AADE 2019 took place in August in Houston, TX. This report includes all of our daily highlights from the meeting, which always offers remarkable insight on on-the-group management of type 1 and type 2 diabetes.
In Diabetes Technology, highlights are split across (i) AID, (ii) CGM, and (iii) digital health. Insulet announced the launch of their Omnipod Dash iOS Apps with secondary display and remote monitoring capabilities. In CGM, Senseonics released US real world data showing high patient satisfaction in a 180-day trial, supporting iCGM. Other sessions focused on the benefit of CGM in young adults and the promise of auto-populating CHM forms using Epic as a new model for clinician CGM training. MedStar’s Diabetes Pathway bootcamp and telemedicine “Virtual Control Center” showed great promise in its mean A1c reduction (11.2% to 8.1%) and $3,000/year cost savings.
Leading highlights in Therapy include new diabetes medications (i.e. oral semaglutide, tirzepatide, SGLTs in type 1, next-gen glucagon), Baqsimi’s (nasal glucagon) possibilities in hypoglycemia treatment, and the future of the type 2 medication landscape. The best of ADA was also reviewed, which included findings on teplizumab’s efficacy, REWIND, and PIONEER 6, among others.
- Big Picture highlights are split across (i) prevention, (ii) psychosocial, (iii) costs and complications, and (iv) additional topics. Various leaders shared their success stories in improving business and operational outcomes associated with Diabetes Prevention Programs, highlighting pertinent, implementable tools and resources. The CDC’s Betsy Rodriguez and Alexis Williams explained how game-based learning can be used for diabetes education and management, and our own Adam Brown discussed his Bright Spots and Landmines for diabetes management. Insulin access and affordability highlighted justified anger in the diabetes community, pointing to systemic failures in the US healthcare system and channeled deep frustrations amongst diabetes care providers. Hypoglycemia was also a focus of AADE: with various talks on reducing hypoglycemia via fear reduction, education, CGM, and frequent discussions.
The full report for AADE 2019 has arrived! AADE took place in August in Houston, TX. This report includes all of our highlights from the meeting organized topically within Diabetes Technology, Diabetes Therapy, and Big Picture. Happy reading!
- Diabetes Technology
- 1. Automated Insulin Delivery
- 2. CGM
- Senseonics Eversense: US Real-World Data Published in DT&T; Outstanding Patient Satisfaction; 180-Day Trial Enrolling to Support iCGM
- Lessons from T1D Exchange and Helmsley’s QI Collaborative: Auto-Populating CGM Forms Using Epic and a New Model for CGM Training
- Dr. Grazia Aleppo on Benefits of CGM in Seniors: “You Can’t Even Put a Price”
- Young Adults Delve into Benefits and Difficulties of Diabetes Tech: CGM Inspires Confidence, Concealment of Many Devices Difficult, Sharing of Data Affords Security but also a Source of Tension
- 3. Digital Health and Additional Topics
- MedStar Diabetes Pathway Boot Camp and Telemedicine “Virtual Control Center”: Mean A1c Reduction from 11.2% to 8.1%, $3,090/Year Cost Savings
- Cecelia Health’s David Weingard and Teresa McArthur and Stanford’s Korey Hood: Technology and Care Teams Should Create “Light Bulb Moments” for Patients
- Real-World Implementation (n=35) of WellDoc’s BlueStar: 0.7% A1c Reduction in Case Group vs. 0.4% in Control Group (Baselines Not Given)
- Quotable Quotes from Kelly Close, Crystal Broj, Daniel DeSalvo, Deb Greenwood, and Jasmine Gonzalvo in “Tic-Tac-Tech: An Expert Panel on the Game of Integrating Technology into Practice
- Early Data from STEPP-UP, Diabetes Technology Guides for Lower-Literacy Patients: No Changes in Glycemia, Increases in Knowledge and Hypoglycemia Fear
- Gary Scheiner Reviews Smart Pen and Cap Landscape: InPen Addresses All Issues Except Complexity; New Study Finds Insulin Users Forget 36% of Basal Doses, 24% of Bolus Doses
- Diabetes Therapy
- Diabetes Medication Options on the Horizon; Excitement for Oral Semaglutide, Tirzepatide, SGLTs in Type 1, and Next-Gen Glucagon Landscape
- 2. Baqsimi Product Theater Highlights Excitement for Newly Launched Treatment Option; Tackles Severe Hypo Myths; Provides Helpful Pronunciation Guide (“back-SEE-me”)
- Highlights from the Emerging Science Industry Posters: Lilly’s Nasal Glucagon Ease of Use (90% vs. 15% success rate for Baqsimi vs. Injectable Glucagon!); DayTwo Data; CREDENCE Review
- What’s New in Type 2 Medications: Pharmacists Point to Oral Semaglutide, Sotagliflozin, and ITCA 650 (!) as the Future of the Field
- Type 2 Pharmacotherapy Session Touches on Optimism about Positive VERTIS CV Results for Steglatro; Advocates for Simply Getting Patients on Any GLP-1 That’s Covered
- Ms. Gretchen Youssef Details the Best of ADA 2019: Teplizumab, D2d, Today2, REWIND, PIONEER 6, Insulin Pricing, Hypoglycemia in Type 2
- Afrezza Product Theater: How Inhaled Insulin Can Reduce the 3-5 Years of Insulin Clinical Inertia, $15 Co-pay Card “Really Works”; Patient Perspective
- Big Picture
- 1. Prevention
- Operational Crises in Managing Diabetes Prevention Programs (DPPs): Tools for Improving Patient and Business Outcomes
- CDC: Game-Based Learning Could Increase Patient Engagement and Retention in National Diabetes Prevention Program (DPP) and Diabetes Self-Management and Support (DSMES)
- “Every Little Step Counts” Diabetes Prevention Program Highlights Success of Culturally Grounded Programs in Minority Communities
- Cities Changing Diabetes Update: Now 22 Cities, 28 Slated to Come on in Next 4-5 Years; Dr. Stephen Linder Describes Underlying Principles of Houston CCD, Introduces Composite Vulnerability
- A Weight Neutral, Non-Diet Approach May Increase Effectiveness of Diabetes Care; “Obesity Paradox” of Mortality and Weight Discussed
- 2. Psychosocial
- Adam Brown Gives His Bright Spots and Landmines for Diabetes Management, Announces New BSLM Journal and 42 Factors Poster Coming Soon
- #LanguageMatters: Why the Language Movement is About Changing Mindsets, Not Policing Words
- AADE’s Practical Approach to Mental Health for the Diabetes Specialist
- Dr. Mark Heyman on Strategies for Overcoming Hypoglycemia Fear: Educate, Challenge Thoughts and Beliefs, Expose, and Refer
- 3. Costs and Complications
- Session on Insulin Access and Affordability Highlights Justified Anger in Diabetes Community
- In with the Fat, Out with the Carbs: Why Dieticians in the 80s Had It All Wrong
- Dr. Diana Isaacs and Ms. Debbie Hinnen on Real World Strategies to Reduce and Treat Hypoglycemia: Education, CGM, and Frequent Discussions on the Topic are Crucial!
- New Systematic Review Highlights a Need for Further Studies on Effect of DSMES on Reducing Hypoglycemia Risk
- Expanding Access to Diabetes Self-Management Training Act Could Lead to $9.4 Billion in Medicare Savings over 10 Years, According to Microsimulation Modelling Results
- Cost Modeling Analysis Demonstrates $300-$900 Savings Per Severe Hypoglycemic Event with Baqsimi vs. Injectable Glucagon
- Dr. Linda Yarrow on Medical Nutrition Therapy to Mitigate CVD Risk
- Virginia Valentine on Best Practices for Managing Severe Hypoglycemia
- 4. Additional Topics
- 1. Prevention
- Exhibit Hall
1. Automated Insulin Delivery
Insulet Omnipod Dash iOS Apps Now Available: DISPLAY (secondary display) and VIEW (remote monitoring)
At a packed product theater, Insulet’s Dr. Trang Ly excitedly announced the availability of the Omnipod DISPLAY and Omnipod VIEW apps for iPhone (see the press release). The DISPLAY app allows users to view pod data from the Personal Diabetes Manager (PDM) data on their own smartphone (secondary display), including insulin on board, last bolus, last meter blood glucose, and a lock screen widget to see pod data side-by-side with Dexcom G6 data. Omnipod VIEW allows caregivers to remotely monitor PDM data from up to 12 Omnipod users. The apps have strong early ratings already (4.7/5 and 3.7/5), and DISPLAY is close to the top 100 most downloaded apps in the Medical category – see the iOS pages here and here. Insulet is now the first company to launch an FDA-cleared, secondary display app that pulls data direct from the pump. (Medtronic’s precursor MiniMed Connect required a keychain uploader to talk to the MiniMed 530G, similar to the DIY RileyLink.) The long-awaited Omnipod apps are launching about two months following the full US launch of Omnipod Dash, and a little over a year after the Dash PDM’s original FDA clearance. Tandem’s similar t:slim X2 mobile app is now expected to launch in 4Q19, in tandem with Control-IQ’s expected launch. Medtronic is poised to launch a companion mobile app with the MiniMed 780G next year. All of these secondary display apps are a stepping stone to the ultimate goal: give users control of their pumps from their own smartphones.
Omnipod DISPLAY brings nearly all of the information from Omnipod DASH PDM available on iPhone. The app communicates with the PDM over Bluetooth, providing insulin on board, last bolus, last blood glucose, active basal rate, and pod status (e.g. battery and reservoir level). DISPLAY also includes an awesome “Find My PDM” feature when the PDM is in Bluetooth range (~30 feet) and smartphone alerts. Lastly, the app has an iPhone “widget” that can be viewed without even opening the app. Omnipod DISPLAY already has 18 reviews on the App Store with an average 3.7/5 rating.
Omnipod VIEW has an almost-identical interface as DISPLAY, allowing caregivers to remotely monitor up to 12 Omnipods. Each Omnipod DISPLAY user can also share their data with up to 12 VIEW users. VIEW will also users to set up alerts on Omnipod status (e.g. occlusion, expired), giving caretakers more peace of mind. The app currently has six reviews with an average 4.7/5 rating on the App Store.
At an Insulet-sponsored event at MinuteMaid Park, Dr. Daniel DeSalvo emphasized the pediatric/parent advantages of remote monitoring – cutting down on text messages and calls. For example, seeing the Dexcom and Insulet data remotely will prevent worries about whether a user bolused for a high blood sugar – it will be clear from looking at the Omnipod app itself. This is a good example of great technology passively taking something away (unnecessary texts/calls/worries) and simplifying communication!
According to a rep in the exhibit hall, Cloud-to-Cloud integration with Glooko (remote, passive data upload) is expected by the end of 2019. This will be a great addition for healthcare providers using Glooko, who won’t need to worry about plugging the Dash PDM in to download it – all the data will be uploaded automatically (presumably over Wi-Fi from the Dash PDM or from the Display app).
Which Patients Should Think About DIY? Gary Scheiner’s Five Considerations: BG Control Sought, Technical Ability, Risk-Taking, Troubleshooting Skills, Equipment/Supplies
Educator extraordinaire Mr. Gary Scheiner (Integrated Diabetes Services) shared five considerations for patients and their providers before starting DIY automated insulin delivery (i.e., OpenAPS, Loop, AndroidAPS): the patient’s desired level of blood glucose control, technical ability, willingness to accept risk, troubleshooting skills, and reliable access to (older) equipment and supplies. For a patient whose goal is to lower A1c from 10% to 7%-8%, they are likely a good candidate for commercial automated insulin delivery systems – i.e., Medtronic 670G and Tandem Basal-IQ. However, for a patient who wants to achieve A1c around 6%, the extra customizability and control offered by DIY systems are necessary. When considering technical ability and troubleshooting skills, Mr. Scheiner emphasized the need to take the patient’s parents, spouse, and support system into account. In two comparative case studies, audience members agreed that a 12-year old with software engineer parents was a better candidate for DIY AID than a 57-year old who relies on her diabetes team for troubleshooting advice. Mr. Scheiner also noted that the difference was not simply due to age; he has seen patients as young as 18 months and as old as mid-70s be successful with DIY systems.
In a great analogy, Mr. Scheiner described a hybrid closed loop system (i.e., automated basal modulation) as a big, fast ship with a small rudder trying to navigate through an ocean full of icebergs (e.g. food, exercise, stress, bolus insulin, medications). He described several limitations of commercial systems, including conservative algorithms, lack of individualization, and slow product adaptation, that drive people to use DIY systems. We hope this changes in the coming years as the next-generation of commercial AID systems come online – especially with faster iteration potential via mobile software and iController/ACE Pump/iCGM frameworks.
As part of her discussion on how CDEs should discuss DIY systems with their patients, Ms. Jennifer Smith (Integrated Diabetes Services) emphasized that clinicians are not responsible for how patients decide to use their pumps, only the “clinical veracity of our recommendations.” For Ms. Smith, all options, including DIY, should be discussed with patients and the importance of setting realistic expectations is key – i.e., that no existing system is truly “closed” and all require some level of engagement.
Selected Questions and Answers
Q: I have an old, extra Medtronic pump I carry around with me when I travel, but I’m not on DIY. If I used it for DIY and it dies on me, is there a black market of old Medtronic pumps? My insecurity for my patients and even myself is if the pump dies, what do you do?
Gary Scheiner: That’s part of the risk. You are SOL if your old Medtronic pump dies; they’re not easy to come by. There is a black market for them, selling them online through eBay. It’s an important point. Both Loop and OpenAPS, if they’re not fully functional they revert back to standard settings. In that way, they’re like commercial hybrid closed loop systems.
Jennifer Smith: Online is the real place that people are finding them. In the Looped Facebook group there is really good documentation specific to Loop which also has very well-documented directions for how to know you’re buying from a reliable seller. It’s a great place to know you’re getting something that’s good. For me, if my old Medtronic pump died, I could switch back to my old Omnipod.
(Editor’s Note: In-warranty, non-Dash Omnipods are of course now compatible with Loop – read the latest on that here.)
Q: I’m at Children’s Hospital of Wisconsin, and we have ten patients on Loop. We’ve talked to risk management and gotten a contract. It says that “it’s not suggested, but we’ll still follow you.” At our pump try-on classes, we talk openly about all the different pumps and give instructions on each one. How would we address DIY there?
Ms. Smith: Would you recommend DIY systems to a brand-new pumper or CGM user? Honestly, they’re going to learn about it online. It’s important to have complete disclosure: it’s not FDA-approved. It’s really important to openly talk about it and for educators to say conventional pumping has its worth. You can say, “Let’s start here,” and dial in everything first. DIY is hard for kids; I have a client who went into Loop a month after diagnosis, but I moved them back to conventional pumping first. It’s not a bad idea to present it as an option, but not a great idea for brand new pumpers.
Q: Is there an example of someone averaging over 200 mg/dl and wants to Loop? How do you titrate down without being too aggressive?
Mr. Scheiner: The beauty is the ability to customize the targets. All the parameters can be customized, so you can set a relatively high target – you don’t want anyone to start experiencing relative hypo when they drop too quick. The customizability is great for someone who already is in poor control.
Q: We are now getting ready for school and we can’t promote something that’s not FDA-approved. How does a school-nurse approach the topic?
Ms. Smith: There are some very good resources in Loop Docs that are school-nurse specific. For a school-nurse, it says what they can do and what they shouldn’t do. I’ve seen so many nurse-specific guidelines or school-specific guidelines that are documented.
Before AADE officially began, Senseonics CMO Dr. Francine Kauffman reviewed very positive real-world data from 90 days of Eversense wear – the same data presented at ADA, and Dr. Kaufman excitedly reported that full results have been published in DT&T. Users spent an average of ~15 hours/day time-in-range, had a mean GMI of 7.2%, with time below 70 mg/dl of ~4% and time spent >180 mg/dl at ~34%. These values compare favorably to similar real-world CGM trials and are fairly close to the just-published time-in-range consensus goals. Patients wore the Eversense 20 hours/day, one-third were CGM-naïve, and 80% had type 1 diabetes. MARD for Eversense against home BGM was 11.2% over the 90-day period, which is very strong relative to fingersticks.
Patient satisfaction metrics have been outstanding in early US users, with ~79% of patients (n=143) opting to receive another sensor after 90 days. In a survey, mean satisfaction was 4.2/5, with both training and customer support at 4.5. 84% of respondents were likely to recommend Eversense . The 21% of users who discontinued Eversense were not asked about their reasons, but insurance coverage “may well have been an issue.” We certainly agree about that. We’re excited about as many differentiated CGM options possible – a rising tide lifts all boats.
Eversense now has ~500 US prescribers and ~250 healthcare providers trained on insertion. A series of slides emphasized the importance of choice in CGM, noting some of the advantages of Eversense: no need for frequent self-insertions, on-body vibration alerts without a phone, gentle adhesive patch, and high transmitter wear time.
The 180-day Eversense XL PROMISE pivotal study (n=180) is still recruiting. 90-day data from this trial (ClinicalTrials.gov page) will be used to obtain an initial iCGM indication, with launch for the 180-day wear and reduced calibrations Eversense XL expected in 2020 (as of 1Q19).
In line with recent updates, one slide shared pipeline plans – including calibration reduction, pediatric labeling, interoperability, 365-day wear, and on-demand swiping to obtain a real-time glucose value without the transmitter (a fully implantable form factor!). These will be exciting advances for Senseonics and make the value proposition even more compelling.
Michael Smith (Nationwide Children’s Hospital) and Dana Hrobar (Texas Children’s Hospital) shared lessons from their hospitals on increasing CGM uptake as part of the T1D Exchange and Helmsley Charitable Trust’s Quality Improvement Collaborative (QIC). The QIC is comprised of a data platform of 30,000 individuals, as well as 11 US diabetes centers. The initiative brings together physicians and educators to improve care using quality improvement methods aimed at filling the gap between innovation and uptake. Small changes are implemented in individual clinics, allowing successes to then be disseminated across the network and scaled. After a short introduction, Michael Smith and Dana Hrobar shared two of those successful programs.
At Nationwide Children’s Hospital in Columbus, OH, Michael Smith was able to reduce the time for patients to get access to a CGM from two weeks to a few days. Mr. Smith serves as the Endocrinology Clinical Leader at Nationwide, but used his background in computer engineering to make the CGM acquisition process much easier. He worked with Epic and Dexcom to make the process completely electronic. Staff can click a button in EHR which pulls in a letter of medical necessity (LMN) that is auto-populated with data from Epic (e.g. name, demographic, A1c, etc.). Another click automatically attaches chart notes and sends the letter to the provider for an electronic signature. The provider can then send the LMN straight to Dexcom. The program was extremely successful, with about half of Nationwide’s patients now using CGM.
Mr. Smith is now working on auto-populating prior authorizations. Automating the LMN process took about four months of work, though he expressed hope that he could get things running faster the second time. Lastly, Mr. Smith encouraged hospitals who want to implement a similar system to reach out to companies (e.g. Epic and Dexcom) for help and emphasized the need for a strong, internal champion with IT knowledge for the project. For more on Dexcom’s EMR efforts with Epic at UVA, see ATTD 2019.
At Texas Children’s Hospital, CDEs and physicians were able to develop a new model to accommodate increasing CGM interpretation visits without getting overloaded. In the old model, patients would meet with their endocrinologist, then subsequently review their CGM data with a CDE. By the time the CDE had gone over the patient’s CGM data and developed recommendations, the endocrinologist had moved on to the next patient. By moving the CDE visit before the endocrinologist’s visit, the CDE could meet with the endocrinologist right before the endocrinologist entered the room and go over their recommendations. According to Ms. Hrobar, the new clinic flow is very popular with physicians, CDEs, and patients, and helped patients feel more empowered to make adjustments on their own.
Dr. Grazia Aleppo on Benefits of CGM in Seniors: “You Can’t Even Put a Price”
Dr. Grazia Aleppo (Feinberg School of Medicine) kicked off AADE 2019 early Friday morning with an explanation of her “stepped” process to starting her senior patients on CGM, which she has done for ~150 of the senior patients she sees. The first step is getting her patients set up with hypoglycemic alerts. According to Dr. Aleppo, older adults are more at risk for hypoglycemia and also have higher rates of hypoglycemia awareness; for this reason, she also does not usually recommend flash glucose monitoring (e.g. FreeStyle Libre) for seniors. (though FreeStyle Libre 2 will correct this, once FDA cleared.) After a few weeks of CGM data, Dr. Aleppo begins to review the data with her patients, eventually adding in hyperglycemic alerts, and finally working up to dosing based on CGM trend arrow guidelines. In her practice, Dr. Aleppo has seen senior patients, many of whom have lived with diabetes for 40-50 years, learn to feel comfortable again with driving, hiking, biking, and more by getting on CGM; “nothing is sweeter – you can’t even put a price on that.”
Dr. Aleppo also gave an overview of results from the WISDM study (n=203), presented at ADA, which showed a primary outcome of 1.7% absolute reduction in time spent <70 mg/dl (27 minutes/day) for seniors using Dexcom G5 after eight weeks. The number of severe hypoglycemic events (defined as requiring assistance from another person) was 10 in the BGM group and just 1 in the CGM group! See our ADA 2019 report for our full coverage.
In her talk, Dexcom’s Director of Medical Science and Education, Ms. Christine Pospisil, noted that the open rate for Dexcom Clarity app’s weekly summary report notification is 80%, an impressive number we’d never heard before. As she made her case for moving beyond A1c, Ms. Pospisil gave an explanation of the glucose management indicator (GMI) and cases when it may paint a different picture than lab-measured A1c. GMI is a measure, calculated from CGM values, of the “estimated A1c” for users if recent behavior was maintained for three months. For example, one user had a lab-measured A1c of 6.9%, but a GMI of 7.4% because he had been traveling and eating out more over the past couple weeks. We note these values can also differ based on red blood cell turnover, where the GMI would be a more accurate picture of glycemia vs. A1c; see Dr. Rich Bergenstal’s ADA talk. Dexcom’s Clarity app can generate weekly reports with GMI and a breakdown of time spent in blood glucose ranges, which users can easily compare with the newly updated ADA Standards of Care.
Questions and Answers
Q: When will G6 be available for Medicare?
Ms. Christine Pospisil: Publicly, it should be available Q4 - very, very soon.
Q: When your GMI and your A1c don’t match, is there any time you’d trust A1c?
Dr. Aleppo: Not really. I’m more glucose-centric than A1c-centric, so I trust the GMI more. Sometimes, especially with women who have higher glucose during their periods, with one click I can understand 30-, 60-, 90-days and have the glucose graph tell me what I need to know. Your GMI is what your real glucose levels are at.
Q: The Standards of Care have different time-in-range goals for different people. Who falls in the older/high-risk category?
Dr. Aleppo: Cardiovascular risk or if they have reduced kidney function.
Q: Does Dexcom have any information on use in dialysis or hepatic failure?
Ms. Pospisil: It is not approved for use in CKD.
Dr. Aleppo: This is off-label, but I use them in dialysis. It’s very helpful, especially with the insulin being removed with dialytes. I use it off-label and patients love it.
NYU’s Ms. Neesha Ramchandani presented the first results from her PhD dissertation, digging into the benefits and challenges experienced by young adults with diabetes technology. 100% of participants in the small (n=21, 18-29 year-olds with type 1) but in-depth, interview-style study were on pumps, and 74% were using CGM, averaging 27 days/month of sensor data – this would appear to be a fairly tech-savvy group. In general, participants found that CGM afforded “a little more confidence” in their ability to manage their blood glucose, albeit to the point of dependency; anxiety at the thought of being separated from a CGM was particularly prevalent in younger females who had not attended diabetes camp. This demographic also found it difficult to conceal the many devices and insertion sites, which served as a constant reminder of their diabetes (“a mental burden”). The ability to share data garnered mixed reviews: While the majority appreciated the safety or “insurance” of someone else tracking CGM readings, others noted that it can create angst and tension between them and their sharer, particularly with a significant other (“it’s like moving in”) or with parents. Those choosing not to use CGM noted the added stress that comes with inaccuracy and constant/inconvenient of alerts. Specific to Medtronic’s 670G hybrid-closed-loop, users were happy when in auto-mode but struggled after being kicked out or woken up in the middle of the night to calibrate. To this end, Ms. Ramchandani concluded that the ability for the young adult to choose their own device – the one that works best for them, rather than the one unanimously prescribed by a provider – is extremely important to success and quality of life, even if it’s not the newest device on the market.
Intriguingly, no diabetes apps were used by Ms. Ramchandani’s study cohort, except two users of Nightscout for DIY closed-loop systems. Considering that this demographic – young enough to ensure tech literacy, but old enough for at least some autonomy in diabetes management – would seem to be a key market for diabetes apps, we were intrigued to here this. Ms. Ramchandani did not provide reasons for the aversion to apps.
3. Digital Health and Additional Topics
Ms. Gretchen Youssef and Ms. Carine Nassar from MedStar, a ten-hospital system in the Baltimore-Washington area, presented encouraging results from a 12-week “Diabetes Pathway Boot Camp”: mean A1c dropped 11.2% to 8.1% in the intervention group (n=366) after 12 weeks and created an estimated $3,090/year in savings from averted hospitalization costs. The program identified people within the MedStar system with type 2 diabetes and A1c ≥9.0% who had been referred to “Diabetes Pathway” by their primary care providers. In the first visit, participants have a detailed conversation with a CDE, focusing on barriers to medication adherence and taking fingersticks, eating patterns and access to food, and self-care behaviors. At visit one, patients are also given a cellular connected BGM (Telcare) that automatically uploads data to a provider dashboard and Diabetes to Go, a series of booklets on understanding hypoglycemia, hyperglycemia, meal planning, various diabetes medications, and taking fingersticks. The group also developed a medication algorithm (with input from endocrinologists, CDEs, and primary care physicians) to allow nurse practitioners to make medication changes. A week later, the patient reviews their use of the BGM and any patterns with a CDE. They also discuss barriers to medication adherence, meal planning, develop a diabetes self-management support plan, before being “handed-off” to their NP in the virtual clinic. This hand-off can occur in-person, but usually happens over telephone or video call. For weeks 3-12, the patient is monitored at MedStar’s Virtual Control Center (VCC) which is managed by NPs. The NP contacts their patients at least once a week, depending on need, through email, phone, or text, and reviews any blood glucose patterns, medication adherence strategies, medication titrations, and patients’ self-management plans. When patients are first making medication changes, they are often contacted multiple times a week. With the cellular-connected BGM, NPs can contact their patients once a hypo- or hyperglycemic reading is recorded, helping create moments of learning for both the patient and their provider. After 12 weeks, the patient is “graduated” from the program and returns to their normal primary care physician or endocrinologist. The approach seems similar in many ways to Livongo’s Diabetes program.
An analysis was performed on the 366 patients who had completed “Diabetes Pathway” by February 2018, using 366 controls matched based on age, sex, race, insurance group, and baseline A1c. After three months, patients in the intervention group saw a 3.1% reduction in A1c (baseline: 11.2%), while patients in the control group saw a still-meaningful 1.4% reduction (baseline: 11.3%; p<0.001). Perhaps more notably, patients on the intervention had 5x higher odds of reaching an A1c <8% and 7x higher odds of reaching an A1c <7%.
MedStar’s Boot Camp also produced statistically significant reductions in acute care utilizations (defined as emergency room visits and hospitalizations). After three months, participants saw a 77% reduction in hospitalizations and 38% reduction in inpatient admissions (p<0.001). Boot Camp patients did not have a statistically significant difference in overall acute care utilization compared to the control group, though the Boot Camp patients were starting from a much higher baseline, since patients were often referred to the program after an event (53% higher risk of utilization in the past 90 days).
Based on the reduction in acute care utilizations, Boot Camp participants were projected to save an average $3,086/year in averted hospitalization costs. The presenters did note that this calculation did not take into account potential added costs from medication changes. A full cost analysis is in progress, which will take the cost of administering Boot Camp, insurance reimbursement for hospital visits, costs of new medications, and hospitalizations averted.
Patients and providers both reported very high satisfaction with the program. In initial feedback from the program (n=98), 94% of patients reported being “very satisfied” with the program and 98% reported being “very satisfied” with their progress. For the ten providers who responded to a survey, all ten reported being “very satisfied” with the structure and quality of care and all requested that the boot camp become an established program in the MedStar system.
Follow-up data from the program is very limited, but shows mixed results. In the pilot study (n=98), 44 patients had a recorded A1c six months after program completion; about one-third saw an A1c increase >1%. Only 28 patients had a recorded A1c one year after program completion; 45% saw an A1c increase >1%, though 57% still had an A1c at least 2% below their initial baseline. This might suggest the “Boot Camp” actually needs to be an ongoing program, which would not be surprising – given the chronic nature of type 2 diabetes.
MedStar is in the process of rolling out the Diabetes Pathway Boot Camp to seven hospitals and even a few primary care clinics. The expansion will require training of new educators at the various sites and a physician or NP to oversee each location.
During Q&A, an audience member asked about reimbursement for Virtual Control Center calls. Currently, MedStar is looking into remote monitoring codes, but noted that it’s been “very, very complicated.” The presenters also noted that MedStar takes on the full cost of its Medicare patients in Maryland and all 32,000 of its employees. “The way MedStar looks at this is that half of our patients are patients that we are responsible for 100% of their cost, and we can get half of them to do well, we can pay for ourselves.”
Cecelia Health CEO David Weingard and VP Teresa McArthur, along with Stanford’s Dr. Korey Hood, outlined their ideal for the relationship between patients, diabetes care teams, and technology. Ms. McArthur explained the “magic of the light bulb moment,” when patients, empowered by data, with the help of CDEs, have a realization that prompts behavior change. The patient-centered focus was a major theme, with Mr. Weingard explaining that neither technology nor coaching are diabetes solutions (on their own), but rather components of a broader support system for patients. The role of coaching, Ms. McArthur explained, is to provide patients with individualized advice from a holistic standpoint, including the development of individualized eating, exercise, glucose monitoring, and insulin injection routines together. Her vision of coaching’s important role is pictured below:
Ms. McArthur also shared insights from the Helmsley-funded Cecelia Health and Jaeb Center “Geek Squad” pilot program (n=36) to guide patients in Wisconsin through CGM adoption outside clinical practice. Notably, the study (announced ATTD 2019) was device agnostic, meaning CDEs help participants choose the best CGM based on their unique needs. The CDEs provided ongoing support to patients, including virtual training on device set-up, data set-up, and data interpretation for three months. Key takeaways from the pilot included the value of video calls in working with patients, patients’ trust in the data, and setting up meetings at convenient times. See our coverage of “Geek Squad” at D-Data Exchange; full results from the pilot are expected to read out at ATTD 2020. With promising pilot results, “Geek Squad” is planning to run a bigger study with 200-300 people in 5+ states in late 2019 or early 2020.
WellDoc’s Ms. Malinda Peeples, Mr. Stephen Lynch (MGH), and Ms. Kathy Schwab (Providence Health & Services) presented mixed results from WellDoc’s diabetes management app, BlueStar. The system includes a smartphone app for patients that integrates device data, provides real-time automated feedback and insights, and a way to contact care teams. Care teams can use BlueStar to get clinical decision support and auto-generated reports. Lastly, health systems or payers can use the platform to track engagement and evaluate performance. To test BlueStar, Ms. Schwab’s team coordinated its implementation into a health system of >40,000 patients with diabetes, overseen by a mere 14 full-time diabetes educators. Of the 537 patients with type 2 diabetes who qualified for the study, 109 were given the prescription needed to use the app; only 35 patients chose to enroll. After three months, patients who participated in the program experienced a 0.7% reduction in A1c, compared to 0.4% in non-enrolled control (baselines not shown); it’s unclear if these differences were statistically significant. Disappointingly, pharmacist productivity actually decreased slightly with the app (81 minutes/initial visit vs. 75 minutes in non-enrolled), but Ms. Schwab suggested that the added time was due to inexperience with the product rather than the product itself. Whether or not the app met its net promoter score goal could not be determined due to the small sample. Just 8 of the 35 patients were “highly engaged,” meaning they used the app on at least 63 of the 90 days studied (i.e., on two out of every three days). Ms. Schwab expressed disappointment towards the limited patient interest but noted that WellDoc management still fully supports the continued development of the app.
BlueStar is now on version 2.0 since the pilot app launched in 2013. The app was originally launched as a prescribed app for people with type 2 diabetes on fingersticks. WellDoc announced earlier this year that it submitted BlueStar to FDA (510(k) clearance) to add CGM integration, type 1 diabetes support, and insulin-on-board; we’re not sure if that has rolled out yet. The app store pages (Apple, Android) do not indicate that CGM integration has launched, though logistically it may already be possible to pull in Dexcom CGM data from Apple Health. The app also has a more streamlined enrollment workflow as well as data integration with Epic using Xealth digital prescribing and analytics.
Ms. Peeples prefaced the talk by discussing the astonishing rate at which the digital health scene has grown. She noted that while traditional therapies usually take around 17 years to go from lab-bench to practice, smartphones have been widely adopted in just 10 years. Ms. Peeples cited the importance of using a “digital therapeutic ecosystem approach” that benefits patients, care teams, and overall health systems. BlueStar’s automated Digital Support System (DSS) acts as a middleman between the in-app diabetes coach, care team clinical decision support, and a population management portal. At the ecosystem’s best, patients can (i) benefit from rapid provider connection; (ii) care teams can access comprehensive health reports (containing patient medications, blood glucose records, time-in-range, etc.) generated by the app; and (iii) health systems can leverage aggregate data to attain quality ratings.
On CGM Access
“The biggest struggle we’ve mentioned here is how do you increase access. If you don’t increase access, [the tech] will be a moot point. To overcome these barriers, it really revolves around access through insurance. For my population, Medicaid coverage is critical. We have “Medicaid coverage” of CGM in Indiana, but there are hoops that need to be jumped through for somebody with Medicaid to access CGM. I can’t write a policy and procedures for how to do it, because it’s a different barrier every time: they didn’t get the fax, we didn’t put the right documentation, etc. We have coverage, but how do you streamline that process and overcome these random barriers? When I try to obtain these devices for people, it feels like a heavy lift when that request comes across my desk. I’m literally working for a request from June 11… still working on getting her Libre. That’s with it covered on her formulary; I can’t even tell you what the barriers are. Until we get standardized, guaranteed, insurance coverage, we’re going to be overcoming these obstacles at this for a while.” – Dr. Jasmine Gonzalvo
“It’s so important that we advocate for our patients - that all folks have access to these technologies. Texas, unfortunately, is one of those 12 or 13 [Medicaid] states that doesn’t cover CGM, so if we unite and come together, and share the stories, the impacts that these technologies can make on the lives of patients. What we’ve done at the center is write letters to Austin, the state capital, to try to make the case that Medicaid should cover CGM. We’re also bringing into the fold patients and their families to talk about the impact CGM has had for them. We think we’re getting close – time will tell.” – Dr. Dan DeSalvo
On How Diabetes Tech Can Enable Behavior Change
“There’s a term I heard from Dr. Jake Kushner, where he describes CGM as a ‘heuristic learning tool,’ meaning you learn cause and effect. It’s an amazing behavior modification tool…Learning these tips and tricks, like from Bright Spots & Landmines, can be so useful in long-term diabetes treatment. With CGM as a behavior modification tool, I focus on three main things: (i) Nutrition - understanding how different foods affect your blood glucose in different ways, understanding that not all carbs are created equally. (ii) Treating hypoglycemia – we often teach the rule of 15 g of carbs when below 70 mg/dl. That rule is different for different people … for me, I learned that 4 g of carbs raises my glucose by about 10 mg/dl… (iii) Pre-meal dosing – by looking at trends, you can get in front of your bolus to avoid that post-meal spike.” – Dr. Dan DeSalvo
On Diabetes Tech and Value-Based Care
“We’ve seen some movement in having new reimbursement codes for the time to look at data. My hope is with value-based care, when fee for service is gone, CDEs can really jump in and take over the space of reviewing data and being able to take the opportunity to really dive into the data and use those data to help people make decisions and make changes. What I hear now, and with people that I used to work with, is just that there’s no time in the day for people to use data to change. That’s where I have hope.” – Dr. Deb Greenwood
“Technology is really great for communicating data. As we get into more of a value-based care model, where quality is being measured, having that data is really important. But getting and using that data means it’s imperative to engage those people with diabetes. That means they need to have a good caretaker that can support them and that’s where CDEs fit in.” – Ms. Crystal Broj
“With my area of expertise in the underserved population, what we know from device usage in minority populations is that the racial disparities are actually lessened when you increase access - you begin to see the A1c disparities close. That’s an obvious advantage with value-based care, to see an improvement where there, historically, are disparities.” – Dr. Jasmine Gonzalvo
Selected Questions and Answers
Q: How can we incorporate pharmacists in the total care for patients? In my experience, even in the best case, the patient sees the diabetes educator and the educator is the person who educates the patient on their medication.
A (Jasmine Gonzalvo): The best way to answer that is to describe the relationship I have through a collaborative practice agreement. Usually, pharmacists that are working in the clinic setting alongside providers have gone to six years of pharmacy school and then two years of residency training. Those are typically the pharmacists that are most interested in the jobs at clinic sites, and depending on state law, you can set up a collaborative practice agreement, allowing you to have certain responsibilities from evidence-based guidelines. That’s how the collaborative relationship can be most productive: it gives the pharmacist a lot of independence with medication management and initiation. We use evidence-based guidelines in a very collaborative way with all the other providers on site.
A (Daniel DeSalvo): At Texas Children’s Hospital for inpatients, we do multi-disciplinary rounds with the physician, med-site nurse, CDE, RD, and the pharmacist is a really important part. We do rounds together and the pharmacist visits with every single family to go over medicines, especially diabetes medicines, and supplies.
Q (Cherise Shockley): People with type 1 diabetes have access to endless technology, which is really exciting. My concern is that people with type 2 diabetes are being left behind. All of this technology is phenomenal. No matter what type of diabetes you’re living with, you should have access. We come across people with type 2 diabetes who are struggling and giving up hope because their providers tell them they should have an insulin pump or CGM and they’re tired of fighting with their insurance company. What do you say those people and to their educators who are fighting this battle daily?
Dr. DeSalvo: Thank you for that comment. I think that’s why we had so much discussion on the need for us to fight. Keep on fighting that good fight. Thank you for what you’re doing for your patients, how you lift them up and make them feel emboldened to manage their diabetes, and if they don’t have access to CGM or pump, make sure they have access to the other things and guide them in that journey and don’t give up.
Kelly Close: All of the patient advocacy in working with the professional groups is why the standards of care and Medicare now recommend CGM for anyone on insulin. We’ve been fighting at diaTribe to get CGM for anyone on insulin or SUs or anything that causes hypoglycemia first. But, eventually, hyperglycemia is the next thing we’re going to fight for. Sometimes people don’t even know what’s in the standards of care, so thank you to all the professional organizations for working on that and getting that word out.
Deb Greenwood: Another challenges with type 2 diabetes is that people are usually managed in primary care. We know a lot of primary care physicians honestly don’t know what to do with all the data. That’s a learning curve that will come, but it will take us and others like us to push for it.
Ms. Valerie Ruelas (Keck School of Medicine of USC) shared some early data from the STEPP-UP project, demonstrating that lower-literacy diabetes technology guides could increase readers’ diabetes knowledge, but also their fear of hypoglycemia. STEPP-UP, funded by the Helmsley Charitable Trust, used focus groups, patients, and community advisors to develop a series of simple language (5th grade reading level) guides to insulin pens and pumps and lessons to accompany the guides. Sixty-four adults with type 1 diabetes were enrolled in a six-month observational trial of the guides and classes, with full data available for 50 of the participants. After six months, there were no statistically significant differences in glycemia, depression, or diabetes distress; however, participants saw increases in their diabetes knowledge (p=0.03) and their fear of hypoglycemia (p<0.001). Notably, some patients moved from syringe injections to pens or a pump (see below), though the movement was not major. The guides are open-source and available in English and Spanish here.
From meetings with patients and community advisors, the team found that a Q&A conversation format was a key feature of the guide. These example conversations helped create repetition of the material and a more relatable context for the information. Illustrations to break up the text were a common request from focus groups, requiring the team to come up with detailed, but generic (non-branded) images of devices.
Highly regarded educator Mr. Gary Scheiner reviewed the emerging smart insulin pen and cap competitive landscape, concluding that Companion Medical’s InPen addresses the greatest number of challenges faced by people injecting insulin. (It’s also the only product on the market!) As motivation, newly published data in Diabetes Care found that 36% of basal insulin doses and 24% of rapid acting insulin doses were missed or forgotten by adults with diabetes (the study used Common Sensing’s Gocap and Dexcom G4). Translating this to A1c, a 2008 study found that two missed bolus doses/week can confer a 0.3%-0.4% increase in A1c and two missed basal doses/week a 0.2%-0.3% increase in A1c. (These are probably underestimates in our view, since those studies did not use dose capture devices.) However, teaching dosage adjustments can take prohibitively long for providers, not to mention numeracy issues among patients (56% (!) of people with diabetes in one study were unable to count carbohydrate grams using a food label). Altogether, Mr. Scheiner identified data logging, missed doses, meal dose calculations, stacking, double-dosing, spoilage, and added complexity of as the major challenges faced by people who inject. So how do the currently approved and closest-to-market connected pens and caps stack up?
Companion’s InPen – temperature monitor, Bluetooth to app, customizable dose calculator, displays and adjusts for insulin on board, generates log reports, missed bolus/basal reminders, FDA-cleared, prescription required: addresses missed doses, double dosing, dose calculations, bolus stacking, spoilage, logging accuracy, logging detail, and training time. The only issue on Mr. Scheiner’s list that the InPen did not meet was “complexity.” Relative to reusable insulin caps, we’d argue InPen is actually simpler, as it doesn’t require recharging, twisting, or any kind of device management. The one downside is the need to get a separate prescription for an insulin cartridge.
Common Sensing’s GoCap – tracks doses and units left in Sanofi (Lantus/Apidra) disposable pen, missed dose alerts, temperature alerts, smartphone app with blood glucose and carb entry fields; commercial launch is slated for 2020, according to Mr. Scheiner: addresses missed doses, double dosing, spoilage (temperature monitoring), logging accuracy, and logging detail (though full detail requires close attention by user). We note one downside of GoCap is the need to twist the cap into place to read the amount of insulin in the pen – more complicated than something like InPen.
Novo Nordisk’s NovoPen Echo (FDA cleared) and NovoPen Echo Plus – displays last dose, time since last dose, and insulin-on-board, latter has 800-dose memory, insulin on board: addresses double dosing, logging accuracy, and complexity. These were CE Marked last fall and Novo Nordisk expected broader launches this year. We haven’t heard updates on this front.
Lilly’s smart pen is under FDA review, as of 1Q19 (April); the team has been expansive in forecasting diabetes “connected care” launches between now and 2021.
Bigfoot Medical’s Timesulin – tracks time between doses on disposable pens; it is not yet FDA-cleared: addresses double dosing and complexity with its simple, on-cap display. As of our interview with Bigfoot in June, the company had pivoted to “aggressively” prioritize Unity, its smart pen MDI titration system, as its first product launch in 2020. Bigfoot Unity aims to include smart caps for disposable insulin pens, basal and bolus insulin dosing advice that appears on the pen cap screens, the ability to scan the FreeStyle Libre 2 sensor with a pen cap, and a paired Bigfoot smartphone app that can receive alarms from the FreeStyle Libre 2 iCGM.
Diabnext’s Clipsulin – counts clicks on most commercially-available pens, displays last dose, Bluetooth transmission to smartphone app with HCP platform for data viewing; not yet FDA-cleared: addresses double dosing, logging accuracy through its app, and complexity with its simple UI. We’re skeptical that FDA would be comfortable with the accuracy based on audible clicks, but who knows.
Many other smart pens and caps are currently under development – see our competitive landscape for the full picture.
AADE Educator of the Year Dr. Diana Isaacs (Cleveland Clinic Diabetes Center) and Dr. Andrew Bzowyckyj (Pacific University Oregon School of Pharmacy) provided a valuable overview on what’s to come in the realm of diabetes medications. Both speakers highlighted promising therapies currently in the pipeline, with notable focus on Novo Nordisk’s oral semaglutide, Lilly’s phase 3 GLP-1/GIP dual agonist tirzepatide, SGLT inhibitors in type 1 diabetes, and next-generation glucagon products:
Dr. Isaacs expressed serious enthusiasm over the potential for oral semaglutide to grow the GLP-1 class, pointing toward its ability to break down barriers commonly associated with GLP-1 prescription. Dr. Isaacs noted that a common reason why prescribers often shy away from using GLP-1s in practice today is the complexity and confusion surrounding how to order the pens that currently available GLP-1s are administered in. Prescribers can often be confused with how many pens to order each month for their patient based off of the varying doses – she emphasized that “unless you have an organized chart explaining this in your office, this can be extremely confusing.” On this front, oral semaglutide should represent a major shift, as its once-daily pill form will be much easier to prescribe (although the morning fasting requirement will require another layer of education that prescribers must consider). Regarding pricing for oral semaglutide, Dr. Isaacs emphasized that the price for the therapy still remains unknown, and that this all-important fact will most definitely impact where the therapy ultimately ends up in clinical practice algorithms. Speculating a bit, Dr. Isaacs noted that the actual dose of the semaglutide molecule is higher in the oral formulation when compared to injectable semaglutide – will this somehow impact price? We also note that manufacturing questions regarding the SNAC technology used for the novel oral formulation will certainly play into these discussions. Although Novo Nordisk itself has not formally commented on pricing decisions, we have sensed a general sentiment that oral semaglutide will be positioned to compete with other oral therapies (instead of other injectables within the GLP-1 class) – could this mean a similar price point to other orals as well? As a reminder, Novo Nordisk submitted oral semaglutide to FDA with a priority review voucher in March 2019; a decision is expected by September 2019. Additionally, CV indications for both Ozempic (injectable semaglutide) and oral semaglutide have been submitted and decisions on both are anticipated ~January 2019.
Optimism abound for Lilly’s Baqsimi (nasal glucagon) and the entire next-gen glucagon landscape. On Baqsimi, Dr. Isaacs emphasized to the audience of CDEs and providers that patients do not need to inhale the therapy, therefore leading to a more consistent dosing and utility in diverse treatment situations. Moreover, the therapy has been robustly tested in those with nasal congestion, with consistent dosing maintained in these patients as well. Dr. Isaacs also displayed an infographic with instructions on how to administer Baqsimi—the first we’re seeing of such materials (see below). Dr. Isaacs did express some disappointment that Baqsimi will be priced at the same level of Lilly’s older glucagon injections ($280.80/pack), noting that this price is quite expensive. Of course, there is a $25 co-pay card for the treatment, although it will only be applicable to those on commercial insurance and by government regulation, will exclude those who are on Medicare/Medicaid (to prevent fraud). We have heard that Lilly is diligently working to further expand affordability option for Baqsimi for more patients – those without any insurance would call the Lilly crisis helpline. As a reminder, Baqsimi was approved in July 2019, becoming the first-ever severe hypoglycemia emergency treatment that does not require an injection. Elsewhere in the landscape, Xeris has also submitted its Gvoke HypoPen (liquid-stable glucagon autoinjector) to FDA, and a decision is expected in September 2019. Zealand also has its HypoPal glucagon rescue pen (liquid stable dasiglucagon) and is targeting an early 2020 NDA submission. Lilly has also submitted nasal glucagon to EMA, and a decision is expected soon.
Ms. Debbie Hinnen (Memorial Hospital Diabetes Center, University of Colorado) led a Lilly-sponsored product theater for its newly launched nasal glucagon, Baqsimi. As a reminder, Baqsimi was approved just a few weeks ago in July 2019, and should soon be available in US pharmacies as the first treatment option for severe hypoglycemia that does not require an injection. Excitement is palpable for this breakthrough therapy, as this product theater dedicated to Baqsimi was overflowing in attendance—it’s clear that educators and providers are curios to learn more about how to immediately apply Baqsimi in practice, given how much of an unmet need it will stand to fill.
Ms. Hinnen kicked off the session with a helpful demonstration on exactly how to pronounce nasal glucagon’s brand name, “Baqsimi.” The phonetic pronunciation, she explained, is “back—SEE—me.” A helpful trick for remembering, and for teaching patients? Explain by pointing to your back (for the first syllable “back”), then to your eyes (“SEE”), and then to your chest (for “me”). Seeing as there has been some confusion on exactly how this new product’s name is pronounced, we found this explanation to be tremendously helpful.
The product theater also “busted” several common myths surrounding severe hypoglycemia and glucagon usage. The myths addressed included (i) if a patient is still conscious, they are not having a severe hypoglycemia event; (ii) type 2 patients on insulin are not at risk for severe hypoglycemia; (iii) patients with high A1c levels are not at risk of severe hypoglycemia; and (iv) severe hypoglycemia can be effectively treated with oral carbs. Ms. Hinnen expertly explained why each of these points is false, weaving in clinical trial data, pathophysiologic explanations, and anecdotes from clinical care.
Ms. Hinnen gave more details surrounding room-temperature storage of Baqsimi. Baqsimi’s label explains that it does not need to be refrigerated and can be stored at temperatures up to 86 oF in the shrink-wrapped tube provided in the packaging. However, Ms. Hinnen warned that patients in hotter climates should not leave Baqsimi in their cars for long periods of time during the summer months; instead, they should leave it in their purse/backpack, so that the therapy is not exposed to severe temperatures for such long period of time.
- Lilly’s Diabetes Solution Center will also assist patients in paying for Baqsimi. We’re glad to see this resource expanded to also include Baqsimi, and would love to see Lilly report how many patients use this resource in regard to accessing nasal glucagon. As a reminder, the Diabetes Solution Center was launched in August 2018, with the goal of connecting US patients to more affordable insulin options. Last we heard, it was assisting around 20,000 patients per month; we’d love to know how many people are applying for help and how this changes from month to month.
This rapid-fire session highlighted the cream-of-the-crop posters from AADE 2019’s accepted submissions. Check out some of the top highlights below!
In one of the most unique talks of the session, Lilly’s US medical lead for glucagon Ms. Julie Settles presented compelling data showing the vastly improved ease of use and overall satisfaction of nasal glucagon compared to its injectable counterpart. To mimic a real-world situation in which emergency glucagon would be needed, site staff first formally instructed a person with diabetes on how to use either nasal glucagon (NG) or injectable glucagon (IG). An hour later, the person with diabetes instructed a “caregiver” – often a parent or sibling – on how to use the same technology. After a week, the caregiver returned to the testing site, where they were challenged with using the assigned technology in a simulated hypoglycemic emergency on a high-fidelity manikin. Of the trained users (n=32), 90.3% of NG users were able to administer medication successfully, while only 15.6% of IG users were able to do so. Impressively, in a follow-up study, even 90% of untrained users (n=33) were able to successfully administer nasal glucagon, while none were able to use the IG successfully. As expected, participants overwhelmingly favored NG, finding it easier to prepare and use, as well as felt more confident while doing is.
President of DayTwo Mr. Josh Stevens presented data showing that personalized, microbiome-based nutrition reduces multiple diabetes markers in individuals with type 2 diabetes. Study participants (n=51) were limited to meals with highly-scoring predictive glucose responses, based on the gut microbiome and CGM data using the company’s algorithm/mobile app. On average, A1c decreased from baseline 7.4 to 6.6% (Δ=0.8%, p<0.001) and time in range increased from 87 to 93.7% (p<0.001). Of note, patients underwent the intervention for a wide range of 4-20 months, which gave little sense of the timeline required for meaningful change. Although these results suggest that personalized nutrition could significantly improve glycemic control for type 2 patients, we hope to see more rigorously controlled data moving forward. As a reminder, DayTwo creates algorithm- and microbiome-based diets for glycemic control, and recently raised $35 million in Series B financing to accelerate discussions with payers, providers, and employers in the US and to advance its pipeline
Mr. Richard Hellmund, Global Health Economist at Abbott, provided data showing that out-of-pocket (OOP) costs for Abbott’s Freestyle Libre 14-day are lower than those of Dexcom’s G5 (7-day) and G6 (10-day) CGM systems in the US. Mr. Hellmund prefaced his data by stating that OOP costs remain one of the greatest barriers for greater uptake of CGM. Assuming a 20% coinsurance for private payers and Medicare Part B, the analysis indicated that the Libre system had lower OOP costs than Dexcom by both private payer DME and pharmacy reimbursements (tier 2 and tier 3), but both systems were comparably priced for CMS DME. While we didn’t hear any specific prices during the talk, pricing comments from the companies have suggested insured OOP cost for Dexcom G6 is between $50-$80 for a one month supply, while “many pay as little as $10 out of pocket” for one-month of Libre (an average co-pay was not given).
Tandem’s Ms. Molly McElwee-Malloy unveiled overwhelmingly positive real-world hypoglycemia data for users of the company’s Basal-IQ technology system, recently published in Diabetes Technology & Therapeutics. As a reminder, the Basal-IQ system consists of the Tandem t:slim X2 pump, Dexcom G5/G6 CGM, and predictive low glucose suspend (PLGS), which stops basal insulin delivery when low blood sugar (<80 mg/dl) is predicted within 30 minutes, and resumes insulin delivery once blood sugar levels start to rise. De-identified t:connect data from individuals (n=8,132; 96% type 1, 4% type 2) who had been on Basal-IQ for at least three weeks showed that the rate of hypoglycemic events (defined as <54 mg/dl for at least 15 minutes) decreased from once every ~9 days (0.11/day) to once every ~30 days (0.03/day), without affecting mean glucose or hyperglycemia. At the end of her presentation, Ms. McElwee-Malloy boldly challenged the audience to find better hypoglycemia results in a real-world study. As a reminder, Basal-IQ does not automatically bolus insulin if blood sugar levels are too high; however, a hybrid closed loop system, Control-IQ, has been submitted to the FDA and is expected to launch for 14+ years in 4Q19.
In a thorough presentation, Dr. Michael Bradley reviewed cardiovascular and renal outcomes from the landmark CREDENCE trial for SGLT-2 inhibitor canagliflozin (J&J’s Invokana). As a reminder, CREDENCE results (n=4,401 type 2s with CKD) showed canagliflozin driving a 30% relative risk reduction (95% CI: 0.59-0.82, p=0.00001!) on the primary renal endpoint of ESKD, doubling of serum creatinine, and renal or CV death. Dr. Bradley also touched on data first presented at ADA 2019, demonstrating that canagliflozin’s benefit was seen in both a primary and secondary prevention cohort, suggesting that canagliflozin can effectively help even those without established CVD. However, we have heard some commentary from KOLs clarifying the extent to which CREDENCE’s primary prevention cohort was truly such a cohort. Dr. Philip Home commented at the time of these results: “When assessing the primary vs secondary prevention cohorts in CREDENCE, it is important to remember that all participants in the study had macroalbuminuria (ACR >300 mg. Such people are known to have a very high prevalence of silent ischemic heart disease (>50 %) and thus are not really a primary prevention cohort. This does not dilute the message that all people with macroalbuminuria and type 2 diabetes can get strong benefit from SGLT-2 inhibitors.” Nonetheless, we’re glad to see the message on CREDENCE results being presented to this specific audience at AADE, and hope to see the field further promote the benefits that the SGLT class can have in improving renal outcomes for people with diabetes.
In a well-attended session despite its early timeslot, Mr. Joshua Neumiller (Washington State University) and Mr. Clipper Young (Touro University) gave a comprehensive update on treatment recommendations and medications for type 2. To begin, Mr. Neumiller stressed the importance for HCPs to periodically modify treatment plans (every 3-6 months), focusing on each patient’s individualized needs in terms of existing health conditions and future goals. We’re glad to see this emphasis, especially in light of recent discussions organized from ADA on how to best tackle therapeutic inertia in diabetes treatment. Mr. Neumiller walked the audience through the ADA’s current type 2 diabetes management algorithm, which follows different treatment paths first based on whether (i) predominating ASCVD; or (ii) predominating heart failure or CKD is a concern, followed by (i) need to minimize hypoglycemia; (ii) need to minimize weight gain or promote weight loss; or (iii) major cost barriers. In terms of major amendments to the treatment algorithm, Mr. Neumiller noted that GLP-1 agonists have now been prioritized over basal insulins as a first injectable in most patients, as written in the 2018 ADA and EASD consensus report. While GLP-1 agonists and basal insulins have comparable effects on A1c (GLP-1 agonists have a slight advantage of -0.12%, p<0.0001), GLP-1 agonists have much greater weight loss benefits (-3.71 kg, p<0.0001), which drove the decision (along with decreased hypoglycemia risk). Updates to the 2019 ADA Standards of Care were briefly mentioned, specifically GLP-1 agonist Victoza’s (liraglutide) recent indication for the treatment of pediatrics with type 2 diabetes, but were not a major focus of the presentation.
Mr. Young then took the podium to discuss the most promising drugs in late-stage clinical development, highlighting oral GLP-1 semaglutide, SGLT-1/2 sotagliflozin, and ITCA-650 (GLP-1 exenatide implantable mini-pump). As a reminder, oral semaglutide, in development by Novo Nordisk, is currently being reviewed by the FDA for indications in both type 2 diabetes treatment and reduction of major adverse CV events with a decision expected September 2019. Phase 3 data from PIONEER 6 showed that oral semaglutide significantly reduced A1c and body weight vs. placebo, but did not demonstrate superiority vs. placebo on 3 point MACE, though the data strongly trended in that direction. Other than the overall advantage of being an oral, Mr. Young noted the compound’s low risk of hypoglycemia, due to its enhancement of glucose-dependent secretion of insulin, as well as delay of gastric emptying to help in weight loss. In terms of disadvantages, oral semaglutide’s fasting requirement dictates that it must be taken 30 minutes before food or other medications. Next, Mr. Young highlighted the submission and subsequent CRL from the FDA for Zynquista (sotagliflozin) in type 1 diabetes. Mr. Young seem particularly excited about the compound’s rapid onset of absorption, sustained A1c reduction, and dual sites of action (as it inhibits both SGLT-1 and SGLT-2), but also explained the drug’s increased risk of DKA. Lastly, he briefly touched upon Intarcia’s exenatide implant (ITCA 650), which we see as having great potential in increasing medication adherence and bringing further innovation to the GLP-1 class; however, it does require surgical implantation and has shown increased rates of nausea compared to placebo. Last we heard, the mini-pump was positioned for resubmission to the FDA mid-2019 following a September 2017 CRL. Interestingly, Mr. Young did not mention either Sanofi’s recent decision to terminate development of sotagliflozin with Lexicon or ITCA 650’s CRL, which we believe to be major points that will dictate each drug’s future timeline.
In a wide-spanning talk on applying the vast armamentarium of type 2 diabetes pharmacotherapies to specific case studies, UCSD’s Dr. Nathan Painter commented on the soon-to-read-out VERTIS CV trial for Merck/Pfizer’s SGLT-2 inhibitor Steglatro (ertugliflozin), noting that he’s “willing to put money on Steglatro showing benefit” in the trial. We share Dr. Painter’s enthusiasm for Steglatro in this trial, and expect to see results further cementing SGLT inhibitors’ class effect on improving cardiovascular outcomes. As a reminder, VERTIS CV is now set to complete in December 2019 (up until about a month ago, the estimate was for slightly earlier in the year) and we’re hoping for a release of topline results not too soon after. VERTIS CV is notable in a few ways: (i) it’s the only SGLT CVOT, to our knowledge, to collect baseline heart failure status in all participants, further bolstering the study’s ability to examine the increasingly apparent link between SGLT inhibition and heart failure outcomes; (ii) we learned last year at EASD 2018 that 22% of VERTIS’ patients have a history of heart failure, which is nearly twice the number enrolled in EMPA-REG OUTCOME; and (iii) the trial is strongly a secondary prevention study, enrolling nearly 100% of participants with established CVD. We’re thrilled to see Dr. Painter and other KOLs start to discuss potential forthcoming results for VERTIS CV to the broader diabetes community; we’re similarly optimistic about what it could mean for patients to have another cardioprotective SGLT inhibitor on the market (and perhaps at a lower cost as well). Commercially, it’s unclear how successful Merck/Pfizer have been in getting Steglatro to patients – we’ve yet to hear any updates on this end on either of the company’s quarterly updates since the product’s approval and launch in late 2017/early 2018. We’re hoping to see increased focus on the product from the two companies after results from VERTIS CV reads out – could it be that Merck/Pfizer view it as essential for Steglatro to garner its own CV indication before competing in the crowded SGLT inhibitor class (where Lilly/BI’s Jardiance, J&J’s Invokana, and AZ’s Farxiga already boast positive CVOT data)? There is certainly investment in marketing at the major scientific meetings, which we are very happy to see. Intra-class competition aside, we still see tremendous potential for the whole SGLT class to improve outcomes for patients: recent analyses show that only a tiny fraction (<10%) of second-line diabetes prescriptions go to SGLT inhibitors, leaving tremendous opportunity for growth.
Dr. Painter also had an important message when it comes to prescribing GLP-1s: Just get patients on any one that’s possible to get them on! Dr. Painter explained that it’s extremely rare for a patient’s insurance (this was a US-oriented talk and he was referring to patients that have insurance) to cover all (or most) of the available GLP-1s on the market. As a result, it’s crucial to advocate for a patient to get on whatever GLP-1 may be covered for them—regardless of intra-class differences between agents. We’re glad to see Dr. Painter emphasize this point, especially in light of growing consensus among thought leaders regarding a class-wide cardioprotective effect for GLP-1s. When it comes to differences within the GLP-1 class in regard to CVOT data, Dr. Painter underscored that these agents are still worth it even if you don’t consider the cardioprotective effects that they might have – the benefits on glucose, weight loss, and more are just too much to pass up. We completely agree.
- First on the list? Teplizumab becoming the first drug to show clinical potential in delaying a type 1 diagnosis. Teplizumab treatment was associated with marked reductions on cumulative diabetes onset (72% vs. 43%, HR=0.41, p=0.006) and time to diagnosis (48 months vs. 24 months) compared to placebo. With these phase 2 results, teplizumab reshapes the paradigm of pursuit for type 1 prevention, validating the idea that a drug could actually delay progression for a period of time.
- Less exciting but still important: The D2d Study. Supplementation with 4,000 IU/day of vitamin D3 did not significantly decrease risk of progression to type 2 diabetes compared to placebo (HR=0.88, 95% CI: 0.75-1.04, p=0.12). However, noted Ms. Youssef, the study did not single out those who were vitamin D deficient. Given the promising trend, would results have shown superiority in this subset?
- The most disturbing outcomes of any study: Today2. The post-intervention follow-up of the TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) study cohort revealed increased cardiovascular, renal, microvascular, and pregnancy risks/complications among 517 original TODAY participants with youth-onset type 2 diabetes. Ms. Youssef called these results “reason for change of policy.”
- Dr. Kamlesh Khunti’s review of hypoglycemia in type 2 diabetes. In the real-world, at least 50% of people with type 2 diabetes have hypoglycemia within the first 2 months of initiating insulin. In the clinic, 59% of patients forget to bring up hypoglycemia, and 26% of providers have admitted to not asking. With annual hospital discharges for hypoglycemia in the US reaching 160,000 in 2011 (and growing), costs were nearly $1.6 billion to the healthcare system. Hypoglycemia in type 2 has also been solidified as a marker of poor prognosis, having been associated with total mortality, CV mortality, and major CV events.
- The CVOTs –REWIND, PIONEER 6. The former demonstrated equal reductions in 3-point MACE for both the primary and secondary prevention populations, while the latter had extremely positive mortality results for the first ever oral GLP-1.
As a final note, Ms. Youssef touched on the “real concern” of insulin affordability. In the past two weeks, a 27 year-old man from her community died after being unable to afford his $1,200 insulin copay. According to Ms. Youssef, hope lies in a new bill just introduced into the Senate, which incentivizes manufacturers to reduce list prices to 2006 levels, which are “still high and still unaffordable but better than today.” She concluded by encouraging audience members to sign ADA’s “Make Insulin Affordable” petition: “We finally have momentum… it’s now critical we move forward.”
At a MannKind product theater for inhaled insulin Afrezza, Dr. Michelle Welch underscored fewer needlesticks, less hypoglycemia, and less clinical inertia as major positives of the therapy. According to her, the clinical inertia of initiating insulin stands around three to five years, and “a lot of that is due to it being an injection.” Without a doubt, earlier intervention in prediabetes and diabetes is highly effective and much needed. In fact, Dr. Vivian Fonseca has previously established that earlier intervention with insulin not only improves glycemic control but also empowers patients and enhances quality of life. To this end, we certainly see Afrezza as an important therapy, especially for those who are averse to needles. That said, we believe there should be greater effort to reduce clinical inertia across chronic disease in general, and we are happy to see leaders such as ADA bringing many stakeholders together to discuss drivers of and solutions to this barrier. On weight, Dr. Welch posited that Afrezza, with its fast-on and fast-off profile (“it’s really the slow off – the long tail – that causes hypoglycemia”), prevents stacking, thereby reducing hypoglycemia, snacking to restore normoglycemia, and subsequent weight gain.
Dr. Welch admitted that she struggled to access Afrezza at first, but that the company’s new $15 co-pay card has really “broken down the barriers.” As she sees it, MannKind has really “stepped up to the plate” in the tough market of insulin access with a copay card “that really works.”
Taking a sip of water before or after inhalation, or inhaling slowly, were advertised by Dr. Welch as two key strategies to mitigate cough. These emerged from the STAT trial, which found significant improvements in time-in-range and time-in-hypoglycemia with Afrezza vs. NovoLog over 4 weeks. Study coordinator Mr. Mark Harmel recently shared these same tips, and more, with The diaTribe Foundation in an interview in March 2019.
We heard from a real-world Afrezza user, who detailed how Afrezza helped him become a “proud diabetic.” As a “needlephobic,” the bolus needlesticks that Afrezza has spared him from have been invaluable, and he underscored how CGM with Afrezza, to visualize the product’s rapid acting effect, is a gamechanger.
In a presentation for DPP program organizers, several speakers outlined the “operational crisis” of low funding and low referrals to DPP programs, before three DPP leaders shared their success stories in improving business and operational outcomes. Alarmingly, only 5% of Medicare beneficiaries and only 6.8% of privately insured patients used DSME services, and a 2017 national practice survey found that only 12% of enrolled patients completed more than 75% of DSMES sessions. (See a self-assessment tool for improving DSMES business outcomes here).
Often, the speakers noted, doctors will frame DSMES and similar programs as soft suggestions, leading patients to only consider them as an afterthought. When doctors emphasize the value of these programs and strongly recommend them, however, patients are far more likely to attend and will often see significant improvement in their diabetes awareness and outcomes. Increased collaboration between physicians and educators, including inviting physicians to witness a class in person, were cited as valuable tools for addressing gaps in referral.
- In an especially illuminating moment, a number of diabetes educators during Q&A expressed frustration over insurance and reimbursement barriers that prevented them from reaching more patients. One audience member noted that Medicare does not reimburse for a class that is offered for free, another explained that she could not convince HMOs to send at-risk patients to her program due to the costs associated with referring out of network, and a third lamented that, once her program received Medicare reimbursement and her patients were given transparent pricing information, her class size reduced from 150 to 17. Likewise, from our view, we remain frustrated that the US insurance structure often forces educators to choose between gaining adequate funding or reaching a wider range of patients, especially given that these insurance-related cost barriers disproportionally affect low-resource patients who are often in most need of this valuable care. While a move toward universal, single-payer systems such as Medicare for All may significantly improve this system by empowering providers to focus solely on patient needs without being hindered by out-of-network costs and by allowing educators to receive reimbursement for classes that are cost-free for all patients, there are other potential barriers associated with this approach.
In what was certainly one of the most fun and interactive presentations of the conference, the CDC’s Betsy Rodríguez and Alexis Williams explained how game-based learning can be used as a powerful tool for diabetes education and management, empowering patients to increase their engagement, retention, and self-efficacy in an entertaining environment with cross-cultural potential (see the AADE’s tip sheet on implementing game-based learning). In the middle of the session, the speakers even divided the audience into teams to play a short game of “diabetes charades.”
- Game-based learning has significant potential to increase retention rates for patients in DSMES and the National DPP, which despite strong evidence supporting their efficacy, continue to struggle with low enrollment levels and patient engagement. Ms. Williams said that games allow people to model behavior and even fail in a low-risk environment, building self-efficacy – a patient’s confidence in their ability to control their behavior and motivation – and encouraging patients to continue their diabetes education to a larger degree. Still, we believe that systematic low levels of referrals to DPP and DSMES at the primary care level and barriers to insurance reimbursement remain some of the most significant obstacles to their more widespread implementation. Therefore, it’s essential that further work is done to increase coordination and awareness at this level so that more patients can ultimately benefit from powerful tools like game-based learning once enrolled in lifestyle intervention programs.
- Ms. Rodriguez said that games have the capacity to transform learning environments, by giving harmony, confidence, security among its members, it can help develop the interest towards some topics and motivates to continue learning.
- Though existing studies and anecdotal evidence are promising, the speakers said that more research is needed into how to most effectively implement and customize game-based learning for different patient groups. DPPs using game-based learning have already uncovered important strategies, including clearly tracking progress and giving opportunities to commit to small actions during times where patients are highly motivated, but more evidence is needed to solidify and increase this approach’s role in diabetes management.
Ms. Elva Hooker (Society of St. Vincent de Paul) gave a highly engaging presentation on how to establish culturally grounded and effective programs that can progressively target individuals along with their entire communities. Programs such as “Every Little Step Counts” address a great unmet need in minority populations that often suffer from higher levels of health issues and lower access to care. Ms. Hooker explained that the Latino population is one such group that faces a disproportionately high burden of type 2 diabetes, with 50% of Latino children projected to develop the disease in their lifetime.
The first randomized control trial for Every Little Step Counts found a significant improvement in BMI, body fat and glucose in the intervention group that remained significant throughout a twelve-month follow up. The initiative launched its first trial in collaboration with Arizona State University, designed as a five year-long study targeting Latino youth between the ages of 14-16. The distinctive feature of the program was the extension of the intervention to the parent group in parallel with the youth cohort, an approach that led to the parent group showing similarly significant improvements in weight and body fat. The program further aimed to progressively involve an individual’s peer group, overall community and the surrounding culture, enabling an effective and grounded approach that could be scaled from the individual to the societal level. Notably, Ms. Hooker explained that often the most important challenge was not to provide health resources but to enable engagement with existing resources in the context of working with a marginalized community.
The two keys to the program’s success were (i) a holistic framework incorporating not only the biomedical and health aspects of each patient but also the emotional, environmental and cultural factors; and (ii) extensive collaboration with various partners in the community. Collaboration with multiple partners and stakeholders enabled the establishment of a wide reach and accessibility for other communities in the area as well as creating more opportunities for funding. Most importantly, having multiple outside perspectives enabled rapid identification of gaps and effective strategies for addressing them. This network of organizations further fostered a culture of trust and understanding with the communities served, as well as helping to mobilize existing resources. To attain both scalability and sustainability, one of the key strategies was developing workforce capacity in the recipient population by training them to become deliverers of care, along with becoming a liaison between the intervention program and the minority group.
Houston Health Department’s Dr. Faith Foreman Hays provided an update on Novo Nordisk’s Cities Changing Diabetes initiative, announcing that the program has expanded to 22 cities worldwide, with 28 more coming on board in the next four to five years. The program has grown rapidly – from 8 cities two years ago, to 16 at AADE 2018, and now to 22 – Manchester (UK), Milan (Italy), Madrid (Spain), Warsaw (Poland), Jakarta (Indonesia), and Seoul (South Korea) have been added in the past year, joining Mérida (Mexico), Buenos Aires (Argentina), Leicester (UK), Beirut (Lebanon), Koriyama (Japan), Vancouver (Canada), Houston (US), Mexico City (Mexico), Copenhagen (Denmark), Johannesburg (South Africa), Rome (Italy), Hangzhou, Beijing, Xiamen, Tianjin, and Shanghai (all in China). Australia is now the only (inhabitable) continent not boasting a partner city, though in terms of diabetes burden, we’d especially love to see involvement from cities in India and Northern/Central Africa (and we were pleased to hear whisperings in the exhibit hall that Egypt would be joining soon). We’re also eager for US efforts to expand, with Dr. Foreman-Hays revealing Philadelphia as the next US city set to launch this fall.
On Houston, Dr. Foreman-Hays delineated the program’s five initiatives (see below), which bring together industry, the public sector, and faith-based organizations for the common good. What’s the secret sauce for Houston’s success? Multi-sector coalitions (“need people that can write checks, take on projects, provide spaces, all at the table”), self-organizing work groups (all initiatives were stakeholder developed and stakeholder funded), leveraging Houston’s diversity and faith system, encouraging collaboration, CDE and patient involvement from day one, and financial support from Novo Nordisk without steering toward any solution. For more, see our coverage of the Cities Changing Diabetes “Faith & Diabetes” meeting in Houston in September 2018.
Director of the Institute for Health Policy at UT and mastermind behind CCD Houston, Dr. Stephen Linder, introduced the concept of “composite vulnerability” underpinning Houston’s program. The concept combines neighborhood factors, economic disadvantage, and biological risk to assess wholistic vulnerability to diabetes, pinpoint locations in greatest need, and identify interventions best tailored to meet residents where they are. To determine the vulnerability of neighborhoods, Dr. Linder’s group collected data on those with diabetes (location, demographics, etc.), then searched for these profiles among residents without diabetes to find at-risk neighborhoods. Three indicators were used to represent economic disadvantage: public assistance, financial hardship, and incomes <199% of the Federal poverty level. Finally, it was found that three self-reported risk factors could reliably distinguish 80% of the population with diabetes in Houston: high blood pressure, age >45 years, and BMI >26.9 kg/m2. With these data in hand, the vulnerable neighborhoods were stratified by economic disadvantage and biological risk into a two-by-two grid (see below): isolated skeptics, concerned seniors, financially pressured caregivers, and time pressured young adults. Interventions in Houston were then tailored to meet the specific needs of each group, rather than forcing blanket solutions on a diverse audience. For a deeper dive, we highly recommend the full research paper on Dr. Linder’s work.
Diabetes educators Ms. Laurie Klipfel and Megrette Fletcher summarized the evidence supporting weight neutral care in the delay and treatment of diabetes. Importantly, this valuable talk centered on physical activity and healthy behaviors -- not the weight loss itself -- being the reasons for improvements in diabetes complications and CV health. Beginning with the idea of thin privilege, both diabetes educators focused their presentations on treating overweight people with diabetes with dignity and respect to lead to equitable health care. They also stressed that diabetes care should focus on optimal health, which is working with existing tools and resources in dynamic and complicated situations, instead of perfect health. Currently, evidence-based diabetes care links obesity, hypertension, hyperlipidemia, and type 2 diabetes to insulin resistance, but the causal nature of this relationship has never been proven. Many health professionals assume that overweight people are more insulin resistant, but studies have shown that thin people with insulin resistance have worse outcomes. Standard health care also assumes that weight gain causes insulin resistance, but it’s possible that insulin resistance is what promotes weight gain. Insulin production is one of the most significant parts of the ominous octet of type 2 diabetes, and as it is driven by genes, age, and a person’s pancreatic state, type 2 can progress regardless of weight. This gives rise to the obesity paradox, in which mortality and weight follow a “J-curve,” with underweight patients more likely to do poorly than patients with severely morbid obesity. Though its unknown why patients with obesity fare better, it is possible that they perform more healthy behaviors in an attempt to lose weight compared to lean people. Interestingly, this relationship appears to hold true for congestive heart failure, coronary artery disease, renal failure, and cancer as well.
A substantial amount of evidence from studies suggest weight loss behaviors can delay diabetes, regardless of the amount of weight lost by the patient. DPP extension trial data showed that lifestyle change was associated with the greatest risk reduction, despite weight loss being equal among all study groups by the end of the study. With this, none of the slight improvement in health outcomes were correlated to weight, and few large positive effects were based on medication use. Instead, increased exercise, healthy eating, engagement with the health care system, and social support may play a role. Similar results were presented in the Look Ahead trial, which sought out to show that weight loss improves long term health. Results showed that there was no difference in health risk or death between the control and weight loss group.
Intentional weight loss has even been linked to increased death rates in patients with type 2 diabetes. Those who maintained their weight throughout the 19-year study had the best prognosis, and overall weight loss of 1 kg/year was an independent risk factor for increased mortality (p<0.01). Not only is advising people to lose weight ineffective, but weight cycling has also been linked to detrimental effects like increased cardiovascular risk, hypertension, visceral fat accumulation, and increased insulin resistance. On this point, we’re hoping to learn more about the ties between weight loss and cardiovascular outcomes once Novo Nordisk’s CVOT for obesity-grade semaglutide (SELECT) reports out in ~2023.
Ms. Klipfel and Ms. Fletcher also argued that the answer to promoting a healthier lifestyle for people with diabetes may be to pivot from medication to lifestyle changes. Some studies have indicated that weight loss medication is expensive and ineffective, with many patients reporting weight regain once they stop taking medication. On this point, it’s possible that fitness may be a more accurate predictor of health risk. Regardless of BMI, unfit people had twice the risk of mortality compared to normal weight, overweight, and obese fit people. In this same study, increased fitness was linked to decreased health risks. Further, general or abdominal obesity in healthy people was not related to mortality risk, while diabetes, hypertension, and dyslipidemia alone were significantly associated with mortality risk. Of course, we still do see an important place for medications that can promote weight loss, especially considering how important this outcome is to many patients.
Weight-neutral diabetes care includes mindful eating, intuitive eating, body positivity and kindness, and health at every size. Diabetes educators may face difficulty addressing weight stigma with their patients with overweight and even unknowingly creating barriers to care for them. Experiencing weight stigma can lead to increased eating, higher cortisol levels, exercise avoidance, and anxiety- which all impact glucose control. Independent of BMI, people who experience weight stigma have a 60% greater chance of mortality. Weight neutral care removes emphasis from weight loss and shifts focus to evidence-based interventions that promote health and wellbeing regardless of weight change. These interventions can utilize AADE’s Seven Self Care Behaviors and set goals that integrate meal plans, activities, and stress reduction. Outcomes unrelated to weight include A1c, fitness, program attendance, sleep records, and quality of life measures. This process should also address social determinants of health because of their interconnectedness with health behaviors. Taking these steps can decrease stigma, improve health outcomes, and strengthen patient-provider relationships.
To a packed audience, our very own head of diabetes technology, Adam Brown, reviewed his book, Bright Spots and Landmines (free download, audiobook, Amazon), and announced a new Bright Spots and Landmines Journal (see below) and 42 factors poster coming soon at shopdiatribe.org. Download his full slide deck here. Like a car on a road, Adam posited, diabetes management is about learning what keeps you on the road, how to do more of those things, and finding what can keep you in “cruise control” – on-road driving with less effort. Equally, what drives you off the road? How can you prevent it and recover? And how can you build guardrails to prevent extreme off-roading? Between the “outrageous complexity” of blood glucose and “ludicrous environment” (even at diabetes meetings, provided snacks consist of chips, pasta, soda, and candy), isolating these bright spots and landmines can prove a challenge, but Adam shared some of his most impactful tips with the audience:
Dr. Matthew Walker’s Why We Sleep is “the most important health book” that Adam has read in the past two years. With 7+ hours of sleep per night, Adam has realized greater time-in-range, lower blood glucose peaks (especially post breakfast), lower insulin needs, less hunger, fewer carb and sugar cravings, stable emotions, mood and energy, less stress, and an easier time losing weight. Imagine, he asserted, if every one of those factors was flipped – “could you imagine a much harder thing for diabetes than the opposite of that list?”
Adam limits himself to 30 g of carbs at one time (one of his “cruise control” bright spots), reducing the likelihood of mistiming or miscalculating a bolus. Of course, this solution cannot be universally applied – for example, in food deserts – but it is entirely possible to eat low carb on a budget and with great variety. At the very least, he believes low carb is worth a discussion and trial period for every person with diabetes. During this trial, logging apps such as Undermyfork (iOS) can help reveal patterns between food and CGM tracings – an invaluable tool to Adam. For tons of tasty recipes and tips, check out the book or Adam’s Corner on diaTribe Learn.
Eat an early dinner more than three hours before bedtime, with no snacking afterwards. This rule-of-thumb helps Adam avoid “the best example of a diabetes landmine that exists” – overnight lows followed by over-correcting snacks (e.g., a “hypoglycemia binge”). As an extra measure, one can build guardrails for over-correcting lows with quantity-limited correction foods that discourage overeating. For Adam, he knows that one glucose tab raises his glucose by 20 points, allowing for quick and simple corrections that he knows he won’t binge: “People tell me that glucose tabs taste so bad… that’s the point, to prevent overeating!”
“Dose walking” after meals and to correct high blood glucose levels. “A common misconception is that exercise must require profuse sweating.”
Blood glucose values should be viewed as neutral information – being out of range is not a failure, only neutral information on which decisions can be based. As Children With Diabetes founder Jeff Hitchcock has previously said, “The only bad blood sugar is the one you don’t know.”
Adam has reframed diabetes in his own life to focus on the positives and the present: “Diabetes management is about today and now… if someone is motivated by avoiding long-term complications, then great! But I find that it’s more successful for me to focus on becoming my best self in the present, which is when I’m in range.” Along with this, he intentionally included 43 bright spots and 16 landmines in his book, encouraging readers to focus more on those things that are working, rather than fixating on difficulties.
#LanguageMatters: Why the Language Movement is About Changing Mindsets, Not Policing Words
2019 Diabetes Educator of the Year Dr. Jane Dickinson presented a witty and compelling case for the diabetes language movement, citing worrisome perception of stigma data from individuals with both type 1 and type 2 diabetes. According to recent research, 52% of individuals with type 2 diabetes, and 76% of individuals with type 1 diabetes believe that diabetes comes with social stigma – perception as being weak, fat, lazy, and not intelligent. Anecdotally, Dr. Dickinson commented that she believes the true incidence in individuals with type 2 diabetes is in fact much higher, but the very existence of social stigma may be preventing more people from voicing their concerns. According to Dr. Dickinson, the high rates of stigma are particularly troubling when considering the psychological pressure such labels create. Dr. Dickinson exemplified this idea by sharing an interesting study on Expectancy Theory performed on rats – lab students were tasked with monitoring how quickly rats could complete a maze, however, the students were also told that some rats in the group were “smart” and others were “dumb.” Without instruction, the students paid much more attention to the rats arbitrarily labeled as smart, giving them greater affection and care, and fascinatingly, those were the rats who performed better at the maze task later on, presumably due to receiving more affection. Dr. Dickinson drew a parallel by explaining that if people with diabetes are constantly perceived and treated in a negative manner, they are likely to be subconsciously influenced by those perceptions and experiences. This insidious influence is why the diabetes language movement is so important. She further emphasized that the goal of the movement is not to “wag fingers” at people for saying certain things but transform the mindset with which individuals with diabetes are viewed and treated.
Dr. Dickinson then pivoted to specific examples of unassumingly harmful words such as “adherence,” “glycemic control,” and even labels that put a person’s diabetes before their personhood such as “T1Ds” or “PWDs.” In particular, Dr. Dickinson acknowledged that changing “adherence” to less limiting terminology will be difficult due to its prevalence in the scientific literature but suggested “medicine taking” or “prescription filling” as matter-of-fact alternatives. The presentation ended with a very engaging exercise in which audience members were asked to practice “revising” pieces of published literature into more positive, patient-centered language. For example, “high blood glucose or low blood glucose can cause damage to the blood vessels in your body” was rephrased to “keeping blood glucose levels in a safe range can protect the blood vessels in your body.” “Poorly controlled diabetes” was rewritten as “HbA1c ≥9%.” The HCP-oriented audience clearly appreciated this activity, cheering at the revisions and snapping pictures throughout. We commend Dr. Dickinson on her commitment to this often-overlooked area of the lived diabetes experience, as well as her award – congratulations!
ADA Nutritional Consensus Report: Individualized, Patient-Centered Approach Emphasized Over Specific Diets
Several notable members of the ADA’s nutritional consensus committee, including the Joslin's Melinda Maryniuk, Kelly Rawlings, and Shamera Robinson, gave a three-part presentation on their newest guidelines to a packed and engaged auditorium audience. While the speakers did discuss several general guidelines – including emphasizing non-starchy vegetables, minimizing added sugars and refined grains, and choosing whole foods over processed foods whenever possible – they periodically highlighted the importance of individualized dietary recommendations that empower patients. In the words of Companion Medical’s Janice MacLeod, “one size fits all does not fit.” (See the full guidelines here).
- During the first session, Ms. MacLeod and UW Neighborhood Clinics Alison Evert emphasized that providers should not take a unilateral approach to nutrition guidance; instead, they should engage in shared decision making – the intersection between patient preferences, research evidence, and clinical expertise and experience. They also emphasized the enormous potential of digital health to aid in providing individualized nutritional guidance. In studies, interventions that included the full technology enabled-self management (TES) feedback loop have been most effective, as they can provide 24/7 automated support and empower patients by showing them how their individual dietary and lifestyle decisions impact their diabetes.
- During Q&A, one audience member questioned why the ADA Nutrition Consensus report did not focus more on plant-based diets, garnering a lard round of applause from the audience. Speakers responded that space limitations prevented the ADA from evaluating every specific diet in-depth, noting that intermittent fasting, like plant-based diets, also received only one paragraph.
- In the second session, Stanford’s Dr. Christopher Gardner explained the significant limitations of existing nutritional studies, humoring the audience with several comical asides throughout, before St. Luke’s Ms. Patti Urbanski outlined how the committee determined eligibility for including studies. Because of the intense level of monitoring required to perform a comprehensive nutritional study, Dr. Gardner highlighted that sample size, funding, study length, and adherence represent significant obstacles to effectively studying nutrition in diabetes. Dr. Gardner likened each individual study as a “puzzle piece” that fits somewhere within the existing body of nutritional studies rather than a piece of absolute, conclusive evidence in and of itself. Though the ADA report considered a large number of studies, Ms. Urbanski explained that the subjects had to be 18 or older, the sample size had to be at least 10, the retention rate had to be at least 50%, and, most importantly, the studies had to include people that had diabetes or prediabetes diagnoses, excluding a number of diabetes prevention-related studies that used only metabolic syndrome as eligibility criteria.
- The final presentation consisted of a series of case studies of “empowered eaters,” where audience members participated in creating a nutritional plan for specific patients with unique background stories, levels of nutritional literacy, and diabetes-related metrics. The goal of this exercise was to further emphasize that the ADA’s consensus recommendations are not intended as mandates for doctors to give patients, but general guidelines through which patients and their doctors can develop individualized plans that consider the patient’s unique needs, goals, and lifestyle. If you missed this presentation and want to read more about the new guidelines, see Rawling's 6 Smart Tips From the ADA's Just-Released Nutrition Report.
AADE’s Practical Approach to Mental Health for the Diabetes Specialist
Pharmacists and psychologists from Eskenazi Health and USC’s Keck School of Medicine summarized ways to approach mental health in people with diabetes. Diabetes and mental health conditions have a complex, bidirectional relationship, with depression, anxiety, disordered eating, and neurocognitive changes being more popular in people with diabetes than in the general population. Before assembling a guide on approaching mental health in people with diabetes, the team conducted a survey for diabetes educators and found that most respondents were concerned by both a lack of resources and mental health training among educators. Thus, there is a need to address existing disparities in psychosocial care for people with diabetes and perform more research to find effective strategies for educators. This session addressed different common mental health conditions and offered treatment advice for diabetes educators. Overall, educators should work closely with health care providers to motivate people with diabetes to problem solve, identify reasonable goals, and decrease the emotional toll of daily diabetes management. Diabetes educators also hold key roles in assessment and referral, and the diabetes field would benefit from more collaboration between educators, endocrinologists, and mental health professionals.
Diabetes and depression often occur together, and diabetes educators should screen and refer all people with diabetes exhibiting symptoms to a mental health care provider. Both children and adults with diabetes are at higher risk for depression and longer depressive episodes (on average, 92 weeks for people with diabetes versus 22 weeks in the general population). Depression is associated with worse glycemic control, more diabetes complications, lower adherence to diabetes self-management, and greater risk of earlier mortality. As of now, the only treatment that has been effective in improving depression and A1c has been cognitive behavioral therapy (CBT) and community-based exercise interventions.
Adults with diabetes have higher rates of generalized and diabetes-specific (i.e. fear of needles or hypoglycemia) anxiety, while people with PTSD are at higher risk for developing type 2. Anxiety is also associated with poorer diabetes self-management, worse quality of life, and higher A1c. Recommended treatment includes CBT and mindfulness training to support social, occupational, and self-care functioning. Systematic desensitization can also help people with diabetes re-establish trust in diabetes devices, while blood glucose awareness training can help ease fears of hypoglycemia. Again, educators should refer patients to mental health providers if they exhibit multiple symptoms of anxiety.
As food choices influence diabetes management, with many needing to eat at times that aren’t dictated by hunger cues, disordered eating behaviors and psychiatric eating disorders can emerge. Adolescents and adults with type 1 and 2 show elevated rates of developing psychiatric eating disorders, with bulimia and binge eating disorder occurring most often. To intervene, diabetes educators can address knowledge gaps and sit down with patients to go over treatment regimens to see what may contribute to disordered eating. A psychologist can perform multidisciplinary CBT and target thoughts, emotional distress, and behaviors related to eating, body image, and weight. If CBT alone isn’t enough, medication that affects satiety and binge eating behaviors can be incorporated into the care plan.
Diabetes distress is a conglomeration of the burdens associated with diabetes self-management and the stress of disease progression and complications. 18-45% of people with diabetes experience diabetes distress, and it can discourage them from maintaining self-care behaviors, leading to higher A1c levels. Diabetes educators should routinely screen for diabetes distress, especially in people who aren’t meeting their goals, and focus on promoting self-management.
Diabetes is associated with cognitive dysfunction, and people with type 1 and 2 are at risk for all types of dementia- with racial and ethnic minorities at the highest risk. Here, it is difficult to intervene because cognitive dysfunction presents in different ways for every person, with some experiencing memory loss while others experience mood swings. If someone with diabetes has confirmed degenerative dementia, educators should monitor their ability to perform diabetes self-management overtime and deploy self-care adjustments when necessary. Diabetes educators can also assist patients and families with finding caregivers and (re)training them as dementia progresses.
People with serious mental illness (schizophrenia, bipolar disorder, major depressive disorder; SMI) are more likely to have reduced life expectancy by 10-25 years and are 2-3 times more likely to develop diabetes. This patient population is of importance to diabetes educators because they are less likely to receive equitable diabetes care and education. Health care provider stigma further perpetuates inequitable diabetes care, which then compounds with the dogma that psychotic symptoms must be addressed fully before diabetes intervention. As some people have SMI symptoms for decades, diabetes care delay can lead to death. To combat this, diabetes educators can partner with health professionals to create diabetes management plans. These plans should promote recovery as the goal over stabilization and reduced adverse events seen in traditional approaches.
The pharmacologic effects of different diabetes and psychiatric drugs can lead to increased morbidity/mortality, CVD, metabolic disruptions, anxiety, and cognitive impairment. Second generation antipsychotics (SGAs) are linked to metabolic syndrome, and the APA recommends that all patients taking SGAs receive metabolic monitoring. Mood stabilizers and antidepressants can also affect weight and appetite. On the other hand, cardiovascular health medications (like smoking cessation agents and statins) have also been linked to neuropsychiatric effects (i.e. depression) and cognitive impairment.
Dr. Mark Heyman outlined four strategies that can be used to help people overcome fear of hypoglycemia: educate, challenge thoughts and beliefs, expose (in a safe and controlled environment) to hypoglycemia, and refer to a mental health professional. Fear of hypoglycemia (FOH) can either be event-based (stemming from a personal experience with severe hypoglycemia) or agency-based (stemming from lack of confidence in one’s ability to be able to effectively deal with hypoglycemia if it were to occur). Fear of hypoglycemia can have a big impact on both quality of life and diabetes self-management, with patients avoiding activities and keeping their blood sugar levels high in order to avoid even a chance of experiencing hypoglycemia. Health professionals can assess for FOH by asking open-ended questions during clinical visits, actively listening to patients, and being curious during their interactions. Though Dr. Heyman does not believe that it is not always practical to use formal assessment tools (i.e. HFS-II, HFS-PYC, FH-15, CHFS) to diagnose FOH in a clinic-setting, they may be helpful to assess progress in patients being treated for FOH.
Though it may feel uncomfortable, exposing people to hypoglycemia in a safe, controlled, and comfortable environment with clinicians on hand can ease fears. Exposure can be graduated (decreasing blood sugar levels X amount per week) or flooded (going directly into hypoglycemia from an in-range blood sugar). A first-hand experience with hypoglycemia shows people what it’s like and “makes the unknown known”. It also gives people evidence that they can handle the symptoms of hypoglycemia and treat them effectively.
Referral to a mental health provider with expertise in diabetes may be required if other strategies are not effective. Referral is especially recommended if a patient has an impaired ability to provide self-care or if their fear of hypoglycemia severely impact quality of life or daily functioning. The ADA’s Mental Health Provider Directory is a good resource for finding professionals to refer patients to.
3. Costs and Complications
Session on Insulin Access and Affordability Highlights Justified Anger in Diabetes Community
A session on insulin access and affordability—led by Mr. George Huntley (President Elect of the National Diabetes Volunteer Leadership) and Mr. Stewart Perry (VP Elect of National Diabetes Volunteer Leadership--pointed to systemic failures in the US healthcare system and channeled deep frustrations amongst diabetes care providers. Mr. Huntley and Mr. Perry provided a valuable overview on the insulin landscape, touching on (i) what the problem is; (ii) how we got here; (iii) how people with diabetes are impacted; (iv) their view of a flawed system; and (v) what the diabetes community can do to take action. See below for quotable quotes from the session, along with accompanying commentary:
“We have so many people taking a bite out of the apple that there’s nothing left but the core…You know why drug prices are so much cheaper in Canada and Mexico? Because there are fewer people between the drug manufacturer and the patient.” – The speakers fleshed out a thesis pointing toward PBMs and insurers as the primary culprits of a broken system that has dramatically and artificially increased insulin list prices. Indeed, net prices have declined for all insulin manufacturers over the past decade (see chart below), while rebates that flow to PBMs have increased dramatically. Notably, Lilly recently released its own data on this point, showing a 8% net price drop in Humalog since 2014. It’s likely that anti-competitive incentives baked into such a rebate structure are a major reason for high insulin list prices; undoubtedly, true multi-stakeholder work is needed but we never see this. (note to team – “true multi-stakeholder work” that did not include manufactures would not be “true multi-stakeholder work” – the team assumes that all the major players are involved)
“How many people here have had their patients ration their insulin or other diabetes drugs?” – Nearly everyone in the audience raised their hands for this question. More rigorous studies—such as those by Yale’s Dr. Kasia Lipska and dQ&A—have shown that about one-in-four or one-in-five patients have rationed their insulin.
“Has anybody in this room had their patients switched from one insulin to another?” – Nearly everyone in attendance raised their hand to indicate “yes” to this question as well, reflecting how changes in formulary positioning can oftentimes haphazardly switch patients from one insulin to another, often to the frustration of the patient and their provider. This is obviously not the fault of the HCPs or patients but the payer (who is rarely blamed).
“A high deductible plan is one of the worst things possible for people with chronic diseases. If you are a patient with a chronic disease: never, ever, buy a high deductible plan.” – Speakers lamented the fact that many patients are burdened with high costs of diabetes medications and supplies at the turn of the new year because of high deductible health plans. For chronic diseases like diabetes, such health plans are arguably the worst option, according to Mr. Huntley and Mr. Perry. Moving forward, we hope to see much further action on exempting insulin from a patient’s deductible; there were some bills on this front floating through Congress as we recall such as the “Insulin for All” bill but none that appear to have made a major difference except one in Colorado.
“Insulin—this whole topic of pricing—really makes me mad.” – This line drew a huge round of applause from the packed-to-capacity room, reflecting the frustration felt by those on the front lines of diabetes care as they struggle to help patients navigate a convoluted and often non-sensical system that has left many priced out of the medicine they need.
In with the Fat, Out with the Carbs: Why Dieticians in the 80s Had It All Wrong
In an absolutely packed auditorium, Dr. Jim Painter praised the benefits of restricting carbohydrate intake for those with obesity and/or diabetes. Dr. Painter’s enthusiasm and focus on lifestyle changes certainly resonated with the HCP-centered audience, who reacted to his jokes (“I used to think Alfredo sauce was doubly deadly… but now I drink the stuff”) with raucous laughter and cheers. Dr. Painter, notably funded by the Atkins diet, started the talk by recognizing his own mistaken villainization of fat in his early years as a registered dietician, stating, “we had it all wrong.” According to Dr. Painter, our current obesity epidemic largely stems from the downfall of fats and rise of carbs following the publication of the 1980 Dietary Guidelines for Americans. Some recent research, however, supports that low-carb diets are effective for (i) promoting weight loss; (ii) reducing blood sugar in type 2 diabetes; and (iii) reducing risk for heart disease by reducing blood saturated fat, LDL cholesterol, and inflammation. Dr. Painter presented a true whirlwind of papers, but most relevant to those with diabetes were (i) a recent review showing that low-carb diets are an effective first approach to treating type 2 diabetes and adjunct to type 1 pharmacology; and (ii) a meta-analysis demonstrating that for those with type 2 diabetes, low-carb diets (<26%) produce up to an 0.2% greater reduction in A1c compared to high-fat diets, though both produce clinically meaningful reductions of ≥0.5%. Minimizing the intake of refined carbs and added sugars is a tenet of the ADA’s Standards of Care; however, Dr. Painter believes that a low-carbohydrate eating plan is framed as a possible means of glycemic improvement rather than one that has proven to be effective. Most recently, data from the DiRECT trial, showed that primary care-led weight management led to a 36% rate of remission in type 2 diabetes over a course of two years.
Diabetes Educator of the Year Dr. Diana Isaacs and Ms. Debbie Hinnen described the consequences of hypoglycemia and new treatment options, providing helpful real-world tips for DCES’s to use in practice. As hypoglycemia causes more hospitalizations than hyperglycemia and is variable by individual, there is great need for creative prevention and treatment regimens. Hypoglycemia is linked to CV death via dead in bed syndrome, and though its exact mechanism is unknown, possible mechanisms include neuroglycopenia, hypoxemia, seizures, MI, and cardiac arrhythmias. Commonly-prescribed diabetes medications, like insulin, SUs, and meglitinides, cause hypoglycemia, so prevention is necessary. Prevention can take the form of patient education, dietary intervention, exercise management, glucose monitoring, medication adjustment, and talking about hypoglycemia at every visit.
Technology, like CGM, can be especially helpful for in-clinic conversations between patients and providers. When health professionals have access to glycemic records, it can be easier to analyze trends and teach patients about how their eating, sleeping, or exercising habits impact blood glucose. However, Dr. Isaacs explained that the CGM ambulatory glucose profile (AGP) only records what’s happening between the 10th and 90th percentile of blood glucose trends, which leads to patterns of hypoglycemia sometimes being omitted (although this is not very frequent). Thus, it is important to review day by day CGM reports, discuss hypoglycemia at every visit, as well as figure out how patients individually define hypoglycemic blood sugar levels.
Ms. Hinnen gave a helpful list of questions for providers to ask patients in order to have proactive discussions on hypoglycemia:
Dr. Isaacs emphasized the importance of the Rule of 15 in treating hypoglycemia, adding that it should be repeated up to 3 times. If this doesn’t work and the patient loses consciousness or seizes, then caregivers need to use glucagon and call 911. Traditionally, glucagon had only been available through injection after needing to be reconstituted- a difficult task for most caregivers in stressful, frightening situations when a loved one has a severe hypoglycemic event. Recently approved nasal glucagon (Baqsimi) is much easier to administer for trained and untrained people alike – Dr. Isaacs also highlighted this point earlier on in the meeting at a talk on new medications on the horizon. Xeris’ Gvoke HypoPen is also currently under review for severe hypoglycemia at FDA with a PDUFA date of September 10. Elsewhere in the landscape, Zealand is also developing its HypoPal glucagon rescue pen (liquid stable dasiglucagon) and is targeting an early 2020 NDA submission.
Drs. Jacqueline LaManna, Jan Kavookjian, Michelle Litchman, and Jane Dickinson presented findings from their systematic review of studies (n=14) examining the impact of DSMES on hypoglycemia outcomes, highlighting the need for (i) more studies in this area; (ii) better descriptions of DSMES; and (iii) more consistent terminology in the literature. The review was published in The Diabetes Educator in August 2019 and used a modified Cochrane method to systematically search and review articles published between 2001-2017 that included DSMES by itself or as a key component of interventions impacting hypoglycemia outcomes. Primary outcomes in the study centered on changes in hypoglycemia events and symptoms, the only two hypoglycemia outcomes targeted in the retained studies; secondary target outcomes included knowledge gain and behavior change, clinical outcomes, humanistic outcomes, and economic and utilization outcomes after diabetes education.
These results highlight that more studies examining outcomes of diabetes education are needed, along with better descriptions of the DSMES content and structure that was delivered; more standardized terminology will also help in being able to compare findings across studies. For example, some studies examined “hypoglycemia events”, and others, the more subjective “hypoglycemia symptoms” which challenges comparison of study results. “Glycemic control” is also judgement-based and can be perceived as stigmatizing in persons with diabetes. Studies also need to include more diverse participants (across the age spectrum, ethnicity, and socioeconomic status), as well as looking at the role of caregivers in reducing risk for hypoglycemia outcomes. Moving forward, we’re curious to see how initiatives such as the Endocrine Society’s recently announced HypoPrevent program will address these points
Significant improvements in psychosocial and humanistic measures were reported in several studies. Decreases in diabetes distress (PAID), health distress, or depressive symptoms (PHQ) were seen in seven of eight studies measuring these, and increases in self-efficacy were reported in the three studies that measured it.
Ms. Kate Thomas (AADE Director of Advocacy) and Mr. Tim Dall (HIS Markit Health economist and Executive Director) presented modelled results on the impacts of the Expanding Access to Diabetes Self- Management Training (DSMT) Act on access and utilization of DSMT, along with potential Medicare savings. As a reminder, the recently introduced Expanding Access to DSMT Act aims to greatly increase Medicare beneficiaries accessing DSMT. Importantly, the bill introduces modifications to existing DSMT benefits in order to promote patient enrollment. Under this bill, the initial 10 hours of DSMT available to beneficiaries during the first year would remain available in subsequent years until fully utilized. The original two hours of DSMT in subsequent years would also be increased to six. Moreover, DSMT services would be excluded from Medicare Part B cost-sharing and deductible requirements, and Medical Nutrition Therapy (MNT) and DSMT would be allowed to be provided on the same day. Physicians and qualified non-physician practitioners not directly involved in managing a patient’s diabetes would be able to refer them for DSMT services. Furthermore, DSMT services could be provided in a community-based location as well as be demonstrated virtually.
A Disease Prevention Microsimulation Model (DPMM) was developed to test three scenarios with and without the cost share provision (full bill vs. partial bill): (i) status quo of utilization of DSMT; (ii) moderate improvement scenario; and (iii) aggressive improvement scenario. The DPMM was designed to model the likelihood and timing of disease onset and severity and the projected medical costs, employment levels, productivity levels, mortality risk and quality of life. The DPMM projected more than 50 clinical and economic outcomes, and medical expenditures were estimated using multivariate regression from the Medical Expenditure Panel Survey and modeled by medical setting and diagnosis category. The model was validated through expert review.
Improving DSMT access was projected to save Medicare $4.9 and $9.4 billion over 10 years in the modest and aggressive utilization scenarios, respectively. Medicare spending was found to decrease across all care settings. Both the modest and aggressive improvement scenarios are conservative estimates of the increase in DSMT utilization over 10 years, with the former projecting 7% of beneficiaries attending and the latter estimating attendance from 17%. However, the model has some limitations. Although clinical benefits from existing studies on DSMT were incorporated, there are relatively few studies in this area generally. At the same time, this study only modeled health benefits from improvements in glycemic levels and body weight, even though DMST is known to have other short- and long-term impacts on health expenses. The savings estimates presented might therefore be on the conservative side.
DSMT has been a Medicare benefit since 1997 and is known to lower A1c, improve the quality of life, reduce complications, and enhance self-efficacy etc. However, less than 5% of newly diagnosed Medicare patients access this service.
As background, AADE worked with the Diabetes Advocacy Alliance and our congressional champions on the introduction of the Expanded Access to Diabetes Self-Management Training (DSMT) Act in the 116th Congress. Senators Jean Shaheen (D-NH) and Susan Collins (R-ME) introduced S. 814, the Senate version of this legislation. Representatives Tom Reed (R-NY) and Diana DeGette (D-CO) introduced H.R. 1840 in the House of Representatives.
A Lilly-sponsored poster detailed results from a cost-offset model of Baqsimi (nasal glucagon) vs. injectable glucagon, demonstrating considerable savings per severe hypoglycemic event with Baqsimi. Specifically, savings were quantified to be $929 for those on commercial insurance, $502 for those on Medicare Advantage, and $335 for those on Managed Medicaid. Savings for Baqsimi were driven by the increased probability of successful administration of glucagon with nasal administration compared to injection – the model used in this study cited success rates of 90% for nasal glucagon administration, compared to 15% for injectable glucagon (we wonder if these rates of successful nasal glucagon administration could be even higher given greater uptake and education with the therapy). Of course, current glucagon reconstitution kits are cumbersome, time-consuming, and error-prone, as they require mixing and injecting steps that often cannot be performed by the individual experiencing the hypoglycemic event. Although this dramatic improvement in success rates is well known, we’re glad to see data linking this ease of use of nasal glucagon to healthcare cost savings in the form of reduced ER visits and treatment.
Dr. Linda Yarrow on Medical Nutrition Therapy to Mitigate CVD Risk
Addressing the various challenges posed by conflicting studies, along with public confusion often fueled by sensational media coverage, Dr. Linda Yarrow presented a thorough analysis of medical nutrition and detailed her own experiences and practice with patients. She reminded the audience that a patient does not have to be showing the symptoms of cardiovascular disease (CVD) for them to be risk, and that individuals who have CVD risk factors earlier in life even without any symptoms are still five-fold more likely to develop CVD later in life. Dr. Yarrow maintained a heavy focus on incorporating whole grains, fruits, vegetables, nuts, legumes and lean protein into her recommended daily diet (she prefers the Mediterranean and DASH diets). Moreover, instead of reducing dietary cholesterol, she advised reducing saturated fats and increasing poly- and mono- unsaturated fats. Most importantly, Dr. Yarrow stressed that all recommendations have to be based on cultural and food preferences, seeing as it’s paramount for patients to be able to follow these diets in a sustainable manner.
Dr. Yarrow pointed to data showing that the consumption of whole grains, nuts, seeds, and legumes is consistently associated with lower CVD risk. A 2019 metanalysis that comprehensively covered literature on the Mediterranean diet found that there was a significant body of evidence suggesting benefits of this diet for CV health, especially considering that no other diet has been tested so extensively and repeatedly. The DASH diet (which is somewhat similar in its incorporation of fruits and vegetables, whole grains, nuts, modest amounts of dairy, poultry/fish, and low incorporation of sugar and red meats) was also found to have improved CV effects by a 2015 metanalysis in subjects with a greater cardiometabolic risk. This diet also improved insulin resistance, hyperlipidemia, and weight loss. As for low carbohydrate diets like the keto diet, a greater body of evidence is still needed. Although they are associated with lower triglycerides and glucose, as well as higher HDLs, a 2019 NHANES study found that those with the lowest intake of carbohydrates were at a 32% higher risk for all cause death. Of course, more studies are still needed on the long-term safety of all of these diets. We do note that ADA’s 2019 Nutritional Guidelines are significantly more receptive to low-carb diets than past versions of these guidelines have been in the past.
Dr. Yarrow also reviewed data supporting the notion that saturated fats are a greater cause for concern than dietary cholesterol. For example, both the National Lipid Association and the American Journal of Clinical Nutrition state that high egg consumption does not have adverse effects on CV health, although people with diabetes could see adverse effects if there was not enough poly- and mono-saturated fat consumption. Overall, more eggs in a diet (2 eggs/day for 6 days/week) could provide greater satiety, protein, and micronutrients, along with aiding in weight management. Moreover, the 2017 AHA Presidential Advisory reported that several randomized control trials found reducing saturated fat intake by replacing them with polyunsaturated fats reduced CVD risk by about 30%, a reduction similar to that achieved by statin treatment. Coconut oil, one of the foods currently hailed as having many health benefits, has been found to increase both HDLs and LDLs. As recent studies show that raising HDL without lowering LDL does not impact CVD, coconut oil can actually have adverse impacts.
Virginia Valentine on Best Practices for Managing Severe Hypoglycemia
In a Xeris-sponsored product theater, renowned diabetes educator Ms. Virginia Valentine highlighted best practices and common trends associated with severe hypoglycemia. She began her talk with a case study of how quickly hypoglycemia can progress to severe levels and, given the lack of blood glucose classification for it, can be unpredictable and difficult to recover from. Hypoglycemia’s progression can be influenced by management (i.e. insulin pump errors), lifestyle (i.e. physical activity), and individual factors (i.e. insulin sensitivity), and this directly plays into how common hypoglycemia is (for example, 50% of type 2 have 1-3 severe hypoglycemic events annually). Individuals can try to stay safe on their own through using CGM and pumps, but as these advancements haven’t eliminated severe hypoglycemia in patients who use them, plans that involve caretakers are still necessary.
Ms. Valentine explained that severe hypoglycemic events can create undue burden at all levels of the socioecological model. For the patient, severe hypoglycemia means a debilitating and distressing experience with fears that end up limiting diabetes management success (i.e. insulin non-adherence). Family and friends also feel distress, while the community and overarching healthcare system feel the impacts of diminished productivity and increased healthcare costs. These rippling effects show the need for intervention in preventing and treating severe hypoglycemic events directly at the source, in order to mitigate broader effects.
Health professionals need to partner with patients to create action plans for severe hypoglycemia that include assessing risk at every clinical visit, along with education, prevention, treatment, and incorporation of glucagon into care plans if necessary. Allied health professionals have the responsibility of asking patients about their recent medical history, with a focus on blood glucose trends. Patient risk factors include aggressive blood sugar control, insulin administration errors, cognitive issues, and overall behavior. Important educational topics that should be discussed include how exercise, skipping meals, and insulin dose adjustments all affect blood sugar levels. Although eating carbs and glucose tabs is a good treatment for mild hypoglycemia, patients need to be aware that they should take glucagon for severe hypoglycemia. Therefore, educators need to ensure that patients know how to administer glucagon, where to store it, and how to identify people who will administer it for them if they are not able to. This includes filling prescriptions for glucagon, as only 0.66 million of the 5.6 million people with diabetes on insulin actually fill it annually. We’re hopeful that as more treatment options for glucagon emerge from the next-gen glucagon landscape, these numbers will steadily rise.
4. Additional Topics
AADE 2019 President Karen Kemmis Reveals “Diabetes Care and Education Specialist” as New Title Chosen for CDEs.
AADE 2019 President Karen Kemmis kicked off this year’s conference with the exciting announcement of the new title chosen for CDEs by a consensus amongst the profession. Acknowledging the complexity and specialty that are major components of the services provided by them, CDEs will now call themselves “Diabetes Education and Care Specialists”. Ms. Kemmis went on to give an inspiring address on the value of positive change and innovation as well as the need for CDEs to own the value of the expertise and services they provide.
CDEs will now identify themselves as DCES: “Diabetes Care and Education Specialists” – a title that better represents the diversity of work that this field pursues. Ms. Kemmis echoed the frustration of many CDEs present in the audience as she described how the title “Certified Diabetes Educator” did not capture the true breath of their work. The new title aims to incorporate key terms identified by a consensus of CDEs as being integral and representative of their work, including words such as “expert, comprehensive, and outcomes oriented.” AADE will now be working to incorporate the new title into practice and educational resources as well as integrating with partner associations. Ms. Kemmis declared that they will achieve success when “this acronym (DCES) is recognized everywhere”.
Ms. Kemmis also introduced Project Vision as another initiative aiming to drive change in the way DCES’s are positioned for success. Asking the audience to describe what they defined as “change”, Ms. Kemmis shared that for her, change was helping reimagine the role of DCES’s, positively impacting those who DCES’s serve, and repositioning their specialty to reflect the what they really do. These aims are captured in Project Vision, an initiative to elevate the roles of DCES’s and position them for success in a constantly evolving environment. Project Vision follows six core objectives: (i) to improve outcomes through patient centered and holistic care; (ii) bridge the clinical and self-management aspects of care; (iii) constantly trying to perfect and increase the repertoire of diabetes management skills; (iv) elevate the role of DCES’s as experts; (v) claim expertise in the cardiometabolic space; and (vi) show that diabetes education centers are savings centers instead of cost centers. All of these objectives are represented by the six-pronged Project Vision framework:
Population Health: The Future of Diabetes Care?
A powerhouse group of DCESs, including MedStar Health’s Ms. Joan Bardsley and Ms. Gretchen Youseff and Innovative Healthcare Designs’ Ms. Teresa Pearson, presented a dynamic lesson on the evolving role of diabetes educators in a field increasingly focused on population health. The idea of population health – health outcomes of an entire group of individuals – has taken off within diabetes care, as often certain barriers to health collectively affect an entire population. Ms. Bardsley noted that although population health can help guide treatment, diabetes care remains person-centered. Person-centered care is one of the central tenets of Project VISION – a new set of values crafted by the AADE that will shape the organization’s future, which Ms. Bardsley also discussed. Out of Project VISION’s six principles – (i) promote person-centered care; (ii) achieve the “quadruple aim” – quality, cost, patient experience, provider experience; (iii) promote behavioral health; (iv) leverage technology; (v) incorporate cardiometabolic and related conditions; and (vi) integrate diabetes management, self-management education, prevention, and support – she seemed particularly passionate about the utilization of technology, urging DCESs in the audience to strive to become experts in tech, as patients now have that expectation. This new responsibility is a clear example of the numerous shifts within diabetes care, on the systems-level, educator-level, and person with diabetes-level, which make up the new “emerging model of care.”
Ms. Pearson (Innovative Healthcare Designs, Minneapolis, MN) taught a lesson on how to actually create population health initiatives by walking the audience through a step-by-step protocol. In particular, the procedure was designed to produce organized, risk-based outcomes, allowing providers to communicate the value of a certain initiative to management. Risk stratification of populations was a key feature of the system, and Ms. Pearson explained that often health initiatives will be implemented in a gradient fashion, prioritizing those most at risk. Ms. Pearson has previously spoken on population health care models, presenting a virtual patient-centered medical home model used in 12 counties in Minnesota at AADE 2013.
Ms. Gretchen Youssef also shared her experience with MedStar Health’s Diabetes Pathway Boot Camp as a case study for new care models. In terms of population stratification, individuals from the overall pool with diabetes were selected based on being type 2 outpatients and then having an A1c ≥9%. In the first visit, participants have a detailed conversation with a DCES, focusing on barriers to medication adherence and taking fingersticks, eating patterns and access to food, and self-care behaviors. At visit one, patients are also given a cellular connected BGM (Telcare) that automatically uploads data to a provider dashboard, and Diabetes to Go, a series of booklets on understanding hypoglycemia, hyperglycemia, meal planning, various diabetes medications, and taking fingersticks. MedStar Health also developed a medication algorithm (with input from endocrinologists, DCESs, and primary care physicians) to allow nurse practitioners to make medication changes. For subsequent weeks, the participant receives ongoing DSMES at least once a week. After 12 weeks, the patient is “graduated” from the program and returns to their normal primary care physician or endocrinologist. Overall, mean A1c dropped 11.2% to 8.1% in the intervention group (n=366) after 12 weeks and created an estimated $3,090/year in savings from averted hospitalization costs.
A Role for Technology for PBMs: Using Text Messages to Improve Medication Persistence and Patient Engagement
Dr. Jennifer Banks and Dr. Patty Taddei-Allen from WellDyneRx, an independent Florida-based PBM, presented promising results from a pilot study of their text message-based intervention, WellConnect. Patients who opted into WellConnect received reminders to take their medication, refill prescriptions, and make doctor’s appointments. Patients also received messages about medication-specific potential side effects (e.g., nausea when starting metformin), links to demonstration videos, and potential cost saving opportunities, such as moving to an equivalent, but preferred formulary agent, or enrolling in patient assistance programs. Lastly, through WellConnect, patients could also have direct access to diabetes educators. In the pilot study of WellConnect (n=216), member engagement (not defined) was 50% across many ages and net promoter score for the program was 49. On a five-point satisfaction Likert scale, nearly 90% gave WellConnect a score of 4 or 5. Unfortunately, neither clinical, financial, nor quality of life outcomes were shared. We like the idea here of using a highly scalable platform – text messages – to offer more on-demand support. It’s also positive to see this from a PBM, given their wide reach in the US healthcare system. How might these interventions be used to help with CGM and pump use, especially in the pharmacy channel?
In their presentation, Drs. Banks and Taddei-Allen also pointed to two similar programs, Sempre Health and RxSavingSolutions. Sempre Health forms partnerships with manufacturers and payers, then uses text messages to encourage patients to perform positive behaviors (e.g., fill a prescription on time), enabling individuals to lower their own copay at the pharmacy counter. Sempre inked a deal with Novo Nordisk and had plans to enroll 10,000 patients in 2018; we haven’t heard updates on this collaboration since then. Kansas-based RxSavingSolutions parses prescription data to identify potential cost-savings opportunities for patients. According to their website, the company covers 3.5 million members and analyzed 19 million pharmacy claims in 2018.
The enormous Abbott booth was bright, well-staffed, and full of energy to discuss FreeStyle Libre and the FreeStyle LibreLink app – now available in the US on both Apple iOS and Android. The iPhone version is in the top 50 medical apps on the App Store, a bit ahead of Dexcom’s G6. Regarding the highly anticipated FreeStyle Libre 2 iCGM, booth reps could only share that it remains under FDA review – we had wondered if clearance might come in time for AADE, but it was not to be. What is taking so long? The device has been available in Germany since last October and been with the FDA since earlier this year. Kelly is testing it now (she has relatives in the EU!) and really thinks the alarms are spot-on and loves the swipe. See our Abbott 2Q19 coverage for more.
In one of the more prominent booths just inside the exhibit hall, Ascensia highlighted its signature Bluetooth-enabled Contour Next One BGM and paired Contour Diabetes app. In walking visitors through the app, reps focused on its pattern recognition, which identifies 14 glycemic trends and provides associated contextual prompts. Reps were also eager to promote Gary Scheiner’s product theater on “Why Accuracy Matters” that Saturday; during Friends for Life last month, Mr. Scheiner advocated for calibrating CGM with Ascensia’s Contour One, because “for my money, it’s got the best accuracy on the market” (an ADA poster of a post-marketing BGM survey backs up this claim). Posters around the booth highlighted Ascensia’s BGM inclusion in both the 670G and Omnipod Dash systems. Like ADA earlier this summer, reps also discussed Ascensia’s partnership with the Chinese CGM manufacturer POCTech – there is still a lot to prove here.
Wow, was Companion Medical’s booth busy when we walked by! After a talk from Gary Scheiner highlighting Companion’s InPen, educators flocked to the booth to learn about the only smart pen currently on the US market. Companion’s new data integrations were a big topic of discussion, with Dexcom, Glooko, and Rimidi all added on just a couple months ago. Company representatives also seemed particularly excited about the ability to pair multiple InPens with users’ smartphones – e.g., to have one at work and another at home. The Companion app is available on iOS and Android, with a notably strong 4.3/5 rating on iPhone (41 reviews) – paired Bluetooth apps for diabetes tech rarely have ratings this high.
DayTwo provides patients with personalized, algorithm- and microbiome-based diets based on an analysis of a sample of their gut microbiome. The mail order microbiome analysis is a pricey $499, and a representative showed us the detailed, roughly 50-page report of individualized information and nutritional recommendations patients receive. The early academic research out of the Weizmann lab correlated microbiome data with CGM responses to different foods – we’d love to see a trial comparing the value of DayTwo’s $499 one-time report vs. intermittent real-time CGM to learn what foods work for an individual. Reps highlighted DayTwo’s attractive reimbursement plan, apparently 100% outcomes based, as evidence of their confidence in the service and its ability to help both patients and payers. The company announced $31 million in Series B funding in June. (Their Hoopla team, though no match for diaTribe this year, also figures to have a strong future with its many young contributors and high team morale.)
Dexcom had one of its smallest exhibit hall booths in recent memory, with a simple open-floor plan to advertise Dexcom Clarity (on desktops) and the G6 mobile apps on iOS and Android. The footprint was noticeably smaller than Abbott’s larger FreeStyle Libre booth and Medtronic’s typically larger booth. Perhaps Dexcom is putting more towards digital marketing or just waiting for the G7? There’s hardly need for anything to drive demand further – the company is already experiencing huge demand. A sign on the back of the booth (below) shared pithy G6 marketing – Powerful, Proven, Protective – focusing on the first-in-class iCGM, value for “insulin-using patients” (great to see this continuing to broaden beyond type 1), DIAMOND and GOLD clinical studies, and urgent low soon alarms.
Insulet’s expansive booth, right at the front of the hall, proudly advertised the newly launched Dash PDM and paired iOS apps DISPLAY (secondary display of key pod info on a user’s own phone) and VIEW (remote monitoring for caregivers). Reps told us that cloud-to-cloud integration with Glooko (passive pump data uploading) and Spanish on the PDM are both expected by the end of 2019 – great to see movement on Spanish so quickly, as reps said educators have been asking for it. (An international launch of Dash is not expected until 2020, where we expect the bulk of translations to launch.) We asked about early experiences with the new mobile apps, and a rep cited one example of a couple where the remote monitoring has really helped improve the relationship – with Omnipod View, the wife can see a bolus has been given for a high blood sugar, rather than texting to ask. This sort of communication benefit will be a huge win for pediatrics/teens and school nurses too – a great example of using technology to both add something valuable (remote monitoring and piece of mind) and take a high-hassle task away (the need for texts, especially those that can be perceived as nagging). We also asked about potential confusion around the Dash PDM – “Is that my own smartphone?” – and reps told us it hasn’t been an issue so far. Of course, Dash is also marketed as a “first step” to the ultimate goal of personal smartphone control. (Expected in 2H20 with Omnipod Horizon)
LifeScan reps highlighted the new OneTouch Delica Plus, a less painful lancing device that debuted during ADA in June. Marketed as an upgrade from the beloved OneTouch Delica, the Plus features 13-depth settings, two different lancet options, and a 50% reduction in vibration from its predecessor. LifeScan also recently joined the growing ranks of BGM producers considering CGM with an announced agreement with Sanvita Medical; reps obviously could not comment on the status of this project. Similarly, there were no updates on a planned six-month study, announced earlier this year, to evaluate the OneTouch Reveal Plus apps in adults with type 2 as part of a joint study with WellDoc and Healthagen (an Aetna business unit within CVS Health).
Livongo made its AADE Exhibit Hall debut with reps wearing shirts advertising the company’s new stock ticker (“LVGO” on NASDAQ). Livongo reported nearly 170,000 Livongo for Diabetes members in its IPO filing, a number that representatives declined to update. Throughout our visit, the representatives emphasized Livongo’s efforts in many areas of chronic care, referring to its mental health (purchased myStrength), hypertension, weight management (purchased Retrofit), and diabetes management programs. The booth’s table included the Livongo-branded cellular-enabled BGM, cellular-enabled blood pressure cuff, and connected weight scale. A representative told us the company was working on expanding into international markets. There were no comments on the FreeStyle Libre Pro partnership or other potential CGM partner plans.
Medtronic’s expansive booth advertised the MiniMed 670G, touting over 180,000 worldwide users and 71% aggregate time-in-range based on the data set shared in June. Reps proudly noted the recent submission to FDA for non-adjunctive labeling, which will open up Medicare coverage of the hybrid closed loop – see our July report. It sounded like there is a lot of pent-up demand for this, especially for those Medicare users currently paying out of pocket for sensors and getting pump supplies covered. Similar to the ADA booth, screens also provided a look at pipeline projects, including the MiniMed 780G advanced hybrid closed loop with automatic boluses (began pivotal trial during ADA; >80% time-in-range goal; launch ambitiously expected by ADA next year), Personalized Closed Loop (FDA submission in November 2020-April 2021), and the Synergy fully disposable CGM (FDA submission in November 2020-April 2021). Elsewhere in the booth, the Guardian Connect standalone CGM and paired Sugar.IQ app got some attention; a rep could not offer any timing on the US launch of an Android version. (We have not heard an update on this in a while.)
The trademark bright green of mySugr was seen throughout AADE as exhibitors handed out tote bags with the memorable tagline “Make Diabetes Suck Less” and mySugr’s logo. The booth featured the mySugr subscription bundle, which comes with the Accu-Chek Guide BGM, 250 strips, lancets, and of course, a subscription to mySugr Pro – a $213 value in the starter kit alone. The subscription is now $49/month, up about 20% from $40/month last year, but still an incredibly great deal for unlimited strips (automatically mailed to the user) for those that use a high number of strips and access to on-demand coaching through mySugr. Currently, coaching is only offered to bundle subscribers, but one representative commented that the company is looking into adding coaching as a separate add-on available for individual purchase. The program is available in the US and Germany, and we’d be interested to know how many subscribe to it. According to mySugr’s website, the app now has 1.8 million downloads and is the “most downloaded diabetes app in the world.” Wow! We’d love to know more about engagement and will be looking to gather more data on this front.
Roche’s booth was buzzing with activity, partly from its giant touchscreen matching game with a public scoreboard. We didn’t hear any updates on US plans for the Roche Accu-Chek Solo patch pump (CE Marked July 2018), which is currently in pilot launch with ~200 people in Austria, Switzerland, Poland, and the UK. See our ATTD coverage for a full breakdown. Notably, our own William Newton and Albert Cai were able to make it onto Roche’s matching game leaderboard, with Albert edging out Will by a mere 0.13 seconds.
Senseonics’ booth was front-and-center with fresh branding and constantly running demonstrations of the Eversense insertion/removal process. In line with the 2Q19 call, reps noted that early discussions have gone well with Medicare, following non-adjunctive approval in June. (Medicare coverage is expected in 2020.) Interestingly, we were told that the very first “patient encounters” (not an official study or trial) with 365-day Eversense wear had begun in Romania. To achieve longer wear time, the Senseonics team had to add more dexamethasone coating, the anti-inflammatory steroid present on the implanted sensor. As a reminder, the 180-day PROMISE Study (n=180) for Eversense XL is expected to complete in 2Q20 (ClinicalTrials.gov page). The plan remains to use data from the first 90 days of the trial to obtain an iCGM indication for the 90-day Eversense. We did not see the enormous mobile Eversense clinic that has been a staple at recent conferences but Dr. Fran Kaufman was there – she’s beloved by diabetes care and education specialists all over the world. .
Tandem’s booth was front-and-center upon walking into the hall, replicating its bright Basal-IQ-focused booth from an eventful ADA. A screen on the edge of the AADE booth implied that Tandem will brand the upcoming “Control-IQ” as an “Advanced Hybrid Closed Loop” – a smart move to distinguish the automatic bolusing from Medtronic’s 670G basal-only “hybrid closed loop.” We also saw new icon branding and marketing for the t:slim X2 mobile app (secondary display, automatic pump data upload), which reps said to now expect in “4Q19” in tandem with the Control-IQ free software update. It will be great to market these launches together, though the mobile app continues to be delayed; previously it was expected by the “end of 2018” (September Analyst Meeting, followed by “early 2019” (3Q18), “summer” 2019 (1Q19), and “1H19” (4Q18). We assume the team has been slammed getting Control-IQ over the finish line – a more important strategic priority. The app will come! The mobile app will launch for both Apple and Android devices, a leg up on Insulet’s Dash apps for iOS only. We liked the marketing: “Office visits should be spent discussing data, not trying to access it.” Reps were obviously quite excited about the FDA submission of the Control-IQ algorithm, adding that Tandem will take some time after approval/clearance to properly train physicians before launching it – great to see this acknowledged now. We’re not sure if Tandem submitted as a PMA or via de novo process to obtain an iController designation.
Sanofi had one of the biggest and most eye-catching booths at this year’s exhibit hall, going all in on branding for its many diabetes products, especially for Lantus (insulin glargine) and GLP-1 combo Soliqua. Like last year, the booth featured large, interactive screens that visitors could swipe through to see facts about the company’s various products. The representatives seemed most excited about discussing Soliqua’s February 2019 expanded indication as a first injectable therapy for individuals with type 2 who require additional glycemic control. Promotional materials were also largely focused on the product, and we were happy to see such heavy promotion of this product considering its impressive A1c lowering capability. Indeed, this product (and Novo Nordisk’s Xultophy) are fantastic, though purist doctors seem to want to titrate each product (basal and GLP-1) separately, which is beside the point of one prescription, one co-pay, etc.
Despite having a large booth last year, AZ brought a smaller booth to the exhibit hall this year that highlighted its BCise autoinjector for GLP-1 Bydureon (exenatide) and its SGLT-2 inhibitor Farxiga (dapagliflozin). The exhibit was adorned with advertisements of cardboard cutout patients, going from gray and knocked down like dominoes to multicolored and exercising. Other than these adverts, there were two kiosks to highlight each drug with touch screens to interact with to learn more about each compound. It appeared that AZ downsized from last year’s VR headsets to demonstrate how BCise works to these neon-sign adorned kiosks and physical presentations from company representatives. When asked about updates on other existing products or those in the pipeline, specifically the recently announced DETERMINE-preserved/ DETERMINE-reduced trials for Farxiga and the oral GLP-1 candidate MEDI7291, reps said they could not share any information outside what was announced in press releases.
Just like last year, MannKind’s booth featured looping interviews of Drs. Anne Peters and Satish Garg endorsing the efficacy and flexibility of ultra-rapid-acting mealtime insulin Afrezza. A representative emphasized the company’s new, non-branded marketing campaign, InhaleMyInsulin, as a means to increase patient awareness of the existence of efficacious insulin that doesn’t require an injection. When asked about company updates, representatives highlighted MannKind’s partnership with United Therapeutics for the development of Technosphere, as well as more details about the recently announced integration of BluHale into the OneDrop ecosystem: Stage one is aimed at teaching patients how to use Afrezza, stage two is aimed at incorporating One Drop technology and teaching patients how to use BluHale to measure their insulin dosage, and stage three is aimed at integrating CGM into the entire process. Already in stage one, MannKind reps let us know that they’re aiming to launch stage two in 2020. We would have been curious to hear more about MannKind’s new direct purchasing program, co-pay card and OUS distribution deal with Tanner Pharma Group, but we were directed to check out recent press releases if we wanted any more company updates.
Merck sported a sizable booth, centered on a froyo bar and dedicated to its entire diabetes portfolio. Individual touchscreens were set up to delineate the package inserts of pneumococcal disease vaccine Pneumovax 23 (recommended for those with diabetes), SGLT-2 inhibitor Steglatro, DPP-4 inhibitor Januvia, and DPP-4/SGLT-2 combination, Steglujan. While mentions of Steglatro have been scarce in recent earnings calls, we have little doubt that the company remains committed to their fourth-to-market SGLT-2 inhibitor. Promotion has been pronounced at recent meetings (see exhibit hall coverage at ADA 2019, ENDO 2019 and AACE 2019), and results for the VERTIS CV CVOT, expected late 2019 or early 2020, will undoubtedly have a major impact on the therapy.
Per the usual, Novo Nordisk brought an impressive booth to AADE 2019, promoting its vast portfolio of diabetes therapies. Most noticeably, for Ozempic (injectable semaglutide), the company rolled out a ~10 foot tall billboard with results from SUSTAIN 7, demonstrating superiority over Lilly’s Trulicity on A1c (~0.4%) and weight (~5 lbs) over 40 weeks – we note Novo Nordisk was also keen on promoting these results at ADA 2019 and ADA 2018 as well. When asked about this direct messaging vs. Trulicity, a representative conceded that there’s a reason that Trulicity is so widely adopted among the GLP-1 class (“it’s simply a fantastic product”) but asserted that Novo Nordisk is confident that Ozempic’s superior glycemic and weight loss benefits should be able to convince patients and providers. As a whole, the company continues to heavily invest in the semaglutide molecule: in its 2Q19 update, Novo Nordisk divulged that it has initiated four new outcomes trials for the therapy, indicating that we’ll continue to learn about this therapy for years to come.
Xeris’ robust glucagon pipeline was the focus of its booth, which increased in size from last year’s small, one-man operation. In the pipeline, a medical team representative highlighted the company’s focus on its Gvoke HypoPen, which is currently under FDA review with a decision expected on September 10. Though Xeris has many candidates in its pipeline currently in phase 2, Continuous Glucagon and Self-Administered Glucagon were mentioned as the company’s current priorities. Reps (understandably) couldn’t speak in any detail on results of studies, but were open to questions and receptive to talking about their products.
--by Ammara Aqeel, William Newton, Ursula Biba, Albert Cai, Rhea Teng, Peter Rentzepis, Martin Kurian, Adam Brown, and Kelly Close