American Association of Clinical Endocrinologists 25th Annual Scientific and Clinical Congress (AACE 2016)

May 25-29, 2016; Orlando, FL – Day #1 Highlights – Draft

Executive Highlights

Hello from hot and humid Orlando (also known as The City Beautiful), where Day #1 of the American Association of Clinical Endocrinologists' 25th Annual Scientific and Clinical Congress got underway this morning! Day #1 featured a series of parallel “special sessions,” two of which were related directly to diabetes and obesity. In the morning, a handful of speakers led a practice update on diabetes technology. Dr. Bruce Bode (Atlanta Diabetes Associates, GA) showed his typical broad situational awareness of what’s going on in diabetes technology – while Drs. Irl Hirsch (University of Washington, Seattle, WA) and Satish Garg (University of Colorado, Aurora, CO) stressed the extent to which report standardization would facilitate CGM/pump adoption. In the afternoon, drugs and obesity took over the spotlight, highlighted by news that the Clinical Practice Guidelines for Comprehensive Medical Care of Patients with Obesity has been published in Endocrine Practice – we have been waiting in anticipation for these guidelines since the AACE/ACE Consensus Conference on Obesity in 2014! Read on below for our Top Highlights from Day #1 in Orlando and check out our preview to see what’s on tap for tomorrow!

Top Four Highlights

1. Dr. Bruce Bode’s (Atlanta Diabetes Associates, Atlanta, GA) overview of current and future diabetes technology offerings labeled Abbott’s FreeStyle Libre a “game-changer,” shared his optimistic view that CGM “will become standard of care in the next five years,” and showed updated T1D registry data on pump and CGM penetration in pediatrics.

2. The need to standardize diabetes data reports emerged as a major theme of a morning symposium on diabetes technology. Are we moving from an era of siloed devices to siloed platforms?

3. Dr. Ron Brazg (Rainier Clinical Research Center, Renton, WA) flipped briefly through a few glucose traces from Medtronic’s pivotal trial of the MiniMed 670G/Enlite 3 – average glucose in one patient after one week on hybrid closed loop dropped to 146 mg/dl vs. 191 mg/dl on open loop (projecting a more than 1% A1c reduction), while another had overnight traces that were “absolutely flat, really impressive.”

4. We learned today that the Clinical Practice Guidelines for Comprehensive Medical Care of Patients with Obesity has been published in Endocrine Practice. We have been waiting for these guidelines since the AACE/ACE Consensus Conference on Obesity in 2014!

Table of Contents 

Top Four Highlights

1. Dr. Bruce Bode’s (Atlanta Diabetes Associates, Atlanta, GA) overview of current and future diabetes technology offerings labeled Abbott’s FreeStyle Libre a “game-changer,” shared his optimistic view that CGM “will become standard of care in the next five years,” and showed updated T1D registry data on pump and CGM penetration in pediatrics. Dr. Bode prefaced his talk by putting the disappointing status of nationwide glycemic control in context, sharing staggering numbers on the number of patients not at goal and stressing that the dismal numbers are a reflection of the underutilization of technology. He did note that penetration is on a promising trajectory based on recent (new to us) data from the T1D registry. Particularly in pediatric patients <13 years old, Dr. Bode showed that pump and CGM use have risen encouragingly over the past five years: (i) increasing from 50% to 62% (pumps) and 4% to 17% (CGM) in those <6 years; and (ii) increasing from 58% to 66% (pumps) and 4% to 10% (CGM) in those 6-12 years. [The registry enrolls patients at the best centers, so US-wide use is certainly lower.] These are solid changes in just a few years and this should accelerate as parents and pediatric endocrinologists become more aware of connectivity (Dexcom G5, MiniMed Connect, pumps in development) and as automated insulin delivery comes to market. More broadly, Dr. Bode estimated that there are presently ~550,000 pumps on the US market, citing “industry” data that Medtronic holds the greatest US market share (61%) followed by Animas (23%), Insulet (11%), Tandem (3%), Roche (1%), and other (1%). That number sounds about right to us, assuming it includes type 2s. On CGM, Dr. Bode lauded recent advancements in connectivity from Dexcom (G5) and Medtronic (MiniMed Connect), while praising Abbott’s effort in getting a factory-calibrated product to the EU market. He did not speculate on an FDA approved insulin-dosing claim for CGM, but he alluded to its potential to expand the number of patients willing to go on CGM and the number of providers willing to prescribe it. As a reminder, Dexcom will have a July 21 FDA panel meeting to debate this issue.

2. The need to standardize diabetes data reports emerged as a major theme of a morning symposium on diabetes technology. Are we moving from an era of siloed devices to siloed platforms? Both Drs. Satish Garg (University of Colorado, Aurora, CO) and Irl Hirsch (University of Washington, Seattle, WA) stressed the extent to which report standardization would facilitate CGM/pump adoption, lamenting the time and effort required to upload data as one of the biggest challenges facing providers on a day-to-day basis. Speakers did praise recent efforts by Dexcom (Clarity), Medtronic (CareLink), Tidepool (Blip, Nutshell) and Glooko (MeterSync Blue) to tackle this challenge, though Dr. Garg also warned that we may be moving from an era of “siloed data” to “siloed platforms” – we agree with that. For example, he highlighted that these interfaces use different color schemes for hyperglycemia and hypoglycemia (e.g., red, green, yellow, blue), provide different default statistics (time-in-range vs. time in hypoglycemia), and define variables differently (hypoglycemia < 70 mg/dl vs. hypoglycemia <60 mg/dl). In addition, it’s often hard or impossible to port data from one platform to another. This remains very challenging for providers – where is the unification, some woulr ask? Dr. Garg stressed that what would help overwhelmed providers (especially PCPs with even more limited time) is standardization and simplification, since the EASE of data downloading and interpretation in the clinic is as critical as any other factor – after all, the most insightful data software is useless if providers do not use it. Dr. Garg explained that just yesterday he spent over two hours trying to help a patient upload G5 data to Clarity to no avail! [This is surprising, as the G5 app uploads automatically to Clarity; perhaps the software was not reading the receiver? Was Dexcom available to help?] Implored Dr. Garg, “When you make these devices, PLEASE make them patient and provider friendly. There’s no point in coming out with new devices if people have to spend two hours figuring out how it works.” We do believe the diabetes data field has accelerated markedly over the past 18 months, but these presentations remind us it is still early days. Standardization is such low hanging fruit, but of course, it’s also a massive coordination challenge. Who should lead this effort? Can companies agree on one report?

  • We wonder what might be learned from other therapeutic areas, such as the EKG in cardiology. How did the EKG become standardized? We continue to hear, too, that medical education woefully underprepares doctors for working with diabetes technology, while EKG training is a cornerstone of medical school curriculums – what kind of educational effort is needed to change this paradigm? Who should spearhead it? See more on this in our coverage of February’s AACE/ACE Consensus Conference.

3. Dr. Ron Brazg (Rainier Clinical Research Center, Renton, WA) flipped briefly through a few glucose traces from Medtronic’s pivotal trial of the MiniMed 670G/Enlite 3 – average glucose in one patient after one week on hybrid closed loop dropped to 146 mg/dl vs. 191 mg/dl on open loop (projecting a more than 1% A1c reduction), while another had overnight traces that were “absolutely flat, really impressive.” This is the first data we’ve seen from the three-month, single-arm trial that wrapped up in March, and Dr. Brazg shared a great deal of enthusiasm for the results despite keeping any numerical analyses (e.g., A1c, hypoglycemia, time-in-range) under wraps. Anecdotally, the few traces we saw showed minimal hypoglycemia under closed loop and very consistent control overnight. [Unfortunately, we were too far back to snap clear pictures.] Results from the pivotal trial will be presented as a late breaker (99-LB) at ADA next month. We assume they will show reductions in average glucose, hypoglycemia, and improvements in time-in-range. There was no control group in the study, meaning comparisons will only be to baseline. Still, the findings should still give an early sense of the 670G’s efficacy and set a bar for other companies to match. Patients in the pivotal trial have loved this product, a sentiment Dr. Brazg echoed – a striking 80% have continued on the system through the FDA’s continued access program. For context, Dr. Brazg’s commentary came during his comprehensive overview of closed-loop technology, and we’ll be back with our detailed coverage of his talk in our full report.

4. We learned today that the Clinical Practice Guidelines for Comprehensive Medical Care of Patients with Obesity has been published in Endocrine Practice. We have been waiting for these guidelines since the AACE/ACE Consensus Conference on Obesity in 2014! These evidence-based guidelines encompass nine broad clinical questions with 123 recommendations (160 specific statements!) and will be presented in detail by Dr. Timothy Garvey (University of Alabama, Birmingham, AL) on Friday. These recommendations provide much needed guidance on clinical decision-making for the real-world medical care of patients with obesity and touch on everything from screening, diagnosis, and evaluation to therapy selection, treatment goals, and individualization of care. We see the publication of these guidelines as a step in the right direction, helping patients achieve weight loss goals and enhancing the overall health of patients. We also learned from Dr. Jefferey Mechanick (Ichan School of Medicine at Mount Sinai, New York, NY) that AACE is working on an Obesity Chronic Care model with key stakeholders, with the intention of holding a second Consensus Conference on Obesity in 2017. We hope that patients will be included at this conference as the fifth key stakeholder “pillar.” As a reminder, they were excluded from the previous consensus conference, in which there were four key stakeholder pillars: (i) Biomedical, (ii) Government & Regulatory, (iii) Health Industry & Economics, and (iv) Organizations, Education, & Research. Incorporating patient opinion into these discussions is of the utmost importance and we hope that by focusing on the person, we will be able to remove some of the stigma associated with obesity. 

  • AACE/ACE also announced that it has developed an app (available for Android and Apple devices) based on its comprehensive type 2 diabetes management algorithm to help guide providers through clinical interactions with patients. The app was supported by a grant from AstraZeneca and includes all the recommendations in the AACE/ACE algorithm to provide HCPs with a practical guide to the whole patient “at their fingertips.” Since launching in February 2016, over 1,000 people in the US, Spain, Saudi Arabia, and other venues have downloaded the app.

-- by Varun Iyengar, Sarah Odeh, Ava Runge and Kelly Close