they actually promote further beta cell loss. Dr. Cornell further suggested that if sulfonylureas were developed today, they would not gain FDA approval by modern standards. Their only remaining use, according to Dr. Cornell, is as a therapy for monogenic diabetes. Until an alternative treatment for monogenic diabetes emerges, she explained that sulfonylureas will remain available on diabetes market. Of course, the generic and “cheap” status of sulfonylureas (not taking into account the costs of the associated hypoglycemia) often leads providers to prescribe this class for patients who are unable to afford other options as well. Indeed, Dr. Cornell mentioned that third-party payers frown upon her criticism of sulfonylureas.
- Dr. Cornell noted that cost and insurance coverage may be impeding the acceleration of GLP-1 agonists to first-line therapy. These are important variables that deter some patients and providers from adding a GLP-1 agonist to a treatment regimen, she explained, acknowledging the normal patient response to out-of-pocket costs. Still, she underscored that GLP-1 agonists are the future of diabetes, especially as we start to see fixed-ratio combinations of GLP-1 agonists with basal insulin and investigations into replacing bolus insulin with a GLP-1 agonist for type 2 diabetes patients. We found such optimistic commentary on GLP-1 agonists notable, and Dr. Cornell seemed even more positive about the class than she was at last year’s pre-conference pharmacology bootcamp – we imagine the demonstration of cardioprotective benefits for Victoza (liraglutide) in the LEADER trial, which she also highlighted in her session, helped sway her toward an even more positive view. We expect to see this class expand, particularly with continued product innovation, such as combination GLP-1/basal from Novo Nordisk and Sanofi, Intarcia’s implantable GLP-1, once-monthly GLP-1 from AZ, oral GLP-1 from Novo Nordisk, etc.
- In making the case for prediabetes interventions, Dr. Cornell pointed out that by the time of diagnosis, the average patient has already been living with type 2 diabetes for nine years. It is so true so much more focus on screening is needed! Most people, she emphasized, realize they have type 2 diabetes after experiencing a related complication, which means the disease has already progressed substantially. According to Dr. Cornell’s presentation slides, at the time of type 2 diagnosis patients have already lost 50-80% of functional beta cells. She added that 60% of people with type 2 diabetes have at least one complication, while 7% experience four or more complications. As she put it, these statistics are “bad for patients and bad for payers.” From both a patient and payer perspective, earlier screening for prediabetes and implementation of interventions could go far in addressing these statistics – we’re thrilled to see Medicare move in this direction with its planned reimbursement of the Diabetes Prevention Program (DPP).
- Dr. Cornell made the case that recognizing prediabetes as a disease could greatly improve health outcomes and would save payers money. This wasn’t the first time we’ve heard this compelling argument – the AMA and CDC’s diabetes prevention cost-saving calculator, for instance, proves the cost-effectiveness of the DPP. According to Dr. Cornell, AGIs, metformin, TZDs, and GLP-1 agonists have all shown efficacy alone and in combination in the treatment of prediabetes. Though medication of prediabetes remains relatively controversial, there is a pressing need to reduce the rate of new-onset type 2 diabetes and we so hope for more productive conversations on and investigations of prediabetes interventions.
- “All the knowledge in the world will do us no good if patients don’t take their medication.” Dr. Cornell bookended her talk with a memorable comment on adherence: she prefaced her discussion of diabetes drugs with statistics on adherence and circled back to the point at the end of the session. For all chronic diseases, adherence declines rapidly in the first year following diagnosis. For diabetes, adherence falls to ~60% by the six-month mark. Patients are less likely to stick to a regimen of oral antidiabetic drugs than they are with lipid-lowering or anti-platelet medications. Dr. Cornell presented this information to demonstrate the need for patient-centered diabetes care. She underscored the immense value in motivating patients early on and in educating them on treatment options so that they remain engaged in their diabetes management long-term. After all, she emphasized, diabetes is a chronic disease that requires chronic care.
GLP-1 Across the Continuum: From Metformin to Basal Insulin (Sponsored by Novo Nordisk)
Melissa Magwire (Shawnee Mission Endocrinology & Diabetes, Shawnee Mission, KS)
In an engaging, well-attended Novo Nordisk product theater on GLP-1 agonist Victoza (liraglutide), Ms. Melissa Magwire advocated for earlier use of GLP-1 agonists within the diabetes treatment algorithm and for GLP-1 agonist and basal insulin dual therapy. She highlighted the positioning of GLP-1 agonists as a potential second-line therapy within the ADA/EASD and AACE diabetes treatment guidelines and emphasized that the AACE guidelines go so far as to suggest GLP-1 agonists as the “preferred” second-line option after metformin. She frequently advocated for aggressive therapy intensification to prevent clinical inertia, highlighting the guidelines’ recommendations to intensify treatment if a patient is not at goal after three months. While Ms. Magwire underscored that GLP-1 agonists are an appropriate choice in combination with many oral agents, she especially extoled the benefits of the use of GLP-1 agonists with basal insulin in particular. She reviewed the “ominous octet” of multiple pathophysiologies underlying type 2 diabetes and pointed out how GLP-1 agonists’ and basal insulin’s complementary effects are able to together address seven of the eight major pathophysiological defects, all except the increased glucose reabsorption at the kidney. We hope that payers understand this – we’re a bit concerned this will be a situation of missing the forest for the trees and wanting to start or continue with one agent solely, for the short-term benefit of cost-savings. Looking to Novo Nordisk products specifically, Ms. Magwire reviewed phase 3 clinical trial data demonstrating the A1c efficacy of Victoza added on to a stable dose of Novo Nordisk’s basal insulin Levemir and the efficacy of Levemir added on to a stable dose of Victoza. In both cases, the addition of the second drug was able to produce greater A1c reductions, lower fasting plasma glucose, and weight loss (with add-on Victoza) or minimal weight gain (with add-on Levemir), all with only a minimally increased risk of hypoglycemia. While Ms. Magwire did not discuss any clinical data on the use of Victoza with Tresiba (insulin degludec), it does appear that the session was aimed at setting up the launch of GLP-1 agonist/basal insulin fixed-ratio combination Xultophy (Tresiba/Victoza combination) by expounding on the benefits of the two classes in combination. There was clear interest in the room on the use of the two together – a positive sign for Xultophy’s prospects in our view.
Achieving Partnerships and Improving Outcomes in Your Diabetes Patients (Sponsored by AZ)
Virginia Valentine (Sage Specialty Care, Albuquerque, NM), Sandra Bollinger, PharmD (Health Priorities, Sikeston, MO), and Joshua Neumiller, PharmD (Washington State University, Spokane, WA)
This AZ-sponsored symposium featured a trio of talks on pertinent issues in diabetes care, interspersed with chef Robert Lewis “the happy diabetic” demonstrating how to make a delicious low-carb angel food cake dessert.
- Ms. Virginia Valentine set the tone for the evening when she highlighted the dismaying statistic that <20% of patients with diabetes are meeting targets for A1c, blood pressure, and lipid levels. Her presentation slides also suggested that more patients are able to reach a less-stringent A1c goal: the proportion of patients meeting A1c goals between 2007-2010 rises to 78% from 53% with a target A1c 8% compared to 7%. That said, Ms. Valentine asserted during Q&A that she still leans toward a 7% A1c target for most of her patients, the exception being older individuals at very high risk for hypoglycemia. We’ve heard several arguments lately for less stringent A1c control in elderly patients (most recently in a JAMA Patient Page by Yale University’s Dr. Kasia Lipska), and while we appreciate the movement toward personalized goal-setting in diabetes care, we were happy to hear Ms. Valentine advocate for A1c <7% since there are alternative ways to reduce hypoglycemia risk without sacrificing glycemic control, including CGM and non-insulin therapies.
- Dr. Sandra Bollinger advocated for better communication between providers and diabetes educators. She argued that the field needs a better referral protocol so that healthcare providers know when to involve a CDE; she pointed to the Diabetes Self-Management Education, or DSME algorithm of care as a potential clarifying protocol. Dr. Bollinger pointed out the abysmal participation we see in diabetes education programs – only 7% of privately-insured, newly-diagnosed adults attend a DSME session. For patients on Medicare, the rate is only 4%, even when factoring in both DSME and medical nutrition therapy (MNT). This means there’s “a lot of work for educators, but also a lot of opportunities,” she assured. To increase utilization of diabetes education programs, Dr. Bollinger suggested that access to DSME must be guaranteed for all type 2 diabetes patients, in terms of feasibility and reimbursement. To bolster our prevention offerings, Dr. Bollinger urged audience members to write-in comments to the Center for Medicare & Medicaid Services (CMS), which is accepting letters on how Medicare should reimburse the Diabetes Prevention Program (DPP) until September 6 before finalizing the proposed Medicare Physician Fee Schedule. The proposal was big news when it was released last month, and we absolutely hope that, with multiple mentions of the recommendation process at this year’s conference, educators across the country will voice their opinion so that the much-needed National DPP is well reimbursed by the start of 2018.
- Dr. Josh Neumiller anchored this symposium with an overview of new fixed-dose combination (FDC) drugs, concentrated insulins, and cardiovascular outcomes trials (CVOTs). He highlighted findings that individuals taking FDC products are 6% more likely to adhere to therapy compared to patients taking multiple loose-dose drugs in combination. He also shared that patients on FDC drugs save $13/month in type 2 diabetes-related healthcare costs compared to their loose-dose counterparts, and he presented data on the superior A1c lowering that results from fixed-dose empagliflozin/linagliptin (SGLT-2 inhibitor/DPP-4 inhibitor combination therapy) vs. either treatment alone – all in all, making a strong case for the use of FDC drugs in diabetes care. Turning to basal insulins, Dr. Neumiller pointed out that right now, the only commercially-available insulin glargine U300 pen delivers a maximum dose of 80 units, which he suggested is prohibitive for patients who need much larger basal doses. Like us, he’s hoping for a pen that offers a larger basal dose option in the near-future. Dr. Neumiller also provided insight into how CVOT results have impacted his clinical practice experience thus far. He noted that he’s noticed an increase in SGLT-2 inhibitor prescriptions in his area since EMPA-REG OUTCOME data was announced and demonstrated cardioprotection. Dr. Neumiller also acknowledged the slight uptick in heart failure observed for some DPP-4 inhibitors, and remarked that although he’s still just as likely to recommend these agents, this potential CV safety concern is something to keep in mind, especially given the relatively modest A1c reductions that we see with DPP-4 inhibitor therapy.
Questions and Answers
Q: Are new combination drugs going to be included in the ADA or AACE treatment guidelines?
Dr. Neumiller: The essence of the combination products is already within the guidelines. It talks about combinations and possibly using basal insulins with GLP-1 agonists, so in essence, it’s there. Part of the issue boils down to insurance coverage for some of these agents.
Ms. Valentine: In Albuquerque, payers aren’t crazy about combination drugs for some reason.
Dr. Neumiller: From the patient standpoint, it would be great if they only faced one co-pay.
Ms. Valentine: And let’s not forget that fixed-dose combinations are better for compliance.
Q: Will new healthcare strategies affect insurance coverage?
Dr. Bollinger: I’m hoping we’ll see expanded coverage. There are new opportunities for coverage as we see with the Diabetes Prevention Program (DPP), and I’m surely hoping that you all log in and make your comments to CMS regarding Medicare reimbursement for the DPP.
Q: Are any of you doing weight management with your patients and billing for that?
Dr. Bollinger: I am doing weight management, but I’m not billing for it at this point. It’s incorporated into my greater diabetes management program, and I count weight loss as one of my markers of improvement. Weight loss is a huge motivator – patients come back if they notice weight loss. I actually monitor percent body fat, so even if the needle isn’t moving on the scale, patients can see their bodies getting healthier.
Dr. Neumiller: I don’t specifically engage in weight management, but I’m working with people with diabetes so that’s always a huge part of the decision-making process. And I agree – it’s an important motivating factor when you start a new medication and lose a couple pounds.
Ms. Valentine: Are either of you using medications for weight loss?
Dr. Neumiller: I’m not recommending them to a large degree. More so, I look at the weight effects of diabetes medications.
Dr. Bollinger: Same for me.
Q: What are your favorite patient education tools?
Dr. Neumiller: I mostly use AADE and ADA. Some drug manufacturers put out tools that are helpful as well, especially in terms of explaining pathophysiology.
Dr. Bollinger: My favorite ones have to do with physical activity – apps like My Fitness Pal that track your steps, etc.
Q: If we know damage from type 2 diabetes begins well before diagnosis for most patients, why have we gone back to an accepted A1c target <8%?
Ms. Valentine: I don’t think we have. You see some people saying <8% is okay, but in our practice I wouldn’t suggest <8% unless I’m dealing with a much older patient at very high risk for hypoglycemia, and thus at high risk for falls. Otherwise, I’d continue to work toward 7%.
Q: Do you think pharmaceutical companies sending free CDEs to physicians’ offices subsequently hurts referrals to out-patient DSME?
Ms. Valentine: (In response to a stir in the audience) Well this is certainly a hot topic!
Dr. Bollinger: I think that’s certainly a possibility.
Ms. Valentine: When the CDEs you’re talking about go to physicians’ offices, they’re not really providing diabetes education. They’re usually offering specific skill training, but a lot of doctors don’t even realize that – that there’s a lot more to diabetes education than this one specific skill.
Debbie Hinnen, (Mid-America Diabetes Associates, Wichita, KS), John Sink (Jones Center for Diabetes and Endocrine Wellness, Macon, GA), and Daniel Einhorn, MD (Scripps Memorial Hospital, La Jolla, CA)
This lively and interactive corporate symposium highlighted the benefits of newer basal insulin formulations such as Novo Nordisk’s Tresiba (insulin degludec) and Sanofi’s Toujeo (insulin glargine U300) and made the case for GLP-1 agonists – what Dr. Einhorn calls “the safest class of drugs out there” – as an excellent option for the intensification of type 2 therapy. An overarching theme throughout the symposium was the wide range of pharmacotherapies now available for type 2 diabetes therapy. Dr. Einhorn remarked that these choices give us the freedom to “adapt therapy to the patient, instead of the patient adapting their life to the therapy.” The ensuing panel discussion, however, made clear that not all patients have the same freedom to personalize their diabetes therapies, practically speaking. Several audience members commented that these newer pharmacotherapies, though exciting in scientific terms, are completely out of reach for the majority of their patients. Panelist John Sink (Jones Center for Diabetes and Endocrine Wellness, Macon, GA), a CDE himself, sympathized with this frustration, but noted that it is the duty of health care professionals to “get up, pull your pants up, and figure out how to get your patients on the drugs they need” – usually via a series of calls to the patient’s insurance company. “As an educator, I want what the patient needs,” he declared, “Not what the PBM thinks they need.”
- The panel highlighted several online resources to facilitate patient access to the most appropriate diabetes therapy. Ms. Hinnen mentioned MMIT Network and Fingertip Formulary as excellent resources for determining which medications are covered under various insurance plans. Furthermore, she noted that discount coupons are available from many pharmacy chains through resources such as goodrx.com and also emphasized the value of online patient assistance programs (such as those developed by Lilly, Novo Nordisk, and Sanofi).
The Role of a Once-Weekly GLP-1 RA Therapy in Improving Glucose Control (Sponsored by AstraZeneca)
Robert Busch, MD (Endocrine Group, Albany, NY)
An AZ-sponsored product theater on GLP-1 agonist Bydureon (exenatide once-weekly) was completely packed and standing-room-only (indeed, our team at Close Concerns only just barely made it in ourselves!) While the content of the product theater was not particularly notable or new, the sheer volume of attendees is a testament to the massive and growing interest in the use of GLP-1 agonist therapy. In the session, Dr. Robert Busch emphasized the benefits of Bydureon on A1c reduction, glycemic variability, and weight loss, reviewing several clinical trials of Bydureon with CGM, head-to-head with basal insulin, and compared to twice-daily Byetta (exenatide). The session also featured a video of a diabetes educator demonstrating the (rather complex) dose administration process for Bydureon – we expect this administration will be simplified once the Bydureon suspension formulation is available. On the way out of the session, each attendee was handed a Bydureon training pen for use at home.
Meet Basaglar (Sponsored by Lilly/BI)
Eugene Wright, MD (Duke University School of Medicine, Fayetteville, NC)
In this interactive, early morning product theater, Dr. Eugene Wright (Duke University, Fayetteville, NC) provided an overview of Lilly/BI’s Basaglar (insulin glargine) in anticipation of the product’s US launch on December 15, 2016. He presented data demonstrating Basaglar’s non-inferiority to Sanofi’s Lantus (also insulin glargine) and emphasized that the product adds an important offering to Lilly’s insulin portfolio. With the addition of a basal insulin, Dr. Wright pointed out that Lilly now has a “complete portfolio of treatments for patients with diabetes,” which he cited as an advantage for prescribing practitioners who can rely on a range of therapies from one company. We agree that Lilly’s experience in the insulin field will certainly benefit Basaglar, reassuring patients and providers on the product’s safety – insulin and biologic manufacturing is notoriously more complex and difficult that small molecule manufacturing . Lilly’s 2Q16 update gave us optimism for Basaglar/Abasaglar (which is currently marketed only outside the US) and although the product is still in its early launch trajectory (it’s been on the market for less than a year), we think the lower price combined with Lilly’s reputation will affect commercial performance very positively. While some would point out that the product has entered a tough competitive landscape for basal insulin, having a lower-priced basal option is extremely valuable in this very price-sensitive environment. Although many patients have been very successful on other insulins, the narratives are changing as prices of those insulins increase - as Dr. Wright put it, choice is a good thing. We would certainly agree that patients need choice in the US as we hear stories of so many patients rationing insulin etc. It’s not yet clear what Basaglar will cost in the US or how well it will be reimbursed by payers, but Lilly representatives shared during this session that price information will be revealed closer to December – there is no doubt, of course, that it will be lower and tremendous “deals” are clearly being made with payers. We expect the US launch will improve Basaglar’s revenue growth in 2017, especially given its preferred status on both the Express Scripts and CVS Health formularies (indeed, the product won exclusive formulary status for CVS as well as for United).
- “Type 2 patients often look at me strange when I say this, but my goal is to get you to live long enough to eventually require insulin.” Dr. Wright pointed out that too many patients with type 2 diabetes have already had poor glycemic control for several years by the time they add insulin to a treatment regimen. Since so many type 2 patients will need insulin anyway, he argued that it’s important for healthcare providers to set that expectation early on and to eliminate negative language surrounding insulin therapy. He outlined the dangerous misconceptions that serve as barriers to initiating insulin: (i) that starting insulin is a sign of failure; (ii) that it will be too complicated for patients; and (iii) that it won’t be effective in type 2 diabetes.
Questions and Answers
Q: How do you store it, and how long does it last?
A: Twenty-eight days. Refrigerated. Once you open it, you can keep it at room temperature.
Q: Will the delivery mechanism for Basaglar be the same?
A: Yes, it’ll be similar to other KwikPens that you’re familiar with, although the color will be different in order to distinguish it.
Q: How do you titrate basal insulin, thinking of a very naïve type 2 diabetes patient who has high blood sugar?
A: I teach residents to start at 0.2 u/kg because I like the weight-based system. Of course, it depends on what works for that particular patient, and some will need to titrate more slowly or more quickly. I like to get the patient involved in making that decision of how to titrate.
Q: I’m used to a 50/50 division between basal/mealtime insulin. I see that you put 30% for Basaglar?
A: In type 1 patients, 30% of total daily insulin dose is where you should start Basaglar. That’s specific to type 1 diabetes patients.
Q: Can you tell us about cost and insurance coverage for Basaglar?
A: Right now, pricing is not available, but it will become available closer to the December timeframe.
Q: There are lots of insulins we could use. Why should we use Basaglar over others?
A: Everyone likes choice. I have a great deal of respect for a company that gives me a full portfolio to work with, plus Lilly has a strong heritage in the insulin field so I’ve worked with them over time. I like the idea of a partner in treating my patients with diabetes.
Q: Can you clarify the real benefits to Basaglar, if it’s pretty much the same as Lantus?
A: To me as a practitioner, the primary benefit is that I now have a choice. If I look at Lilly’s portfolio of drugs, I now see the whole gamete of insulins – basal, concentrated, mealtime, etc. – residing within one company. Basaglar shows comparable PK/PD results and comparable safety to Lantus, so it’s really all about choice.
Going Further with Invokana: A Leading Option After Metformin
Davida Kruger (Henry Ford Health System, Detroit, MI); Debbie Hinnen (University of Colorado, Boulder, CO); Virginia Valentine (Sage Specialty Care, Albuquerque, NM)
In this J&J-sponsored product theater, Ms. Davida Kruger (Henry Ford Health System, Detroit, MI) outlined what she sees as important benefits to SGLT-2 inhibitor Invokana (canagliflozin), namely significant A1c lowering, weight loss, and relatively low hypoglycemia risk. The panel reviewed data showing Invokana’s superiority vs. DPP-4 inhibitor Januvia (sitagliptin) in reducing A1c. Ms. Kruger presented the weight loss benefit as a motivating factor for patients that increases adherence. Similarly, she argued for low hypoglycemia risk as a key variable to look for in evaluating drug options – “If I cause hypoglycemia,” she asserted, “I lose that patient’s attention.” Thus, according to Ms. Kruger, weight loss and low hypoglycemia risk make SGLT-2 inhibitors a very patient-friendly treatment option for type 2 diabetes. The speakers highlighted that Invokana has seen >8 million prescriptions since launch and that the product is covered by 70% of commercial insurance plans and 90% of Medicare Part D plans in the US. They also pointed out that 45% of patients take Invokana as mono or dual therapy, while 28% take it as part of triple or quadruple therapy and 27% take it alongside insulin. The panelists used these numbers to overturn misconceptions that Invokana can’t be used effectively in a multiple drug regimen and that SGLT-2 inhibitor therapy is mutually exclusive with insulin therapy.
The Importance of Utilizing a Comprehensive Approach when Managing Patients with Type 2 Diabetes
Jonathan Marquess, PharmD (Institute for Wellness and Education, Woodstock, GA)
Dr. Jonathan Marquess (Institute for Wellness and Education, Woodstock, GA) led this Sanofi-sponsored session on comprehensive diabetes care. He shared valuable commentary on how to attack diabetes from all angles, focusing especially on using a variety of metrics for glycemic control – fasting plasma glucose, postprandial plasma glucose, A1c – and concluding his talk with a suggestion to improve medication adherence. Despite ADA recommendations to check A1c every three months, 39% of patients check only once a year according to Dr. Marquess. He stressed that patients can be too reliant on fasting blood glucose, forgetting that postprandial sugar levels and A1c are also highly indicative of your state of glycemic control. Moreover, he added that many type 2 diabetes patients spend most if not all of their day in a postprandial state. Dr. Marquess placed equal emphasis on lifestyle changes and drugs to treat diabetes. He pointed out that listed at the very top of ADA’s treatment guidelines are “healthy eating, weight control, increased physical activity, and diabetes education,” all of which he considers to be essential lifestyle modifications for patients with diabetes. He argued that the importance of lifestyle changes should be reiterated at every doctor’s visit, but also criticized excessive delays in intensifying drug therapy. According to Dr. Marquess, the average healthcare provider waits 1.5 years to add a second agent to metformin (vs. three months, as stipulated by leading guidelines) and takes six years to put a type 2 diabetes patient on insulin. Lastly, he underscored the need for better communication channels between diabetes educators and pharmacists. He noted that the average patient refills a 30-day supply of medications every 43 days. The pharmacist can supply this “report card” to the CDE, Dr. Marquess explained, to orchestrate comprehensive care for the patient and to motivate better medication adherence.
Panel Discussion: Current Challenges, New Ideas
Steve Edelman, MD (TCOYD, San Diego, CA), James Gavin III, MD, PhD (Healing Our Village, Atlanta, GA), Virginia Valentine (Health-Scripts, Albuquerque, NM), and Martha Funnell (University of Michigan Medical School, Ann Arbor, MI)
An outstanding keynote panel, chaired by Virginia Valentine and featuring Martha Funnell and Drs. James Gavin III and Steve Edelman, surveyed the entire ecosystem of diabetes, touching on topics such as the role of the educator, patient engagement, opportunities with CGM, and diabetes prevention. The panelists agreed that, despite our growing therapeutic toolbox, outcomes in diabetes have remained flat for many reasons, including lack of patient engagement (diabetes is invisible) and a poor track record of helping patients stick to therapies. They suggested that clinicians, particularly educators, need to do a better job of connecting with patients, understanding their barriers, and helping them follow a regimen. Dr. Gavin was particularly emphatic on this point, noting that educators must simultaneously understand what makes patients “tick” and what makes them “sick” – both are of course difficult! Ms. Funnell, in turn, challenged the two doctors to encourage more patients to sign up for education (only ~6%-7% currently do – this is astoundingly low). The panel shared strong praise for CGM: “We are prisoners of static measurements – there are a lot of paths to an average, and that’s what A1c is. To be able to see whether people are in or near range, a concept made possible by CGM, changes everything...” (Dr. Gavin) and “If you told me I had to go back to NPH and regular to keep my Dexcom, I’d say yes. Type 1s should get a Dexcom as soon as they can” (Dr. Edelman). At one point, the conversation turned to prevention, where Ms. Funnell raised a very important point: With the success of DPP, there is now a whole new population that educators need to reach out to, because prevention is a continuous battle. See the most notable quotes in the detailed discussion below.
On the State of Type 2 Diabetes and Prediabetes
- “If money were no object, if I had to pick a single therapy to prevent type 2 diabetes, it would be GLP-1 agonists.” – Dr. Gavin
- “It’s interesting – we know a lot about the causes of type 1 diabetes, and we have no prevention strategies. Then look at type 2 diabetes – we know little about the cause of type 2 diabetes, but we can prevent it! Look at a type 2 diabetes patient – caregivers say they’re overweight, non-compliant – if you think about it, there’s a lack of urgency because there are few symptoms when you have type 2 diabetes. You have to be motivated to stay on top of it even if you don’t feel any different if you take your medications or not! The CDE role is so important, because all of you keep them motivated. If someone doesn’t take their medications, what good is it?” – Dr. Edelman
- “Type 2 diabetes is an incredibly complex disease. Within and between populations, when you see one case of diabetes, all of the factors are not equally weighted. That makes it far more difficult to cure. But we can treat it to make it look cured.” – Dr. Gavin after he was asked about a cure for type 2 diabetes
- “We need to show that prediabetes is not benign. Because it’s not.” – Dr. Gavin
- “There have been so many drug developments, but A1c in this country is flat and has not changed in the past 10 years! The issues of adherence and persistence are shockingly bad in type 2 patients.” – Dr. Edelman
- “None of our toolbox matters if we can’t deploy and engage it. Persistence is about reassurance, problem-solving, and relationships. You have to hear somebody say ‘it’s going to be ok’. Not read it. That core relationship is where the heart of education is.” – Dr. Gavin
- On CGM: “In type 2 diabetes, we can clearly be more effective in monitoring the efficacy of our treatments…We are prisoners of static measurements – there are a lot of paths to an average, and that’s what A1c is. To be able to see whether people are in or near range, a concept made possible by CGM, changes everything when it comes to determining if medicines are doing what they are designed to do.” – Dr. Gavin
- “If you told me I had to go back to NPH and regular to keep my Dexcom, I’d say yes. Type 1s should get a Dexcom as soon as they can.” – Dr. Edelman
- “Technology only works if we have people like us. That speaks to the complexity of care. We need to be there to help patients interpret data so they’re not overwhelmed. Our job has gotten more complex on one hand, and on the other, those are the best teaching tools in the world. They give us the opportunity to teach diabetes in very personal way. Part of our job is to be part of that process – to be in right place at right time, and also to let patients know these things are available. How can we help patients know to ask for them? That’s an active and appropriate way to engage people in their own care.” – Ms. Funnell
- “I want to push the envelope on what CGM can offer us. For prediabetes, look at what we depend on for diagnosis of diabetes: we make the diagnosis on one metric alone, which is static in nature. And that’s not nature. We need something that can capture moment to moment variations. Before the diagnosis is made, we have a tool.” – Dr. Gavin
- “When I see caregivers throwing patients on blinded 3-day CGM, it doesn’t make any sense. With un-blinded, even if lifestyle has changed the control, you not only have the diagnosis, but the treatment.” – Dr. Edelman
On Diabetes Education and Behavior Change
- “I want to challenge you two – we know only 6-7% of patients get education. We know we’re important. But we want your help getting our message out to other providers.” – Ms. Funnell to Drs. Edelman and Gavin
- “The world is changing for sure. We have to think about how we provide education and how we get out of the hospital. If we’re still in a room with patients showing powerpoints, we need to rethink that.” – Ms. Funnell
- “As educators, we believe we should be the encyclopedia of diabetes. It’s not an encyclopedia world. It’s a google world. We are the google of diabetes. Our job is to provide education in a way consistent with the way people want to learn it.” – Ms. Funnell
- “One of the most important things we give patients is hope.” – Ms. Valentine
- “We’ve created a whole new population of people to reach out to [with the DPP]. We need to get out of the hospital and into the community to help patients sustain all they have done to accomplish these huge goals.” – Ms. Funnell
- “Our mantra is ‘It’s just as important to know what makes them tick, as it is to know what makes them sick.’ If you can’t connect and help them realize how important therapy is, then you’re worthless.” – Dr. Gavin
Patient Engagement and Access
Looking Beyond A1c as the Gold Standard Diabetes Outcome
Robert Vigersky, MD (Medtronic, Washington, DC)
Dr. Robert Vigersky continued his crusade against A1c as the sole “gold standard diabetes outcome” – we previously heard from him on this topic at DTM 2015 and ATTD 2016 – arguing in favor of a composite metric that paints a more holistic picture of a treatment’s therapeutic value. As he has in the past talks, he began by explaining the NFL QB rating, a single composite number for comparing quarterbacks in professional football (touchdowns, interceptions, completion percentage, and more). More importantly, this metric correlates with outcomes – wins – and he argued for a similar composite metric in diabetes that correlates with positive health outcomes (e.g., extended lifespan and reduced complications). According to Dr. Vigersky, A1c is “woefully inadequate” because it neglects a whole host of crucial factors, and also because it does not immediately reinforce behavior (A1c is an average measure of hemoglobin glycosylation over the three months prior to the test), like a more directly glucose-centric measurement would.
- There have been a number of suggested formulations for what a composite measure for diabetes outcomes might look like: (i) the glucose pentagon (DT&T 2009 and JDST 2012), a single graph and number combining five elements of glycemia (A1c; SD; time >160 mg/dl; AUC > 160 mg/dl; and mean glucose); (ii) the Q-score (BMC Endocrinologist Diab 2015), a single numerical value combining five primary factors that determine CGM profiles (central tendency, hyperglycemia, hypoglycemia, intra- and inter-daily variations); and (iii) his own novel approach (published last year in JDST) combining A1c, hypoglycemia, and weight change in a single score out of 100. The audience quickly picked up on the flaw with the glucose pentagon – it didn’t include hypoglycemia! Dr. Vigersky revealed that he has been collaborating with the pentagon’s creator, Dr. Andreas Thomas (Medtronic, Meerbusch, Germany), to replace/add a vertex of the pentagon with hypoglycemia. There are, as Dr. Vigersky put it, “at least a dozen hypoglycemia metrics”, so he proposed a novel composite one. This is still a work in progress and we look forward to what comes of it!
- Dr. Vigersky believes that we can leverage big data to determine whether a given proposed metric correlates positively with short- and long-term outcomes. It is theoretically possible to test any new composite metric on the vast quantity of existing clinical data. The alternative would be a time-consuming and expensive outcomes trial, so we were glad to hear him say this. If the FDA agrees with Dr. Vigersky, then the next step will be to standardize which trials the metrics are to be tested on. But for now, baby steps!
- Since AADE, the FDA hosted a public workshop, featuring Dr. Vigersky, Kelly Close, industry, and other members of the Diabetes Community, entitled “Diabetes Outcome Measures Beyond Hemoglobin A1c” on August 29th. Please check out our full report of this amazingly productive discussion!
Maximize Medication Adherence by Minimizing Barriers
Bill Polonsky (Behavioral Diabetes Institute, San Diego, CA)
Dr. Bill Polonsky implored HCPs to stop using the term “non-adherence” and emphasized the importance of language generally in talking to patients about adherence. He presented “non-adherence” as a serious pet peeve: “Please, never use that term. You can perhaps say ‘poor’ medication adherence, but suggesting that people do nothing is never true and it leads us to work against each other.” Instead, as Dr. Polonsky put it, providers and diabetes educators should be aligning themselves with patients to (i) set shared goals; (ii) make invisible facets of diabetes visible to their patients; and (iii) understand where a patient’s “poor adherence” may be coming from. Building on his message that words matter, he suggested that we present A1c as “safe vs. unsafe” instead of “good vs. bad.” Given that diabetes is a chronic disease in which high glucose scores aren’t associated with pain, it’s understandable that patients don’t always feel a strong sense of urgency and can’t always see the long-term implications of uncontrolled glycemia, Dr. Polonsky explained. Helping patients grasp what glycemic control means for their long-term health by highlighting “safe” and “unsafe” A1c is one way to make the invisible, visible. Moreover, Dr. Polonsky pointed out a key issue that people miss when they say their patients are “non-adherent” – patients quit medications because they’re actually trying to be healthy, and a complicated schedule of drugs is seen as a sign of disease. He underscored that we already have the tools to change these notions, starting with the language we use. Dr. Polonsky’s talk was a refreshing take on drug adherence, a topic that is clearly extremely important to payers. Terms like “compliant” and “non-adherent” can definitely be off-putting, creating distance between patient and provider or patient and educator when in reality, all parties in diabetes care have the same end goals. While we see “adherence” as a step up from the word “compliance,” we wonder if there are better alternatives still – we continue to preferen the term “engaged” – though we also believe there is plenty the system could do to better engage HCPs.
Sharing Evidence-Based Hope with Your Clients
Bill Polonsky, MD (Behavioral Diabetes Institute, San Diego, CA) and Richard Jackson, MD (Joslin Diabetes Center, Boston, MA)
In a joint presentation, dynamic duo Dr. Bill Polonsky and Dr. Richard Jackson urged healthcare providers to offer hope to their patients by putting diabetes complications risk into context. We found this talk most compelling. The pair built off of their previous presentations and drove home the message that “well-managed diabetes is the number one cause of NOTHING!” – Dr. Polonsky even had mugs with this message on hand for sale. (We do know a range of patients with complications who do not agree with this saying.) They pointed out that frequent warnings that diabetes is the leading cause of kidney failure, blindness, or other complications lead to a sense of “diabetes fatalism” among many patients, where they feel hopeless about their diabetes and feel that they will eventually experience serious complications from the condition no matter what they do. Dr. Polonsky noted that, if these patients feel that their complicated, inconvenient, and expensive therapy regimens are unlikely to provide any benefit, they will be less likely to take their medication as prescribed, check their blood glucose, and engage in other self-management behaviors. In response, according to Dr. Jackson, some providers will interpret the patient’s lack of engagement as being in denial of the possibility of complications from diabetes and double-down on their efforts to educate the patient on these. The duo argued that not only is this ineffective and further exacerbates the sense of diabetes fatalism, the risk of complications for diabetes when treated with modern therapies is often overstated. People with diabetes are living longer with less complications overall – in fact, the team pointed out that the actual event rates in cardiovascular outcomes trials such as RECORD and ACCORD were roughly one-fourth the estimated event rates for the trials, as the estimates were based on 20th century risk calculations that grossly overestimate 21st century risk by 2-3 times. Ultimately, Dr. Jackson called for a shift away from population-level thinking and for discussions on the risk of diabetes complications to individualized, personalized evaluations of risk when interacting with individuals with diabetes. We greatly appreciated this very patient-centered session and the hope and optimism Drs. Polonsky and Jackson extended to those in the room.
- Practically speaking, the pair suggested a four-step approach to discussing diabetes management with patients who may feel discouraged and disengaged:
- (i) Gather the patient’s perspective (“how do you think diabetes will affect you over the years?”);
- (ii) Acknowledge their realistic and unrealistic concerns (“with an A1c of 9.3%, you are indeed at risk and terrible complications can and do occur”);
- (iii) Talk about the good news (“but terrible complications do not have to happen. With good care, odds are good you can live a long and healthy life with diabetes);
- (iv) Review what action, if any is needed (“our goal is to help you to get your numbers to a safe place and you get the biggest bang for your buck by taking the appropriate medications”)
- Dr. Jackson shared two compelling patient stories on how diabetes fatalism can severely impact the quality of life of even patients with relatively well-managed diabetes. The first patient – “Susan G.” – was diagnosed with type 1 diabetes at age three by Dr. Elliot P. Joslin, the founder of the Joslin Center, and he scared her and her family so much that she is constantly profoundly worried about having complications from diabetes. As a result, she “missed most of her life” and has never had a relationship or a family while striving to maintain A1cs between 6.8% and 7.3% over the 66 years she has lived with diabetes. Another patient – “Marilyn M.” – had type 1 diabetes for 44 years that was reasonably well-managed (8.2%-8.6%) and very good numbers for LDL and HDL cholesterol, blood pressure, and albuminuria suggesting that she is at low risk for complications, yet she wakes up every morning concerned and deeply discouraged about her A1c (despite the fact that an A1c of 8% was associated with a very low risk of complications over 30 years in the DCCT trial and its follow-up). Choking up a bit, Dr. Jackson sadly noted that none of her world-class physicians at the Joslin Center had ever told her that she was at relatively low risk of complications and they had never encouraged her to worry less and live her life.
Mastering the "Why?", "Whether To?" and "How?" of Successful Behavior Change in Diabetes Care
Paul Ciechanowski, MD (Samepage Health, Seattle, WA)
Dr. Paul Ciechanowski (Samepage Health, Seattle, WA), a psychiatrist devoted to helping patients with depression and diabetes, explained the connection between the two conditions, why the current care model fails to incite behavioral change in patients with depression, and a proven method for empowering and treating them. He began by framing the problem: Depression is twice as common in people with diabetes (everyone raised their hand when asked if they had seen a depressed patient in the past year) and, in his experience, it is nearly impossible to help patients manage their diabetes if the depression isn’t addressed first. The issue, he continued, is that providers flog patients with demands without aligning their own goals with the needs and lifestyles of the patient. Instead, he recommended the seven-step Problem Solving Treatment approach that encourages the patient to clarify and define the problem, set realistic goals, generate multiple solutions (“We are good at telling them what they should do, but it’s important to try to evoke the answers from them. They feel much more confident if they came up with their own solutions”), evaluate and compare the solutions, select a feasible solution, implement the solution, and evaluate the outcome (see picture below for an example of the first four steps).
- According to a 2004 JAMA paper (“Community Integrated Home-Based Depression Treatment in Older Adults”) by Dr. Ciechanowski et al., the method works – after only six months and six sessions, over half of the participants, who had a mean of 4.6 chronic conditions, reported >50% reduction in depression scores. Even more impressive, the effects lasted at least 12 months, despite no further treatment after the six-month mark, and led to better health outcomes. This strategy may seem simple, and that’s because it is – it simply allows the patient to pick a therapeutic path that works for them. We need more clinicians to embrace the philosophy of treating the person (not the disease), but we must remember that the underlying problem is that providers often don’t have the time to sit down and tailor treatment to an individual; to thoroughly go over a patient’s diabetes metrics and enlist the seven-step Problem Solving Treatment would take at least 20 minutes, while the average appointment lasts under 10.
- Dr. Ciechanowski also touched on “decisional balance”, another simple way to motivate behavioral change. Patients fill out a 2 x 2 table to ponder the pros and cons of changing and not changing (example below for someone who wants to quit smoking). Typically, in problem solving, we only consider the benefits of changing and the costs of not changing, but those don’t get at the emotional and personal reasons that the person has a given behavior in the first place – the man who wants to quit smoking “could go to Wikipedia and find reasons to quit, but that won’t motivate him.” The other two boxes (highlighted; the costs of changing and the benefits of not changing) are more personal. In this case, the man will likely not actually quit smoking until deal breakers such as stress, weight, and quality time with friends are addressed. We love this approach!
Change (New state)
No change (Status quo)
Less coughing, wife would be happy, socially acceptable, faster healing
Helps deal with stress, helps him think clearly, keeps weight off.
Would likely gain weight, won’t spend as much time with smoker friends at work
High risk of cancer, poorer health, bad smell.
Diabetes Management and Education in the Era of Healthcare Transformation – An Optimist’s View
Evan Benjamin, MD (Tufts University, Boston, MA)
In a rousing keynote call-to-action, Dr. Evan Benjamin encouraged diabetes educators to (i) advocate locally; (ii) change the narrative; (iii) embrace innovation; (iv) have hope in order to spearhead the shift toward a value-based, patient centered healthcare system. He emphasized that the current volume-based healthcare system, with its rising costs, is unsustainable and called for a “new normal” that focuses on improved care and coordination to optimize the value of healthcare. In particular, he put forth a triple aim framework for healthcare reform involving (i) improvement in the health of the population; (ii) improvement in the experience of care through better coordination and safety, and (iii) lowering the per capita cost. That said, Dr. Benjamin acknowledged the tensions that can often exist between these three aims and emphasized that providers will need to work to find the right balance. To achieve this, Dr. Benjamin advocated for a shift from (i) fee-for-service payment models to global payment models that offer a pre-fixed amount to cover the entirety of an individual or a population’s healthcare; (ii) fragmented care to coordinated care; and (iii) a focus on individuals to a focus on individuals, populations, and communities. He also emphasized the need for a focus on prevention within this new health system – music to the ears of the audience and ourselves. Dr. Benjamin offered several actionable steps that diabetes educators can take to lead the shift toward this new value-based, patient-centered system. He encouraged diabetes educators to advocate locally for prevention and education, urging them to approach local architects of innovative health reform programs and discuss the value and cost-savings of prevention. He asked educators to change the narrative around healthcare provision by implementing shared decision making practices. As he put it, instead of asking “what’s the matter?” providers should move toward asking “what matters to you?” We loved this patient-centered approach and reframing of a classic healthcare question. Dr. Benjamin further asked educators to embrace innovation, highlighting several exciting new models of care delivery that involve telehealth, new payment models, or the forging of new partnerships between providers to improve healthcare novel and unexpected ways. Finally, Dr. Benjamin closed with the simple reminder to have hope and positioned health reform as a new era of opportunities for diabetes educators. Dr. Benjamin’s presentation underscored the need for buy-in from varied healthcare providers – including physicians, diabetes educators, nurses, physician assistants, dieticians, and more – into the benefits of value-based care and the key roles care teams comprised of these professionals will need to play in order to make the transition to a new health system paradigm.
- Dr. Benjamin pointed out that healthcare costs in the US continue to grow at unsustainable rates but without appreciably better outcomes than many other countries that spend substantially less. In particular, he emphasized that reliability within the healthcare system is more – for instance, the reliability of a patient receiving appropriate medication after a heart attack is lower than airline baggage handling. He also highlighted the high rate of medical errors in the US (over one million serious preventable medication errors in the US annually) and suggested that a significant portion of these errors can be attributed to overuse of healthcare therapies and treatments, rather than misuse or underuse. He further noted that 30% of healthcare spending in the US goes toward “useless” treatments, costing $600 billion/year, and argued that this situation is the result of a system with misaligned incentives and an emphasis on volume rather than value – as exemplified by the fee-for-service model of healthcare payment. Other factors contributing to higher healthcare costs according to Dr. Benjamin include fragmented care delivery that leads to additional expense and frustration for patients, a lack of transparency on the costs and quality of healthcare, quality defects, rising rates of chronic disease in aging populations, a lack of attention to preventive care, and the structure and supply of providers in the US. On the last point, Dr. Benjamin highlighted the contrast between the US where two-thirds of physicians are specialists and other countries where two-thirds of physicians are primary care doctors.
The e-community: How eHealth Can Engage People and Providers
Deborah Greenwood, PhD (Sutter Health, Sacramento, CA), Perry Gee (Dignity Health, Sacramento, CA),
In back-to-back-to-back presentations, Dr. Deborah Greenwood (Sutter Health), Dr. Perry Gee (Dignity Health), and “e-Patient Dave” deBronkart (see below) explained that healthcare is transitioning to a model in which patients, informed through social media and expansive online resources, collaborate with their providers to ensure personalized care of the highest quality. Dr. Greenwood spoke to the need for e-Communities by citing a statistic from Livongo’s Mr. Manny Hernandez: Patients only spend 0.007% of their time with a healthcare provider (~45 minutes per year). The remainder of the time, they are left to self-manage their diabetes, which inevitably leads them online. Dr. Greenwood spoke positively about so-called “e-Patients” (only ~50% of the room recognized the term), noting that they are Empowered, Educated, Enabled, Expert, Equipped with skills and tools, Equal partners in care, and Engaged. Forward thinking providers understand that the e-community is beneficial to patient health, but supporting literature is surprisingly thin. Drs. Greenwood and Gee are in the midst of trying to fill this void. They have obtained funding from Patient-Centered Outcomes Research Institute (PCORI) to develop partnerships, with the ultimate goal of conducting a study comparing the effectiveness of various approaches to online peer support. The duo has previously written papers together on an e-Health Enhanced Chronic Care Model – see more below and view the latest paper here.
- Drs. Greenwood and Gee’s eHealth Enhanced Chronic Care Model (eCCM) details the e-Community’s role in facilitating more productive interactions between clinician and patient. See image below for more details on the intricate and important feedback loop.
The e-community: How eHealth Can Engage People and Providers
Dave deBronkart (“e-Patient Dave,” epatientdave.com)
E-Patient Dave took to the podium to deliver a fascinating overview of the birth of the e-patient, beginning with an 1871 quote from physician Oliver Wendell Holmes claiming that patients would be burdened by (and therefore shouldn’t have access to) their medical information, traversing a number of visionaries who chipped away at Dr. Holmes’ (widely-held) belief, and eventually arriving at Dr. Tom Ferguson’s founding of e-patients.net. Dave was thankful for Dr. Ferguson’s trailblazing, as both he and his oncologist partially attributed his surviving stage IV renal cancer to advice from the online community. He then put on his engineering hat to dissect the mechanism by which the internet helps the e-Patient thrive. He described information like a nutrient – when present, it enables a more robust response – and social media provides the capillaries by which the information (nutrients) is distributed. Eventually, connected patients and clinicians form networks of networks that exchange information, accruing levels of knowledge and wisdom that would be unattainable for a single individual. Still, he argued, this tremendous resource is mostly underutilized. If usership were to increase, patients would feel more informed, and therefore empowered to participate in, and possibly even co-direct, their own care. The world’s most famous e-Patient encouraged attendees to do their part to make this scenario a reality, reminding them of the great Stewart Brand quote: “Once a new technology rolls over you, if you’re not part of the steam roller, you’re part of the road.” By the end of the session, the whole room knew a whole lot more about what it means to be an e-Patient – hopefully they disseminate this information and encourage their patients to get involved with the DOC! We continue to hear providers at conferences that are worried about “misinformation from Dr. Google,” “privacy,” and “liability,” and we think it’s high time these concerns are put to rest (Dave does too – see his rebuttal to the viral picture of the mug that read “Please do not confuse your google search with my medical degree). All technology has drawbacks, but fields must adapt with the times – patients are going online, meaning healthcare providers must understand it and do their best to engage
Tailoring Treatment Plans and DSME for Food Insecure People with Diabetes
Morgan Smith, RN, CDE (Interventions for Health Manager, Feeding America, San Diego, CA) and Sunny Smith, MD (UC San Diego, CA)
In an inspiring – and at times heartbreaking – session, Feeding America’s Mr. Morgan Smith and UCSD’s Dr. Sunny Smith shed light on food insecurity in people with diabetes and presented promising results on the positive impact pilot programs to address food insecurity can have on diabetes outcomes. Mr. Smith highlighted results from a pilot study conducted by Feeding America, the nation’s largest food bank network, which provided diabetes-appropriate food, blood glucose monitoring, primary care referrals, and self-management education and support to food bank clients with diabetes (n=687) for six months. The pilot program produced a 0.48% reduction in A1c (baseline A1c 9.52%, p<0.001) and was associated with more participants achieving an A1c less than 9% (43% vs. 52% at baseline, p<0.001), greater fruit and vegetable intake (3.0 servings per day vs. 2.8 servings per day at baseline, p<0.01), a higher self-efficacy score (7.2 vs. 6.7, p<0.001), a lower diabetes distress score (2.8 vs. 3.3, p<0.001), and fewer tradeoffs between food and medicine or diabetes supplies (p<0.001). Furthermore, the pilot suggested improvements in medication adherence and severe hypoglycemia, though these differences were not statistically significant. Building on this, Mr. Smith noted that Feeding America is embarking on a two-year randomized controlled trail, FAITH-DM, to provide food bank-based interventions to people with diabetes, including screening, diabetes-appropriate foods, diabetes self-management education, and primary care referrals. The primary outcome of the trial will assess changes in HbA1c levels, and secondary outcome measures will include several diabetes- and food security-related measures. The study will also assess participant healthcare utilization, such as primary care and emergency department visits. Dr. Sunny Smith (no relation) conducted a similar study to Feeding America’s pilot within the student-run free clinic at UCSD, with a twist – she partnered with Feeding America San Diego (a local food bank) to deliver bags of food into the clinic itself for distribution to patients with diabetes and compared the diabetes outcomes of those who received food through this model with those who were simply given a referral to access a local food pantry. The trial found that those who received fresh food on-site in the clinic had improved A1c, diabetes distress, and fruit and vegetable intake (manuscript in development). Furthermore, Dr. Smith emphasized that, as patients of a free clinic, all of the participants in both groups were already receiving free medications and supplies and didn’t have to make tradeoffs in food and healthcare that other populations might, thus suggesting that the provision of healthy food to address food insecurity can improve diabetes outcomes in and of itself. As Dr. Smith put it, for people with diabetes, “food is medicine” and urged providers in the room to implement routine food insecurity screenings (which can be as short as two key questions) into the clinic. We so appreciated this session for drawing attention to an oft-overlooked issue in diabetes care and the practical solutions it offered healthcare providers who want to begin to address these social determinants of health. We would love to see a greater difference in eating healthy foods and A1c changes but we appreciate that both were directionally positive.
- Mr. Smith pointed out that food insecurity is associated with increased risk of many health conditions including hypertension (25% increased risk), kidney disease (~50% increased risk), and obesity, and this increased risk is exacerbated in people with diabetes. Furthermore, among low-income people with diabetes, 64% of those experiencing food insecurity report difficulty following a diabetes-friendly diet (compared to 49% of those who are food secure). Intake of fruits and vegetables is also lower among those with diabetes and food insecurity: 0.8 average daily servings of fruit (compared to 1.1 among those who are food secure) and 1.8 daily servings of vegetables (compared to 2.1). Further, Mr. Smith shared that those with food insecurity were more likely to have A1c>8.0% (and much more likely to have A1c>11%) than those without food insecurity. We suspect that both the food insecurity itself and the difficult choices between medical management and food that those with food insecurity often are forced to make contributed to this finding. Mr. Smith also shared data indicating that hospitalizations for hypoglycemia rise toward the end of the month, when food and funds are more likely to run out for many households. For her part, Dr. Smith shared a heartbreaking story of one of her patients from UCSD’s free clinic who was taking insulin but didn’t have money for food and experienced a severe hypoglycemic episode while in a grocery store trying to get emergency food with money she had gathered from friends and family. Situations like this contribute to those with food insecurity having higher healthcare costs, leading to a viscous cycle in which higher household healthcare costs exacerbate food insecurity in turn.
- Mr. Smith emphasized that food insecurity is much more common than most realize, affecting 14% of all US households and 48.1 million people (including 7.9 million children) and occurring in every state, every country, and every community. Furthermore, Mr. Smith pointed out that many of the government programs designed to address food insecurity such as the Supplemental Nutrition Assistance Program (SNAP, formerly known as food stamps) have strict income guidelines and 26% of food insecure households are income ineligible to receive SNAP, thus relying on safety net programs such as food pantries to meet their needs. In a survey of people serviced by Feeding America’s network of food banks, a startling 66% of clients indicated that they had to often choose between paying medical costs or buying food each month (and one-half to one-third of clients also indicated that they had to choose between food and paying for housing, utilities, or transportation as well). The survey also highlighted several coping strategies that many food insecure households employ to survive – the most common was purchasing inexpensive, less healthy food in order to stretch limited funds further, with 79% of all households surveyed and 84% of households of children reporting use of this strategy.
Diabetes Prevention Program
Current State of DSMT Reimbursement and Healthcare Reform
Patty Telgener (Emerson Consultants, Excelsior, MN)
Powerhouse Ms. Patty Telgener, an annual favorite at AADE, urged healthcare providers to submit feedback on CMS’ proposed regulations surrounding Medicare coverage of DPP during a completely-packed lecture on the current diabetes self-management training (DSMT) reimbursement landscape. The most significant change in DSMT reimbursement over the past year, and the main focus of Ms. Telgener’s talk, was Medicare’s proposed expansion of its coverage to include reimbursement for the Diabetes Protection Program (DPP) beginning in January 2018. Ms. Telgener expressed great enthusiasm for this policy change, highlighting the beneficial public health impact of broader DPP access for the millions of Americans with prediabetes (many of whom rely on Medicare). While in theory this piece of healthcare reform is clearly well-aligned with the incentives of diabetes education, the details of the policy’s implementation remain fairly vague, particularly with regard to the payment model, despite CMS’ recent release of a draft of the 2017 Medicare Fee Schedule that provides an initial look at some guidance. Ms. Telgener passionately and repeatedly urged her audience of physicians and diabetes educators to submit their recommendations to CMS, which is accepting feedback on this matter until September 2016 with a final ruling expected in November 2016. The CMS is also seeking commentary on increasing access to current coverage of diabetes self-management training (DSMT), a valuable service which, sadly, is “vastly underutilized” according to Ms. Telgener. With policies such as these, the devil is in the details. We couldn’t agree more with Ms. Telgener that insight from diabetes educators will be an instrumental factor in ensuring that the DPP expansion is implemented as effectively as possible. We are particularly concerned about awareness, and hope that Medicare’s final decisions on DPP coverage and removing barriers to DSMT coverage policies prioritize this, in addition to measures that make these programs as accessible as possible, both in terms of logistical convenience and affordability.
- Optimistically, positive health and economic outcomes for the Medicare DPP coverage could help demonstrate the value of investment in diabetes prevention in the prediabetes population – we would love to see commercial and other government payers (Medicaid, VA, etc.) follow the example set by Medicare. Furthermore, perhaps widespread investment in lifestyle interventions for prediabetes could eventually pave the way for reimbursement of pharmacotherapies for prediabetes, such as metformin.
What Will it Take Prevent or Delay Type 1 and Type 2 Diabetes?
Robert Ratner, MD (ADA, Arlington, VA)
ADA Chief Medical Officer Dr. Robert Ratner strongly advocated for widespread implementation of the lifestyle and pharmacotherapy interventions employed in the successful Diabetes Prevention Program (DPP) trial. Dr. Ratner emphasized that, at the current increasing diabetes prevalence rates, the health system will be overwhelmed by people with type 2 diabetes unless we implement effective prevention strategies. He pointed out that it’s not as if we don’t know how to prevent type 2 diabetes, as the DPP trial demonstrated the efficacy of both intensive lifestyle therapy and metformin to prevent diabetes in patients with prediabetes. In the trial, lifestyle therapy was able to reduce the risk of progression to diabetes by 20% and delay progression to diabetes by an average of 11 years. Metformin was able to reduce the risk of progression by 8% and delay progression by an average of 3.3 years. Dr. Ratner especially highlighted the health economic argument for DPP-style lifestyle therapy for prediabetes intervention, noting that its $10,037 cost per quality-adjusted life-year (QALY) puts it in the realm of childhood vaccinations and makes it four-times more effective than mammography. Dr. Ratner praised Medicare’s decision to cover DPP lifestyle therapy for its beneficiaries and expressed optimism that all plans will soon offer coverage for DPP by ACA mandate. Regarding metformin as a prediabetes intervention, Dr. Ratner shared that the ADA is meeting with the FDA this month to propose expanding the label of metformin to include a prediabetes indication, which should help expand its usage as such – we’re so excited to hear this and hope that an expanded indication can help encourage earlier and more widespread intervention in prediabetes.
The National Diabetes Prevention Program and AADE's Diabetes Prevention Program
Joanna DiBenedetto (Diabetes Prevention Program, Chicago, IL)
In a session on AADE’s Diabetes Prevention Program (DPP), the organization’s Ms. Joanna DiBenedetto overviewed what works and what challenges remain in the fight to prevent type 2 diabetes, namely marketing and reimbursement. Ms. Linda Schoon (Clear Valley Hospital, Fort Collins, CO) illustrated these concepts by sharing her personal experience launching a DPP. Empirical evidence is clearly in favor of the DPP, Ms. DiBenedetto argued, presenting data that the program lowered new-onset of type 2 diabetes by 58% while metformin treatment lowered incidence by only 31%. The intensive lifestyle intervention is undoubtedly effective in her view (and ours). Ms. DiBenedetto also pointed to findings from a 2015 survey of AADE members in which 81% of respondents reported that they treat people with prediabetes to underscore both the great interest in diabetes prevention among educators (which we’re happy to hear) and the great need – 86 million Americans are living with prediabetes, while nine out of 10 don’t realize they’re at high risk for type 2 diabetes. Both Ms. DiBenedetto and Ms. Schoon cited unawareness of prediabetes as one of the primary obstacles for the DPP, explaining that CDEs and providers, already taking on an additional task in implementing prevention initiatives in their practices, understandably don’t have the time or resources to market the program. This limits reach in terms of recruiting participants and selling the DPP to payers – without reimbursement, the program is unlikely to be sustainable long-term. Raising awareness of prediabetes needs to be a goal in carrying the DPP forward, according to this duo. Ms. Schoon also called attention to another challenge in that the DPP requires a year-long commitment, whereas people are hard-wired to want a quick fix. Group settings and motivational coaching, both of which provide psychosocial support, are thus essential components of the National DPP and the AADE’s DPP.
- Ms. DiBenedetto urged educators to submit feedback to the Centers for Medicare & Medicaid Services (CMS) by September 6 on the proposed expansion of Medicare reimbursement to cover the DPP. “Please, we’re really imploring you to look at the schedule and make comments. Once CMS creates a ruling, it’s really hard to change, so let’s get this right the first time.” We heard this call for feedback many times at this year’s AADE, first from Ms. Patty Telgener (Emerson Consultants, Excelsior, MN) on Day #1. We’re certainly glad that the gravity of this decision is being communicated. Given that reimbursement is one of the main challenges in the fight to prevent type 2 diabetes, Medicare coverage would be so meaningful, especially if commercial payers follow-suit, as often happens and as was encouraged by the AMA in a June announcement.
Aligning Payment Models with Effective Diabetes Program Management
Leslie Jebson, MBA (SIU School of Medicine, Springfield, IL)
In a riveting session full of audience participation, Mr. Leslie Jebson (SIU School of Medicine, Springfield, IL) explained how value-based care will push the current healthcare system to be better aligned with optimal diabetes treatment. Where the fee-for-service model incentivizes sending a patient to multiple, fragmented healthcare providers, conducting a high number of lab tests, and charging for many different products throughout the course of treatment, a value-based model should encourage medical professionals to collaborate and give the patient the best possible diabetes care. Mr. Jebson emphasized that we’ll see more bundled payments and coordinated care when pay-for-performance takes root, and all incentives will be aligned to reduce a patient’s A1c and avoid complications. He forecasted that by 2018, 90% of all healthcare payments will likely be linked to quality (although he acknowledged that the 2016 presidential election will be a huge determining factor, as continued support from the White House is essential). Another theme of the session was price transparency, which Mr. Jebson defined as making cost information available to educators and patients even before they’re referred to an endocrinologist. Greater price transparency is closely linked to the precision medicine movement, according to Mr. Jebson, as both will help ensure that all patients are able to get the right medicine for them, at the right time.
- Several audience members expressed frustrations surrounding patient accountability. They argued that even if seven out of 10 patients engage actively in their treatment regimen, the three who don’t take their medications or visit their providers regularly are hospitalized for complications and become expensive cases.
- In response, Mr. Jebson encouraged everyone to measure success based on the seven patients they do keep out of the emergency room.
- He pointed out that low patient engagement often stems from cost-prohibitive prescription drugs. In the world of big pharma, he forecasted that cost pressures will lead to pricing for medications along a sliding scale, a trend he’s started to notice among big device manufacturers.
- Mr. Jebson called attention to the tremendous role smartphones could play in increasing patient engagement. As he put it, we should be sending texts, whether automated or manual, with positive reinforcement, appointment reminders, medication schedules, and other advice that supports patients in their diabetes management.
- “Non-managed diabetes is good for business – how terrible!” Under the fee-for-service model as it currently stands, Mr. Jebson explained that “our incentives are upside down” – an ophthalmologist gets $5,000-7,000 for treating diabetic retinopathy when we should really be rewarding the diabetes care team that helps a patient maintain low A1c and avoid complications. While he recognized that it will take a “big leap” to get to truly ideal payment models for effective diabetes management, Mr. Jebson shared his optimistic outlook that US healthcare is gaining momentum in the right direction.
Psychology of Diabetes
Diabetes Stigma: Who Feels It, What’s the Impact, and What Can We Do About It?
Adam Brown (The diaTribe Foundation, San Francisco, CA)
Our very own Adam Brown highlighted the insidious and seldom-addressed issue of diabetes stigma, which affects a disturbingly high percentage of people with diabetes (52% of type 2s, 76% of type 1s) and is highest in the patients who need the most help – watch the 17-minute talk here and download the slides here. Adam shared compelling data on the prevalence and forms of stigma from diabetes market research company dQ&A (originally a late-breaker at ADA 2014). dQ&A surveyed a patient panel of 12,000 people with diabetes, asking them ‘Does diabetes come with social stigma?’: 52% of type 2s responded yes (n=3,850), as compared to 76% of type 1s (n=1,572). Why, given all the discussion on stigma in type 2 diabetes, do people with type 1 feel more stigma? Adam suggested that this is an issue of therapeutic visibility. Stigma stems from deviance from cultural norms, and type 1 diabetes is an extremely visible disease, involving wearable devices, more frequent blood sugar measurements, and insulin injections/pump therapy. To this point, dQ&A found that among respondents with type 2 diabetes, stigma increases as therapy intensity (and therefore visibility) rises: 49% of type 2s on orals, 55% of type 2s on insulin, and 61% of type 2s on intensive insulin – the latter almost reaching the level seen in type 1 diabetes. Parents of children with type 1 diabetes felt the most stigma by far – a striking 83%! Tragically, across both diabetes types, those most in need of help were also the most negatively impacted by diabetes stigma. Adam showed how negative emotions (guilt, shame, blame, embarrassment, isolation) related to stigma were more prevalent in people with higher A1cs (>9% vs. <6%), higher BMIs (>35 vs. <25), and who self-reported as being in poor control – exactly the patients we want to engage and NOT feel stigmatized. Negative emotions were also more prevalent as therapy intensity rose: from 20% of type 2s not on insulin to 38% of type 1s strongly agreeing (9 or 10 on a 10-point scale) that other perceptions’ of their diabetes caused guilt, shame, embarrassment, and isolation. Adam concluded with recommendations to reduce stigma, including better public education about diabetes and how hard it is to live with. We think this talk has many implications for product development (what therapies reduce stigma?), HCP-patient conversations (see below), product marketing, and broad public awareness of diabetes. More details below from this talk; please let us know what you think about this very important topic!
- The most prevalent forms of stigma were notions that people with diabetes have a character flaw/failure of personal responsibility and are a burden on the healthcare system. A respective 81% and 65% of respondents identified as having experienced these forms of stigma, sharing responses like: “It is always the person’s fault by being overweight and eating too much sweets and candy” and “Insurers don’t like diabetics, due to perceived costs to them.”
- A greater proportion of females with diabetes reported feeling stigmatized, compared to their male counterparts. This is true across all categories of diabetes treatment intensity. Adam did not speculate as to why this may be the case, but we are extremely curious to understand more about potential gender differences in the way diabetes stigma is directed and perceived.
- Do type 1s and type 2s feel the same kinds of stigma? One compelling slide from the presentation showed the boxes shown below side by side – can you guess which box is type 1 and which is type 2? (Answer below picture)
A: They are all type 2s!
- Reducing stigma could come from better public education about diabetes. Adam underscored the need to increase public awareness of the general causes of diabetes, via educational campaigns and nationwide PSAs in the media. “People need to be enlightened on how difficult it is to live with diabetes,” he explained, highlighting how the public does not understand how complex and multifactorial blood sugar is, and how challenging and time consuming it is to manage. Mr. Brown told a story of how he once remarked upon this issue in conversation with a cab driver who had type 2 diabetes. The driver summarized the frustrating nature of diabetes perfectly: “Diabetes can be depressing – to feel like you have done everything right and still get a 225 mg/dl on the meter.”
Helping Individuals Deal with Diabetes Stigma and Guilt
Susan Guzman, PhD (Behavioral Diabetes Institute, San Diego, CA)
Dr. Susan Guzman compellingly explained that feelings of stigma and guilt are a substantial and too-often unaddressed issue in diabetes care – download the slides here. As a psychologist at the Behavioral Diabetes Institute, the only nonprofit dedicated to psychological issues of diabetes, she has heard the stories of countless people with diabetes and deeply understands how stigma can lead to disengagement that prevents individuals from seeking the education, treatment, and support required to effectively manage their diabetes. Her presentation outlined five core lessons that she has learned from these conversations, with the underlying theme that diabetes educators and physicians have a crucial role to play in replacing society’s negative messaging surrounding diabetes with facts and empathy.
- Lesson 1: Feeling stigmatized leads to hiding, avoidance, disengagement, shame, and guilt. To exemplify this phenomenon, Dr. Guzman told the story of one of her patients. Deb is a 45-year-old kindergarten teacher who has had type 1 diabetes for 25 years. Her A1c hovers between 8%-9.5% and her BMI is >31 kg/m2. An endocrinologist of hers framed an A1c over 6.5% as a “failure” at diagnosis, continually asking,“Don’t you care that you’re overweight?” As a result of this stigma, Deb struggles with depression and shame. Only her husband and best friend know about her diabetes and she stresses over concealing her Dexcom alarm to prevent other people in her life from finding out. We do not think Deb’s story is an extreme case – for so many people with diabetes, this is a condition to conceal from employers, from strangers, etc.
- Lesson 2: As a health care provider, your messages matter a lot; be aware of how you think and talk about diabetes. Dr. Guzman emphasized the nuance underlying the language we use to discuss diabetes. Words like “non-compliant,” “unmotivated,” and “failure,” beyond being discouraging, are entirely unhelpful. Psychologists have long understood that labeling someone as a failure is a self-fulfilling prophecy. Furthermore, less than 20% of people with diabetes have their A1c, blood pressure, and cholesterol numbers at goal, so what does ‘non-compliant’ really mean? Equally damaging is the vocabulary of “prevention,” “reversible,” and “cure.” According to Dr. Guzman, words like these give false hope and do nothing to acknowledge diabetes as a chronic disease. In Q&A, Adam noted that the issue of language is so nuanced that the many don’t realize the distinction between a blood sugar “test” (a grade!) and a “check.”
- Lesson 3: Managing diabetes is hard work; your empathy goes a long way. Dr. Guzman highlighted the constant decision making and mental gymnastics involved in everyday diabetes management, underscoring that this is a burden people without diabetes often do not realize. There is no true finish line in diabetes, and her patients have expressed that it is difficult to expend such time and mental energy managing their blood sugar under circumstances where the best outcome is simply, “Nothing bad happens.” Dr. Guzman emphasized that it would make an immense difference if CDEs and physicians acknowledged more often that diabetes is hard work. We hope every diabetes HCP goes through a week of living with diabetes, wearing devices, checking blood glucose, etc.
- Lesson 4: This is about the person first. There are an infinite number of reasons why someone may be struggling to manage their diabetes – they lost their job, spouse died, etc. Dr. Guzman reminded her audience of the importance of taking an interest in what is going on each individual patient’s life. Blood glucose measurements are rarely the whole story.
- Lesson 5: Diabetes educators have the power to change the conversation. Dr. Guzman conjured imagery of breast cancer and Alzheimer’s disease awareness parades, rhetorically asking the audience why no such thing exists for diabetes. She declared CDEs have a key role to play in shifting the dialogue on diabetes in their communities into a conversation that asks “how can I help you?” instead of “what did you do?”
Questions and Answers
Q: How can we find diabetes psychologists in our area? Do you have an association? What resources are available?
Dr. Guzman: Unfortunately, we are few and far between. In California there are five, for example, and three of them are in San Diego. But that doesn’t mean you can’t find a diabetes-competent mental health professional. The ADA has paired with the APA to try to address this. Psychologists don’t feel they have a role to play in diabetes, and we should do more to engage the mental health community.
Mr. Brown: There are also good resources out there. BDI has some excellent one on its website. I’ve also written about this in some of my diaTribe.org columns.
Q: You were talking about people who already have diabetes. What I find in my practice is people who are newly diagnosed and feel stigma already. They bring that stigma from the get-go, from the outside world. They expect me to yell at them about their new diagnosis! This is also part of our problem with no-shows.
Dr. Guzman: There is a lot of blame language, and that is so unfortunate.
Q: Patients show up in my office who are newly diagnosed, and they don’t know why they are referred there. I am the one to tell them for the first time that they have diabetes. Do you have any advice for that?
Dr. Guzman: That is such a tough position. We have a resource for you at BDI called “Don’t Freak Out” that addresses some of the myths and covers how to have the conversation.
Mr. Brown: We have tips on diaTribe.org for the newly diagnosed, both type 1 and type 2. The biggest thing I would say is that fear is a terrible motivator; it’s not helpful. People need to know where to go to seek knowledge and information.
Q: I’m in a rural population with few adult endocrinologists and very underserved mental health resources. How can CDEs better address these psychological issues?
Dr. Guzman: CDEs kind of have to do it all, and it must be hard not to have an endocrinologist. How I start any overwhelming job is to think about the things I can do that will actually have an impact. Or start with one thing you think will have an impact. Picking small things in a giant problem can be an effective strategy, because it isn’t possible to do everything. You have to pick your priorities and accept that you can’t reach everyone and can’t do it all. That’s a problem for us helpers.
Q: I appreciate the conversation here. I’ve been a CDE for decades and have attended AADE several times and this is the absolute best seminar I’ve ever been to. It’s the first time a seminar has brought me to tears. I wish people knew how much harm we do when we talk about “preventing” diabetes. Say “delay”! Then people don’t feel like failures when they become diabetic. If you say “treat” rather than “cure” or “reverse,” it would make so much difference. I wish the ADA, CDC, and everyone wasn’t so bent on this idea of prevention. It’s doing so much more harm than good.
Mr. Brown: Wording has so much nuance, and can do so much damage. Another example is that people don’t “test” their blood sugar, they “check” it. Test implies a grade; we know so many factors influence blood glucose, and not every out-of-range value is a patient’s fault. Susan brought up a whole list of other ones. You just have to be so vigilant.
Dr. Guzman: And we are talking not just about the words but the concepts behind them.
Mr. Brown: I just adopted a dog, and when you go to the SPCA, they only tell you one thing about training a dog – use positive reinforcement. When I heard that I thought “Wow! Diabetes care is the complete opposite.”
Q: I certainly agree with asking “how can I help you” but when patients come to me and their numbers aren’t where they want them to be, they often do know what they should be doing and say that I can’t help them. How can I overcome that?
Dr. Guzman: Listen for what that person’s strengths and barriers are. That’s how we can make behavior change. Is it a cost barrier? Reluctance to take medication? Where can I help the patient get their biggest bang for their buck, and what changes are they most interested in making? What are the barriers I can collaborate on with them for a solution? After all there are so many good reasons why they might be struggling.
Mr. Brown: I wrote a very detailed column on the topic of motivation. I’ve also been obsessed with this idea of Time Perspective. Some people are future oriented and make decisions based on future consequences. But a lot of people are present oriented and think about the here and now. Diabetes is not a disease for present-oriented people – it’s all about the future! This is why it’s so critical to help people with diabetes understand why managing their blood sugar is important NOW: whether it helps them think better, have more energy to do what makes them happy, enjoy time with their family, etc. You can find this at http://www.diaTribe.org/motivation.
Q: I had a patient who wouldn’t take her insulin and had been in the hospital several times. She had diabetes for 20 years and was very, very resistant to taking basal insulin. As I talked to her, she kept saying that she didn’t want a needle sticking her skin. I asked her a few more questions and finally she confided that she had a friend die of heroin overdose when she was 13. That’s what needles sticking skin meant to her.
Dr. Guzman: That’s a powerful story that shows that there are lots of reasons why people struggle. Thank you.
Q: I’m a CDE and I’ve had type 1 for many, many years. I have gotten braver to speak up recently. I have appointments to speak to the Lions Club and the Rotary Club in my community about diabetes. And I’ve titled my talk “Diabetes Facts and Fiction.” Thank you for your talks, because they make these issues very clear. I took training as a personal coach, so I am now a coach for people with diabetes. This is something that CDEs can all do, even if we can’t become psychologists. That gives wonderful tools for working with quality of life.
Dr. Guzman: Absolutely. Training CDEs with these skills is more scalable than training more mental health professionals. And I applaud your courage in becoming an advocate and speaking up.
Q: I’ve been a licensed social worker for 20 years. I learned that social workers can become CDEs who focus on these social and emotional issues. They would be great on a diverse diabetes management team.
Dr. Guzman: Yes, absolutely. Any licensed psychologist can become a CDE as well.
Q: My husband has type 2 diabetes. He hasn’t been exercising and I do remind him from time to time. Is that a bad thing? Should I keep doing that? Is it bad?
Dr. Guzman: Often times that’s a conversation you need to have with your husband. But keep it simple: ask him, “Is this helpful?” If it’s helpful, do it; if it’s not helpful, don’t do it!
Type WE: The Positive Power of Life Partners in Diabetes Self-Management
Nicole Johnson, DrPH (University of South Florida, Tampa, FL) Stephanie Melton, PhD (University of South Florida, Tampa, FL), and Lorraine Stiehl (Patient Advocate, San Diego, CA)
USF’s Drs. Nicole Johnson and Stephanie Melton underscored the difficulties of being the partner of a person with diabetes and detailed their unique education pilot program for partners. Dr. Johnson began by putting the conundrum in the simplest terms possible: The words “The impossible diabetes caregiver scenario: Strike a balance between harping and abandoning = helping” occupied the screen. A video of a woman complaining about a headache provided further context for the talk – the camera angle eventually revealed that she had a large nail protruding from her forehead, but she becomes upset when her partner tries to tell her that the nail is the root of her problem, telling him he just needs to listen to her. As a result of this balancing act, partners frequently report feeling discouraged, guilty, angry, and isolated. For better or for worse, the literature supports a role for family and marital support in treatment adherence, adaptation to illness, and blood glucose control. With this in mind, Dr. Melton completed 19 in-depth interviews to investigate emotional strain and factors influencing the caregiving role. Her research revealed that (i) worry, fear (especially of severe lows), and helplessness are the primary emotions caregivers feel; (ii) caregivers get most of their information from the person with diabetes or “Dr. Google”; (iii) partners consciously try to avoid replicating a parental role; and (iv) balancing support and independence, plus effectively communicating are really hard tasks! Drs. Melton and Johnson molded these learnings into an education pilot program for partners, where they encourage constructive conflict management, friendship/intimacy and positive affect, and shared meaning and goals (videos from such sessions can be found online at Diabetesempowerment.org). It is great to hear that this group is so dedicated to helping partners, an often overlooked population in need of guidance. Eloquent patient advocate Lorraine Stiehl added candor and great learning to this panel.
- Eloquent patient advocate Lorraine Stiehl gave a first-hand account of the ups-and-downs of being the partner of a person with diabetes. Her husband, Chris, has had diabetes for 57 years, and they have been together for about 30. Every decade of partnership has brought about new challenges: In the first decade, there was little to no technology available, and Chris had many complications. Decade number two was an improvement – technology empowered the couple, they learned what an A1c was, and things were better. The third decade presented new challenges as Chris continued to age into his late 60s. The couple has managed to stay strong thanks to a sense of humor, but Ms. Stiehl still believes that the role of the CDE is crucial – “we need help even if we don’t ask for it.” Dexcom Share has been a particularly big gamechanger for Lorraine – we love this example of technology significantly improving a relationship – from a high base!
- Partner Diabetes Distress (PDD) Scale is a ~30-question survey designed to evaluate the amount and kind of diabetes distress a caregiver is experiencing. According to the web page, after the survey has been completed, the program provides personalized results, tips, and education on the impact of a spouse or partner's diabetes on their loved ones. Example questions (the partner indicates to what degree he/she agrees) include: “During the past month, I have been feeling unclear about how much I should be involved in managing my partner’s diabetes”, “Over the past month, I have been frustrated at my partner shuts me out of his/her diabetes”, and “I have been feeling overwhelmed by the constant demands of my partner’s diabetes.”
- Dr. Johnson revealed that there will be a Type WE Retreat in Orlando February 25-26, 2017. The agenda includes sessions from Diabetes 101 all the way through sex and intimacy. We strongly encourage couples to attend this program!
Obesity Management in Diabetes Care and Education: Exlore Our Current and Future Armamentarium
Donna Ryan, MD (Pennington Biomedical Research Center, Baton Rouge, LA)
Powerhouse obesity expert Dr. Donna Ryan (Pennington Biomedical Research Center, Baton Rouge, LA) delivered an inspiring keynote on obesity management, putting the onus on providers and educators to be open minded about weight loss therapies. While she acknowledged a few lingering reasons that people avoid obesity treatment (for many in the diabetes field, medical management of obesity is still outside their “comfort zone”), she underscored that it’s high-time for this resistance to go. Dr. Ryan presented weight loss as “very powerful medicine” and, in a key takeaway, urged providers and educators to duly consider all available options for obesity treatment, including medication, devices, and surgery. To this end, she reviewed the “armamentarium” of available obesity drugs, devices like the AspireAssist, and different types of bariatric surgery. Additionally, she advocated that providers and educators set reasonable (~5%) weight loss goals, gauge the need for weight loss based on health risks rather than a patient’s appearance, and lead the charge in abolishing stigma associated with treatment for obesity. She also called upon payers to better reimburse effective, intensive weight loss programs. Dr. Ryan framed the talk as a kick-off to AADE’s first-ever dedicated prediabetes day (which did not disappoint!), arguing that we need a lot more emphasis on obesity management in the realm of diabetes prevention and type 2 diabetes care. We were happy to hear such clear, comprehensive education on the various treatment options available, but we think education will only go so far until the field simultaneously overcomes bias against pharmacological weight loss therapies and other interventions beyond lifestyle change. We found Dr. Ryan’s call-to-action incredibly moving, and we so hope that more commentary from leading healthcare providers can tackle the stigma plaguing obesity treatment.
- To help break the stigma, Dr. Ryan suggested following pre-set guidelines to determine which patients need more aggressive weight management. According to Dr. Ryan, an intervention should be implemented for patients who present with a BMI >25 kg/m2 plus a risk factor like elevated waist circumference (>35 inches for women; >40 inches for men). She hypothesized that following established criteria will make it easier for people to talk about weight loss and viable therapeutic options – “it removes the issue of you having to decide who needs to lose weight.” She also stressed that providers and educators must never lose sight that weight loss is a pathway to better health and treating chronic diseases; it’s not about a patient’s appearance. We felt this was a wonderful message and we’d love to see this simple, low-cost screening criteria implemented in doctors’ offices to identify patients who could benefit from targeted obesity treatment, whether it be lifestyle modification or an effective drug. In recently-released AACE obesity guidelines similarly recommend a more holistic approach to determining which patients may benefit from weight loss than simply BMI: the guidelines utilized a complications-centered approach to define “stages” of obesity.
- Payers should see obvious incentives in reimbursing weight management programs, especially early, intensive therapy, Dr. Ryan asserted. She backed up this claim with hard data – of all participants in the Look AHEAD trial who lost >10% of baseline body weight in their first year of treatment, 70% were able to maintain >5% weight loss at four-year follow-up. Not to mention, Dr. Ryan positioned weight management as a treatment that addresses the root cause of type 2 diabetes with a plethora of added benefits, including improved glycemic control, enhanced quality of life, reduced cardiovascular risk factors, healthcare cost-savings, etc. In her view, payers should at the very least be reimbursing 14 intensive weight management sessions over six months. We’d be beyond thrilled to see more recognition from payers that weight management therapy is important for long-term health outcomes and cost-savings.
- Following the keynote address, Dave deBronkart “e-Patient Dave” added another element to Dr. Ryan’s call for better reimbursement: “Reimbursement for motivational coaching? Hell yes!” As he articulated so well, if healthcare was all about giving people information, a doctor’s job would consist of handing out flyers. “There’s a lot more to medicine than that,” and e-Patient Dave shared how motivational coaches were invaluable in his efforts to lose weight and control his prediabetes through the DPP. We certainly appreciated this recognition that many patients struggle to lose weight on their own and could benefit from intensive coaching on this front, along with additional medical support potentially.
- Dr. Ryan underscored that most weight loss benefits occur in the first 5% shed, and that keeping off 5% of baseline body weight is a realistic long-term maintenance goal. She shared evidence that 5% weight loss is enough to achieve the maximum benefits to adipose tissue insulin sensitivity and liver insulin sensitivity, arguably two of the more relevant benefits for people with or at risk for type 2 diabetes. Empirical investigations of the Diabetes Prevention Program (DPP) showed that all major health benefits occur in the first 5 kg (~11 lbs) of weight loss and that there are no accumulating benefits after 10 kg (~22 lbs) of weight loss. Dr. Ryan wanted audience members to recognize and spread the message that “modest weight loss means major health benefits.”
- “Now go out there and prevent some diabetes!” At the end of an extremely engaging hour, Dr. Ryan emphasized that much work remains to improve obesity management in the context of prediabetes and type 2 diabetes. She explained that a lot of this work is in the hands of providers and educators, and left the audience with a rousing, motivational call-to-action.
Weight Loss Medications in Prediabetes and Type 2 Diabetes: Who, When, How?
Jessica Kerr, PharmD (SIUE School of Pharmacy, Edwardsville, IL); Charmaine Rochester, PharmD (University of Maryland School of Pharmacy, Baltimore, MD); Amanda Stahnke, PharmD (UMKC School of Pharmacy, Kansas City, MO); Lisa Meade, PharmD (Wingate University School of Pharmacy, Wingate, NC)
This panel outlined the advantages of weight loss drugs, with Dr. Charmaine Rochester (University of Maryland, Baltimore, MD) expressing a very positive view of Arena/Eisai’s Belviq (lorcaserin) and describing the benefits of modest weight loss goals. Dr. Rochester summarized findings from the BLOOM-DM trial, which showed significant weight loss (44% of patients on Belviq dropped at least 5% of baseline weight vs. 16% of placebo patients, p<0.001) as well as significant reductions in A1c (down 0.9% vs. placebo) and fasting plasma glucose (down ~27 mg vs. placebo). In her view, it’s advantageous for patients with type 2 diabetes and obesity that this drug indicated for weight loss also has pronounced benefits for glycemic control. Dr. Rochester further discussed Belviq as an agent that can be taken without regard to meals, which makes it more convenient for patients, and that requires a lower number needed to treat (NNT) in order to achieve 5% and 10% weight loss in one year compared to orlistat. On that note, Dr. Amanda Stahnke (UMKC School of Pharmacy, Kansas City, MO) pointed out that although orlistat has been on the market the longest, it’s unpopular among patients and prescribers due to bothersome side-effects, from GI disturbances to oily stools. The panel characterized the emergence of more advanced medications with a more tolerable side-effect profiles have emerged for the treatment of obesity as very good news. The bad news, as we see it, is that providers and educators are still often reluctant to consider non-lifestyle modification interventions for weight loss.
- When panelists surveyed educators in the audience, there was resounding endorsement of screening for obesity and referring patients to dieticians. That said, we suspect this sampling may also be skewed by the fact that many dieticians attend this meeting. In contrast, only a smattering of hands went up when educators were asked how many of them would consider a pharmacological intervention if diet and exercise don’t suffice. We enjoyed hearing about the efficacy of available weight loss drugs, and we’re hopeful that commentary like this will soon overpower the ongoing resistance that continues to discourage providers, educators, patients, and families from considering weight loss medications. We’d love to hear more ideas for concrete solutions to address the persistent perception that obesity is not a disease that requires medical management and pharmacotherapy. We perceive a high unmet need for education in this arena, as well as a need for better reimbursement of effective obesity drugs that help patients manage weight as well as type 2 diabetes.
- Dr. Rochester stated that we must set reasonable expectations for weight loss (~5-15%) in order to see long-term success. Admittedly, losing 5% of baseline body weight isn’t nearly as exciting as dropping to half your size – this, according to Dr. Rochester, is why people watch The Biggest Loser. But she pointed out that most contestants on the reality TV show are unable to maintain their weight loss long-term. Dr. Rochester outlined an acceptable definition of successful weight loss: a ~5-15% reduction from baseline body weight that improves a patient’s blood pressure and cholesterol and makes type 2 diabetes easier to manage or prevents the onset of type 2 diabetes in people with prediabetes.
- Very surprisingly, there was little discussion specific to Novo Nordisk’s Saxenda (liraglutide 3.0 mg for obesity). At the very end of the session, Dr. Jessica Kerr (SIUE School of Pharmacy, Edwardsville, IL) made a comment about GLP-1 agonists being popular in the diabetes field. This is especially surprising considering that Saxenda currently holds the majority of the obesity market in the US by value (63% of market as measured by revenue) and is growing fast in terms of prescription volume (16% of market as measured by total prescriptions [TRx]).We wonder if the lack of attention to Saxenda may be driven by its relatively new status on the market, by aversions to various aspects of the product (its high cost, injectable nature), or by panelists wanting to provide education on lesser-known obesity drug options.
- The data Dr. Rochester presented from Drugs in Context shows that Vivus’ Qsymia (phentermine/topiramate extended-release) actually requires the lowest NNT, followed by liraglutide. A lower NNT value corresponds to better efficacy in achieving 5% or 10% weight loss in one year on the drug. We were surprised to see this given Saxenda’s domination of the obesity market by value (63%) right now and its growing popularity, although admittedly, Saxenda is much more expensive and still holds less than half the market by total prescription (TRx) volume compared to Qsymia (16% vs. Qsymia’s 37%). We’re very curious to see how J&J’s phase 2 canagliflozin/phentermine combination for obesity will fare in terms of NNT, given that SGLT-2 inhibitors are considered to cause greater weight loss than GLP-1 agonists and phentermine is a potent component of Qsymia. We also look forward to learning the NNT for Novo Nordisk’s next-generation GLP-1 agonist semaglutide for obesity (in phase 2 trials), given the company’s repeated statements that semaglutide is a more efficacious drug than liraglutide.
- Dr. Lisa Meade (Wingate University, NC) called attention to Qsymia’s efficacy in her talk, highlighting its mechanism of action. She explained that phentermine and topiramate have powerful complementary effects. Phentermine is released immediately from the capsule and suppresses appetite, while topiramate is released after a delay to prolong feelings of satiety. That said, Dr. Meade acknowledged that participants in the CONQUER trials demonstrating Qsymia’s efficacy were 90% Caucasian, suggesting that it may be important to investigate this agent and others in its class with a more diverse patient population.
- Importantly, although all four speakers called for more consideration of obesity drug therapies, they emphasized that diet, exercise, and behavior change should absolutely accompany medication. The optimal regimen for weight management, they asserted, is comprehensive care that incorporates healthy lifestyle modifications always and obesity drugs when indicated.
No Guts No Glory: Microbiota and Diabetes
Meghan Jardine (Physicians Committee for Responsible Medicine, Dallas, TX)
Ms. Jardine delivered an informative and humorous overview of the gut microbiome to a p-a-c-k-e-d (standing-room-only) lecture hall (despite it being AADE’s very last session!). Ms. Jardine reviewed the existing literature on the role of the microbiota in diabetes and obesity, outlining the prevailing hypothesized mechanism by which the microbiome influences metabolism. She explained that individuals who are insulin-resistant or obese exhibit a distinctive bacterial profile, characterized by reduced genetic diversity, a higher phylum-level ratio of Firmicutes to Bacteroidetes bacteria, and an increase in bacterial species like E. coli and Staphylococcus, which enhance inflammation. This pro-inflammatory microbiota phenotype is believed to increase gut permeability (an issue that is exacerbated by a high fat diet), which leads to increased fatty acid storage in adipose tissue, increased caloric harvest, and eventually increased insulin resistance. Nutritional intervention, Ms. Jardine emphasized, is one very feasible way to overcome this vicious cycle. A meta-analysis published this year demonstrated that probiotic diets produce significant reductions in fasting plasma glucose in people with type 2 diabetes, although A1c reductions were not reliably found across all studies included. The majority of probiotic studies have been short-duration and enroll only a small number of participants, but this offers preliminary evidence that diets that promote a healthy microbiome can minimize the progression of type 2 diabetes and obesity. “There’s something we can do right now,” remarked Ms. Jardine in closing, “We do it three times a day. It’s what’s on our plate.”
- Ms. Jardine suggested that insulin resistance and obesity-associated microbial profile is determined by diet more than genetics, which is encouraging news for CDEs hoping to counsel their patients about the importance of healthy eating. Ms. Jardine described a “diet switch” study from Nature in which volunteers from rural Africa and the United States changed diets for two weeks. Prior to the beginning of the study, microbial composition heavily skewed toward Bacteroides (“good bacteria”) for individuals from Africa and Fermicutes (obesity-associated “bad bacteria”) for individuals from the US. Amazingly, these ratios flipped after the dietary intervention. The dietary intervention additionally caused modifications in metabolic phenotype: the American volunteers developed a more diversified microbiome after two weeks on the African-style diet, and the opposite was true for the African volunteers on the American-style diet.
- Despite the importance of diet, Ms. Jardine stressed that this is only one of many factors contributing to metabolic health. She listed smoking, stress, exercise, sleep, and the environment as other important considerations.
Questions and Answers
Q: What information do we have about the effect of various artificial sweeteners on the microbiota?
A: I’m not sure, but that’s an excellent question.
Q: Have any studies shown that you need a certain length of time to change your diet to see these changes?
A: The microbiome is very sensitive to dietary changes, but to have prolonged benefits you need to continue the new diet over the long term.
Obesity, INsulin Resistance, and Gut Microbiota
Kristina Martinez, PhD (University of Chicago, Chicago, IL)
Dr. Martinez provided an overview of her work, which investigates the gut microbiome’s role in mediating metabolism. She began to suspect a relationship between microbiome and metabolism after observing that germ free (GF) mice with no microbiota are resistant to diet-induced obesity; regardless of being fed an exclusively high-fat diet, they do not become overweight. This appears to be a function of lipid metabolism: GF mice have decreased rates of triglyceride absorption, decreased fatty acid transport into cells, and decreased expression of lipid transporter proteins throughout the gut. All of these physiological markers are reversed after GF mice are reconstituted with the microbiota of another animal, but the extent to which the GF animal’s lipid metabolism is restored depends on the diet of the microbiota-donor animal. GF mice conventionalized with microbes from a low-fat diet animal exhibited normal levels of lipid uptake. On the other hand, GF mice conventionalized with microbes from a high-fat diet animal exhibited highly increased lipid uptake, ultimately leading to an increase in adipose tissue and eventually obesity. These results suggest that a “beneficial” microbiota profile depends on diet. What component of the diet is responsible for this? Dr. Martinez hypothesized that dietary prebiotics promote the growth of metabolically-beneficial microbes. She investigated this question in humans: volunteers (n=8) with prediabetes (BMI = 25-35 kg/m2) consumed supplements of the commercially-available prebiotic inulin for three weeks. Half of the volunteers were unchanged by this dietary regimen, but the other half (the “responders”) exhibited improved glucose tolerance and a phylum-level shift in their fecal microbial profile (more Bacteriodetes and less obesity-associated Fermicutes). Furthermore, mice exposed to a stool sample from a responder experienced a decrease in mesenteric fat weight (even though the mice were on an obesogenic diet at the time!). Although the mechanisms by which the diet influences the microbiome and the microbiome influences metabolism remain unknown, Dr. Martinez’ work compellingly demonstrates how closely entangled these three factors are.
- Though her work demonstrated the power of prebiotics to improve glucose metabolism (albeit in a small population), Dr. Martinez suspects that postbiotics will be the “next big thing” in diabetes and obesity drug development. Prebiotics promote bacterial growth, whereas postbiotics are the actual metabolites that bacteria produce. As a drug development candidate, postbiotics are better option: rather than indiscriminately promoting bacterial growth of all kinds, it is more strategic to design a drug that specifically mimics the effect of a certain class of beneficial bacteria.
Questions and Answers
Q: Is there any specific benefit for pectin?
A: I would imagine that soluble fibers like pectin would have a more dramatic effect on the gut bacteria, but I haven’t looked into that specifically. Changing your diet will influence the microbiota more than supplementation.
Q: How long do the effects from the fecal transplant last?
A: The bacterial communities start to shift after about 2 weeks after FMT.
Q: Do you have any ideas as to why some people responded well and others didn’t respond at all?
A: It probably has to do with genetic variation and the immune system.
Q: I’ve been made aware of several different companies that will map your microbiota. Should I do this for my patients?
A: The Human Microbiome Project is one. You can send in a stool sample and have your microbiota analyzed. However, the microbiota responds very rapidly to what you’re eating, so make sure you are sending in a representative sample.
Q: With FMT, what is the holdup? Why hasn’t it taken off as a way to manage obesity and diabetes? It is extreme, but seems less extreme than surgery.
A: Studying FMT is very difficult; there are a lot of hoops to jump through for researchers and clinicians, but I do think it will eventually take hold. The current work is more focused on FMT as a treatment for diabetes than obesity.
Q: How many grams constitutes a high fat diet?
A: The high fat diet in our mice contained 37.5% of calories from fat.
Q: How long does someone need to take probiotics or prebiotics in order to impact the microbiota?
A: I can’t really comment on that, except to say that in our study 3 weeks was enough to see a significant change. Bacterial composition shifts so easily, so I imagine it is important to continue these changes in the long term.
What do Diabetes Educators Need to Know about NAFLD and NASH?
Jamie Wolosin, MD (Sharp Rees Stealy Medical Group, San Diego, CA)
Though no drugs are FDA-approved for the treatment of nonalcoholic steatohepatitis (NASH), local physician Dr. Jamie Wolosin (Sharp Rees Stealy Medical Group, San Diego, CA) suggested a few options: TZD pioglitazone, GLP-1 agonist exenatide (AZ’s Byetta [twice-daily] and Bydureon [once-weekly]), obesity medications, and bariatric surgery. After delivering a crash course on nonalcoholic fatty liver disease (NAFLD) and NASH, Dr. Wolosin turned to the high unmet need for viable therapies, but with an optimistic twist. While we wait for products in the crowded competitive landscape to advance, he claimed that we already have agents in our toolkit that could offer some benefit. The “hallmark therapy,” according to Dr. Wolosin, is gradual, sustained weight loss of ~10-15 lbs. Of course lifestyle modification isn’t enough for some patients, so he advocated for weight loss drugs, though acknowledging that these agents aren’t very popular among patients and prescribers. He even went “out on a limb” to say that “bariatric surgery is the most effective treatment for fatty liver disease.” That said, he also shared evidence that exercise is advantageous independent of weight loss, in that exercising will help ameliorate fatty liver even if the patient doesn’t lose weight. Dr. Wolosin highlighted Ocaliva (obeticholic acid), recently approved by the FDA for primary biliary cholangitis (PBC), as a potential NASH therapy, an application that has been garnering much attention. In the realm of diabetes drugs, he pointed to pioglitazone has potentially offering meaningful benefits in NASH. A recent study (n=101 patients with prediabetes or type 2 diabetes and biopsy-confirmed NASH) demonstrated histologic improvement of NASH in 58% of the pioglitazone group vs. 17% of the placebo group and resolution of NASH in 51% of the pioglitazone group vs. 17% of the placebo group. Notably, patients on pioglitazone experienced reductions in fatty liver despite gaining weight and Dr. Wolosin noted that many experts are moving toward pioglitazone as an established treatment for NASH. Pioglitazone is experiencing particularly good press of late – studies have suggested that the TZD can improve cardiovascular outcomes and prevent type 2 diabetes in patients with prediabetes and a history of stroke. Dr. Wolosin also mentioned that excitement over GLP-1 agonists has sparked consideration of exenatide for the treatment of NASH, but emphasized that this has not been empirically proven or FDA-approved. Still, he urged the audience to think about both pioglitazone and exenatide when treating a patient with type 2 diabetes and fatty liver. Novo Nordisk is investigating its next-generation GLP-1 agonist semaglutide for a NASH indication and we hope this more-potent molecule can have even greater benefits on this condition. Dr. Wolosin concluded the session with a reminder to refer patients to clinical trials, given that so many agents for NASH are pre-market in clinical development. This was surely an insightful session on a topic we’ve been itching to learn more about, and we loved Dr. Wolosin’s practical suggestions for treating NASH in patients with type 2 diabetes and/or obesity.
- Dr. Wolosin also offered a terrific, compact argument for why people in the diabetes field should care about NASH. Beyond often occurring as comorbidities, diabetes and NASH share common risk factors such as obesity and hyperlipidemia. Both diabetes and fatty liver greatly increase a patient’s risk for cardiovascular disease (CVD). In fact, CVD is the leading cause of death both among patients with NAFLD and among patients with diabetes.
- Dr. Wolosin implicated insulin resistance in the “two-hit” hypothesis for the development of fatty liver disease. He listed both insulin resistance and type 2 diabetes as potential “first hits” that increase an individual’s likelihood of developing signs of fatty liver. Other possible “first hits” include hyperlipidemia and elevated triglycerides in the liver, which are also problematic for type 2 diabetes. Continuing on, Dr. Wolosin explained that the “second hit” leading to NAFLD or NASH could be irregular hepatic iron, oxidative stress, microbiome abnormalities, altered cytokines, etc.
- On the theme of individualized care, Dr. Wolosin pointed out that individuals of Asian descent may be at risk for NAFLD and NASH at a lower BMI threshold. Despite many providers and educators being aware of this, Dr. Wolosin recognized that it’s not easy to talk about weight loss, especially when your patients have a lower BMI. “I always cringe when I have to tell someone who’s 130 lbs that they’re overweight and need to lose 10 lbs. But it’s just a different disease.”
Questions and Answers
Q: How do you distinguish between compensated and decompensated cirrhosis?
A: “Decompensated” is a descriptive term for individuals who have malnutrition, ascites, poor functional status, edema, low albumin – essentially, symptoms. You’ll generally see lower platelet count in liver disease, but that’s not an indication in itself. “Decompensated” really refers to functional status.
Q: For those of us caring for patients with advanced NASH, when should we stop metformin?
A: Indeed, there’s a concern over lactic acidosis risk. This is a difficult clinical decision, one that has to be based on the individual patient. Often, as individuals get sicker from liver disease, they start losing weight, fat comes off, appetite goes down, and low and behold their diabetes becomes more controlled. If metformin can be pulled at that point then yes, it should be stopped, especially if the patient’s cirrhosis is decompensated.
Q: Can you comment on high fructose corn syrup and how that contributes (or doesn’t contribute) to NAFLD?
A: This is still a very prominent topic. I think high fructose corn syrup is one cause for many issues going on, especially obesity. It’s such a highly concentrated source of sugar, which goes directly to the liver. It should be avoided if possible.
Q: One of the studies you presented suggests that light alcohol intake may be beneficial in protecting against fatty liver. How many drinks is considered “light”?
A: One drink or less per day.
Q: Does alcoholic fatty liver look really different from NAFLD?
A: The insult to the liver is different, because one emerges from insulin resistance and the other is caused by a toxin bombarding the liver. The conditions themselves are night and day. That said, if I do a biopsy of the fatty liver, it’ll look very similar whether it’s caused by alcohol or by diabetes. Early on, we thought all people with fatty liver disease were alcoholic, but that’s not the case. Even though the two diseases look very similar in presentation on the liver, their physiology is worlds apart.
Q: Do you have any specific diet recommendations related to NAFLD?
A: It’s the exact same diet that you’d recommend for a patient with type 2 diabetes and hyperlipidemia.
Comment: I have a friend who’s a 20-year survivor of a liver transplant, and he’s an extremely healthy vegetarian.
A: A whole separate topic of discussion is plant-based diets, vegan/vegetarian diets, and their health benefits. Many people, myself included, feel that there’s an overwhelming amount of data to show that plant-based diets are the preferred option with health in mind. Now, not everyone is ready for a vegetarian diet. If you’re a standard omnivore, you just have to watch fats and calories.
Q: I’ve read that if you take <400u of vitamin E, you don’t experience the side effects. Does that half dose do any good for the liver?
A: No one really knows. Few of these dietary studies are well controlled, so it’s hard to get good data. The studies investigating vitamin E in fatty liver disease were done with 800u daily, so I don’t know reliably how the 400u daily intake would affect liver health.
Q: How would you identify rapid weight loss as it contributes to fatty liver disease?
A: When I say “rapid weight loss,” I’m referring to a really catastrophic situation – typically trauma or injury. With gastric bypass you’re losing 100 lbs over 6-12 months, in which case liver enzymes will shoot up from acute fatty liver, but will eventually go away.
Q: You made a comment about herbal supplements having an effect on NAFLD. Are people trying to treat it with that? Are particular supplements damaging to the liver? I had a patient recently told by his physician to take milk thistle.
A: If you have an insult going on in the liver, whether it’s fatty liver of hepatitis B, your liver is going to be more susceptible to adverse events. This makes herbal supplements somewhat risky, but not all are bad, and milk thistle is one that’s been looked at for decades as a treatment for liver disease. It’s still quite popular. But we do see supplement-induced hepatitis all the time. And finding out exactly what caused the problem is impossible, because usually the supplement is a combination of herbs manufactured in different places. Understand that with supplements, safety hasn’t always been studied.
Q: In prescribing statins, there’s a cutoff point for ALT 3x the upper limit of normal. Is there a gray area for using statins in patients with fatty liver in that range?
A: Great question. FDA recommendations (like the 3x upper limit) are generic, one-size-fits-all. You should look at each patient individually and weigh risks vs. benefits. If someone has completely normal liver enzymes and the statins suddenly increase their levels, be wary of that. However, aside from the occasional idiosyncratic allergic reaction, statins are actually pretty darn safe for the liver. If you’ve got an ALT 3-5x the upper limit of normal, and if you have really high LDL, metabolic syndrome, and other risk factors, a statin really will provide some benefit. Yes, there is a gray area, and it’s called clinical judgment.
Comment: Pioglitazone (Actos) accumulates water, so the weight gain is from water, not fat. Your dilemma with patients who are obese – I would keep in mind that it’s not fat weight.
Joanne Gallivan (National Diabetes Education Program, Bethesda, MD); Christine Nicols (Hager Sharp, Washington, DC)
Ms. Christine Nicols (Hager Sharp, Washington, DC) reviewed the key findings from a 2015 evaluation of Diabetes HealthSense, an online resource of the National Diabetes Education Program (NDEP) that facilitates behavior change and provides psychosocial support for patients with diabetes and people at risk for diabetes. The evaluation compared 15 intervention sites (n=187 individuals at pre-test) with 10 comparison sites (n=207 individuals at pre-test), and found that people engaged with Diabetes HealthSense showed significantly greater improvements in knowledge about diabetes management, healthy eating and exercise behaviors, and self-efficacy (p<0.05). The importance of self-efficacy was emphasized during Q&A, when a diabetes educator in the audience shared that her patients who report higher confidence in being able to achieve their goals are more likely to show positive health outcomes. Ms. Nicols underscored that Diabetes HealthSense was effective for patients as well as for people at risk for developing the disease. However, she cited short duration of data collection as one limitation of the study – the analysis didn’t reveal if Diabetes HealthSense reduced the rate of new-onset diabetes in people at risk or its impact on A1c in patients with diabetes. It would be “fabulous,” she added, if a future evaluation looked at long-term maintenance of diabetes self-management goals and assessed how the behavioral/psychosocial intervention affects physiological measures including A1c, blood pressure, lipid levels, etc. Ms. Joanne Gallivan (NDEP, Bethesda, MD) followed the presentation of results with a discussion of how to incorporate Diabetes HealthSense into your practice. She captured wonderfully the potential benefits to this program which offers necessary support and motivates patients to take an active role in their own healthcare – “it can save you time, and it can save you money.”
- Other limitations of the 2015 evaluation include reliance on self-report and difficulty in isolating components of the intervention. Changes in behavior were quantified based on self-report, which could be biased. Ms. Nicols and Ms. Gallivan mentioned that due to positive patient feedback on the introductory presentation to Diabetes HealthSense, which walks you through how to utilize the resource, the NDEP is planning to make the welcome PowerPoint available on the organization’s website. During Q&A however, an educator in the audience who worked at one of the study’s intervention sites expressed skepticism that the presentation would be beneficial on its own. Educators deviate from PowerPoints, she asserted, answering patient questions and offering nuanced advice, so a series of slides with no human interaction might not have the same beneficial behavioral and psychological effects. Hopefully, future evaluations of Diabetes HealthSense are able to identify the most effective components so that the program offers maximum benefit to people with diabetes and prediabetes.
- The study found no significant effect of the program on emotional health. Patients with diabetes and people at risk reported feeling equally overwhelmed before and after Diabetes HealthSense, with no significant deviation from the comparison group. During a lively Q&A, discussion turned to how emotional health and feeling capable plays into self-efficacy and overall success with diabetes management. One CDE in the audience commented that helping patients set realistic goals is crucial because it allows them to feel successful, which is a key motivating factor in long-term diabetes self-management.
Questions and Answers
Q: What statistical test did you use in last year’s evaluation? I understand probabilistic findings, but I need to know what really happened. Did people actually change their behavior?
A: We used linear mixed models. Knowledge was assessed based on percent correct answers to 16 questions, pre- and post-test. Self-report is of course a limitation of this study, but people did report an increase in the healthy behaviors we want to see.
Comment: When you use the AADE7 to track, a patient sets a goal and then at the bottom marks their confidence in being able to accomplish this on a ruler. With follow-up, you clearly see that patients scoring higher on this ruler experience more positive outcomes.
Q: I’m from Louisville, Kentucky, and we were actually an intervention site. It’s nice to see these results! Are you going to follow-up and see if patients are able to maintain their goals long-term? For the group at risk for diabetes, did you see lower incidence of new-onset diabetes?
A: Importantly, people at risk had the same success with Diabetes HealthSense as patients with diabetes. We saw the same significant increases in knowledge, self-efficacy, and healthy behaviors. In terms of behavior change maintenance – that’s another limitation of the study. We didn’t track behaviors over six months, or a year, or longer, which would be fabulous to do. This evaluation looked at a relatively short time frame. Perhaps someday we’ll test this again with a longer interval.
Q: I want some more clarity on how you defined “the intervention.” Was it access to HealthSense? Or is there a formulaic way of going through HealthSense that constitutes “the intervention”?
A: The intervention involved going through all the resources available. We’re in the process of making that introductory presentation available to diabetes educators on the NDEP website, because it received very high praise on surveys. Patients appreciated that first mediated session.
Comment: I followed your PowerPoint to an extent, but we’re diabetes educators – we don’t read PowerPoints, we talk. I have some doubts that the PowerPoint itself will provide the same benefits as when you interact with your patients on site. I went through the PowerPoint, but I deviated – not purposely, but when patients ask questions our instinct as diabetes educators is to respond and offer more tailored advice. How can we isolate that part of the intervention from these results? None of this is to say that I wasn’t very pleased to see positive results.
Q: Did you measure A1c, blood pressure, or blood lipids?
A: Not in this study, no. It would be nice to do that eventually.
Q: Are there any future plans to look at reduced risk of readmission from participating in Diabetes HealthSense? I ask because this would really affect the support I’m going to get from administration to implement such a program.
A: We don’t have any plans currently, but if we take this to the next level we’d definitely love to look at outcomes measures.
Q: How did you measure coping?
A: We used questions from Michigan and Stanford to get at a lot of the different relevant behaviors. To be honest, though, I’m not sure if our study was enough to look at all the behavior changes relevant to coping.
Q: Is there something similar to Diabetes HealthSense that can be utilized by gestational diabetes patients?
A: That’s a great question. I’m sure there are resources that you could adapt, but there’s nothing specific in Diabetes HealthSense right now about gestational diabetes. Obviously if you’ve had gestational diabetes, you’re at risk for developing diabetes later on, so you could benefit from prevention strategies.
Q: Are you tracking usage of the site? I’d find it very helpful to see how many of my patients are accessing it.
A: We collect data on hits to the site and so forth, but I don’t know that we could do this on a local level.
Comment: You noted no significant effects of Diabetes HealthSense on emotional health, in that people felt equally overwhelmed pre- and post-intervention. I’ve found that this often correlates with people being able to carry a behavior through. Maybe some people are setting goals that are too hard to obtain? Thirty minutes of physical activity could be a lot for someone who’s hardly moving from the chair to the kitchen.
A: Certainly, if 30 minutes/day is too much, you should break that down into small, achievable steps. That’s something you can work out with your patients.
Comment: Perhaps this should be made clear at all sites. I’ve seen how powerful it can be to make patients feel comfortable and successful. Patients feel good when they are achieving their goals, and this sense of competence is crucial to self-efficacy and long-term diabetes self-management.
Q: What was the age range of participants? How did you make resources available for those without computer access?
A: It was a screening criteria that people had to have Internet access and be at least 35 years-old.
Comment: I applaud you for the research you’re doing, but I think research on diabetes education is extremely difficult. It’s only part science. Providers and diabetes educators fuse their own opinion into interventions, because you have to meet patients where they are. The real question is identifying the bias. People who want to do this research need validated tools and more standardized methods of reporting their findings on diabetes education.
Developing a Safe and Effective Exercise Program for People with Prediabetes and Type 2 Diabetes
Todd Galati (American Council on Exercise, San Diego, CA)
In a light-hearted and very interactive session, Mr. Todd Galati of the American Council on Exercise (ACE) shared his expertise as a fitness instructor on how diabetes educators can implement feasible and effective exercise programs for their patients. ACE’s principal goal, Mr. Galati explained, is simply to “get people moving.” He emphasized that this is achievable for patients with diabetes and prediabetes, regardless of their initial level of fitness and led the audience of ~50 CDEs, nurse practitioners, physicians (and Close Concerns associates) in a demonstration of several aerobic exercise circuits that can be performed at home or even in the office. Each was easy to begin with, but had the ability to be escalated in intensity and difficulty. According to ACE, the key to inspiring patients to adopt a lasting routine of physical activity – or any form of behavior change for that matter – is to work together to set goals that are: (i) specific; (ii) measurable; (iii) attainable; (iv) relevant; and (v) time-bound. That is, the path to an active lifestyle – ideally involving 150 minutes of exercise per week – involves a series of well-defined and easily-achievable goals that can be interfaced with ordinary daily tasks. Such goals can range include challenging oneself to climb an extra flight of stairs or walk an extra lap around the neighborhood. This empowering philosophy of gradual, sustainable behavioral modifications permeated the afternoon-long course, and attendees enthusiastically spent the session breaks walking the halls of the conference center and comparing heart rates. Noting that physical activity is the principal modifiable risk factor for many chronic diseases (including diabetes, obesity, and cardiovascular disease), and specifically honing in on data supporting exercise’s ability to improve insulin sensitivity and glucose homeostasis, Mr. Galati concluded the session by remarking that “exercise is medicine.” He emphasized that a more prominent role for health coaches, wellness experts, and fitness professionals in the diabetes care arena could improve patient outcomes and cut healthcare costs on both an individual and societal level – hear hear!
Abbott’s booth drew AADE attendees in with its familiar oversized monarch butterfly flapping from the rafters, bright yellow coloring, and a remarkable sugar sculpture of buildings from across the US. Similar to the what we saw at ADA, the booth sported a rotating circular sign reading “FreeStyle Libre Pro”, marking the second major US conference at which the device was displayed under glass. Signs footnoted, “Pending PMA approval,” in line with comments from the July financial update that expected approval imminently. It is unfortunate that approval for the retrospective, blinded system has taken more than a year at this point (submitted in 2Q15)! FreeStyle Libre has yet to be submitted to the FDA, which makes the new 1Q17 US launch goal highly ambitious (implying a ~6-7-month review at most for the first factory calibrated sensor in the US; see the July financial update). There were no additional updates on pipeline front, but reps and booth infrastructure seemed devoted to disseminating as much information as possible about the Pro – numerous booth-goers were of course unaware of the yet-to-be-approved product, which should hopefully end soon. There was also a sliver of the booth dedicated to LibreView, Abbott’s new data management software that we saw at ADA.
The AgaMatrix booth showed off the FDA-cleared Jazz Wireless 2 Bluetooth-enabled BGM and paired app (picture below). Reps told us the goal is to launch within a month, and educators came by in a steady stream to pick up a free meter. We got one too and were impressed with the meter’s tiny size (USB-like) and streamlined design (harkening back to the iBGstar – everything is about the app). AgaMatrix is working out the details of a co-pay buy-down program, ideally offering a 30-day supply of strips for $15. We got a first look at the paired AgaMatrix Diabetes Manager app (Android, iOS), which had a streamlined and simple interface and a nice color-coded statistics & logbook export (easy to send to a provider or even integrated into EMR systems). The app (like Dexcom Share) also sends and receives notifications to care providers, friends, and loved ones (“Zoe Shaw measured 102 mg/dl”).
- The app’s automatic smart reminder feature is something we hope all BGM companies will add – These reminders can be time- and/or event-based and are configurable. For example, “Test glucose 2 hours after a hyperglycemia event,” “15 minutes after a hypoglycemia event”, or add a custom option (“Bolus 15 minutes before breakfast.” (Most reminder features in diabetes apps are less specific; we love the focus on automatic reminders that only appear after hypoglycemia/hyperglycemia.)
The Contour Next BGM portfolio – Next, Next EZ, and Next Link (wirelessly communicates with Medtronic pumps and uploads to CareLink software via USB) – were heavily featured in Ascencia’s booth. The Next Link was a significant focus, especially given the just-approved MiniMed 630G and capability of remote bolusing from the newest version of this meter, the Contour Next Link 2.4. A soon-to-be-activated web page, Contour Next Concierge on demand, was also introduced at AADE. The site will streamline online ordering of sample meters, strips, educational materials, and more for clinicians. [As an aside, we have been impressed with Ascensia’s DTC cash-pay pricing on Amazon, with 100 strips costing a remarkably low $19.] Reps were giving away popular educational posters featuring information on hypoglycemia, diet, AACE and ADA goals for glycemic control, and A1c-blood glucose correlates.
AZ recently extended its free Fit2Me app to include helpful resources for patients with or at risk for cardiovascular disease, and accordingly, Fit2Me was a huge focus of the company’s exhibit hall presence. In addition to its main exhibit, which heavily promoted the resource program, AZ had a second exhibit toward the back of the hall dedicated exclusively to Fit2Me. A prominent overhead sign advertised Fit2Me and Fit My Fridge. A tall monitor at the heart of the main exhibit allowed conference attendees to learn more about how this app works – for example, users can enter information about the ingredients in their refrigerator, how long they want to spend cooking, etc. and the program will output an enticing photo and instructions on how to cook the healthy, diabetes-friendly meal. The exhibit dedicated to Fit2Me featured a large mock-up of the famous Fit2Me food truck and served healthy slushie samples. The floor was made to look like bright green grass. As people slurped slushies, they were encouraged to download the app on site. Multiple slogans on display described the personalized advice that the app provides to patients with diabetes, and now other chronic diseases, including “my plan, my way,” and “a plan in my hand!” AZ’s other products were somewhat sidelined by the promotion of Fit2Me. One corner of the company’s main exhibit was dedicated to GLP-1 agonist Bydureon (exenatide once-weekly), with small monitors, handouts, and information on how providers can help patients access a 90-day prescription of Bydureon for just a $25 copay. The company’s other major diabetes products (SGLT-2 inhibitor Farxiga [dapagliflozin], SGLT-2 inhibitor/metformin combination Xigduo [dapagliflozin/metformin], DPP-4 inhibitor Onglyza [saxagliptin], DPP-4 inhibitor/metformin combination Kombiglyze [saxagliptin/metformin], and GLP-1 agonist Byetta [exenatide twice-daily]) were listed on the overhead sign, but were otherwise not featured within the exhibit.
As promised pre-conference, BD debuted the innovative MiniMed Pro infusion set with FlowSmart technology for the first time in a hall. We thought this would’ve been a great opportunity to bring “Lipo Larry” (the classic lipohypertrophy dummy) out of retirement, but settled for faux-tummies on which to test the new infusion set. Reps said that feedback was extremely positive – patients and providers repeatedly asked how and when they could get their hands on one. BD previously announced that there will be a small (at least 1000 patients, ~three months) initial launch of the set in the US and France to gather feedback, followed by the full scale global rollout, likely by December. At the moment, there is no test drive program in place, but BD will send sample boxes to clinicians so they can allot individual units for patients to try. As a reminder, the set will be made available for Medtronic and non-Medtronic pumps (Animas, Roche, Tandem), though Medtronic will control distribution in both cases.
- The booth also called attention to FITTER, last October’s forum about best practices for injection, insulin safety, and infusion sets. Recommendations will be published in a top American medical journal next month. We found out that the recommendations will even include best practices for the Pro-Set side-port catheter. Granted, these may change as more information is gathered from the launch.
- BD brought back the immersive virtual reality experience about injection technique from ADA. The two demos allowed us to experience an injection technique counseling session as a patient with type 2 diabetes who had just been instructed to go on insulin, with one video documenting common mistakes physicians make and the other documenting best practices. We love seeing next-gen consumer technology brought into diabetes – VR is all the rage in Silicon Valley, and we wonder how it could be leveraged in diabetes education (either for providers or patients).
DarioHealth (formerly LabStyle)
DarioHealth reps (who were happy about the name change, commenting that it “makes much more sense”) reported that the Android version of the BGM smartphone app will be first approved for Samsung phones, followed by other Android phones. No timeline was provided for either launch. They also mentioned that they had heard rumors of expansion into Italy and South America soon, but couldn’t provide concrete details. The smartphone BGM (headphone jack) system is currently in the US, UK, Netherlands, New Zealand, Australia, and Canada. Version 3.2 of the iOS app, recently launched, includes a number of simple, user-friendly modifications, and the next version, 3.3 is slated for a Q3 launch. Reps also spoke about the company’s mission to better engage the type 2 community, but offered no further details.
Though AADE 2016 is in its hometown, Dexcom opted for a very small booth this year (it was actually dwarfed by Tandem’s neighboring exhibit). Two smartphones showed of G5 mobile, though we spent our time talking to the reps about the positive July 21 FDA panel vote for non-adjunctive use of G5. Reps were clearly excited about the vote, and reiterated one of our big takeaways from the panel and Dexcom’s subsequent 2Q16 call – there are a number of training details to hammer out. We believe this approval is a matter of “when” rather than “if,” though it’s hard to know how long the FDA negotiations will take. Reps did point us to a newly published 52-week, four-arm trial (n=65; Soupal et al., DT&T 2016), offering a highly positive takeaway for Dexcom: adding CGM to MDI drove a similar A1c reduction as adding CGM and a pump (-1.2%; baseline: 8.3%). Further, adding a pump alone (without CGM) only drove a 0.5% reduction in A1c (baseline: 8.4%). Though the study was very small (n=12 on CGM+MDI, n=15 on CGM + pump, n=20 on pump alone, and n=18 on MDI + SMBG), it was great to see the long length and four arm design. The results confirm the preliminary findings from the DIaMonD study (presented at ADA), and what the field has long known – CGM offers significant benefits to MDIs.
DiaSend’s modest booth featured a couple of monitors showing off the universal web-based data management platform, with reps demoing the product’s impressive device compatibility (140+). The company recently adopted part of the standardized, one-page Ambulatory Glucose Profile (AGP) – the key modal day graph – and management is in talks to integrate the rest of the very helpful views and statistics. Educators occasionally approached reps to ask questions about how to do something within the platform (such as fixing mis-calibrated time stamps), but these matters were quickly resolved, and the majority of feedback that we heard was overwhelmingly positive. Diasend gets great remarks from most who use it, and we hope the company can continue to drive better insights and pattern recognition (which currently lags behind other data download platforms in our view). In an earlier session, President Mr. Richard Laurits alluded to an upcoming initiative focused on type 2 patients – aptly named “Project Type 2” – but reps didn’t comment on the program.
Glooko featured the same capabilities it showed in June at ADA, highlighting its next-gen work to optimize insulin dosing: the DreaMed MD Logic Pump Advisor partnership (study starting later this year) and its Mobile Insulin Dosing System for type 2s (studies in 2H16; launch in 2017). Medtronic integration is in final testing and expected to launch within the next month, just slightly behind the July expectation at ADA. The team demonstrated the Medtronic integration live to visitors to its booth – great to see this is coming imminently, and boy has it been a long time coming. Glooko won praise from expert CDE Gary Scheiner on Saturday, who highlighted the new pump and CGM insight features (e.g., linking infusion set wear time to glucose values). Glooko is now in 1,300 health systems throughout the US, a clear victory following the partnership with Insulet in January. Based on comments from both companies, this seems to be going incredibly well. Reps eagerly spoke about being “device agnostic,” and shared enthusiasm for a CDE User panel – on the desk was a signup sheet for educators who wished to participate in a feedback session.
Though not an AADE exhibit hall booth, we had the opportunity to go to Glysens’ San Diego headquarters to meet with CEO Bill Markle, CTO Dr. Joe Lucisano, and UCSD Professor of Medicine/Board Member Dr. Robert Engler. Dr. Markle confidently shared clinical data showing a ~15% MARD over a period of 12 months for the company’s fully implantable CGM, along with dQ&A and T1D Exchange survey data demonstrating that many patients would opt for the device over alternatives. Glysens has two, small, ongoing clinical studies, which have demonstrated impressive signal stability over the 12-months of use, with minimal monthly drift (one calibration per month). Right now, Mr. Markle added, bringing the MARD down into the low teens via an improved digital signal processing algorithm is the main priority. If that happens by this fall, the company will proceed to initiate a CE approval trial (n=30) in San Diego, likely in 1Q17. Mr. Markle believes that this study would also contribute to the phase I cohort of the US pivotal trial. We’re glad to see Glysens pushing forward with its fully implantable CGM, but even if things go exactly as planned, the device will still not be market-ready for quite some time (we assume over 1.5 years). In the pipeline (for later-gen sensors) is a plan to eliminate the fairly bulky receiver and push data to a smartphone with a relay device (e.g., a watch that receives the RF signal from the sensor and relays it to the phone via Bluetooth). The company also hopes to extend the lifespan to two years, and drive a 40% smaller sensor that will likely have memory capabilities to backfill data (e.g., if the receiver is out of range). In-house manufacturing capacity is adequate for now (“hundreds of sensors per month”), but the company has only $21 million in cash as of last December (Mr. Markle assured this will last through 2018, and there’s “more where that came from” from independent donors. Strategic partnerships with the likes of Dexcom and/or Medtronic are possible in the future. This is an exciting, albeit highly competitive, time in CGM – Glysens’ fully implantable sensor (no external parts on the body like Senseonics) could open up more of the market, though the company still has much to prove and the bar keeps rising for CGM accuracy, reliability, and form factor.
A Glytec rep we spoke with was very enthusiastic about uptake of Glucommander, the cloud-based inpatient insulin dosing software now utilized in 130 hospitals in the US. When asked if the company had any plans to expand to OUS anytime soon (Glucommander received a CE mark last year), he said that it has its hands full stateside, and doesn’t have the infrastructure, nor the staffing, to commercialize in Europe just yet. We were under the impression that Glytec would look to start international efforts this calendar year, but it’s possible that stateside demand has occupied more resources than anticipated. There were no updates on expanding outpatient use of Glucommander, which impressed us in a late-breaker at ADA – a 2.7% A1c reduction (baseline 10.3%) in a 41-patient, uncontrolled, 3-month study at Dr. Bruce Bode’s clinic in Atlanta.
GSK’s very small booth – squeezed between dLife and Dannon in a long row of other booths – was essentially entirely occupied by a small Medical Information desk staffed by two representatives. The booth had no flashy advertisements for its GLP-1 agonist Tanzeum (albiglutide), though a LCD screen did display information on several ongoing clinical trials for the product, noting that many were still recruiting. Overall, the small booth from a very large and well-financed company suggested that GSK does not consider diabetes to be a major area of focus, although that may have changed recently with the latest Verily deal announced at the start of August.
InSpark reps revealed that Vigilant, the Android and iOS blood glucose pattern recognition app, is no longer exclusively compatible with Accu-Chek CONNECT meters, but any that upload data to platforms such as Apple’s HealthKit. This is a win for BGM users looking for insights into upcoming periods of risk. We reported at ADA that Vigilant will move to a low-cost subscription model, but a rep told us that they now plan to move to a model in which payers cover the cost – this is great to see, since patients are loath to pay for things. On the strategic front, the company is making strides to focus on population health (i.e., a provider can look at a population overview to determine which patients are at risk for short- and long-term complications).
Insulet’s fun booth showed off the company’s new branding in a major way – the feel was markedly less corporate than the Insulet of a few years ago. The pod demo kits have changed a bit, now giving HCPs a clear OmniPod so they can see exactly what’s inside the device. (Apparently this is a frequent question.) Reps handed out popcorn and attendees took pictures with Toby the Turtle, Insulet’s new mascot (the shell looks like a pod, and like the OmniPod, turtles can be in water or on land). iPads demoed the educational storybook app launched at FFL, which has received positive reviews from adults with type 1 (to show their kids) and school nurses. Reps seemed excited about the next-gen PDM, but could not offer further details or timing. Per Insulet’s 2Q16 call two weeks ago, it will “debut” at ADA 2017 (not clear if this means approved or just shown for the first time).
Intarcia’s double-sided booth was all about attracting people to its technology and to its mission, emphasizing innovation, disruption, and rebirth. On one side, the company demonstrated the insertion and removal of its newly-branded Medici drug delivery system (the mini-pump used for the delivery of Intarcia’s implantable GLP-1 agonist exenatide ITCA 650). Doubling down on the background of the Medici name, the system featured the tagline “Renaissance of medicine delivery in chronic disease.” A representative shared that Intarcia hopes to attract pharmaceutical partners to develop additional therapeutics for delivery via the Medici system. However, the representatives were unable to discuss ITCA 650, other potential therapeutics, or anything related to the patient experience of implantation and removal and quickly directed visitors to medical affairs when such topics arose. On the other side of the booth, Intarcia proclaimed “Dare 2 Disrupt!” and invited job applicants to join the company. The recruitment is a testament to the rapid expansion of the company – growing from ~50 to ~250 employees in five years, according to a representative. Intarcia is seeking certified diabetes educators in particular to work closely with physicians and in anticipation of the launch of a patient support program in this innovative GLP-1 arena.
J&J dedicated about half of its expansive space near the center of the exhibit hall to Janssen products SGLT-2 inhibitor Invokana (canagliflozin) and SGLT-2 inhibitor/metformin fixed-dose combination Invokamet (canagliflozin/metformin). The overhead sign announced in bold letters that Invokamet is now approved as a first-line therapy, highlighting a recent expanded indication granted by the FDA. A few clinical data-heavy, outward-facing displays demonstrated superior A1c lowering from Invokana vs. DPP-4 inhibitor Januvia (sitagliptin), but much of the exhibit was focused on a patients support app called “Check Your Numbers.” Conference attendees could see what the app looks like on an iPad and interact with the interface. Representatives highlighted some of the app’s most helpful features: (i) patients can monitor their medications and are better able to stick to their regimen; (ii) providers can print out materials for patients who are less tech savvy; and (iii) the app is integrated with J&J’s CarePath program that streamlines the prior authorization process for providers.
LifeScan brought back the pillars encouraging booth-goers to think about the biggest challenges they face as patients and providers (e.g., time, adherence, access, coordination, other) that we saw at ADA, once again giving reps the opportunity to share how the LifeScan portfolio could address these concerns. While the Animas pump business had the lion’s share of visitors, a few attendees spoke with the LifeScan about the One Touch Verio Flex, just launched this past February with an updated OneTouch Reveal app. A rep shared that Reveal version 3.0, featuring tweaks based on user feedback, will be available as soon as 4Q16, but more likely in 1Q17. There were no updates on the One Touch Via bolus-only insulin delivery patch device – we still anticipate the device to be commercially available in select markets outside the US by late 4Q16 and in the US soon thereafter in early 2017, per ADA 2016. Reps in the bustling Animas section excitedly told patients about the G4-integrated Vibe system. As a reminder from July’s Keystone Conference, a single-arm pivotal trial beginning in 4Q16 will test Animas’ next-gen hypoglycemia-hyperglycemia minimizer with Dexcom’s G5 CGM in 200 adults, adolescents, and pediatrics, slating the product for a November 2017 – May 2018 launch.
Lilly’s booth drew quite a crowd toward the fresh-squeezed lemonade stand located in the center of the booth. Information on its various products radiated outward from the central lemonade stand in an almost flower-like (or “lily-like”) manner. In prime location directly next to the stand, a large free-standing wall featured clinical trial data for GLP-1 agonist Trulicity (dulaglutide) on one side and BI-partnered SGLT-2 inhibitor Jardiance (empagliflozin) on the other side. A little further from these prominent displays, smaller sections featured several other BI-partnered products, including SGLT-2 inhibitor/DPP-4 inhibitor Glyxambi (empagliflozin/linagliptin; with the Pixar-like duo from previous booths making a reappearance), DPP-4 inhibitor Tradjenta (linagliptin), and metformin combinations Synjardy (empagliflozin/metformin) and Jentadueto (linagliptin/metformin). The opposite end of Lilly’s booth devoted significant floor space to its Humulin U500 KwikPen, with the section featuring aqua tones to complement the pen’s aqua-colored body, in a departure from the red and white themes of the rest of the Lilly booth. Flanking the Humulin U500 KwikPen section were spaces devoted to biosimilar insulin glargine Basaglar (with prominent signage emphasizing that it would be available in the US on December 15, 2016) and the Humalog U200 KwikPen (featuring materials suggesting that patients would have to worry less about running out of insulin with the U200 formulation).
MannKind occupied a small booth in the exhibit hall, but put forth a single loud-and-clear message: Afrezza is here to stay. A monitor on one side of the booth played a demonstration of Technosphere technology, while on the opposite side, an enlarged model of the Afrezza device was mounted to the wall. In the center was a simple slogan, written in playful purple font: “You know mealtime insulin. Let’s talk about Afrezza.” Pamphlets on Afrezza featured the slogan “OUTsulin” – a play on Afrezza’s disruptive approach to insulin.
Medtronic’s ample booth had several MiniMed 630G pumps on display, fresh off the approval just a day before AADE started (shipping in 6-7 weeks). It was impressive the pump made it into the booth at all, given the timing. A group of educators surrounded a rep to learn more about the new pump platform’s features, including the color screen, waterproof, remote bolusing from the Contour Next Link meter, and other additions discussed in last week’s report. There was a lot of excitement for the enhanced features, and many asked about the upgrade pathway for current Medtronic pumpers. Reps did not share specifics, but as we noted last week, it will be $599 or $3,100 out of pocket for current users (depends on whether the current pump was purchased after or before May 1, 2016, respectively; assumes the old pump is traded in for a $400 credit). The company confirmed with us separately that there will be a pathway for current Medtronic users to get on the 670G, though Medtronic has not worked out all the details yet. As we noted last week, however, the 630G cannot be software-updated to add the 670G algorithm. It will be fascinating to see how quickly the 630G sells, how quickly patients get on the 670G, and what early experiences are with the first commercialized hybrid closed loop system.
We ran through the 630G’s interface in the booth and several things jumped out:
- The new navigation and screen is a definite improvement over current Paradigm pumps.
- There are now four separate menus that can be accessed from the home screen (a bolus menu, a basal menu, a general pump menu, and a status menu) – we like that bolus and basal are very easy to access now, though the new layout is pretty multi-layered and will definitely require some learning. We have also heard this is true of the 670G.
- Patients can stop a bolus midway through delivery (like Tandem’s t:slim). This is terrific to see, since it’s very easy to change one’s mind after hitting “Deliver.”
- The bolus calculator fits very nicely on the larger screen and shows all the math line-by-line.
- The pump carries doses to the thousandths place, impressive precision (especially for pediatrics). Some in the field might argue this is illusory precision (given bigger sources of error like carb counting), but it could appeal strongly to parents.
- The 630G prominently shows the last entered blood glucose on the home screen when CGM is not being used.
- The new platform is larger and a tiny bit heavier than previous Paradigm pumps. It will be interesting to see how patients trade off the curvier and mildly weightier design for the waterproof, color screen, and other new features. We think the company made the right call, but these nuances of product design are always very difficult.
In a spacious exhibit with plush, gray carpet, Merck highlighted with equal emphasis DPP-4 inhibitor Januvia (sitagliptin) and combination drug Janumet (sitagliptin/metformin). Large displays featured graphs depicting A1c lowering with each drug vs. metformin alone, while two tall, interactive monitors shared specific patient stories and additional data on the advantages of Januvia and Janumet. The only other product making an appearance was Pneumovax 23, a vaccine protecting against pneumococcal disease. Two small, outward-facing monitors displayed six patient scenarios to underscore the importance of the vaccine for people with chronic diseases such as diabetes.
mySugr exhibited on US soil for the second time ever with big news: the limited US launch of mySugr Coaching in September – watch the inspiring and compelling video here, featuring educator extraordinaire Gary Scheiner (“Let’s be honest: doctors don’t have the ability to manage people’s blood sugars on a day to day basis.”). The product will have an introductory price of $19.99 per month ($39.99 ongoing), leverage the world’s most popular diabetes app (Logbook; 770,000+ registered users), and add a killer iPad Pro interface for diabetes educators (coaches) to view patient data and communicate seamlessly with users. Noted mySugr’s Scott Johnson: “I’ve got Gary Scheiner in my pocket.” We got a glimpse of the iPad interface in the company’s exhibit and were impressed – the company expects the chat-like interface will enable coaches to handle hundreds of patients at a time. Gary Scheiner and his colleagues Jennifer Smith and Lisa Foster-McNulty will be the first coaches on the platform, bringing incredible expertise to help the company refine the offering. The introductory launch in September will initially be for 200 patients, and if all goes well, expand from there.
- We appreciated the company’s careful wording – “extend the reach of world-class educators like you” – positioning the app as an enabler for CDEs, not a replacement. We love the vision of “filling the gap between office visits” and giving patients “high-quality personalized diabetes education from the convenience of their smartphone.” In our view, human accountability + technology is where diabetes care must go to drive significant behavior change.
- The mySugr team told us that educators like Gary waste a lot of time downloading data, a handicap that will be increasingly eliminated with this app – patients will take care of data input, with an increasing number of devices sending data automatically to the app (Roche’s Accu-Chek Connect BGM, Dexcom CGM via Apple Health, iHealth meters). More integrations are planned this year, and patients can also upload data from Abbott’s FreeStyle Libre and Medtronic’s Enlite via a web-interface (though the company sees this as an intermediate step.) Educators will have access to the data at their fingertips, eliminating cables, downloading, and wasted effort. The challenge, of course, will be if patients don’t enter any data at all, though this should be less of an issue with an out-of-pocket subscription model and accountability to a coach.
- If mySugr Coaching drives strong outcomes, this model seems like a valuable option for payers and health systems. The service approach is where healthcare (and diabetes) seems to be going, and the use of technology to scale human expertise is the only option for diabetes care going forward – there are too many patients and too few providers for the status quo to continue.
- mySugr now has a US headquarters in San Diego, and CEO Frank Westermann is even moving from Vienna! Now that’s a clear commitment to the stateside market from a company founded and based in Europe. We hope Logbook’s bolus calculator (only available in Europe now) comes here too – US patients do not have an FDA cleared option on the phone aside from Roche’s Accu-Chek Connect (meter required) and WellDoc’s BlueStar (prescription required).
Novo Nordisk occupied two booths prominently featured at the center of the exhibit hall. The larger booth drew a bustling crowd intrigued by Novo Nordisk’s virtual reality game promoting next-generation basal insulin Tresiba (insulin degludec). Attendees donned headphones and a thick pair of black virtual reality goggles and sat turning their heads and rotating in low-slung white chairs along the booth’s periphery. The game featured a detailed and realistic 3D landscape that changed as the participant moved their eyes and rotated their body in space. In this virtual world, attendees could board a small plane, enjoy dynamic birds-eye views of the virtual landscape below, and finally sky dive to the ground below – all while coming across panes of information about Tresiba. The sky diving imagery incorporated well with Tresiba’s messaging in the booth, which lauded its ability to promote “proven A1c descent.” Tresiba dominated the booth’s floorspace and touchscreen displays by a wide margin. Peripheral signage referenced rapid-acting insulin NovoLog (insulin aspart) and GLP-1 agonist Victoza (liraglutide) but there was virtually no mention of Novo Nordisk’s older basal insulin analog Levemir (insulin detemir) or its obesity medication Saxenda (liraglutide 3.0 mg). The second, smaller booth was geared specifically toward CDEs, with a large blue sign overhead reading “Diabetes Educators.” At the center of the booth was a table where Novo Nordisk representatives sat, eager to offer perspective and commentary about Novo Nordisk’s products. Surrounding the table were large, rectangular touchscreen panels featuring patient vignettes and how different combinations of Novo Nordisk drugs fit their diabetes treatment needs.
OneDrop announced the upcoming launch of One Drop Premium: an impressive ~$30-40 per month cash pay for unlimited test strips, a Bluetooth-enabled BGM, 24/7 in-app CDE coaching, and a “digital therapeutics program” (AADE/ADA-based) in the One Drop app. The sharp One Drop Chrome meter (pictured below – we also tweeted about this late last week) is currently under FDA review, and we confirmed with CEO Jeff Dachis that the Premium service is expected to ship in October 2016 – on par with the goal as of SXSW, and impressively, just ~18 months after the app initially launched for iOS in April 2015. One Drop Android is expected to launch publicly in September, and the Premium service will be offered on both platforms – great to see, since most companies go iOS first, leaving many unable to access the benefits. One Drop’s accompanying Indiegogo crowdfunding campaign launched on July 25 and has already raised ~$25,000 – a testament to the interest in the consumer-product-feel and unlimited strips cash-pay model (less than the cost of a co-pay for many patients these days, and well less than the cost of a service that includes coaching). The meter, lancing device, 100-ct test strips, and vegan leather carrying case cost $65 alone, though purchasing a 12-month commitment to One Drop Premium costs only $395 ($33 per month) and includes the kit free. At the high end, a one-month commitment to One Drop Premium is ~$37 per month. CEO Jeff Dachis told us these pre-launch prices will stay roughly consistent once the platform launches this fall – if the economics work out, this would be highly impressive. OneDrop hasn’t disclosed the manufacturer of the meter and strips, but certain components look similar to the AgaMatrix Jazz 2 wireless meter and the original small profile iBGStar (this is our speculation, as neither company would confirm). We look forward to trying the platform and believe many can benefit from the low-cost unlimited strips, in-app coaching, and “look and feel” of the entire initiative.
- A big focus at AADE was the provider side of the new platform, “One Drop Experts” (CDE coaching) and “One Drop Professional” (a population health management offering). One Drop Experts uses a browser-based interface enabling educators to chat with patients (near-time, asynchronous communication). Educators would see all data patients enter into the app, collected automatically (Bluetooth-enabled BGM integration, HealthKit, other devices) or manually inputted (e.g., insulin doses). From our view, the company seems well in line to leverage success through its broad-reaching data and systems – while the system “looks” cool, what’s cooler is the streamlined data and insight it will be able to share with patients. Indeed, OneDrop has said its goal is to be a Big Data company, and in line with this, the company is calling One Drop Professional a “population health management service” targeted at payers and HCPs – very smart.
A Roche rep shared that (i) the company is working hard to bring new innovation to the marketplace including the Accu-Chek Insight CGM in the US (launching by end of 2016 in the EU); and (ii) the next device in the US pipeline is the Medingo-acquired Solo patch pump, which is still under-development and timing wasn’t available – we’re surprised to hear it is still in development! Most of the exhibit hall terrain was dedicated to the Accu-Chek line of meters, though it focused more on the digital features offered to users. Reps were excited to talk about Accu-Chek Connect, the Bluetooth-enabled BGM and paired app that includes a bolus calculator (launched in summer 2015). Anecdotally, patients utilizing the app have seen advances in their diabetes care, not to mention that the online portal makes it easier for clinicians to check in on their patients. There were no updates on the partnership with mySugr (announced in April), which is coming this fall according to mySugr’s blog. Another online tool designed to help patients is Accu-Chek Assist, a simple, yet time-saving web page that provides personalized estimates of out-of-pocket costs for test strips and setup instructions for the Connect BGM. But the main attraction of the booth was the “Target Toss Challenge” – visitors were encouraged to toss a suction cupped object at a graphic of an Accu-Chek Connect three-day report to win prizes (measuring spoons, measuring cups, portion plate, food model). Our favorite part of the game was the tagline off to the side that perfectly captured day-in, day-out glycemic management: “A game of skill and chance.”
Sanofi occupied two commanding booths at the center of the bustling exhibit hall. Sanofi’s main booth was calm and minimalist, as usual, and was sparsely attended compared to others in the exhibit hall. Sanofi dedicated the entirely of its booth to its varied insulin analog offerings. Some signage highlighted flagship Lantus (insulin glargine) and Apidra (insulin glulisine), but the vast majority of the booth’s floorspace was dedicated to next-generation basal insulin Toujeo (U300 insulin glargine). Several touchscreens provided interactive displays pointing to information on Toujeo’s efficacy in clinical studies and ease of use, and the perimeter of the booth was adorned with four-foot tall replicas of the Toujeo pen. GLP-1 agonist Adlyxin was nowhere to be found in the booth, perhaps because it was approved only a few weeks before AADE. Sanofi’s mountain-climbing-themed booth also made a reappearance, dominated by bright red signage and rugged rock walls, beneath large signs reading “Are you a glycemic explorer?” A humming crowd surrounded each of the touchscreens interspersed within the booth, eager to participate in the Glycemic Challenge multiple choice game, which quizzed attendees on little-known facts about insulin therapy for type 2 patients. For instance, one question read “How long do physicians typically wait to add insulin to therapy for patients with an A1c above 8%?” – the answer is a startling 6 years! A counter at the center of the booth filled with healthy, outdoorsy snacks like nuts, wasabi peas, and trail mix drew a substantial crowd as well.
Tandem’s very spacious hardwood-floored booth promoted the company’s trifecta of pumps (t:slim, t:slim G4, t:flex), though our attention was drawn to the pipeline slides on the plasma screens flanking the booth. Reps confirmed the plan (as of the 2Q16 call two weeks ago) to launch the t:slim X2 pump in 4Q16. This pump will be nearly identical to the t:slim, but add a new two-way Bluetooth radio and manufacturing under class III controls. The latter will enable online software updates (via the newly cleared Tandem Device Updater) to add Dexcom G5 and G6 CGM integration and automated insulin delivery algorithms (predictive low glucose suspend, TypeZero hybrid closed loop algorithm). Tandem will be the first pump in the industry to offer this upgradeability, and its fully touchscreen interface (no buttons on the hardware) is a clear enabler on this front (easy to deploy different user interfaces, new menus, on-screen buttons, etc.). Tandem’s upcoming PLGS algorithm was “developed internally in consultation with industry thought leaders,” and the feasibility study at Stanford will be completed by the end of this month (as expected). From hallway conversations at AADE, we heard a lot of excitement from type-A patients about the t:slim X2 – the assured upgrade path (via software updates) de-risks the pump choice process as innovation begins moving at a faster clip.
The Valeritas booth was essentially identical to the one at ADA, presenting the V-Go and promising data from recently completed clinical trials. Valeritas recently cut back its sale force by >50% – a rep shared that the strategy is akin to hitting the reset button, and the company plans to reconstruct the force again, but surround them with more online and social media sales support. AADE was a “highly successful” conference for the company, with good-sized crowds congregating around its booth at multiple points. The rep could not comment on a potential EU launch, though we assume a distribution or manufacturing partnership is possible. CEO Mr. John Timberlake said on a call last week that the company will not establish infrastructure in Europe.
Walmart showcased its very low cost ReliOn brand of diabetes products. A rep shared that there will be a next-gen talking BGM available by next year for <$15, along with next-gen strips, which will use an alternative enzyme. There’s no doubt that the ReliOn products are cheap, but they have come under fire in the recent past for their accuracy, or lack thereof. In response, reps were handing out mini-posters detailing a study that compared the accuracy of the ReliOn Prime with the Abbott Freestyle Lite and the OneTouch Ultra 2. In the trial, the three BGMs were tested side-by-side on the same 180 study participants. The results suggested that the ReliOn Prime and Freestyle Lite were equally accurate, while the OneTouch Ultra 2 performed slightly worse. We wonder if the results will be published in a peer-reviewed journal.
--by Adam Brown, Abigail Dove, Helen Gao, Brian Levine, Payal Marathe, and Kelly Close