AADE 2019 (American Association of Diabetes Educators)

August 9-12, 2019; Houston, TX; Day #3 Highlights – Draft

Executive Highlights

  • Greetings from Houston! AADE 2019 wrapped up on Monday, and we’re back with our second highlights installment detailing notable findings from the meeting.

  • In tech, Gary Scheiner shared five things patients and HCPs should consider before starting DIY AID – that’s short for do-it-yourself automated insulin delivery: 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. Both Mr. Scheiner and Ms. Jennifer Smith (Integrated Diabetes Services) noted patients of all ages (from 18 months to mid-70s) successfully using DIY systems, with Ms. Smith stating all options should be discussed with all patients. The Q&A in this session was very insightful, illustrating many of the pros/cons and challenges among the diabetes care and education specialist population.

  • In diabetes therapy, a rapid-fire session on the cream-of-the-crop posters from AADE 2019 included compelling data on the improved ease of use of nasal glucagon Baqsimi (90% success w/ trained users vs. 15% for injectable glucagon), data from DayTwo on its personalized, microbiome-based nutrition for type 2 (n=51; 0.8% A1c drop from 7.4% baseline; time in range increase of 7%), and a review of landmark CREDENCE results. A well-attended session on new type 2 medications also highlighted oral semaglutide, sotagliflozin in type 1, and Intarcia’s exenatide mini pump ITCA 650.

  • In big picture, Dr. Faith Foreman 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. Furthermore, Dr. Jane Dickinson presented a witty and compelling case for the diabetes language matters movement, citing worrisome perception of stigma data from individuals with both type 1 and type 2 diabetes. We also attended an entertaining and interactive presentation on how game-based learning can be used as a powerful tool for diabetes education and management—organized by two stellar speakers from the CDC!

  • We also have coverage of 18 exhibit hall booths, including 11 in technology and 7 in therapy.

    Greetings from Houston, where the 2019 iteration of AADE 2019 has just wrapped up. Below, you’ll find our second installment of top highlights from the meeting separated into: (i) Diabetes Technology, (ii) Diabetes Therapy, (iii) Big Picture, and (iv) Exhibit Hall coverage. Read on for all the details, and be sure to see our first highlights installment here as well. We’ll be back tomorrow with our final highlights report, along with exhibit hall coverage from the meeting.

     

    Table of Contents 

    Diabetes Technology Highlights

    1. 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.

    2. Cecelia Health’s David Weingard and Teresa McArthur and Stanford’s Korey Hood: Technology and Care Teams Should Create “Light Bulb Moments” for Patients

    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.

    3. Real-World Operational Pilot of WellDoc’s BlueStar (n=35) Provides Important Lessons for Digital Health Implementation in Primary Care; 0.7% A1c Reduction in Case Group vs. 0.4% in Control Group (Baselines Not Given)

    WellDoc’s Ms. Malinda Peeples, Mr. Stephen Lynch (MGH), and Ms. Kathy Schwab (Providence Health & Services) presented lessons learned from integrating WellDoc’s diabetes management app, BlueStar into primary care practices that are moving to value-based paymentsThe 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.

    Mr. Lynch from the Ambulatory Practice of the Future (APF) at MGH described the challenges facing providers in the transition to value-based services stating that clinical practice adoption and integration of technology moves at the “Pace of Humanity” not at the “Pace of Technology.” As he discussed the integration of BlueStar into their primary care practice, he described the “DNA” of organizational change as a combination of people, processes, tools and team development to help clinicians work at the “Top of their License.”

    Ms. Schwab described historical experience with a diabetes app in 2013 which provided some learnings but did not meet their team’s needs or desired outcomes. After extensive search, BlueStar was selected for an operations pilot to determine the best way to improve the reach of the 14 educators in their 41 primary care clinics. In the 2 practices where BlueStar was launched, 537 patients had a diagnosis of type 2 diabetes. Providers ordered BlueStar via a digital care platform within the Epic EMR for 109 patients, however just 35 of these patients activated BlueStar via the email generated from the Epic order. After three months, patients who participated in the program experienced an 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. 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 integrating a new product into clinic workflow. Although the target net promoters score of >60 was not met, a substantive score of 50 was achieved. 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 and provider interest but noted that their organization believes that these findings are consistent with other innovation projects, and WellDoc fully supports the continued development of the app.

    • BlueStar is now on version 5.3 since the 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; release pending FDA clearance. The app store pages (AppleAndroid) 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.

    Diabetes Therapy Highlights

    1. 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

    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” – a spouse, sibling, or close friend – 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). CGM systems with lower out-of-pocket costs, such as the FreeStyle Libre 14-day system, can help reduce the cost burden for patients and overcome a significant barrier to the increased use of CGM by patients.

    • 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.

    2. What’s New in Diabetes Medications: Pharmacists Point to Oral Semaglutide, Sotagliflozin, and ITCA 650 as the Future of the Field

    In a well-attended session despite its early timeslot, Dr. Joshua Neumiller (Washington State University) and Dr. Clipper Young (Touro University California) gave a comprehensive update on treatment recommendations and medications for diabetes management. To begin, Dr. 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. Dr. 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 (iii) need to minimize hypoglycemia; (iv) need to minimize weight gain or promote weight loss; or (v) major cost barriers. In terms of major amendments to the treatment algorithm, Dr. Neumiller noted that GLP-1 agonists have now been prioritized over basal insulins as a first injectable in most patients (unless A1c >11%), 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 Medical Care were briefly mentioned, specifically GLP-1 agonist Victoza’s (liraglutide) recent indication for the treatment of pediatrics with type 2 diabetes age at 10 or above, but were not a major focus of the presentation.

    • Dr. 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, Dr. 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, Dr. Young highlighted the submission and subsequent CRL from the FDA for Zynquista (sotagliflozin) in type 1 diabetes. Dr. 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 receptor agonist 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, Dr. Young did not mention Sanofi’s recent decision to terminate development of Zynquista with Lexicon, which we believe to be a major point that will dictate the drug’s future timeline.

    3. 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!

    2020 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. 

    Big Picture Highlights

    1. 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

    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.

    2. #LanguageMatters: Why the Language Movement is About Changing Mindsets, Not Policing Words

    2019 Diabetes Educator of the Year Dr. Jane K. 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 – perceived 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. The Expectancy Theory demonstrates that labels lead to implicit biases, which affect behaviors and in turn outcomes. 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 from shame and blame to acceptance. 

    • 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 “Type 2s.” 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, person-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!

    3. CDC: Game-Based Learning Could Increase Patient Engagement and Retention in National Diabetes Prevention Program (DPP) and Diabetes Self-Management and Support (DSMES)

    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.

    4. 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 says that, although it is not settled science, the data seems to support a low-carbohydrate eating plan as a probable means of glycemic improvement. 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.

    5. 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.

    Exhibit Hall

    Diabetes Technology

    Abbott

    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.

    Ascensia

    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.

    DayTwo

    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

    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

    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

    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

    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

    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.)

    Roche

    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

    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

    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. 

    Diabetes Therapy

    Lilly/BI

    Finding Lilly/BI’s exhibit this year took some navigation skills, as the booth was again dwarfed by many of its pharmaceutical peers. Luckily, the booth’s beloved espresso station remained a constant, and the cappuccinos were as delicious as ever – and wow, the letters GLP-1 were imprinted in the topping! Although Lilly/BI had two small tables dedicated to GLP-1 Trulicity and a variety of insulin pens, virtually all of the booth’s branding was dedicated to newly approved nasal glucagon Baqsimi. Excitingly, we had a chance to talk to a representative and try a mock-up of the technology for ourselves while we were there. Stored in a nifty case, the nasal administrator was only about 1.5 inches tall and quite comfortable to hold. The representative simply informed us to make the “green line on the plunger go away” (take a look at the device below), and with a simple push, the emergency dose was “administered.” Impressively, we felt like we could have used the device even without instruction. The plunger goes through a preliminary “loading” click, and the full dose is pushed through after a second click, which are both intuitively performed as one fluid motion. In terms of useful tidbits, the representative informed us that Baqsimi can be used with a cold/congestion, does not have to be inhaled (rather it is absorbed through the vasculature), and will be priced the same as injectable glucagon. We would have loved to see a bigger showing from Lilly in the exhibit hall considering this monumental product, however the small size was not surprising after representatives last AADE cited that Lilly has deprioritized its exhibit hall exposure due to “restructuring.” Like Dexcom, demand has never been stronger for many of its products like once-weekly GLP-1 Trulicity and we believe opportunity cost has the funds going elsewhere.

    Sanofi

    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.

    AstraZeneca

    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.

    MannKind

    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

    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 2019ENDO 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.

    Novo Nordisk

    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

    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