June 9-13, 2017; San Diego, CA; Full Preview – Draft

June 9-13, 2017 – San Diego Convention Center – San Diego, CA

Conference Website

Online Itinerary Planner

Mobile app (or search “ADA 2017” in Apple/Android app stores)

Registration

List of Corporate Symposia

List of Product Theaters

List of diaTribe Foundation social and educational events (Thursday evening, Monday evening)

The diaTribe Foundation/TCOYD 11^th Annual Diabetes Forum (Monday, June 12, 6:30-9 PM) 

The diaTribe Foundation 2^nd Annual Musings Under the Moon: Discussions on Digital Health (Monday, June 12, 9:30 PM-Midnight)

The diaTribe Foundation/Diabetes Research Connection Brews & Blood Sugar (Thursday, June 8, 8 PM – Midnight)

ADA 2016 Full Report (500 pages, 20 sections, 43 themes)

It’s that time of year again, with the biggest gathering of brilliant diabetes thinkers right around the corner. That’s right – we’re less than a month away from American Diabetes Association’s 77^th Scientific Sessions, held from June 9-13 in sunny San Diego! This year’s Scientific Sessions feature over 2,100 abstracts, 49 oral presentation sessions, and 99 symposia. This meeting is a bit more manageable - last year’s meeting featured over 2,500 abstracts, 50 oral presentations, and 95 symposia. The full schedule is available through the conference’s online itinerary planner here. Full abstracts will be made available online at 5:00 PM EST on Friday, June 2.

Below, we outline some of the biggest highlights from each day’s agenda. Stay tuned for our category documents later this month, which will include links to the titles of abstracts organized by topic area.

Diabetes Drugs

As is now tradition for ADA, Monday afternoon will steal the show with the presentation of not one but two cardiovascular outcome trials (CVOTs): DEVOTE for Novo Nordisk’s Tresiba (insulin degludec) and CANVAS (and the CANVAS-R renal trial) for J&J’s SGLT-2 inhibitor Invokana (canagliflozin). The two presentations are back-to-back in the very same room – be sure to arrive early! Topline results for DEVOTE revealed Tresiba’s cardiovascular non-inferiority to Lantus, but we’ll be especially looking out for the hypoglycemia data. Virtually no information is available about the CANVAS or CANVAS-R data as J&J has not announced the topline results yet – we’ll be waiting on the edge of our seats. The CVOT newsflow doesn’t stop there – it actually starts earlier, with a Sunday morning session will highlight new cardiovascular and secondary endpoint data from the LEADER CVOT for Novo Nordisk’s GLP-1 agonist Victoza (liraglutide), expanding on primary results presented at last year’s ADA meeting. The agenda also features full results from a suite of phase 2 and 3 trials of Lexicon/Sanofi’s SGLT-1/2 dual inhibitor sotagliflozin in type 1 diabetes, long-awaited results from TrialNet’s oral insulin trial, results from the ODYSSEY DM program evaluating Sanofi’s PCSK9 inhibitor Praluent in people with diabetes specifically, and much, much more. Compared to last year, we’re noticing more post-marketing data for diabetes therapies that are already on the market rather than phase 3 data for upcoming drugs. This is likely a reflection of the many, many new diabetes drug launches over the last few years and the fact that many of the candidates currently in the diabetes drug pipeline are in earlier-stage trials.

Diabetes Technology

While this year’s diabetes technology lineup lacks the flare of last year’s Medtronic MiniMed 670G pivotal trial, Dexcom’s DIaMonD study, and Abbott’s FreeStyle Libre IMPACT study, there will be some important new data this year: Dexcom will present more results from DIaMonD; Insulet will share Omnipod Horizon feasibility data from a pediatric cohort; Dr. Satish Garg will present one+ year data from the 670G continued access phase in a late breaker; Dr. Bruce Buckingham will discuss the potential for closed loop to restore hypoglycemia awareness; One Drop has a late-breaking poster with additional outcomes data from its coaching and education platform; and we’ll see new closed loop data from Tandem (PLGS system), Cambridge (acute general hospital setting), OHSU (single vs. dual hormone control), and Montpellier/UVA.

The symposium lineup features sessions on CGM outcome standardization (chaired by Dr. Bruce Buckingham and Ms. Kelly Close), what is sure to be a fascinating debate on using CGM in type 2 diabetes (Drs. Jeremy Pettus and Bill Polonsky), progress toward an artificial pancreas (with Drs. Stu Weinzimer, Rich Bergenstal, and many others), updates on connected health (with NIH’s Dr. Judith Fradkin and FDA’s Dr. Bakul Patel) and apps, a debate on beta-cell replacement vs. technology (Drs. Jeffrey Millman and Aaron Kowalski), and more. Corporate symposia from Abbott, Dexcom, and Insulet are sure to be full of updates on FreeStyle Libre, non-adjunctive use of G5, and the latest on the OmniPod. The exhibit hall will hopefully show off Medtronic’s MiniMed 670G for the first time in a major US Exhibit Hall, offer a first look at Insulet’s next-gen Dash PDM, and possibly (?) show J&J’s OneTouch Via patch delivery device. We expect plenty in the poster hall too, where lots of ADA technology data tends to comes from.

Obesity

The obesity agenda includes a Novo Nordisk-sponsored symposium on Sunday evening focused on stepwise integration of obesity pharmacotherapy (including Saxenda) into a patient’s medication regimen. A mini-symposium on Saturday afternoon includes a talk by Dr. Melanie Davies on glucagon-based therapies for obesity (a pertinent topic, as Novo Nordisk, Lilly, and Sanofi, among others, have glucagon analogs and GLP-1/glucagon dual agonists in development for diabetes and obesity). Scattered oral presentations will discuss the weight effects of different diabetes drugs as well as novel drug candidates. A Monday morning session will cover eight in-human studies of weight loss agents, headlined by canagliflozin/phentermine co-administration, and on Sunday we’ll learn the findings of a SUSTAIN 1-5 meta-analysis focused on semaglutide’s consistent weight loss efficacy. A late-breaking poster will share data on fibroblast growth factor-21 (FGF-21) as a protective agent against developing insulin resistance in obesity (Novo Nordisk has an FGF-21 analog in phase 1 for obesity). All in all, the agenda is scarce in major new data on effective obesity treatments, which unfortunately reflects a theme we noticed at ADA 2016. That said, we’re very much looking forward to several sessions on prediabetes and type 2 diabetes prevention, where weight management is a critical component. Dr. David Nathan will present the latest findings from the Diabetes Prevention Program (DPP) research group during a session of orals on Sunday morning, and Tuesday morning features a highly-anticipated symposium on missed opportunities for intervening in prediabetes.

Thursday, June 8

• (8:00 PM – 12:00 AM, Stone Brewing Taproom) The diaTribe Foundation/Diabetes Research Connection Brews & Blood Sugar. Kick off your ADA and kick back at the second Brews & Blood Sugar, hosted by The diaTribe Foundation and Diabetes Research Connection at San Diego's famous Stone Brewing Taproom. This event is back by popular demand after a very successful run at AADE last August. Held at the same venue, that event featured a number of scientists and patients sharing their research and experiences with alcohol and diabetes, as attendees from various backgrounds enjoyed flatbread pizza, brews, and each other’s company. Purchase tickets here.

Friday, June 9

• (11:30 AM – 12:30 PM, Room 24) Mini-Symposium: The Future Face of Diabetes Care – Beta-Cell Replacement vs. Technology. This debate will pit Wash U’s Dr. Jeffrey Millman, a disciple of Dr. Doug Melton who will make the case for replacement, against JDRF’s Dr. Aaron Kowalski, who will argue for closed loop. In our opinion, the key questions are “when” each will make a major difference in a broad population, “who” they will help, and “how much” they will cost. Closed loop is obviously a NOW solution, as Medtronic has begun the customer training phase for the MiniMed 670G (broader launch starting in June), DIYers are making their own closed loop systems, and many product launches are expected in 2018 and beyond. Meanwhile, the majority of beta cell encapsulation and replacement approaches are still in early clinical development, with ViaCyte and Sernova leading the pack in phase 1/2 trials. Questions abound for both technologies. For closed loop: Cost and coverage? Ideal candidates? On-body burden? Additional workload/burden (alarms), especially for MDI/SMBG users? Faster insulins? IP insulin delivery? For beta cell replacement: Immune response? Encapsulation? Source of cells and frequency of replacement? Regulatory? Sustainable business model? Cost and coverage? Safety?
• (11:30 AM – 12:30 PM, Room 31) Mini-Symposium: Big Data, Small Data, and Type 1 Diabetes – Practice Redesign at the Intersection of Families, Providers, Value-Based Reimbursement, and Technology. Dr. Laura Gandrud (Children’s McNeely Pediatric Diabetes Center, Minneapolis, MN) and OptumLabs’ Dr. Aylin Altan will look at remote monitoring of children with type 1 diabetes through the physician and health economist lenses, respectively. Dr. Gandrud will anecdotally examine remote monitoring as a disease management strategy, while Dr. Altan will share the results of a randomized pilot study of intensive remote monitoring. We’re convinced monitoring has merit, but the commercial questions are all about scalability, patient hassle factor, frequency of contact, and driving better outcomes at lower costs while fitting into current clinical/reimbursement paradigms. Remote glucose monitoring has been a gamechanger for many patients and families, and the number of commercial products has expanded dramatically since just a few ADA’s ago: starting with Dexcom’s G4/G5, we’ve quickly seen Medtronic’s MiniMed Connect and Abbott’s LibreLinkUp, Roche’s Accu-Chek Connect, Ascensia’s Contour Next One, Livongo’s platform, and many more.
• (12:45 PM – 1:45 PM, Room 31) Mini-Symposium: New Therapies for Diabetes in Youth – What the Future May Bring. This session will cover two topics: (i) Dr. Carla Greenbaum (Benaroya Research Institute, Seattle, WA) will present on disease-modifying therapies for type 1 diabetes, followed by (ii) Dr. Philip Zeitler on options beyond metformin for type 2 diabetes when it appears in younger patients. As the Chair of TrialNet, we expect Dr. Greenbaum to provide updates on the latest in TrialNet’s slate of type 1 diabetes prevention and intervention clinical trials that attempt to sustain endogenous insulin secretion from the beta cells. She’ll likely touch upon both drugs that are already indicated for other conditions as well as therapies still in development, offering a preview of what’s on the horizon for disease-modifying therapy in pediatric type 1 diabetes. At Endo Fellows 2017, she emphasized that diabetes care will move away from the symptoms-management of adjusting pumps, etc. to truly disease-modifying therapy – a future that endocrinologists must be prepared for. She alluded to data from the 532-participant trial of oral insulin for prevention of type 1 diabetes among at-risk relatives of diagnosed patients. These results (ten years in the making!) will be presented on Monday at ADA 2017, and we’re eager to hear Dr. Greenbaum’s commentary.
• (12:45 PM – 1:45 PM, Room 29) Mini-Symposium: What’s App? Opportunities and Challenges in Diabetes Mobile Technologies. Vanderbilt’s Dr. Shelagh Mulvaney leads this cleverly-titled symposium with a talk entitled “Translating Behavioral Science for mHealth Systems.” We’ll also hear from Tidepool’s talented Lead Designer Ms. Sarah Krugman, who has type 1 herself, on how diabetes data can impact the lives of patients and families. Digital software and apps continue to leverage mixes of human (coach) accountability, social media/community, gamification, data analysis, and real-time feedback. Where is the field going and who will develop the stickiest, most effective apps? At AADE 2014, Dr. Mulvaney spoke about two adolescent diabetes self-management mobile platforms that she helped to develop: YourWay, an internet and mobile social networking program that features to-do checklists, customizable backgrounds, and interactive digital stories. The second program, called “SuperEgo,” is a tailored text messaging service that sends personalized texts that address the psychosocial barriers of self-management. We wonder how these are progressing and how her philosophy of mobile behavior change has evolved in the past few years.
• (12:45 PM – 1:45 PM, Room 30) Mini-Symposium: Sulfonylureas – Should I Stay or Should I Go? Dr. Kamlesh Khunti (University of Leicester, UK) will speak to the role of sulfonylureas, if any, in type 2 diabetes care. Thought leaders have been divided on this topic at recent scientific meetings. On the one hand, the generic status of these agents makes them highly-affordable compared to other therapy classes, and Dr. Robert Ratner suggested at CMHC 2016 that cost considerations have kept sulfonylureas in play. On the flip side, experts like Dr. Jay Skyler have advocated for the complete elimination of sulfonylureas from diabetes care (at CMHC 2016, he proclaimed “take them out of the algorithm!”). Sulfonylureas come with a heightened risk of hypoglycemia, and have also been linked to increased frequency of CV events – we absolutely think that the costs of hypoglycemia or downstream CV events must be taken into consideration for any cost-effectiveness calculation for sulfonylureas. The ADA’s 2017 Standards of Care recognize the hypoglycemia risk associated with sulfonylureas, but also list their low cost and treat them as a still-valid therapeutic option. We recognize that cost is an important consideration, especially for the ever-higher number of US-based patients with type 2 diabetes with high deductible health plans or no insurance. That said, we much, much prefer generic TZD pioglitazone as an alternative “low-cost” diabetes option – while TZDs are associated with their fair share of safety concerns as well (though we think these are manageable with low doses of the drug), pioglitazone has a much lower risk of hypoglycemia, promotes insulin sensitization rather than beta cell burnout, and may be cardioprotective. Will this recommendation change in the next iteration of the Standards of Care? Dr. Khunti will weigh in on this controversy, and we’re excited to hear his perspective.
• (2:00 PM – 4:00 PM, Ballroom 20A-C) Symposium: Update on Cardiovascular Outcomes Trials (CVOTs). This symposium will be all about some of the hottest topics in type 2 diabetes care currently: CVOT results, their impact on guidelines and clinical care, and how these trials might evolve in the future. Dr. Tina Vilsbøll will kick off the session by reviewing the cardiovascular outcomes from the SUSTAIN 6 CVOT for Novo Nordisk’s once-weekly injectable GLP-1 agonist semaglutide – these results demonstrating a cardioprotective benefit for semaglutide were previously presented to great fanfare at EASD 2016 (and simultaneously published in NEJM) and we’re curious if we’ll be treated to additional data or post-hoc analyses from the trial in Dr. Vilsbøll’s presentation. Given these and other impressive results from positive CVOTs (EMPA-REG OUTCOME for SGLT-2 inhibitor empagliflozin and LEADER for GLP-1 agonist semaglutide), the great Dr. Anne Peters will discuss how clinical practice guidelines should digest these results. The ADA Standards of Care have already incorporated a recommendation to consider empagliflozin and liraglutide in patients with type 2 diabetes and established CV disease. On the other hand, the positioning of these agents in the next iteration of the AACE guidelines remains a question, with some suggesting a potential first-line role and others suggesting that more evidence is needed for their inclusion at all. Given that the positive outcomes thus far were demonstrated in studies that were designed primarily to demonstrate cardiovascular safety/non-inferiority to placebo, questions have abounded on how the design of CVOTs might evolve – Dr. Lawrence Leiter will tackle this very question in this session. Rounding out the stellar lineup, Dr. Amanda Adler will discuss the impact of CVOT data on the cost-effectiveness equations for these agents – while some have (misguidedly, in our view) advocated for the use of older drugs like human insulins and even sulfonylureas in some cases due to the high cost of newer diabetes drugs, we think the impact on long-term cardiovascular and renal outcomes (not to mention the short-term cost savings of severe hypoglycemia avoidance, etc.) are immensely important considerations in any cost-effectiveness calculation. We’re so glad that Dr. Adler will draw attention to this very important issue in this symposium!
• (4:15 PM – 6:15 PM, Ballroom 20A-C) Symposium: SGLT-2 Inhibitors – Still More to Explore. The legendary Dr. Julio Rosenstock will headline this symposium, discussing the current and future role of SGLT-2 inhibitors in clinical care. While SGLT-2 inhibitors are currently largely positioned as second-line therapy in diabetes treatment algorithms (and are preferentially recommended in some guidelines for patients with type 2 diabetes and cardiovascular disease), it’s clear that some envision a much broader role for these agents given the impressive cardiovascular and renal benefits demonstrated for empagliflozin (not to mention the class’ effects on weight loss, reduced glycemic variability, reduced blood pressure, and low risk of hypoglycemia). Indeed, several studies are ongoing investigating the impact of SGLT-2 inhibitors on heart failure and on chronic kidney disease – notably, many of these trials are enrolling both patients with and without diabetes. That said, SGLT-2 inhibitors have faced a complicated story since their arrival in 2012 and the class has been plagued with a number of high profile safety concerns – on that note, Dr. Matthew Weir will discuss the connection between SGLT-2 inhibitors, diabetic ketoacidosis, and the kidney (a preview: Dr. Weir emphasized at AACE 2017 that the cardiorenal benefits of these agents greatly outweigh the risk of DKA) and Dr. Lisa Yanoff will offer a look at the FDA’s take on the bone fracture risk reported for J&J’s Invokana (but, notably, not Jardiance or Farxiga). Also in this session, Dr. Richard Kibbey will discuss the connection between SGLT-2 inhibitors and glucagon.
• (4:15 PM – 6:15 PM, Room 23) Oral Presentations: Obesity and Type 2 Diabetes in Children – What’s New? As youth-onset prediabetes and obesity grow in prevalence, it’s becoming increasingly pertinent to establish best practice treatment guidelines and to advance care for this pediatric population – especially since most type 2 diabetes drugs are not currently indicated in children. This session of orals will cover some of the latest research on variables affecting adiposity, glycemia, and type 2 diabetes risk in children. A presentation by NIDDK’s Dr. William Knowler will quantify how severity of obesity at a young age impacts long-term risk for type 2 diabetes. Prevention expert Dr. Lise Bjerregaard (Institute of Preventive Medicine, Copenhagen, Denmark) will share findings on whether remission from childhood obesity to healthy body weight in early adulthood is sufficient to avoid new-onset type 2 diabetes, or whether childhood obesity confers a heightened risk for a type 2 diagnosis later in life independent of weight changes. We’ll be curious to hear Dr. Bjerregaard’s commentary on how diabetes prevention strategies can be implemented earlier (in children/adolescents) and on a wider scale.
• (4:15 PM – 6:15 PM, Room 6DE) Oral Presentations: Prediction and Prevention of Cardiovascular Complications. Dr. Ian Neeland (UT Southwestern, Dallas, TX) will present a sub-analysis of EMPA-REG OUTCOME describing the impact of SGLT-2 inhibitor empagliflozin (Lilly/BI’s Jardiance) on visceral adiposity, abdominal obesity, and total adiposity. He’ll go on to discuss how these three variables confound the impact of empagliflozin on three-point MACE (non-fatal MI, non-fatal stroke, and CV death). The profound weight loss benefit of SGLT-2 inhibitor therapy is not lost on us, and we’re keenly interested in any research that unravels the complicated interplay between hyperglycemia, obesity, and CV risk, especially when there’s a medicine on the market that can effectively lower glucose, lower weight, and lower the frequency of CV events. Also during this session, Dr. Christoph Saely (Academic Teaching Hospital, Feldkirch, Austria) will present findings on chronic kidney disease and mortality among patients with type 2 diabetes and established CV disease. The icing on the cake from some positive CVOTs, including EMPA-REG OUTCOME and LEADER for Novo Nordisk’s GLP-1 agonist Victoza (liraglutide), has been the data on microvascular outcomes and potential renal-protective effects – full renal data from EMPA-REG OUTCOME was reported for the first time at ADA 2016, while renal results from LEADER were reported in full at Diabetes UK 2017. We look forward to Dr. Saely’s new data on this front, and we’re curious to see how it contributes to the conversation on prescribing diabetes drugs to preserve or enhance kidney function.
• (5:15 PM – 6:15 PM) Reaching an International Consensus on Standardizing Continuous Glucose Monitoring (CGM) Outcomes―Aligning Clinicians, Researchers, Patients, and Regulators. Boy, are we excited for this “getting-on-the-same-page” symposium, co-chaired by Stanford’s Dr. Bruce Buckingham and our very own Ms. Kelly Close. The agenda is broken up into three 20-minute windows: First, IDC’s Dr. Rich Bergenstal will discuss CGM outcomes, right on the heels of AACE recognizing the Ambulatory Glucose Profile report as a “standard” earlier this month. Following Dr. Bergenstal’s talk, Kinderkrankenhaus auf der Bult’s Dr. Thomas Danne will present conclusions from the ATTD International Consensus on Standardized CGM Outcomes. Finally, JDRF’s Dr. Aaron Kowalski, USC’s Dr. Anne Peters, and Sheffield’s Prof. Simon Heller comprise an unmatched panel that will discuss hurdles limiting adoption and implementation of standardized CGM outcomes. Hopefully we’ll walk out with strategies and a plan of attack to facilitate the widespread adoption across the field. What will it take to get every BGM/CGM manufacturer and app/software company on board? Will AGP become the EKG in diabetes, and how long will it take to do so?
• (6:30 PM – 8:30 PM, Upper Level Outside Terrace) Opening Reception.
• (6:30 – 9:10 PM, Marriott Marquis San Diego Marina, Marriott Grand Ballroom 1-6) Corporate Symposium: CVOTS and Combination Therapy: Updates and Advances at ADA 2017 (Sponsored by AZ). No speaker details have yet been posted.
• (6:30 – 9:15 PM, Marriott Marquis San Diego Marina, Marriott Grand Ballroom 8-13) Corporate Symposium: Optimizing Comprehensive Glycemic Management in Challenging Patients with Type 2 Diabetes (Sponsored by Sanofi). No speaker details have yet been posted.
• (6:30 – 9:30 PM, Hilton San Diego Bayfront, Sapphire Ballroom A-N) Corporate Symposium: La Evolución Continua en el Tratamiento de la Diabetes Tipo 2 : Alcanzando los Objetivos con Mayor Seguridad (Presented in Spanish; Sponsored by Novo Nordisk). No speaker details have yet been posted.

Saturday, June 10

• (5:30 – 7:45 AM, Hilton San Diego Bayfront, Sapphire Ballroom A-N) Corporate Symposium: Continuous Glucose Monitoring as Standard of Care: Clinical Outcomes, Improved Access, and Non-Adjunctive Use (Sponsored by Dexcom). We anticipate that this symposium will be jam-packed, even though it may still be dark outside when attendees wake up that morning! We will get to hear from three experts in diabetes technology. Chair Dr. Rich Bergenstal will begin by reviewing two recent CGM in MDI studies – Dexcom’s DIaMonD trial and the GOLD study in Sweden, both published in JAMA earlier this year. UCSD’s Dr. Steve Edelman will follow with a clinical review of patient case studies – we expect he will focus on how to safely make insulin-dosing decisions based off CGM trend arrows, as he and colleague Dr. Jeremy Pettus published a paper in JDST on this very topic last August. Lastly, UVA’s Dr. Boris Kovatchev will talk all things algorithms, “from closed-loop control to MDI decision support.” We’ll be listening closely for any hints at Dexcom’s plans to provide insulin dosing decision support, especially for MDIs. Dexcom management has long talked about providing more guidance to users, so perhaps we’ll hear more in this session. TypeZero is coming off its own string of partnership announcements, including Senseonics earlier this month (R&D development agreement), Cellnovo in April (closed loop), and Tandem last summer (closed loop).
• (8:00 – 10:00 AM, Ballroom 20D) Oral Presentations: Where Is Glucose Monitoring Taking Us? This oral session, co-chaired by Diabetes America’s Dr. Pablo Mora and Joslin’s Dr. Elena Toschi, showcases three of the major CGM developments of the past year – data for CGM in MDI, launch of implantable CGM, and growing use of machine-learning to analyze CGM data: Dexcom’s Dr. David Price will present data on CGM in MDI, hopefully offering additional details from the DIaMonD cohort a year after the initial results were unveiled; University of Amsterdam’s Dr. Hans DeVries will present data from the PRECISE European pivotal trial of the implantable Senseonics Eversense CGM (FDA approval expected in 4Q17, per the 1Q17 call); and Medtronic’s Pratik Agrawal will shed new light on the IBM Watson-partnered Sugar.IQ app (full US launch expected May-October, per JPM). We’ll also hear results from a study testing SMBG in noninsulin-treated type 2 patients and a fascinating analysis of “diabetes devices and the profiles of clinicians who subscribe them” from Stanford’s Dr. Molly Tanenbaum.
• (8:00 – 10:00 AM, Hall A) Oral Presentations: GLP-1s and SGLT-2s – To Do or Not to Do in Type 1 Diabetes Mellitus? Dr. John Buse (University of North Carolina, Chapel Hill, NC) will take the stage first to present results from Lexicon’s phase 3 inTandem1 study of sotagliflozin (an SGLT-1/2 dual inhibitor) in type 1 diabetes. The company announced topline results in September 2016 (significantly greater A1c reductions with the 200 mg and 400 mg doses vs. placebo, significantly lower risk of severe hypoglycemia, but a slight signal for DKA) and just recently released additional topline data on secondary endpoints from the trial (significantly greater weight loss and systolic blood pressure reductions, alongside smaller insulin boluses and lower fasting plasma glucose). We’ve been itching for the full results from inTandem1, and we’re eager to hear the major takeaways as outlined by Dr. Buse. The second oral in this session also comes from the inTandem program: Dr. Paul Strumph (Lexicon, Lynchburg, VA) will share findings from inTandem4, a phase 2, 12-week dose-ranging study of sotagliflozin in type 1 patients, which reported topline results in October 2016. We’re happy to see a substantial presence from Lexicon and from sotagliflozin at ADA 2017 – several late-breaking posters will also highlight phase 2 and 3 data for sotagliflozin as well (see below). Sotagliflozin stands as one of the most promising novel drug candidates for type 1 diabetes (it would be the first oral agent for this indication), and we see an indisputable need for better adjunct therapies for type 1. Lexicon has a meeting scheduled with the FDA for end of 2Q17, ahead of a planned 1Q18 filing of sotagliflozin for type 1 diabetes. For the rest of the session, the focus will shift to GLP-1 agonists for type 1 diabetes. We’ll see data from the investigator-initiated Lira Pump trial (liraglutide for type 1 patients on insulin pump) and hear analysis on how liraglutide affects pancreatic islet function. Ever since Novo Nordisk’s decision not to pursue a type 1 indication for Victoza (liraglutide), hope for GLP-1 agonists in type 1 diabetes has worn thin. That said, we do think that there is probably a subset of responders to GLP-1 agonists among people with type 1 diabetes – namely, those with detectable C-peptide and residual beta cell function, but this requires further study and we’re not sure the incentive is there for Novo Nordisk given their current focus on establishing next-generation semaglutide as a treatment for type 2 diabetes, obesity, and NASH. We certainly see more imminent potential for SGLT-2 inhibitors in type 1 diabetes care – and in fact, this was a big theme at last year’s ADA meeting – so we’ll be listening with rapt attention for any commentary on this front. Of course, the DKA concerns are the big question mark for this class in type 1 diabetes, though we do think this risk is manageable and it does appear at first glance that the DKA rate in the sotagliflozin trials is lower than that observed in trials of selective SGLT-2 inhibitors in type 1 diabetes.
• (8:00 – 10:00 AM, Room 23) Oral Presentations: Targets and Pathways in Diabetic Kidney Disease (with State-of-the-Art Lecture). This oral presentation session takes a deep dive on renal issues in diabetes, from diabetic nephropathy to diabetes drugs with a renal mechanism – namely, SGLT-2 inhibitors. On the diabetic nephropathy front, we are looking especially forward to hearing from ProMetic’s (Laval, Canada) Dr. Lyne Gagnon and University of Kentucky’s (Louisville, KY) Dr. Qian Lin on preclinical studies of two drug candidates for diabetic nephropathy: PBI-4050 and FGF-1. We previously saw promising phase 2 results for PBI-4050 in patients with type 2 diabetes and metabolic syndrome, demonstrating an impressive 0.8% A1c reduction (baseline A1c=8.3%) and improvements in markers for cardiovascular and renal complications. Increasingly, new diabetes drugs must meet a high bar and ideally address outcomes beyond glucose-lowering, so we’re eager to learn more about PBI-4050’s renal potential. Additionally, Dr. Kumar Sharma (Scripps Clinic, La Jolla, CA) will provide what is sure to be an insightful overview of the pathways underlying diabetic nephropathy and corresponding potential new drug targets; Dr. Pedro Geraldes (University of Sherbrooke, Canada) will follow with a deeper look at how free fatty acids and insulin resistance affect the pathophysiology of diabetic nephropathy. On the SGLT-2 inhibitor front, we are looking forward to hearing from Dr. Volker Vallon (University of California, San Diego, CA) on the additive effects of SGLT-1 inhibition on top of SGLT-2 inhibition on blood glucose control. Indeed, SGLT-1/2 dual inhibitors are already of great interest to pharmaceutical companies; most notably, Sanofi’s Lexicon-partnered sotagliflizon is currently in phase 3 development.
• (8:00 – 10:00 AM, Room 28) Oral Presentations: Glucagon and GLP-1 Physiology and Pharmacology. This session takes a deep dive into basic biology of two increasingly important therapeutic targets: GLP-1 and glucagon. On the GLP-1 front, we will hear from Dr. Thomas Farb (Lilly, Indianapolis, IN) and Mr. Alexandre Martchenko (University of Toronto, Canada) on how GLP-1 secretion is potentially regulated by antagonism of somatostatin receptor 5 and the block gene Bmal1. On the glucagon front, we will hear from Dr. Per Lundkvist (Uppsala University, Sweden) on the possibility of a direct effect of SGLT-2 inhibitors on glucagon secretion from alpha cells. Tying it all together, we are also looking forward to hearing from Dr. Maria Svane (Copenhagen University Hospital, Hvidovre, Denmark) discuss the varying effects of different macronutrients on glucagon and GLP-1 secretion in people before and after bariatric surgery and CSO and founder of Rexahm Pharmaceuticals Dr. Chang Ahn on the potential of dapagliflozin to improve incretin sensitivity in beta cells.
• (8:00 – 10:00 AM, Ballroom 20A-C) ADA Diabetes Care Symposium: Diabetes Care and Research Through the Ages. This symposium features an all-star speaker lineup and is a can’t-miss for sure. Newly-minted Chief Scientific Officer, Chief Medical Officer, and Chief Mission Officer of the ADA, Dr. William Cefalu, will deliver opening remarks. We hope this highly-respected scientist and thought leader outlines goals for his tenure with the ADA. In an interview with us shortly after his new position was announced, Dr. Cefalu mentioned hopes to strengthen investments in research and advocacy, disseminate the ADA Standards of Care more effectively via technology, and hear more input from diverse players in the field – we’d love any updates or more specific details on his platform six months later. Later in the session, Dr. Cefalu will also present the “Profiles in Progress” plaques to Dr. Mark Atkinson and the late great Ms. Mary Tyler Moore’s husband Dr. S. Robert Levine (Dr. Atkinson co-authored a moving tribute to Ms. Moore in Diabetes Care this month). Dr. Jay Skyler (University of Miami, FL) will speak second, offering an overview of “how we got here,” to our current state of diabetes treatment. Historical perspectives tend to be inspiring, since the angle is how things are better today than they were decades ago. We absolutely cannot wait to hear Dr. Skyler’s perspective – he is widely considered one of the smartest researchers and clinicians around. We may hear Dr. Skyler’s views on some aspects of diabetes care that haven’t advanced as much as we’d expect – we’ll see! Third on the agenda, the great Dr. Bernard Zinman (University of Toronto, Canada) will share his opinion on how well we’re doing in getting patients to goal with modern treatment paradigms – once again, we expect an emphasis on areas for improvement. Renowned Dr. Michael Riddell (York University, Toronto, Canada) will follow with a talk on future directions for CVOTs. This is a hot topic in diabetes right now, and we’re curious for the ADA’s position on how these trials should be designed and how the results should be implemented in real-world practice. We’re extremely happy that the ADA’s 2017 Standards of Care incorporate positive CVOT results from EMPA-REG OUTCOME and LEADER, in that both SGLT-2 inhibitor Jardiance (empagliflozin) and GLP-1 agonist Victoza (liraglutide) are recommended for type 2 diabetes patients at high-risk for CV events. Last but certainly not least, Dr. Ele Ferrannini (University of Pisa, Italy) will share his vision for the future of diabetes care. With so many powerhouse thought leaders packed onto one panel, this symposium is bound to offer heaps of learning, and we absolutely can’t wait.
• (8:00 – 10:00 AM, Room 1) ADA Education Recognition Program Symposium – Introduction to the 2017 National Standards for Diabetes Self-Management Education and Support. This session will provide an overview of the 2017 National Standards for Diabetes Self-Management Education and Support, which include assessing communities before creating tailored education plans, assuring the quality of diabetes self-management education (DSME), establishing a written curriculum that is grounded in the latest evidence, personalizing education, and more. Dr. Deborah Greenwood (Sutter Health, Sacramento, CA) and Ms. Joni Beck (University of Minnesota, Minneapolis, MN), who co-chaired the committee behind this document, are both featured speakers. We’re excited to hear from these co-chairs firsthand about the process of establishing national standards for DSME and about the need for consensus. Dr. Greenwood, who is also past president of the AADE, is a well-respected voice on this topic. At WCPD 2016, she made a powerful pitch for social media as a tool to improve DSME, and we wonder what role she envisions for technology in these new national standards.
• (8:00 – 10:00 AM, Room 24) Awards: Vivian Fonseca Scholar Award. Dr. Kishwar Azad (Bangladesh Institute of Research and Rehabilitation for Diabetes and Metabolic Disorders, Shahbag, Bangladesh) will receive this year’s Vivian Fonseca Scholar Award, an honor that recognizes diabetes research focused on the South Asian, Asian American, Native Hawaiian and Pacific Islander populations. We look forward to hearing more about the Perinatal Care Project she spearheaded, a WHO-supported collaboration between the Diabetic Association of Bangladesh and University College London which seeks to improve neonatal and maternal health as it relates to gestational diabetes and childhood diabetes.
• (10:15 – 11:15 AM, Room 6AB) Awards: Outstanding Educator in Diabetes Award Lecture. This year’s Outstanding Educator in Diabetes Award will be granted to the highly esteemed diabetes nurse practitioner Ms. Davida Kruger (Henry Ford Health System, Detroit, MI). Ms. Kruger is a fixture at major diabetes conferences speaking about the imperative of education, the challenge of adherence, and conveying patients’ and HCPs’ response to new drugs and devices, most recently speaking on CGM and SGLT-2 inhibitors at AADE. A true champion of diabetes care, Ms. Kruger’s award lecture is certainly not to be missed. For a taste of her insights, read her thoughtful interview with our diaTribe team from a decade ago.
• (1:45 – 3:45 PM, Room 6DE) Symposium: The New Psychosocial Position Statement from the ADA – Implications for Practice. This session will start with the Richard R. Rubin Award Lecture, delivered this year by Dr. Michael Harris (OHSU, Portland, OR), an expert in pediatric psychology and chronic disease management. His lecture is intriguingly titled “Your Exclusion, My Inclusion – Treating the Most Challenging in Diabetes.” The talk will likely blend Dr. Harris’ two predominant areas of expertise – we expect him to discuss the psychology behind pediatric diabetes and how providers should help their pediatric patients balance daily diabetes care with the other social/emotional experiences inherent to being a kid. Following this bound-to-be excellent award lecture, the rest of the symposium will dive into the ADA’s most recent position statement on psychosocial care for people with diabetes. Dr. William Herman (University of Michigan, Ann Arbor, MI) will summarize the main ideas in the position statement and will argue that these ideas are long overdue for the diabetes field. Dr. Mark Peyrot (Loyola University, Baltimore, MD) will go into greater detail on the specific recommendations within the position statement, and Dr. Deborah Young-Hyman (Medical College of Georgia, Augusta, GA) will present the different roles to be played by various members of the diabetes care team in ensuring patients receive necessary psychosocial support. Dr. Mary de Groot (Indiana University, Indianapolis, IN) will review the proper screening measures for psychosocial assessment, and Dr. Felicia Hill-Briggs (Johns Hopkins, Baltimore, MD) will close the session with suggestions for how to implement all these ideas in real-world practice. We were pleased to see a larger presence of psychosocial support in the 2017 ADA Standards of Care vs. earlier versions, and we’re glad to see a symposium on the ADA 2017 agenda dedicated to unraveling the association’s latest position on this very important topic.
• (1:45 – 3:45 PM, Room 6AB) Symposium: Into the Endocrine Bowels of Diabetes. This symposium will delve into a hot topic: the role of the gut hormones in diabetes. We are looking particularly forward to hearing the esteemed Dr. Jens Holst (University of Copenhagen, Denmark) discuss the basic physiological interplay between the gut and glucose homeostasis. Another highlight will be Dr. Michael Nauck’s (Diabeteszentrum Bad Lauterberg, Harz, Germany) discussion of the past and future of incretins as therapeutic targets in diabetes – we particularly hope he discusses the future of GLP-1/glucagon and GLP-1/GIP dual agonists (or even GLP-1/GIP/glucagon tri-agonists). Dr. Christopher Rayner (University of Tasmania, Hobart, Australia) and Dr. Nancy Puzziferri (UT Southwestern Medical Center, Dallas, TX) will also speak on the role of the upper gut in diabetes pathophysiology and the proposed mechanisms underlying the effectiveness of metabolic surgery of the gut in the treatment of diabetes – key knowledge in the development of less-invasive pharmacotherapies to mimic the metabolic effects of surgery.
• (1:45 – 3:45 PM, Ballroom 20A-C) Symposium: Dealing with the Rising Costs of Insulin – An Active Dialogue. The controversy over the rising cost of insulin will take center stage in this symposium. The very cost-conscious Dr. Kasia Lipska will kick off the session with a historical perspective on the issue – Dr. Lipska has previously written a series of high-profile NYT editorials on the high cost of insulin and its impact on her patients (one was very provocatively titled “Break Up the Insulin Racket”) and is infamous for frequently espousing the view the newer insulins (including all analogs) and non-insulin diabetes drugs (GLP-1 agonists, etc.) do not necessarily offer substantial benefits in glycemic control and hypoglycemia compared to human insulin – her high profile study of new drug utilization and population-level A1c and hypoglycemia includes misguided conclusions to this effect. While the cost of insulin has clearly become untenable for far too many patients, we hope that the “active dialogue” promised in this symposium title will generate discussion of strategies to lower the financial burden of diabetes care for patients without relegating them to the use of human insulin, sulfonylureas, etc. To that end, we’re very much looking forward to hearing from former ADA Chief Medical Officer Dr. Robert Ratner, who returns to his old stomping grounds with a talk on “paving the path forward.” Dr. Ratner has previously highlighted the ADA’s efforts to cut through the “blame game” (“It’s Big Pharma! It’s the PBMs!”) by increasing transparency in insulin pricing and rebates to better understand where in this complicated system to intervene. The ADA launched a petition in November 2016 calling for increased access to affordable insulin and we hope for an update on these efforts. Underscoring the opaque nature of the US drug reimbursement system, pharmacist Dr. Alan Carter will present an overview of the major players in the rising costs of insulin – this is key knowledge as we look to craft solutions to this issue and especially important given that so few members of the public (or even the healthcare field) understand what a PBM is, for example. Zooming in from the big picture, Dr. David Robbins will provide a practical guide to clinical decision-making in a cost-conscious environment.
• (1:45 – 3:45 PM, Room 30) Symposium: The Good and the Bad of Glucagon Physiology and Therapeutics. Glucagon, the often-forgotten hormone also implicated in diabetes, will take center stage during this symposium. Speakers will sound off on the potential for glucagon-based diabetes therapies as well as the niche glucagon might play in bihormonal bionic pancreas systems. The great Dr. Melanie Davies (University of Leicester, UK) will focus on the former – glucagon as a drug target. This is a pertinent topic, as many pharmaceutical companies (including Novo Nordisk, Lilly, and Sanofi, among others) have long-acting glucagon analogs, GLP-1/glucagon dual agonists, and even a GLP-1/GIP/glucagon tri-agonist in development for diabetes and obesity – see our competitive landscape for a comprehensive overview of the pipeline. We’re eager to learn what Dr. Davies thinks about this mechanism of action for glucose-lowering and weight loss, and we hope she’ll also share a candid opinion on how feasible it will be to get these products to market. Dr. Ananda Basu (Mayo Clinic, Rochester, MN) will shift focus to diabetes technology. His presentation will summarize progress on an artificial pancreas system that incorporates both insulin and glucagon to maximize time-in-range and minimize hypoglycemia. We’ve heard the MGH/BU team (Drs. Ed Damiano and Steven Russell) articulate the need for glucagon in achieving truly automated control, and we expect Dr. Basu to draw upon similar arguments while also reviewing some of the most recent data on the bihormonal bionic pancreas, including results from the 11-day home study published in The Lancet. A pivotal study of Beta Bionics’ bihormonal Bionic Pancreas was most recently slated to begin in mid-2018, while a pivotal trial of the insulin-only system was last scheduled to begin in late 2017/early 2018.
• (1:45 – 3:45 PM, Room 31) Symposium: ADA Pathway to Stop Diabetes. In this always highly-anticipated session, we will hear from past winners of the ADA’s Pathway to Stop Diabetes initiative, an ambitious program launched in 2014 which awards grants of up to $1.625 million over five years to young, talented diabetes researchers. We are looking particularly forward to hearing from the acclaimed 2015 award winner Dr. Zhen Gu (North Carolina State University, Raleigh, NC), an expert in the exciting area of glucose-responsive insulin. We most recently heard Dr. Gu speak about his very promising work at the JDRF Mission Summit in January, and Dr. John Buse expressed great excitement over Dr. Gu’s research at the recent ADA Postgraduate Course, sharing that pig studies will begin “very soon.” We can’t wait to hear the latest updates and look forward to following Dr. Gu’s achievements in the coming years. The symposium will also feature remarks from two members of the first class of awardees: Dr. Joshua Thaler (University of Washington, Seattle, WA) and Dr. Kathleen Page (University of Southern California, Los Angeles, CA). Both of these esteemed researchers are investigating the role of the nervous system in diabetes: Dr. Thaler’s research targets central nervous system pathways – specifically, the interactions between neuronal and glial cells – that contribute to diabetes and obesity while the goal of Dr. Page’s work is to use neuroimaging techniques to unravel the mechanisms behind the link of diabetes exposure in utero and an elevated risk of diabetes and obesity later in life. For more see Close Concerns’ interviews with Dr. Thaler and Dr. Page just after they were awarded their grants. Closing out the symposium, we will also hear from three 2016 award winners: Dr. Daniel Ceradini (NYU Langone Medical Center, New York, NY) is investigating whether restoring a key antioxidant pathway can reverse the impaired tissue regeneration associated with diabetes; Dr. Praveen Sethupathy (University of North Carolina, Chapel Hill, NC) is exploring links between obesity and the gut microbiome; and Dr. Phillip White (Duke University, Durham, ND) is using metabolomics to better understand the biochemical signatures of diabetes and obesity.
• (1:45 – 3:45 PM, Room 23) Awards: Roger Pecoraro Award. The Roger Pecoraro Lectureship Award recognizes a researcher who has made scientific contributions to improving our understanding of the detection, treatment and prevention of diabetic foot complications. We look forward to hearing remarks from this year’s recipient, Dr. Dane Wukich (UT Southwestern Medical Center, Dallas, TX), on his internationally-recognized work in diabetes-related limb salvage.
• (4:00 – 6:00 PM, Ballroom 20AC) Oral Presentations: Landscape of Therapeutic Trials in Type 2 Diabetes. This can’t-miss session is p-a-c-k-e-d with high-impact phase 3 data on type 2 diabetes drugs. On Merck/Pfizer’s SGLT-2 inhibitor candidate ertugliflozin, Dr. Richard Pratley (Florida Diabetes Center, Orlando, FL) will present 52-week data from the VERTIS FACTORIAL trial comparing ertugliflozin/sitagliptin (Merck’s DPP-4 inhibitor Januvia) combination therapy vs. each agent as monotherapy. A poster at EASD 2016 featured 26-week data, showing that co-administration of ertugliflozin/sitagliptin is significantly more effective in A1c-lowering vs. ertugliflozin alone and vs. sitagliptin alone. We’ll also hear 52-week data from the VERTIS SITA2 trial extension; 26-week data presented at EASD 2016 demonstrated ertugliflozin’s A1c-lowering and weight loss efficacy vs. placebo when added to a sitagliptin/metformin treatment regimen. VERTIS SITA2 data were included in Merck/Pfizer’s submissions of ertugliflozin, a fixed-dose combination of ertugliflozin/sitagliptin, and a fixed-dose combination of ertugliflozin/metformin to the FDA – a decision on all three products is expected by January 2018. In another highlight of the session, Dr. Liana Billings (NorthShore, Skokie, IL) will present full results from DUAL VII, a trial comparing Novo Nordisk’s basal insulin/GLP-1 agonist fixed-ratio combination Xultophy (insulin degludec/liraglutide) vs. basal-bolus therapy in patients with type 2 diabetes. Topline DUAL VII results were released in December 2016 – Xultophy showed non-inferiority in A1c-lowering and superiority in weight loss and reducing hypoglycemia risk. We’re excited for the specific numbers and p-values, and we’re particularly keen to learn what percentage of participants in each study arm were able to achieve composite endpoints consisting of A1c targets, hypoglycemia, and body weight. We see the newly-launched GLP-1 agonist/basal insulin combos as a very viable alternative to basal-bolus therapy for patients on basal insulin in need of treatment intensification – DUAL VII provides further reinforcement for this view. Also during this session, Dr. Juan Frías (National Research Institute, Los Angeles, CA) will present findings from DURATION-7, a study of AZ’s Bydureon (exenatide once-weekly) among type 2 diabetes patients uncontrolled on basal insulin glargine (Sanofi’s Lantus) alone. Dr. Yehuda Handelsman (Metabolic Institute of America, Tarzana, CA) will share data comparing dual therapy with sitagliptin/metformin vs. triple therapy with saxagliptin/dapagliflozin/metformin – we’re very intrigued by the concept of a three-drug polypill for diabetes treatment.
• (4:00 – 6:00 PM, Room 6AB) Symposium: Harnessing the Power of Digital Connectivity in Sickness and in Health. This session on connected health features two esteemed government representatives: Dr. Judith Fradkin, Director of the Division of Diabetes, Endocrinology and Metabolic Diseases within NIH’s NIDDK, and Dr. Bakul Patel, Associate Center Director for Digital Health at FDA. Maryland’s respected Dr. Charlene Quinn will also explore the gaps in diabetes digital health research, a very important topic (e.g., those that are not tech savvy will likely be at the top of the list). Dr. Fradkin, who will speak about new research from NIH’s perspective, has been a huge champion for the Precision Medicine Initiative in recent talks. We last heard from her at AACE, where she discussed several ongoing NIDDK-sponsored trials that hope to shed light on which therapies work for which subsets of people with diabetes. Of course, data and smart algorithms will be the key piece here! Meanwhile, Dr. Patel will give his take on mHealth apps for diabetes management from a regulatory perspective. Dr. Patel has emphasized the Agency’s risk-based approach to digital health and goal to be a partner of innovators rather than a barrier (SXSW 2016) – something it has done an incredible job with in our view! That said, it’s impossible for the Agency to police every app/smartphone device, and many apps are breaking very new ground with insulin dosing decision support, startups’ plans for “wellness CGMs,” etc. Where will the FDA draw the line on regulation? How can it become more efficient in this domain and work better with companies? The agency is extremely busy as is (per former Commissioner Dr. Robert Califf at AACE), so we’ll be interested to hear how diabetes app regulation might evolve in the years ahead.
• (4:00 – 6:00 PM, Room 5) Awards: Norbert Freinkel Award Lecture. This year’s Norbert Freinkel Award, an honor granted to a researcher who has made outstanding contributions to the field of diabetes and pregnancy, goes to Dr. Gernot Desoye (Medical University of Graz, Austria). We look forward to hearing an overview of his fascinating research on the transfer of glucose between mother, placenta, and fetus and the effect of maternal diabetes on fetal development.
• (6:15 – 9:15 PM, Marriott Marquis San Diego Marina, Marriott Grand Ballroom 1-6) Corporate Symposium: Novel Approaches to Improving Adherence in T2D (Sponsored by Intarcia). No speaker details have yet been posted.
• (6:15 – 9:15 PM, Marriott Marquis San Diego Marina, Marriott Grand Ballroom 8-13) Corporate Symposium: The Physiologic and Mechanistic Rationale for Achieving HbA1c Target Goals with Basal Insulin in Vulnerable Patients with Type 2 Diabetes (Sponsored by Sanofi). No speaker details have yet been posted.
• (6:15 – 9:15 PM, Hilton San Diego Bayfront, Sapphire Ballroom A-N) Corporate Symposium: The Clinical Benefits of Flash Continuous Glucose Monitoring (Sponsored by Abbott). Abbott almost always shares updates in its symposia on FreeStyle Libre, and we expect this session to be no exception. (Its ATTD iteration was packed and headlined by real-world data from 55,000+ FreeStyle Libre users.) We expect plenty of comments from physicians with early experience using the Pro version of FreeStyle Libre, which launched last fall and will have its first ADA this year. Perhaps Abbott will share an update on the real time consumer version of FreeStyle Libre, which is currently under FDA review for both adjunctive and non-adjunctive labeling claims; the last update in 4Q16 pegged approval in 2H17, though timelines for a product like this are hard to predict.
• (7:00-9:30 PM, Roy’s Restaurant) How to Benefit from a Changing Healthcare Environment (Sponsored by Insulet). Insulet Medical Director Dr. Trang Ly will lead a panel that includes UCSD’s Dr. Jeremy Pettus, TriHealth’s Dr. Michael Heile, and Group Practice Forum’s Dr. Leonard Fromer in a discussion about how to be prepared for “new metrics in the changing healthcare landscape with business solutions.” We expect a big focus on digital technology enabling real-world data collection, remote monitoring, and outcomes/value-based care. Day-to-day outcomes, including patient-reported outcomes, will hopefully take on a larger role as the healthcare landscape evolves – how do these smart physicians envision themselves and clinic workflow evolving?

Sunday, June 11

• (6:15 – 7:45 AM, Hilton San Diego Bayfront, Sapphire Ballroom C-P) Corporate Symposium: DCRI Evidence to Practice Series: Management of Diabetes for Heart Failure Patients (Sponsored by BI). No speaker details have yet been posted.
• (8:00 – 10:00 AM, Ballroom 20A-C) Symposium: Inhibition of PCSK9 in Dyslipidemia Patients with Diabetes. Very excitingly, this symposium will feature new data for Sanofi’s PCSK9 inhibitor Praluent (alirocumab) in patients with diabetes specifically – we see great potential for PCSK9 inhibitors to lower residual CV risk in people with diabetes and we’re very eager for clinical data in this population specifically. Following introductory remarks from Drs. Kausik Ray (Imperial College London, UK) and Bertrand Cariou (Université de Nantes, France) on unmet need in treating overlapping diabetes/dyslipidemia/high CV risk and on the impact of diabetes on endogenous PCSK9, respectively, Dr. Dirk Müller-Wieland (University Hospital Aachen, Germany) will provide an overview of the design and participant population of the ODYSSEY DM program for Praluent. Dr. Lawrence Leiter (St. Michael’s Hospital, Toronto, Canada) will present findings from the ODYSSEY DM-INSULIN trial investigating Praluent’s safety and efficacy among type 1 and type 2 diabetes patients facing high CV risk. Dr. Robert Henry (UCSD, San Diego, CA) will share insights from the ongoing ODYSSEY DM-Dyslipidemia study, investigating Praluent in people with type 2 diabetes and mixed dyslipidemia. We especially look forward to learning how the LDL cholesterol lowering efficacy of Praluent in a diabetes population compares to that of a general population and learning how Praluent therapy might affect glycemic control (if at all). Our ears will also be peeled for commentary on the ODYSSEY Outcomes CVOT expected to complete in December 2017 (especially now that the FOURIER trial has shown Repatha’s significant cardioprotective benefits). Following the presentation of results, Dr. Henry Ginsberg (Columbia University, New York, NY) will provide independent commentary. Dr. Ginsberg is a respected voice on lipid management in diabetes and has spoken previously about the rapid advancement of PCSK9 inhibitors from lab bench to clinic. We’re especially looking forward to his expertise to contextualize these results.
• (8:00 – 10:00 AM, Room 1) NDEP Symposium: Shared Decision-Making – Strategies for Improvements in Patient-Provider Communication. This star-studded symposium features a number of can’t-miss speakers on the crucial issue of shared decision-making, and how to improve communication and foster understanding between patients and providers. We are particularly excited to hear from two high-powered women from Washington, the CDC’s Dr. Ann Albright and the NIDDK’s Dr. Judith Fradkin. Dr. Albright will tackle the subject of diabetes risk and prevention, and we imagine she will provide updates on the CDC’s National Diabetes Prevention Program – the subject of a fantastic keynote address she gave at the 2015 AADE meeting. The great Dr. Judith Fradkin will discuss research challenges and opportunities in the domain of shared-decision making and we hope to hear more of her thoughts on upcoming efforts from the NIDDK to move toward the holy grail of precision medicine in diabetes, an initiative that she discussed at AACE only a few weeks ago. On the physician side, we look forward to hearing remarks from the esteemed former ADA president Dr. John Buse (University of North Carolina, Chapel Hill, NC) on the difficult issue of goal setting and treatment choice in cases where evidence is ambiguous – this is especially important given the large number of type 2 diabetes drug classes that are now available and the infeasibility of a randomized, controlled trial to comparatively assess every single potential combination of therapies in every kind of patient. Another highlight of this packed session is Dr. Monica Peek (University of Chicago, IL) on social and cultural factors that play into shared decision-making. We think shared decision-making is key in promoting patient engagement with their diabetes care and we’re so pleased to see ADA 2017 spotlight this very important and emerging topic.
• (8:00 – 10:00 AM, Room 6AB) Joint ADA/JDRF Symposium: Progress Towards an Artificial Pancreas. We’re looking forward to this jointly sponsored symposium, which includes talks from two of the PIs from the Medtronic MiniMed 670G pivotal trial: Yale’s Dr. Stuart Weinzimer and IDC’s Dr. Rich Bergenstal. Interestingly, however, these gentlemen will not be speaking about their experiences with Medtronic’s flagship diabetes product, but will deliver forward-looking speeches. Dr. Weinzimer will look beyond hybrid closed loop systems, we assume, looking at additional input signals, hormones, IP delivery, etc. that may make fully automated insulin delivery possible. (We’d note that fully automated closed loop is possible for those eating fewer carbohydrates at one time...just saying!) Dr. Bergenstal will approach automated insulin delivery from a different perspective: What tools need to be built to support clinical decisions pertaining to an artificial pancreas? Current systems in development focus on adjusting insulin delivery parameters on a real-time basis in pumps, but in a fully automated system that learns and adjusts to the operator, what support will the physician need? Cambridge’s Dr. Roman Hovorka and Yale’s Dr. Eda Cengiz will also 0ffer their perspectives on hybrid closed loop delivery systems – both are amazing speakers and we always learn something from their on-the-ground experiences. Much has been said about the only hybrid closed loop system on the market, and we heard a deeper dive into the strengths and limitations of the MiniMed 670G at CDTM last month. We expect ADA 2017 will mark the real “official” launch of the MiniMed 670G, coming one year following the pivotal trial results at ADA 2016 and subsequent FDA approval last fall.
• (8:00 – 10:00 AM, Ballroom 20D) ADA Diabetes Symposium: Emerging Therapeutic Targets and Mechanisms of Action. This star-filled symposium looks to the future of emerging targets and innovative new mechanisms of action for novel diabetes drugs. We’re particularly looking forward to hearing from the esteemed Dr. Matthias Tschöp (Helmholtz Zentrum Munchen, Munich, Germany) on his work at the very frontier of diabetes drug development. As we first learned at last year’s Keystone Symposia, Dr. Tschöp (in close collaboration with the legendary Dr. Richard DiMarchi) is working on bioengineering single-molecule polyagonist combination therapies for diabetes and obesity, including GLP-1/glucagon dual agonists, GLP-1/GIP dual agonists (“twincretins”), and GLP-1/GIP/glucagon triple agonists. We are also excited to hear from Dr. Michael Schwartz (University of Washington, Seattle, WA) on the role of the brain in glucose homeostasis and diabetes. We anticipate that he will emphasize the role of the neurohormone leptin in determining body weight, and the promise of the study of gliosis (the reactive change to glial cells in the brain) as a promising area of future research – topics we have previously with him in a fascinating interview last year. We also expect Dr. Schwartz to discuss his recent Nature Medicine publication on the use of a single intracerebroventicular (ICV) injection of FGF1 to produce diabetes remission in mice.
• (8:00 – 10:00 AM, Hall A) Oral Presentations: Translating Therapeutics to the Real World. Headlining this session, Dr. David Nathan (MGH, Boston, MA) will present the latest findings from the Diabetes Prevention Program (DPP) research group: 15-year data on how metformin delays the onset of type 2 diabetes, including sub-analyses that identify which subgroups are most likely to benefit from metformin as a prevention strategy – we heard a little about this subgroup analysis from Dr. Judith Fradkin at AACE 2017 and we’re eager to learn more given that identifying the most appropriate population for different interventions is the first step toward precision medicine. Many thought leaders have endorsed metformin as a prediabetes intervention, and Dr. John Buse made an extremely compelling health economic argument at WCPD 2016 – it would cost a little over $4 billion to treat the entire US prediabetes population (86 million people) with metformin vs. >$1.2 trillion to treat this group with liraglutide and ~$1.4 trillion to treat this group with intensive lifestyle intervention as provided by the DPP ($100/person/session). These numbers make it hard to argue against metformin as a population-level solution, and we’d love to see greater use of the low-cost agent for prediabetes. Achieving this may require an updated indication for metformin approved by the FDA, and we hope to inch toward this as evidence accumulates (including the data Dr. Nathan will share). Looking to tech, we’re looking forward to results from a real-world trial of Valeritas’ patch pump V-Go in patients with type 2 diabetes. We’re also intrigued by other abstract titles in this session as well. Dr. Saad Sakkal (Lindenwald Medical Associates, Mason, OH) will discuss data showing how GLP-1 agonists save Medicare $200 million/year over DPP-4 inhibitors. Dr. Robert Ryder (Sandwell and West Birmingham Hospitals, UK) will share real-world results from a nationwide audit of SGLT-2 inhibitor dapagliflozin (AZ’s Farxiga) prescribed to patients with renal impairment across the UK – we’re looking forward to this as a little preview for what we might learn from the recently initiated Dapa-CKD renal outcomes trial. We’ll also get to see real-world data from a large-scale (n=747,392) evaluation of different DPP-4 inhibitors and their associated CV risk. Concerns have been raised surrounding a possible increased risk for heart failure hospitalization with DPP-4 inhibitor therapy – the SAVOR-TIMI study of AZ’s Onglyza (saxagliptin) found a worrisome 27% increased risk (p=0.007) and the EXAMINE trial for Takeda’s Nesina (alogliptin) found a similar heightened risk, while the TECOS trial for Merck’s Januvia (sitagliptin) reported a neutral hazard ratio for this endpoint of 1.00 (95% CI=0.8-1.20) but the FDA issued a Complete Response Letter (CRL) to have this data included on the Januvia label.
• (8:00 – 10:00 AM, Room 5) Oral Presentations: Thinking and Working Outside the Box – Prevention and Intervention Approaches. Each oral presentation in this session investigates a specific platform for preventing type 2 diabetes or enhancing a patient’s diabetes self-management, whether it be a gamified mobile application, a shared decision-making approach, or occupational therapy. Northwestern’s Dr. Matthew O’Brien will share results from the PREVENT-DM study comparing lifestyle intervention delivered by community health workers vs. metformin in participants with prediabetes. Though the landmark Diabetes Prevention Program (DPP) trial already demonstrated the efficacy of both approaches (though lifestyle intervention was substantially more effective than metformin in preventing diabetes), we’re interested in learning how it might be possible to scale the DPP using community health workers. Additionally, PREVENT-DM was conducted in a population that is particularly vulnerable to type 2 diabetes (Hispanic females with low socioeconomic status) and offers information on how these interventions fare in a “real-world” setting – thus, these results will be particularly informative for those tackling the prediabetes epidemic in underserved areas.
• (9:00 – 10:00 AM, Ballroom 20A-C) Symposium: New Learnings from the Results of the Liraglutide Effect and Action in Diabetes – Evaluation of Cardiovascular Outcome Results (LEADER) Trial. One of the highlights of ADA Day #3 – and indeed, likely of the whole meeting – will be this session featuring new analyses of CV data and new long-term metabolic and safety data from the LEADER CVOT for Novo Nordisk’s GLP-1 agonist Victoza (liraglutide). Dr. Steven Nissen will kick off the packed session with a recap of the CV data from LEADER – new post-hoc analyses of the CV are promised as well and we’re very eager to see these to better understand the patient population that stands to benefit the most from liraglutide therapy. Dr. Richard Pratley will then take the stage to present the new long-term clinical and metabolic data – we previously saw renal outcome, weight loss, and quality-of-life data during the original LEADER presentation at ADA 2016 – followed by full renal data at Diabetes UK 2017 – and we’re eager to see what new information will be revealed at ADA 2017. Likewise, we’re looking forward to Dr. Stephen Bain’s presentation of new safety data as well – safety data from the original presentation highlighted a 20% risk reduction for blood glucose-confirmed hypoglycemia and a 31% risk reduction for severe hypoglycemia – we hope Dr. Bain will dig into these results a little more.
• (10:15 – 11:45 AM, Halls G-H) President, Medicine & Science Address and Banting Medal for Scientific Achievement. Dr. Alvin Powers (Vanderbilt University, Nashville, TN), current ADA president of Medicine & Science, will deliver the annual President, Medicine, and Science address. Given his research focus on basic diabetes pathophysiology and how glucose stimulates insulin secretion, we anticipate that his talk will delve into greater characterization of how this process goes awry in type 1 and 2 diabetes, and biological insights into how these abnormalities could potentially be reversed. Next we will hear from Dr. Domenico Accili (Columbia University, New York, NY), recipient of the Banting Medal, the ADA’s highest scientific award to honor lifetime career achievement in diabetes research.  Titled “The New Biology of Diabetes,” we imagine his address will provide a deep dive into beta cell biology, given his significant research contributions to elucidating the physiology of beta cell failure.
• (12:00 – 2:00 PM, Poster Hall) Late Breaking Poster Session. Just a few of the highlights in this session include the following posters – we’ll be back later this month with our top 100 posters document and notable abstracts further broken down by category.

Diabetes Technology

• Impact of a Diabetes Mobile App with In-App Coaching on Glycemic Control (63-LB). We’ll see outcomes from One Drop’s coaching platform in this poster, following two retrospective posters presented in March. One poster reported a 1% improvement in self-reported A1c from a baseline of 8.2% in 1,372 One Drop Mobile app users, and another suggested that use of One Drop Experts (in-app coaching + education) over four weeks dropped average blood glucose from 185 mg/dl at baseline to 158 mg/dl.
• Maintaining Glucose Control at One+ Year of MiniMed 670G System Home Use: Single Center Experience (126-LB). Dr. Satish Garg presented one-year data from Barbara Davis’ MiniMed 670G continued access phase cohort (n=19) at ATTD. There were three big takeaways from the results: (i) the study phase improvements in A1c, time-in-range, hypo/hyperglycemia, and glycemic variability have been mostly maintained out to one year in BDC patients (with some exceptions for adolescents); (ii) time in hybrid closed loop (auto mode) and sensor utilization have dropped off slightly in both BDC groups, particularly in adolescents (~2 less hours per day spent in Auto Mode at one year vs. the pivotal study phase); and (iii) BDC adults did better on the system than adolescents at one year. No severe hypoglycemia or DKA has been seen, and the fourth-generation sensors “were accurate.” We’re not sure if this poster will present the same data or if it will be expanded. Dr. Bruce Bode also real-world data from the 670G limited launch at AACE, also resembling the trends in the pivotal trial.
• Safety and Feasibility of Omnipod Hybrid Closed-Loop in Children Aged 6-12 Years with Type 1 Diabetes Using a Personalized Model Predictive Control Algorithm (132-LB). The clinical trial program of Insulet’s Omnipod Horizon automated glucose control system commenced late last year, and we got our first peek at ATTD – in 24 adults, the system performed very well overnight, though Dr. Bruce Buckingham acknowledged that there is still work to be done with post-prandial control. How will the system perform in pediatric patients? In its 1Q17 call, Insulet maintained 2019 launch expectations, with a pre-pivotal study planned for this year and a pivotal study in 2018.
• Continuous Glucose Monitoring-Related Behaviors in the DIaMonD Randomized Controlled Trial (97-LB). Dexcom’s DIaMonD study of CGM in MDI impressed many at ADA last year, and more data was shared at ATTD from the type 2 cohort and the second phase for type 1s (pump vs. MDI). We look forward to hearing more about CGM usage trends in these trials – Dexcom made a big point last year that CGM wear >6 days per week was seen in an impressive 89% of patients at six months.
• Automatic Estimation of Basals, ISF, and Carb Ratio for Sensor-Augmented Pump and Hybrid Closed-Loop Therapy (127-LB). As of May 3^rd, there are (at least) 278 people using OpenAPS and other DIY closed loop implementations globally, according to openaps.org. OpenAPS co-founders (and husband-wife duo) Dana Lewis and Scott Leibrand dig into their algorithms in this poster. We’re not sure if it will include outcomes data, as the pair’s poster did last year. We’re very glad to see patient-generated real-world research!
• The Disruption Continues: Negative Impact of Medicare Competitive Bidding Program (175-LB). Featured as authors on this poster are Drs. Gary Puckrein, Irl Hirsch, and David Marrero, the first and last of which were authors on the March 2016 Diabetes Care paper documenting increased mortality with the CMS program. Since then, Drs. Marrero and Puckrein sat on a panel at DTM where they had harsh words for the CMS program, and AADE released a 25-page report detailing more troubles and calling on Congress to fix them.

Diabetes Therapy

• Comparable Glycemic Control, Greater Weight Loss, and Lower Hypoglycemia with Once-Weekly Dulaglutide vs. Insulin Glargine, Both Combined with Lispro, in Type 2 Diabetes and Moderate-to-Severe Chronic Kidney Disease (AWARD-7) (138-LB). This study (n=577) compared the efficacy of Lilly’s once-weekly GLP-1 agonist Trulicity vs. basal insulin glargine (Sanofi’s Lantus) as an add-on to rapid-acting insulin lispro (Lilly’s Humalog) in patients with type 2 diabetes and chronic kidney disease. We’ve been eagerly waiting for these results for some time – the trial was initiated in July 2012 and finally completed in June 2016, according to ClinicalTrials.gov. The secondary endpoints will be of particular interest here – especially the body weight, hypoglycemia, and renal biomarker data.
• 24-Week Efficacy and Safety of Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy to Insulin in Type 1 Diabetes (inTandem2) (146-LB). Full 24-week phase 3 inTandem2 results for Lexicon/Sanofi’s SGLT-1/2 dual inhibitor sotagliflozin in type 1 diabetes will be presented in this late-breaking poster. Topline results were shared in December 2016, demonstrating A1c efficacy on top of optimized insulin with similar hypoglycemia rates and a slight (but in our view, manageable) increase in DKA. We’re especially looking forward to secondary endpoint data in this late-breaker, including body weight, postprandial glucose, blood pressure, net benefit composite, and quality of life. These results are complemented by full phase 3 inTandem1 and phase 2 inTandem4 dose-ranging results, to be presented in an oral presentation session Saturday morning at 8:00 AM.
• 12-Week Efficacy and Safety of Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy to Insulin in Young Adults with Poorly Controlled Type 1 Diabetes (JDRF Study) (147-LB). Continuing the string of long-awaited sotagliflozin data at ADA, this late-breaker features full results from the JDRF-partnered study of sotagliflozin in younger adult patients with poorly managed type 1 diabetes. While the primary endpoint of A1c reduction did not achieve statistical significance, topline results did demonstrate a one-third increase in time spent in range with sotagliflozin therapy. In our view, the big value of sotagliflozin will be its impact on outcomes beyond A1c, including glycemic variability (and we’re very excited for pooled CGM data from inTandem1 and inTandem2, due in 3Q17). We’re looking forward to digging into the impact of sotagliflozin in this population of very high unmet need.
• DURATION-8 Randomized Controlled Trial 1-Year Results: Efficacy and Safety of Once-Weekly Exenatide (ExQW) Plus Once-Daily Dapagliflozin (DAPA) vs. ExQW or DAPA Alone (141-LB). Nearly nine months after the primary results presentation at EASD 2016, one-year extension study results from the DURATION-8 trial of co-administration of AZ’s SGLT-2 inhibitor Farxiga (dapagliflozin) and GLP-1 agonist Bydureon (exenatide once-weekly) will be featured in this late-breaker. DURATION-8 was the first and only randomized, controlled trial of SGLT-2 inhibitor and GLP-1 agonist co-administration, though many in the field had extolled the potential additive or synergistic benefits of these two classes together. The 28-week primary results – which were simultaneously published in The Lancet Diabetes and Endocrinology – demonstrated superiority of co-administration for A1c efficacy, weight loss, fasting plasma glucose, postprandial glucose, and systolic blood pressure. We’re eager to see if these impressive results are sustained at one year.
• Patient-Reported Outcomes (PROs) in Insulin Degludec/Liraglutide (IDegLira) vs. Basal-Bolus (BB) Therapy in Patients (Pts) with Type 2 Diabetes (T2D): DUAL VII Trial (124-LB). This late-breaker very notably features patient-reported outcomes data from the DUAL VII head-to-head trial of Novo Nordisk’s combination Xultophy (insulin degludec/liraglutide) and basal-bolus therapy in type 2 diabetes. Based on the topline results, we suspect that the patient-reported outcomes for Xultophy will be very, very positive, given the strong A1c efficacy (-1.5% from a baseline of 8.2%) coupled with very impressive hypoglycemia risk reduction (-89%) and a 3.6 kg (7.9 lbs) end-of-trial weight difference in favor of Xultophy. Full results from DUAL VII will also be presented during the Scientific Sessions in an oral session at 4:00 PM on Saturday.

Other Highlights

• Does Time-in-Range Matter? Perspectives from People with Diabetes on the Success of Current Therapies and Drivers of Improved Outcomes (93-LB). dQ&A conducted a survey of 3,461 people with diabetes, first presented publicly at last summer’s FDA workshop on outcomes beyond A1c. In this poster, ADA attendees will see some of the key findings: (i) a large majority of patients do not believe they are successful on their current treatment regimen (whether it’s emotional wellbeing, blood glucose goals, and beyond); (ii) time in range has a significant impact on daily life with diabetes; and (iii) therapies are not delivering well on keeping blood glucose in range. We think this data will provide a strong reminder as to why outcomes beyond A1c, leveraging CGM, must be tracked in clinical trials of all sorts going forward.
• One-Year Time Analysis in an Academic Diabetes Clinic: The Burden of Diabetes Care (174-LB). Dr. Irl Hirsch teased this late breaker at ENDO, announcing that it will reveal how much time he and his colleagues spend managing their diabetes patients. We’re glad it was accepted and looking forward to seeing the data, even though we have to assume it will be incredibly grim. With endocrinologists frequently telling us things along the lines of “I love when thyroid patients come in because they are easy and allow me to spend more time with my diabetes patients,” the time is right to bring this issue to the mainstage.

• (12:00 – 1:00 PM, Room 1) Professional Interest Group Session: Joint Position Statement on the Use of Language in Diabetes – Why Language Matters. Given the enormous impact the use of thoughtful language has on people living with diabetes, we’re excited to see a symposium dedicated to educating healthcare providers about this very important topic. Extraordinary patient advocate Dr. Jane Dickinson will set the stage by providing real-life examples of the impact of language in diabetes – Dr. Dickinson has previously spoken compellingly on this topic to us and we’re looking forward to her sure-to-be moving talk at ADA. Backing up Dr. Dickinson’s personal experiences, Dr. Susan Guzman will provide an overview of the research on this topic, while CDE Ms. Melinda Maryniuk will close out the session with practical recommendations to incorporate these learnings into clinical care. Want to study up on preferred terms for diabetes before this session? Check out this great communication guide from The diaTribe Foundation.
• (12:00 – 1:00 PM, Room 33) Professional Interest Group Session: Staging Presymptomatic Type 1 Diabetes – Is There Enough Evidence? J&J’s Dr. Richard Insel (former Chief Scientific Officer of the JDRF) will make the case for a staging system for presymptomatic type 1 diabetes. Dr. Insel may be one of the most qualified people to speak on this topic and we’re excited to hear his perspective. While at the JDRF, Dr. Insel spearheaded a workshop in collaboration with the ADA to propose a new classification system for type 1 diabetes – the fruit of this labor was announced as a new staging system in September 2015. Under this system, “stage 1” type 1 diabetes is characterized by the presence of two autoantibodies and normal glucose tolerance, “stage 2” is characterized by two autoantibodies and abnormal glucose tolerance but no clinical symptoms, and “stage 3” is symptomatic type 1 diabetes (the traditional point of diagnosis). This formal, presymptomatic staging system creates an opportunity for type 1 diabetes intervention and prevention trials and TrialNet has fittingly leveraged this new staging system heavily in its materials since – staging of presymptomatic diabetes offers more formal opportunities to intervene in type 1 diabetes progression and measure the efficacy of potential interventions. On the other hand, Dr. Dorothy Becker (Children’s Hospital of Pittsburgh, PA) will question whether there is currently enough evidence for didactic staging of presymptomatic type 1 – we’re looking forward to a productive discussion between these two!

• (2:15 – 3:15 PM, Room 31) Oral Presentations: Mechanisms and Modulators of Cardiovascular Complications. In the era of CVOTs and increasing interest in diabetes drugs which may protect against cardiovascular disease, we imagine this oral session on the mechanisms underlying cardiovascular complications of diabetes will generate a great deal of attention. The majority of talks in this session focus on the potential cardioprotective mechanisms of existing drugs. Dr. Saiko Murakami (Kumamoto University, Japan) will discuss early evidence of empagliflozin’s ability to suppress the progression of atherosclerosis in a mouse model of diabetes. This drug was the first to demonstrate a cardiovascular benefit in the famed EMPA-REG OUTCOME trial, and it is possible that this reduction of atherosclerosis could be a contributing factor behind this effect though most thought leaders feel that the atherosclerotic impact of empagliflozin in humans is limited and most of the benefit is driven by a heart failure benefit. Liraglutide has also demonstrated a cardiovascular benefit in the LEADER trial, and accordingly Dr. Hideki Kushima (Tokyo University of Pharmacy and Life Sciences, Japan) will present data to support that liraglutide’s cardioprotective effect derives from its enhancement of endothelial nitric oxide production, leading to prevention of vascular restenosis. There have been no CVOTs to date demonstrating CV superiority for any DPP-4 inhibitors, but Dr. Sri Batchu (University of Toronto, Canada) will present early data that substrates of DPP-4 can improve cardiac function. Similarly, Dr. Sebastian Diebold’s (University Hospital RWTH, Aachen, Germany) presentation will focus on the DPP-4 inhibitor linagliptin’s ability to improve left ventricular function.
• (2:15 – 3:15 PM, Room 28) Awards: Kelly West Award for Outstanding Achievement in Epidemiology. Dr. Dana Dabelea (University of Colorado, Denver, CO) is this year’s recipient of the Kelly West Award, which recognizes significant contributions to the field of diabetes epidemiology. We look forward to hearing her insights on the rising rate of type 2 diabetes in youth, given her status as one of the first researchers to identify this troubling trend nearly 20 years ago.
• (2:15 – 4:15 PM, Ballroom 20A-C) Current Issues: Should Continuous Glucose Monitoring Be Prescribed for People with Type 2 Diabetes? A Pro/Con Discussion. UCSD’s Drs. Jeremy Pettus and BDI’s Dr. Bill Polonsky face off in a three-part debate concerning the use of CGM in type 2 diabetes. The discussion will focus on three groups:
  
  • For People with Type 2 Diabetes on Intensive Insulin Therapy? Dr. Pettus will argue highly in favor (“Of course, This is a Great Idea!), while Dr. Polonsky has a more moderated “Well, Maybe So, But Not For Everyone” stance. Patient selection is indeed the big question for CGM in type 2 diabetes, and one very likely to be driven by cost/reimbursement, ease of use, and product form factor (e.g., next-gen products like Abbott’s FreeStyle Libre and Dexcom/Verily have much better chances than previous gen product). We think that CGM can be helpful for anyone who doses insulin and will use it, but as OHSU’s Dr. Jessica Castle said at CDTM: “Think of the CGM like a toothbrush; having it in your drawer doesn’t reduce dental decay, using it does.”
  • For People with Type 2 Diabetes on Basal Insulin Therapy? Type 2s on basal insulin is more of a gray area – Dr. Pettus believes CGM is “Likely to Be of Significant Benefit” in this population, but Dr. Polonsky urges “Let’s Consider the Psychological Burden.” It’s an interesting group to consider, since the huge value of CGM – spotting hypoglycemia and seeing real-time trends after meals – do apply to basal insulin users. However, without mealtime insulin to adjust, the number of levers to pull is more limited in basal-only users. Still, we see huge potential for CGM in this population!
  • For People with Type 2 Diabetes Not Using Insulin? This is where the doctors flip-flop! According to Dr. Pettus, CGM “Might Be a Waste of Time” in this population, but Dr. Polonsky believes it could be “Terrific” if done right. For patients not at risk of data exhaustion, we also agree that CGM would be greatly beneficial, especially for mealtime choices – what foods keep my blood sugar in range and what foods drive it out of range? Wow – exercise (walking!) actually lower my blood glucose? Again, we see significant potential here, and agree with Dr. Polonsky that the “If done right” piece is critical – the sensor needs to be wrapped around education and significant ease of use. Cadence will also be interesting – how should professional vs. real-time be used in this population, and how often? This is an area with huge potential, but clearly the most uncertainty on the product design and reimbursement fronts.
• (2:15 – 4:15 PM, Hall A) Symposium: Results of the JDRF Reducing with Metformin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL) International Multicenter Trial. This session will feature full results from the five-year, JDRF-sponsored REMOVAL trial investigating the CV effects of metformin in type 1 diabetes. Boy are we excited for this data! The study’s primary endpoint is averaged mean far wall common carotid artery IMT. Secondary endpoints include A1c, LDL cholesterol, weight change, insulin dose, measures of kidney function, retinopathy, and endothelial function. REMOVAL is one of very few large-scale, long-term clinical trials of metformin in type 1, despite the drug’s popularity as an off-label treatment for this patient population, so this data could have major implications for the field. We hope the results influence prescribing patterns – and in our fondest dreams, perhaps they might support a label update. Following an in-depth presentation on the study itself (covering trial design, participant pool, glycemia, primary endpoint data, secondary endpoint data, and safety findings), Dr. Naveed Sattar (University of Glasgow, Scotland) will provide the discussant. We’re very curious to see how he contextualizes REMOVAL, and to get a sense of how confident he is in the rigor of results, since support from diabetes thought leaders will be an important piece of disseminating these findings so they can influence real-world clinical practice.
• (2:15 – 4:15 PM, Room 31) Awards: Edwin Bierman Award Lecture. Dr. Mark Cooper (Baker IDI Heart and Diabetes Institute, Melbourne, Australia) is this year’s recipient of the Edwin Bierman Award, which honors a leading scientist in the field of macrovascular complications and contributing risk factors in diabetes. We heard fascinating insights from Dr. Cooper on the possible hemodynamic and metabolic mechanisms underlying diabetic complications at his award lecture for the prestigious Claude Bernard medal at EASD 2016 and hope that his remarks at ADA will delve deeper into this. Titled “Metabolic Karma, the Atherogenic Legacy of Diabetes,” we imagine his address will focus particularly on cardiovascular complications – certainly a timely issue in this era of CVOTs. We are certainly not surprised to see Dr. Cooper’s achievements honored at both major diabetes conferences this year; his impressive, hypothesis-driven science has carried him a long way, and he has improved the lives of so many people through his work. Huge congratulations to him!
• (4:30 – 6:30 PM, Room 31) Joint ADA/ASN Symposium: Effects of New Diabetic Treatments on Diabetic Kidney Disease. This joint symposium zooms in on the renal effects of diabetes drugs, an area of renewed interest in light of recent positive renal outcomes data for SGLT-2 inhibitor empagliflozin and GLP-1 agonists liraglutide and semaglutide. Kicking off the session, well-respective nephrologist Dr. David Cherney (University of Toronto, Canada) will discuss the role of SGLT-2 inhibitors in diabetic kidney disease – a topic he previously touched on at EASD 2016 and we’re excited to hear his views on the eve of the CANVAS and CANVAS-R outcomes presentations for canagliflozin. We’re also looking forward to Dr. Katherine Tuttle’s (University of Washington, Spokane, WA) discussion of the renal impact of GLP-1 agonists, given the impressive results observed in the LEADER and SUSTAIN 6 trials. Also in this session, Dr. Mark Cooper (Baker IDI Heart and Diabetes Institute, Melbourne, Australia) will examine DPP-4 inhibitors (frequently cited as a preferred therapy for patients with diabetes and renal impairment) and Dr. Mark Williams (Joslin Diabetes Center, Boston, MA) will tackle insulins in diabetic kidney disease.
• (4:30 – 6:30 PM, Ballroom 20A-C) Symposium: What’s New in Insulin-Related Therapy? Whether it’s drugs or devices that most readily capture your interest, this session will undoubtedly have learning to offer, as speakers sound off on concentrated insulins, advanced methods of insulin delivery, and software solutions to support insulin titration. First up will be Barbara Davis Center’s Dr. Satish Garg on concentrated insulin products. In rapid-acting formulations, we expect Lilly’s Humalog U200 (insulin lispro) will be discussed in the presentation. We’re hoping Dr. Garg will discuss ultra-concentrated insulins in the pipeline and how they might be used in insulin delivery devices (including pumps that would enable small on-body footprint). On the basal insulin side, we expect him to discuss Novo Nordisk’s Tresiba (insulin degludec) – which comes in a U200 formulation – and Sanofi’s Toujeo (insulin glargine U300), the next-generation basals that offer a flatter profile of action vs. standard of care Lantus (insulin glargine U100). Perhaps he’ll also mention concentrated human insulin such as Lilly’s Humulin U500, which was a topic of some controversy at ADA 2016, with some arguing that increasing the concentration of insulin also increases hyper and hypoglycemia unless it’s accompanied by strong patient education. Next, Dr. Linda DiMeglio (Indiana University School of Medicine, Indianapolis, IN) will review cutting edge insulin delivery devices. We’ll be listening closely for any mention of smart pens like Companion Medical’s Bluetooth-enabled InPen, which received FDA clearance in August 2016 and was last expected to launch in the US this year. Ms. Lori Berard (Diabetes Canada, Winnipeg) will close out this session by discussing software solutions that make insulin therapy easier for patients with type 1 and type 2 diabetes, and we’d love to hear her take on the slew of FDA-cleared apps like Voluntis’ Insulia, Lilly’s Go Dose, Sanofi’s My Dose Coach, Amalgam’s iSage Rx, and others (see our competitive landscape here). We love seeing greater overlap between therapy and technology and can’t wait for these products to be widely available – none have broadly launched in the US yet.
• (4:30 – 6:30 PM, Ballroom 20D) Oral Presentations: Beyond Glycemic Impact. The bar for diabetes therapy continues to rise. New drugs that offer glucose-lowering alone will have difficulty on the market – patients, providers, and payers are now looking for additional benefits, from cardioprotection, to renal protection, to weight loss. This theme connects the eight oral presentations in this session, and we’re so glad to note an emphasis on these outcomes beyond A1c at ADA 2017. Dr. Ildiko Lingvay (UT Southwestern, Dallas, TX) will present a meta-analysis of SUSTAIN 1-5 for Novo Nordisk’s once-weekly GLP-1 agonist semaglutide to show the agent’s consistent weight loss efficacy. Dr. Maurice Bizino (Leiden University, the Netherlands) will share how liraglutide (Novo Nordisk’s once-daily GLP-1 agonist Victoza) impacts ectopic fat accumulation in people with type 2 diabetes. Dr. Fernando Bril (University of Florida, Gainesville, FL) will present a study of TZD pioglitazone in NASH (the trial enrolled participants with prediabetes or type 2 diabetes). Many thought leaders, including Dr. Robert Eckel, have spoken to the potential of pioglitazone as a NASH treatment, which is exciting given that no therapies are yet approved for this prevalent condition/common comorbidity of type 2 diabetes (see our NAFLD/NASH competitive landscape here). We’re looking forward to Dr. Bril’s talk and we very much hope for positive data supporting pioglitazone’s efficacy in NASH among people with prediabetes as well as type 2.
• (4:30 – 6:30 PM, Room 23) Oral Presentations: Lipid-Modifying Interventions and Their Consequences. Dr. Om Ganda (Joslin Diabetes Center, Boston, MA) will present a meta-analysis of 10 studies from the ODYSSEY program for Sanofi/Regeneron’s Praluent (alirocumab), the main focus being safety and efficacy of the PCSK9 inhibitor among patients with type 1 or type 2 diabetes and atherosclerotic CV disease. We’re always eager for more data on PCSK9 inhibitors in a diabetes patient population – we heard confirmation of Praluent’s safety in people with diabetes at ACC 2017, but excitingly, this meta-analysis looks at efficacy as well. Of course, more rigorous data on this front – from the ODYSSEY DM program – will be presented earlier this morning as well (8:00 AM on Sunday, in a dedicated symposium). As an aside, we’re also itching for a sub-analysis of FOURIER participants with diabetes to see how Amgen’s PCSK9 inhibitor Repatha (evolocumab) affects CV events in people with comorbid diabetes/dyslipidemia. The last oral in this session addresses the risk of statin-induced diabetes: Dr. Rachel Miller (University of Pittsburgh, PA) will share data on statins and worsening glycemic control in patients with type 1. At AHA 2016, Dr. Naveed Sattar (University of Glasgow, Scotland) argued in a lively debate that the benefits of statins far outweigh the small risk of statin-induced diabetes. We’re curious to see where Dr. Miller’s results fall.
•  (6:45 – 9:15 PM, Hilton San Diego Bayfront, Sapphire Ballroom C-P) Corporate Symposium: Supporting Your Patient’s Climb to Success: Stepwise Progression for Using Obesity Pharmacotherapy for Weight Management in Patients with Type 2 Diabetes (Sponsored by Novo Nordisk). No speaker details have yet been posted.
• (6:45 – 9:30 PM, Marriott Marquis San Diego Marina, Marriott Grand Ballroom 1-6) Corporate Symposium: Individualized T2D Plans in the Midst of CVOTs Galore: Applying the Data in a Practical Sense (Sponsored by Lilly/BI). No speaker details have yet been posted.
• (7:00 – 9:00 PM, Hilton San Diego Bayfront, Aqua Salon) Joslin Diabetes Center reception. No details on the agenda have been posted but this event is sure to be a hit. Register here.
• (7:00 – 9:30 PM, The Skybox at DiamondView East Village) Corporate Symposium: Sex, Insulin, and Rock-n-Roll (Sponsored by Insulet). This psychosocial-focused discussion will share wisdom on sex, alcohol, and body image while living with diabetes. Insulet got rave reviews for the first iteration of this session at AADE last year, and we’ll be interested to see how speakers address these “awkward” and “taboo” issues.
• (7:00 – 9:30 PM, Omni Hotels San Diego, Grand Ballroom) JDRF/NIH Closed-Loop Research Meeting. This gathering is an annual fixture of the ADA agenda – this year, following introductory remarks from NIH’s Dr. Guillermo Arreaza-Rubin and JDRF’s Dr. Aaron Kowalski, Jaeb’s Mr. John Lum will take the floor to overview closed loop research highlights from the last year. Next, researchers will deliver rapid talks about what’s going on with closed loop right now (initial use of MiniMed 670G, patient experiences with hybrid closed loop controllers), in the next five years (better exercise/meal/sleep detection, faster-acting insulins, stable glucagon, etc.), and in the next ten years (implantables, non-invasive glucose sensing, etc.). At last year’s meeting, we got a heads up about two major artificial pancreas papers that were published in Diabetes Care: Artificial Pancreas Pivotal Study Design Considerations and A Consensus Report on Outcome Measures for Artificial Pancreas Clinical Trials – who knows what kind of sneak peeks we’ll get this year! This is always a packed house and filled with learning!

Monday, June 12

• (8:00 – 10:00 AM, Room 6DE) Symposium: Digital Data – Clinical Liability and Patient Safety. As more people transition to connected devices, greater masses of glycemic and insulin dosing data are available to providers outside of standard clinic visits. This raises key questions about the role of the healthcare provider in the connected age: Namely, what are they responsible (and therefore liable) for when it comes to monitoring these data? FDA’s Dr. Courtney Lias will offer the Agency’s guidance, and DiabetesMine’s Ms. Amy Tenderich will present on what the e-patient expects. For sure, this is an issue that is likely to evolve over the coming years, since there is limited clinical bandwidth and no reimbursement infrastructure to support continuous monitoring by diabetologists. (Providers have different views on this – Ohio State’s Dr. Kathleen Wyne recently shared that she uses Dexcom Follow to track up to five patients at once, to which USC’s Dr. Anne Peters replied, “You’re sweet, but I don’t do that.”) Physicians are overburdened as it is just getting through in-person visits, though the million-dollar question is whether in-person visits can decrease as more continuous, remote care takes over. And if so, will companies increasingly shoulder the burden of care? Of course, non-doctor HCPs, educators, and health coaches may be able to take on some of the monitoring too, though getting the balance right between algorithms and humans will be a big focus of the field’s efforts. We believe that remote monitoring is more likely in technology’s domain – to identify trends and trouble spots – and then escalate accordingly with alerts and notifications.
• (8:00 – 10:00 AM, Room 6AB) Symposium: Combination Therapy in Type 2 Diabetes – Promise Delivered? This session will be all about combination approaches, covering co-administration of multiple agents as well as fixed-dose/fixed-ratio combination products currently available for type 2 diabetes. The great Dr. James Gavin (Emory University, Atlanta, GA) will outline the pros and cons of simultaneous vs. stepwise medication regimens. This was a big debate at EASD 2016, when Dr. Julio Rosenstock argued for simultaneous therapy to overcome clinical inertia, get patients to goal more efficiently, and remove the hassle of switching prescriptions several times and Dr. Neil Skolnik argued back that no clinical trial has yet compared these two approaches to determine superiority (we’d love to see this study come to fruition, though Dr. Ralph DeFronzo’s triple therapy study provides some evidence for the benefits of initial combination therapy). We’re curious to hear Dr. Gavin’s stance and how he justifies it. Ms. Roopa Mehta (National Institute of Science, Medicine, and Nutrition, Mexico) will review options for fixed-dose/fixed-ratio combinations. Most likely, she’ll cover DPP-4 inhibitor/metformin tablets, SGLT-2 inhibitor/metformin tablets, DPP-4/SGLT-2 fixed-dose combos (including AZ’s recently FDA-approved Qtern and Lilly/BI’s Glyxambi), and basal insulin/GLP-1 agonist fixed-ratio injectable therapies (including Novo Nordisk’s Xultophy and Sanofi’s Soliqua). Dr. Luigi Meneghini (UT Southwestern, Dallas, TX) will follow with commentary on the limitations of each of these combination therapy classes (we expect he’ll point out the lack of flexibility in being unable to titrate ratios of medication independently when administered via combination). He’ll also point to remaining gaps, foreshadowing what the next great combination might be – perhaps an SGLT-2 inhibitor alongside a GLP-1 agonist, based on positive data from AZ’s DURATION 8? This would require the development of either an oral GLP-1 formulation or an injectable SGLT-2 formulation, which poses an additional set of challenges compared to oral FDCs, though both Intarcia and vTv Therapeutics have certainly expressed interest in such a combination. Continuing on this theme of looking to the future, Dr. John Buse (University of North Carolina, Chapel Hill, NC) will speak to the future of combination therapy for type 2 diabetes. His opinion certainly holds weight within the diabetes community, so we’re eager to hear his recommendations for which combinations to prescribe when throughout the course of diabetes progression.
• (8:00 – 10:00 AM, Ballroom 20D) Oral Presentations: Pumps and Loops. This session should be a goldmine and present updates on behalf of a number of groups working on closing the loop: Tandem, Cambridge, OHSU, UVA, and Diabeloop. A Tandem executive hinted at AACE that the data for the predictive low glucose suspend device, to be presented by Barbara Davis’ Dr. Gregory Forlenza, is “looking good.” The system is set to launch in early 2018, with a pivotal trial getting underway shortly (per Tandem 1Q17). Hood Thabit, who shared fascinating closed-loop data in type 2 diabetes last year, will present another RCT of the Cambridge system in an acute general hospital setting (we assume this will also be type 2 data). OHSU’s Dr. Peter Jacobs will present his group’s data on single vs. dual-hormone closed loop control with automated exercise detection to prevent hypoglycemia, University of Montpellier’s Dr. Eric Renard will demonstrate that closed loop outperforms low glucose suspend in prepubertal type 1 patients (UVA’s Dr. Marc Breton is a co-author, so this presumably leverages some version of the DiAs system), and Diabeloop will present additional data on the system’s superiority over SAP during exercise, gastronomic challenges, and rest (initial data seen at ATTD).
• (8:00 – 10:00 AM, Room 31) Oral Presentations: Obesity Pathogenesis and Treatment – Insights from Human Studies. This session takes a detailed look at human studies of obesity, a crucial comorbidity of and risk factor for type 2 diabetes, and an increasing global epidemic. On a clinical note, we are particularly interested to hear from Dr. David Polidori (Janssen, San Diego, CA) on body weight and energy intake changes in overweight individuals treated with the SGLT-2 inhibitor canagliflozin (currently indicated only for diabetes), the existing obesity drug phentermine, or combination therapy with both agents. We previously saw promising 26-week weight loss results from this phase 2 study at ADA 2016 and EASD 2016 and we’re eager to see what this oral will add. Combination therapy is a major theme across the obesity drug competitive landscape, with the ultimate goal of finding an agent (or combination of agents) that can reach beyond the 10% weight loss typical of existing obesity pharmacotherapies. In this session we are also looking forward to hearing a series of talks on proposed mechanisms underlying the pathophysiology of obesity, including remarks from Dr. Frankie Stentz (University of Tennessee Health Center, Memphis, TN) and Dr. Amar Abderrahmani (Lille University of Health and Law, Lille, France) on the epigenetics of obesity, insights from Dr. Elena Leineweber (Lübeck University, Germany) on the role of circadian rhythmicity in obesity, and Dr. Kálmán Bódis (University of Düsseldorf, Germany) on differences in adipose tissue thickness and mitochondrial efficiency in people with type 2 diabetes and obesity.
• (10:15 – 11:45 AM, Halls G-H) Awards: Outstanding Scientific Achievement Lecture Award. Dr. Gregory Steinberg (McMaster University, Hamilton, Canada) is this year’s recipient of the ADA’s prestigious Outstanding Scientific Achievement Award. His research focuses on understanding how hormones regulate the body’s storage and breakdown of fat and its response to insulin, and we look forward to hearing a deeper description of these insights in his award lecture.
• (12:00 – 1:00 PM, Room 24) Professional Interest Group Session: To Screen or Not to Screen for Diabetes. We are excited to hear Drs. Bill Herman (University of Michigan, Ann Arbor, MI) and Naveed Sattar (University of Glasgow, Scotland) debate the merits of screening for type 2 diabetes. We are certainly of the belief that diagnosing type 2 diabetes earlier should become a greater national priority, particularly for groups at high risk, and expect Dr. Herman to take a strong stand – we previously heard him debate this viewpoint at IDF 2015, where he advocated for earlier identification of diabetes and prediabetes in order to improve long-term outcomes. We hope he will also point to the cost-effectiveness of diabetes prevention (undiagnosed diabetes costs a staggering ~$18 billion annually, according to the ADA). We wonder on what grounds Dr. Sattar will criticize the idea of type 2 diabetes screening, as this seems like our only way of effectively identifying those with type 2 diabetes in an effort to treat them aggressively and optimally at each stage of the disease, thereby avoiding long-term complications and improving quality of life. That said, some have argued that broad screening for prediabetes and diabetes can lead to overdiagnosis, overtreatment, and “disease-mongering.” Indeed, the potential psychological stress of a prediabetes diagnosis was one of the criticisms of the ADA/CDC/Ad Council prediabetes screening campaign.
• (12:30 – 1:30 PM) The Next Generation OmniPod System – Innovation at Work (Sponsored by Insulet). Insulet Medical Director Dr. Trang Ly will offer a sneak peek at the next-gen OmniPod Dash system and elaborate on future hybrid closed loop plans. This is the first time we’ll see Dash in person, and a US launch is expected in late 2017/early 2018. A 510(k) will be filed with the FDA in 2H17. The PDM will use a locked down Android phone (cellular turned off, no more integrated BGM), will communicate with the pod via Bluetooth exclusively, and also talk to a secondary display app on a user’s smartphone to display pump data and likely Dexcom CGM data too. The November Analyst Day report has pictures and our deep dive. The hybrid closed loop system in development, OmniPod Horizon, system is slated for a “2019” launch, per the 1Q17 call. We saw the first feasibility study data (n=24 adults with type 1; 36 hours inpatient) from the system at ATTD, and a huge selling point is that patients will remain in closed loop even when the handheld is out of range (algorithm embedded into the pod).
• (2:15 – 3:15 PM, Halls G-H) Symposium: Cardiovascular Safety of Insulin Degludec vs. Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) Trial Results. In the first of two back-to-back CVOT presentations, the long-awaited results from the DEVOTE outcomes trial of Novo Nordisk’s next-generation basal insulin Tresiba (insulin degludec) is sure to draw a crowd – get there early for prime seating and stay put for CANVAS immediately after (see below)! Dr. Steven Marso will open the session by presenting the trial design. Dr. Darren McGuire will present the primary cardiovascular endpoint results – we learned from the topline data that DEVOTE demonstrated a reassuringly neutral effect on CV outcomes for Tresiba. More exciting, in our view, will be Dr. Bernard Zinman’s presentation of the glycemic efficacy and hypoglycemia results from the trial. In the topline results announcement, Novo Nordisk shared that (i) 27% fewer patients on Tresiba vs. Lantus experienced severe hypoglycemia;(ii) there was a 40% overall risk reduction for an adjudicated, severe hypoglycemic event with Tresiba vs. Lantus; and (iii) there was a 54% relative risk reduction for severe nocturnal hypoglycemia with Tresiba vs. Lantus. We very eager to learn more about these impressive data, which further reinforce the hypoglycemia benefit of Tresiba over first-generation basal analogs demonstrated in the SWITCH 1 and SWITCH 2 trials. Following this, Dr. Richard Pratley will present additional safety data from the trial while the great Dr. John Buse will conclude with the clinical takeaways from these results. We imagine the hypoglycemia data will be featured prominently in discussant Dr. Elizabeth Seaquist’s independent commentary following the results presentation – Dr. Seaquist is a prominent member of the International Hypoglycemia Study Group and recently co-chaired a JDRF/Helmsley Charitable Trust workshop on hypoglycemia in type 1 diabetes. The DEVOTE results have been a long-time coming – the trial was initiated in response to the Complete Response Letter issued by the FDA for Tresiba in 2013. The product was finally approved in late 2015 on the basis of interim data from DEVOTE – we can’t wait to get the full results!
• (2:15 – 4:15 PM, Room 1) Symposium: Cognitive Functioning and Decision-Making in Diabetes. This symposium will be packed with insights from the realm of diabetes psychology, and we are particularly excited to hear Dr. Mark Espeland (Wake Forest University, Winston-Salem, NC) present a retrospective analysis of the Look AHEAD trial, investigating the long-term impact of intensive lifestyle intervention vs. diabetes support and education on cognitive outcomes among individuals with diabetes. The initial Look AHEAD results, presented at ADA 2013, demonstrated that intensive lifestyle therapy was associated with favorable improvements in chronic kidney disease and retinopathy, but no difference in CV outcomes (though risk factors were positively impacted). Additionally, the original presentation noted that intensive lifestyle intervention reduced the risk of progression to mild or more severe symptoms of depression by 20% (versus diabetes support and education), so we are intrigued to learn whether lifestyle intervention has a similar benefit for other domains of mental health and cognitive function. We are additionally looking forward to hearing insights from Dr. Cynthia Berg (University of Utah, Salt Lake City, UT) on the implications of youth cognitive functioning in diabetes management, Dr. Katharine Barnard (Bournemouth University, Dorset, UK) on how to optimize diabetes management with the right devices at the right time, and Ms. Kellie Rodriguez (UT Southwestern Health System, Dallas, TX) on the value of shared decision-making and its potential to improve diabetes care.
• (2:15 – 4:15 PM, Room 5) Symposium: Pairing Nutrition and Exercise in Type 1 Diabetes. MGH’s Dr. Steven Russell headlines this symposium, as he explores the implications of exercise and dietary management on artificial pancreas systems. Other speakers will touch on post-exercise hypos using CGM and diet (Dr. Peter Adolfsson), the role of nutrition in managing blood glucose during and after exercise (Ms. Francesca Annan), and diet/behavior considerations in youth with type 1 diabetes (Dr. Craig Taplin). One of the best ways to reduce mealtime glucose variability, hypoglycemia, and diabetes burden is to minimize intake of carbohydrates, something Adam writes extensively about in his just-published book, Bright Spots & Landmines. (This also applies to automated insulin delivery – in our experience wearing Loop, hybrid closed loop on a lower-carb intake (less than 30 grams per meal) is basically fully automated glucose control. Glucose rarely goes over 160 mg/dl, even without pre-meal boluses.) Exercise is of course very challenging in type 1 diabetes, since balancing insulin and food intake with rapid (and unpredictable) changes in blood glucose during activity is very difficult – including for hybrid closed loop systems. Some closed loop groups are considering integrating additional input signals to detect exercise (heart rate sensor, accelerometer), others are just requiring a meal announcement (no carb counting) or using updated algorithms to incorporate automatic bolusing, and still others are investigating IP delivery to get around slow onset and offset of insulin action. We’ll be especially curious to hear Dr. Russell’s takech we suspect will argue for the benefits of glucagon in the meal and exercise settings.
• (3:15 – 4:15 PM, Halls G-H) Symposium: The Integrated Results of the CANVAS Program. In one of the most highly-anticipated sessions of the Scientific Sessions – if not 2017 as a whole – full results from J&J’s CANVAS and CANVAS-R outcomes trials for SGLT-2 inhibitor Invokana (canagliflozin) will finally be presented. Get here early (or better yet, just sit tight after the DEVOTE trial presentation immediately preceding in the same room) – we expect nothing short of a packed auditorium as this data are highly-anticipated, and for good reason. For one, the company released no topline results, which goes against custom for major positive CVOTs (including LEADER for Novo Nordisk’s Victoza, SUSTAIN 6 for Novo Nordisk’s semaglutide, and EMPA-REG OUTCOME for Lilly/BI’s Jardiance). This silence is curious, and Dr. David Nathan expressed some concern at ENDO 2017 that CANVAS may in fact show neutral CV effects. This would be disappointing given management’s decisive optimism during J&J’s 3Q16 update: “We have very strong reason to suspect that the combination of CANVAS and CANVAS-R will give data very similar to what was reported with EMPA-REG OUTCOME.” That said, J&J management has been radio silent on CANVAS in the last half year and we’re definitely in wait-and-see mode. If positive, CANVAS would be the second CVOT to show CV benefit for an SGLT-2 inhibitor and would thus contribute important evidence for a cardioprotective class effect, which would be groundbreaking for diabetes care and our ability to extend CV disease-free life for patients. Our fingers are so very crossed that Invokana significantly reduces risk for three-point MACE (non-fatal MI, non-fatal stroke, and CV death), the primary endpoint in CANVAS. Dr. Bruce Neal (George Institute for Global Health, Newtown, Australia) has the honor of presenting CV outcomes data. In addition to the CV outcome data, we’re looking forward to the renal outcome results, presented by Dr. Dick de Zeeuw (University of Groningen, Netherlands), given the impressive renal benefit observed in EMPA-REG OUTCOME. That said, the primary endpoint progression to albuminuria in CANVAS-R is “softer,” but could provide optimism for positive renal outcomes in the ongoing dedicated renal CREDENCE study. Also of particular note will be the safety data from the CANVAS program, presented by UNSW Sydney’s Dr. Vlado Perkovic, especially since the FDA just added a warning to Invokana’s label for increased risk of lower limb amputations based on full results from CANVAS and CANVAS-R. We’ll also be looking out for DKA, acute kidney injury, and bone fracture data. All of these safety warnings are included in Invokana’s label as well and our sense is that, with the exception of the DKA risk (which we think is manageable), the other safety concerns are less well understood. We hope that the CANVAS program results can help shed light on the magnitude of risk and suggest directions for clinical management. There’s a lot to learn here in less than an hour (!) and we’re glad that the great Dr. Clifford Bailey (Aston University, Birmingham, UK) will provide the discussant to help contextualize these results.
• (4:30 – 6:30 PM, Ballroom 20A-C) Symposium: Type 1 Diabetes Immune Intervention Trials. This packed session will feature results from not one, not two, but three highly-anticipated type 1 diabetes intervention trials. First up are results from TrialNet’s oral insulin trial in people with multiple autoantibodies and normal glycemia. The esteemed Dr. Jay Skyler will set the stage with an introduction and background on the study and the great ADA immediate past-president Dr. Desmond Schatz will share the results of the phase 3 trial. Dr. Peter Gottlieb will also take the stage to present results from a mechanistic study of oral insulin in type 1 diabetes intervention and Dr. David Maahs will provide the independent commentary on these results. Switching gears, Dr. Stephen Gitelman will present results from a trial of imatinib (Novartis’ cancer drug Gleevec) in new-onset type 1 diabetes. Finally, Dr. Åke Lernmark will introduce the DIAPREV-IT trial of GAD-Vaccine, with results presented by Dr. Helena Elding Larsson. Dr. Joseph Wolfsdorf will provide commentary on this trial.
• (4:30 – 6:30 PM, Room 31) Oral Presentations: New Insights into Prevention and Treatment of Hypoglycemia. This oral session explores all things hypoglycemia-related, with talks dedicated to various methods of hypoglycemia treatment and prevention. Most notably, Dr. Bernie Zinman (University of Toronto, Canada) will present a sub-analysis of the LEADER trial exploring trends in severe hypoglycemia, cardiovascular outcomes, and death – earlier data from LEADER demonstrated an impressive 20% risk reduction for confirmed hypoglycemia and 31% risk reduction for severe hypoglycemia and we’re eager to hear Dr. Zinman dig into these results further. Another heavy hitter in this session is Stanford’s Dr. Bruce Buckingham, who will present data on the potential of closed-loop therapy to restore hypoglycemia awareness. We are also interested to hear insights from Dr. Adriana Viera de Abreu (University of Utah, Salt Lake City, UT) on the use of tricyclics to prevent hypoglycemia unawareness and Dr. Kim Rokamp (University of Copenhagen, Denmark) on the intriguing possibility of a genetic polymorphism that enhances the risk of severe hypoglycemia in people with type 1 diabetes. This is certain to be an excellent session!
• (6:45 – 9:15 PM, Marriott Marquis San Diego Marina, Marriott Grand Ballroom 1-6) Corporate Symposium: Understanding and Managing a Complex Dual Dilemma: Diabetes and Dyslipidemia (Sponsored by Amgen). No speaker details have yet been posted.
• (6:30 – 9:00 PM, Hard Rock Hotel San Diego) The diaTribe Foundation/TCOYD 11^th Annual Diabetes Forum. TCOYD and The diaTribe Foundation will co-host the eleventh Annual Diabetes Forum with proceeds benefitting both non-profits. This year’s panel features renowned speakers Dr. Vanita Aroda (MedStar Health Research Institute), Dr. Bruce Buckingham (Stanford University), Dr. John Buse (UNC), and Dr. Ralph DeFronzo (University of Texas Health Science Center), who will join Dr. Edelman and our own Ms. Kelly Close. The conversation is always wide-ranging (drugs, tech, policy, obesity) and provides a great summary of ADA on Monday night. Possible areas of focus include cardiovascular and renal outcome trials, combination therapy, tech and digital health in diabetes care, type 2 drugs for type 1 diabetes, obesity, and prediabetes, outcomes beyond A1c, the future of glucose monitoring, insulin pricing, precision medicine, health citizenship, and more. Last year’s Forum was a hit and debuted a very funny short video on a future where automated insulin delivery is widely available…
• (9:30 PM – 12:00 AM, Ultimate Skybox, Petco Park) The diaTribe Foundation 2^nd Annual Musings Under the Moon: Discussions on Digital Health. The diaTribe Foundation will host its second annual late-night event: “Musings Under the Moon: Discussions on Digital Health” from 9:30 pm to midnight. The panel is star-studded with players driving this field forward: Abbott’s Mr. Jared Watkin (Senior VP, Diabetes Care), BD’s Mr. Ken Miller (CEO), Dexcom’s Mr. Kevin Sayer (CEO), Qualcomm Life’s Mr. Rick Valencia (CEO), and Lilly’s Dr. Howard Wolpert (VP of Medical Innovation). Our own Ms. Kelly Close and Mr. Adam Brown will co-moderate the panel, which will aim to answer questions such as: Where are digital health and diabetes technology going? What will change the game and what is hype? What will 2020 look like? Last year’s panel was a can’t-miss, with Bigfoot CEO Jeffrey Brewer, Medtronic Diabetes President Hooman Hakami, Qualcomm Life’s Dr. James Mault, IBM Chief Health Officer Dr. Kyu Rhee, Novo Nordisk Executive Vice President Jakob Riis, and Mr. Sayer sharing awesome insight on the field. We highly recommend giving last year’s panel a pre-read – boy has a lot changed in the past year, and we expect a lot of excitement from this panel about the future ahead.

Tuesday, June 13

• (7:30 – 9:30 AM, Room 28) Symposium: Prediabetes – Are We Missing Opportunities for Intervention and Risk Reduction? The worldwide diabetes epidemic has reached a scale too large to be solved by treatment alone. Rather than merely reacting to hyperglycemia with glucose-lowering therapies, we must also be proactive in prevention efforts. Four speakers will take the stage at this symposium to discuss prediabetes as a target for prevention. Ms. Rachel Huxley (Curtin University, Perth, Australia) will elaborate on the implications of shifting the prediabetes diagnosis. In what ways does the accepted definition of prediabetes affect how patients perceive their condition, how providers respond to it, and how regulatory authorities like the FDA consider it? Dr. Richard Grant from our hometown San Francisco (UCSF) will present research on how a prediabetes diagnosis sways patient behavior, which is sure to be fascinating. We’re also invested in getting the FDA to recognize prediabetes as a disease so that therapies like metformin and maybe even liraglutide can be indicated for diabetes prevention – to this end, we’re curious to hear from speakers how they might make a compelling case to the FDA. Dr. Steven Kahn (University of Washington, Seattle, WA) will give a talk on the pathobiology and epidemiology of prediabetes, and Dr. Jeremy Sussman (University of Michigan, Ann Arbor, MI) will give a talk on best practice prevention tactics for individuals and communities affected by prediabetes.
• (9:45 – 11:45 AM, Ballroom 20D) Oral Presentations: ADA President’s Oral Session. You’ll definitely want to stick around until the very end of ADA 2017 for this session that compiles some of the best oral presentations of the entire meeting across scientific categories. One of the main attractions this year will be Dr. Matthew Cavender’s (UNC, Chapel Hill, NC) presentation of a new analysis of the CVD-REAL study an AZ-sponsored real-world study comparing heart failure and mortality outcomes between patients starting SGLT-2 inhibitor therapy (n=154,523) vs. patients starting treatment with another glucose-lowering medicine (n=154,523). The initial results, presented at ACC 2017, found a 39% risk reduction for heart failure hospitalization associated with SGLT-2 inhibitors vs. other products (p<0.001) and SGLT-2 inhibitors reduced risk for all-cause mortality by 51% (p<0.001) and for the composite endpoint of heart failure hospitalization or death from any cause by 46% (p<0.001) – we are certainly intrigued to hear more details. We’re also very eager to hear UCSD’s Dr. Jeremy Pettus present results from a phase 1 trial of glucagon receptor antagonist REMD-477 in type 1 diabetes – this trial was announced in December 2015 and began dosing patients in April 2016 and we’ve been eagerly awaiting results. The session will also feature Dr. Leona Plum-Morschel, CEO at Profil Mainz in Germany, with highly-anticipated results from a safety and efficacy study of oral basal insulin in type 2 diabetes. We’re also looking forward to hearing more about the PKM2 story from Harvard’s Dr. Weier Qi – we recently wrote a deep dive about the findings from the Joslin Medalist cohort, showing that PKM2 is elevated in the kidneys of patients that are protected against diabetic nephropathy. For a complication that has no specific biomarkers or treatments, PKM2 has tremendous potential to catapult research and development forward, and we’re hoping that Dr. Qi shares some future directions.

--by Abigail Dove, Helen Gao, Brian Levine, Payal Marathe, Adam Brown, and Kelly Close