June 13-16 – Keystone Conference Center – Keystone, CO
The 2017 Practical Ways to Achieve Targets in Diabetes Care (ATDC) Conference – traditionally known as “Keystone” – will take place from July 13-16 at the Keystone Conference Center in Keystone, Colorado. As always, the conference organizers have delivered with an incredible program consisting of eight plenaries (each followed by a Q&A/panel discussion with the renowned experts speaking), more than 40 talks, intimate meet-the-peers sessions, and several industry-sponsored dinners and workshops (Insulet, Medtronic, Dexcom, Novo Nordisk).
Here are a few sessions of the many at this gathering we are particularly excited about:
- Dr. Bruce Buckingham (Stanford University, CA) on the current status of hybrid closed loop systems;
- FDA’s Dr. Courtney Lias on future artificial pancreas approval guidelines;
- Dr. Jay Skyler (University of Miami, FL) on the latest CVOT data;
- ADA’S Dr. William Cefalu on highlights from ADA 2017 and pharmacological interventions for prediabetes; and
- Many, many more!
Read on for summaries of the sessions, events, and talks on the Keystone conference schedule. The official program, including a detailed list of speakers, events, and logistics for the conference, can be found here. In preparation for this always-outstanding meeting, refresh your memory on our takeaways from past Keystone conferences by reading our full reports from 2016, 2015, 2014, 2013, and 2012. We are so looking forward to being in Keystone again – let us know if we’ll be seeing you there!
Wednesday, July 12
- (6:30-9:00 pm): The Artificial Pancreas: Expectations, Experiences and Evolution (sponsored by Insulet). Moderated by Dr. Trang Ly (Medical Director, Insulet, Billerica, MA), speakers Dr. Bruce Buckingham (Stanford University, Palo Alto, CA), BDC’s Ms. Laurel Messer, and our very own Adam Brown (Close Concerns, San Francisco, CA) will ring in Keystone 2017 by discussing the current artificial pancreas landscape. Dr. Buckingham gave a similar rundown at ATTD in February, summing up current and in-development closed loop systems: “Night is the low-hanging fruit for hybrid closed loop – there’s no major disturbance with food and exercise. Every hybrid closed loop system has done that quite well, reducing highs, reducing lows, and reducing variability.” According to the latest update, Insulet’s hybrid closed loop system – OmniPod Horizon – is slated for a 2019 launch with a pivotal study beginning in 2018 – we’ve seen positive preliminary data at ATTD and ADA (poster #1 and poster #2). See our automated insulin delivery competitive landscape for how Insulet’s system fits in to the bigger picture. Bottom line, real-world experiences with closed loop systems (especially Medtronic’s MiniMed 670G) give reason to be hopeful, but the amount of user interaction they require necessitates support, training, and management of expectations, especially during the day.
Thursday, July 13
- (7:45-11:00 am) Hybrid Closed Loop: Advancing Your Practical Knowledge of the MiniMed 670G System (sponsored by Medtronic). Medtronic CMO Dr. Francine Kaufman will provide critical insight into the company’s MiniMed 670G hybrid closed loop system. This session is a can’t miss, given that Medtronic is in the process of rolling out the system to over 20,000 priority access program participants. At this year’s ADA, we were heartened to hear that real-world 670G data has closely aligned with that seen in the pivotal trial (including 74% time in range!). From talking to clinicians with 670G experience and attending conferences, it’s clear that there are many, many practical considerations for use of the 670G – at CDTM, Yale’s Dr. Jennifer Sherr and BDC’s Ms. Laurel Messer shared their tips and tricks, and Dr. Rich Bergenstal gave his take last month at ADA. One thing’s for sure – we’ve come a long way since Keystone a year ago, when Dr. Kaufman speculated on launch timing in the wake of results from the pivotal trial.
- (8:30-11:00 am) The Choice is Yours: An Exploration into Patients with Type 2 Diabetes (Sponsored by Novo Nordisk). Dr. Anita Swamy (La Rabida Children’s Hospital, Chicago, IL) will lead this industry-sponsored workshop on therapeutic options for type 2 diabetes. We imagine a number of Novo Nordisk’s products will come up, including next-generation basal insulin Tresiba (insulin degludec) and GLP-1 agonist Victoza (liraglutide), for which the company is seeking a new CV indication based on positive results from the LEADER trial. At the recent FDA Advisory Committee meeting to discuss this label update, voting members highlighted the heterogeneity of type 2 diabetes, pointing out that liraglutide may be particularly beneficial for patients at very high-risk for CV events. We’re looking forward to Dr. Swamy’s perspective on this (especially since type 2 heterogeneity isn’t talked about nearly enough), and we hope she shares insights on how HCPs should factor in CV risk in devising a diabetes treatment plan. Notably, the DEVOTE CVOT for Tresiba was recently presented at ADA 2017 – insulin degludec demonstrated CV safety vs. Sanofi’s Lantus (insulin glargine), but showed a significant risk reduction for severe hypoglycemia, and we’re excited to hear Dr. Swamy’s commentary on the real-world implications of these results.
- (12:00-2:25 pm) Plenary One: Is Artificial Pancreas the Future? Continuing with the theme of hybrid closed loop in the real world, Dr. Bruce Buckingham will open with updates on the current status of hybrid closed loop systems, detailing implementation challenges. We imagine these will be mostly in the vein of barriers to optimal use in patient hands, though he may also go in the direction of reimbursement and access challenges. Many insurers have said they would cover 670G, though Anthem, for one, has issued a non-coverage decision, citing that data is “too limited.” Later in the session, Schneider Children’s Dr. Moshe Phillip will examine the utility of algorithms in artificial pancreata – does it matter which one a system employs? PID, MPC, and Dr. Phillips’ Fuzzy Logic have all been shown to be effective, but how do they stack up? A large, NIH-funded pivotal trial comparing MiniMed 670G with a similar Medtronic system with the Fuzzy Logic algorithm may begin to answer this question. Lastly, Jaeb Center’s Dr. Roy Beck will provide insight into future directions for the artificial pancreas – faster insulins? Intra-peritoneal insulin delivery/glucose sensing? Additional hormones? Adjunct therapies? We’re looking forward to hearing his view here…
- (2:50-5:30 pm) Plenary Two: Recognition and/or Management of Prediabetes. This session, chaired by NIDDK’s Dr. Pamela Thornton, will address prediabetes, an increasingly prevalent but underdiagnosed problem. Dr. Richard Kahn (UNC, Chapel Hill, NC) will speak to the efficacy of lifestyle interventions in preventing new-onset type 2 diabetes, likely discussing results from the CDC’s National Diabetes Prevention Program (NDPP). We’re particularly excited for Dr. John Buse’s (UNC, Chapel Hill, NC) presentation on the CV risk associated with prediabetes. J&J has expressed interest in conducting a CVOT for SGLT-2 inhibitor Invokana (canagliflozin) in people with prediabetes, and though it’s unclear whether or not this project will continue, we’re very keen to see CV prevention efforts earlier in the course of disease progression, given the enormous burden of CV morbidity and mortality within the diabetes patient population. ADA Chief Scientific and Medical Officer Dr. William Cefalu will discuss pharmacological interventions for prediabetes, most likely including metformin and Saxenda (Novo Nordisk’s high-dose liraglutide for obesity). Dr. Jay Skyler (University of Miami, FL) will anchor this session with a keynote address on roadblocks remaining for an immune intervention that delays or prevents type 1 diabetes. This is an active but slow-moving research area (in part, due to the need for long-running clinical studies), and we’d love Dr. Skyler’s insight on how to best move this field forward.
- (6:45-9:00 pm) Hybrid Closed Loop: Three Months Later: A Panel Discussion Between Providers, Educators and Patients (sponsored by Medtronic). Dr. Francine Kaufman will lead a panel discussion detailing the hybrid closed loop system. We eagerly anticipate the nuanced and highly informative perspective this diverse group of speakers will no doubt deliver.
Friday, July 14
- (8:10-8:40 am) Keynote: Best of ADA 2017. ADA’s Chief Scientific and Medical Officer Dr. William Cefalu will present highlights from ADA’s 2017 Scientific Sessions. We expect CANVAS and DEVOTE results (CVOTs for J&J’s SGLT-2 inhibitor canagliflozin and Novo Nordisk’s basal insulin degludec, respectively) to be near the top of the list. Other possible highlights include DURATION-7 data for AZ’s GLP-1 agonist Bydureon (exenatide once-weekly) added onto basal insulin, as well as new SUSTAIN 6 analyses to show that the retinopathy risk associated with Novo Nordisk’s GLP-1 agonist semaglutide should be highly-manageable in real-world clinical settings. Overall though, we’ll be listening with rapt attention for what Dr. Cefalu considers to be the most important learning from the meeting (we’ve always considered Keystone to be an intimate follow-up to ADA, when thought leaders come together to debate and discuss the “what now?” of all the new studies presented).
- (8:40-10:40 am) Plenary Three: Diabetes Care Standards. Dr. John Buse will chair this session covering different treatment guidelines for diabetes care: the ADA/EASD algorithm, the AACE algorithm, and inpatient guidelines for diabetes patients in the hospital. Dr. Simon Heller (University of Sheffield, UK) will present on the first, while Dr. George Grunberger (Grunberger Diabetes Institute, Bloomfield Hills, MI) will address whether or not the AACE/ACE 2017 algorithm is too strict (as past president of AACE, his view on this should be particularly interesting). Dr. Guillermo Umpierrez (Emory University, Atlanta, GA) will review strategies for optimizing outcomes in the hospital. Dr. Jay Skyler will talk about shortcomings in current treatment guidelines. At CMHC 2016, he advocated for the removal of sulfonylureas from the ADA’s recommendations for second-line therapy after metformin – we would love to see this, especially once data from the GRADE study and CAROLINA CVOT, comparing Lilly/BI’s DPP-4 inhibitor linagliptin vs. sulfonylurea glimepiride, are reported. We’re eager to learn Dr. Skyler’s latest opinions on sulfonylureas, and we’re very curious for his take on the utility of current treatment guidelines for real-world HCPs.
- (10:55-12:55 pm) Plenary Four: Role of Nonprofits in Diabetes Care and Research. What function should nonprofit organizations play in diabetes research and in advancing diabetes care? NIDDK’s Dr. Pamela Thornton will share the NIH perspective, with a particular focus on health disparities. Chief Scientific and Medical Officer Dr. William Cefalu will share the ADA viewpoint, while Dr. Aaron Kowalski (JDRF, New York, NY) will do the same from the JDRF perspective and Mr. David Panzirer (Helmsley Charitable Trust, New York, NY) will discuss Helmsley’s perspective. With these four outstanding leaders on one panel, the Q&A discussion at the end of the plenary is bound to be incredibly engaging.
- (1:55-3:35 pm) Plenary Five: Diabetes and Cardiovascular Outcome Trials. This plenary, chaired by Dr. Richard Kahn, will be all about CVOTs. Dr. John Buse will kick-off the discussion with background on the burden of CV disease as a type 2 diabetes complication. We expect he’ll approach this topic from an epidemiological perspective (how common are CV events for people with diabetes?) as well as a health economic one (how costly are diabetes-related CV events for the individual and for the healthcare system?). Next, Dr. Jay Skyler will present the latest CVOT data: We expect a review of recent results from CANVAS (J&J’s SGLT-2 inhibitor canagliflozin, branded Invokana) and DEVOTE (Novo Nordisk’s next-gen basal insulin degludec, branded Tresiba), both highlights of ADA 2017. Cardiologist Dr. Steven Nissen (Cleveland Clinic, OH) will offer a justification for CVOTs. Given his major role in creating CVOT guidelines, his clinical expertise, and his previous commentary on the FDA’s “arbitrary” 1.3 and 1.8 hazard ratio cutoffs for demonstrating non-inferiority, we expect his talk will be filled to the brim with important insights on how to interpret completed CVOTs and future directions for these large outcomes trials.
- (3:55-5:30 pm) Meet the Peers: Pediatric & Adult. These parallel sessions will feature presentations with practical advice on the treatment of either children or adults with diabetes.
- On pediatric care, Dr. Shideh Majidi (University of Colorado, Denver, CO) will emphasize psychological support for youth. Dr. Majidi’s work is focused on suicide risk and depression in pediatric patients with type 1 diabetes, and we expect lots of learning on proper screening and treatment. Dr. Kimber Simmons (University of Colorado, Denver, CO) will present on diabetes in school and daycare. Dr. Paul Wadwa (University of Colorado, Denver, CO) will follow with a talk about the potential of telemedicine in caring for children with type 1 diabetes, an important tool in improving access to quality care in underserved areas, which he also spoke about at Keystone 2014.
- On adult care, Dr. Simon Heller will discuss challenges to treating diabetes in the elderly, a topic we recently heard about at ADA 2017. We’re curious to hear Dr. Heller’s opinion on A1c targets for older patients with diabetes, since some (like Yale University’s Dr. Kasia Lipska) have argued for goals >7%, although we believe strong patient education and other tools like CGM can help elderly patients avoid hypoglycemia without sacrificing good glycemic control. We’ll also hear during this session from Dr. Aaron Michels (Barbara Davis Center, Aurora, CO) on managing diabetes comorbidities and from Dr. Guillermo Umpierrez on transitioning from inpatient to outpatient care.
Saturday, July 15
- (8:10-8:40 am) Keynote: Will Guidelines for Future Artificial Pancreas Approvals be Different? Back presenting at Keystone for the third time (see Keystone 2016 and 2012), FDA’s highly regarded Dr. Courtney Lias will present the Agency’s perspective on future artificial pancreas guidelines. After 2.5 years of monthly meetings with Medtronic (per Dr. Lias’ DiabetesMine Innovation Summit talk), FDA approved the MiniMed 670G in just 104 days based on a three-month, single-arm pivotal trial. Dr. Lias wishes that FDA could do this for every novel product, but in reality, this was a special case of a first-to-market system, and FDA is too overburdened as it is – what will the Agency look for going forward from clinical trials, demonstrations of safety, and manufacturing? We fully expect that Dr. Lias will emphasize interoperability, as she has done in the past (recently at Keystone 2016, DiabetesMine Innovation Summit, and the inaugural Digital Diabetes Congress), and we also hope for commentary on FDA’s AP guidance. We wonder if progress toward component systems that would allow multiple devices to interact in automated insulin delivery system would necessitate an updated guidance – current guidance dates back to 2012. We’re delighted to see, once again, that the device division is open to a clear and open exchange of ideas with the diabetes community. On a side note, Dr. Lias, Dr. Stayce Beck, and the rest of the artificial pancreas team are up for a 2017 People’s Choice Service to America Medal – we can’t think of anyone more deserving. Vote for them here!
- (8:55-10:30 am) Plenary Six: CGM Advances. In an absolutely star-studded session, Drs. George Grunberger, Bruce Buckingham, and Roy Beck will probe critical questions regarding CGM, such as the timeline for CGM replacement of SMBG, CGM in MDI, and sensors of the future. Dr. Grunberger will begin by presenting the AACE and ATTD guidelines for CGM – he has been a staunch supporter of outcomes beyond A1c and report standardization (namely IDC’s AGP), and was a member of an impressive panel at ADA that pushed the field ever closer to a consensus on CGM outcomes metrics – what to measure, how to measure it, and how to display it. The conversation continues July 21st in Bethesda at another diaTribe Foundation-organized consensus conference on glycemic outcomes, where highly-respected clinicians, researchers, and advocates will have FDA’s ear as they discuss next steps such as expanding and cementing consensus, terminology, and ultimately, implementation. Dr. Buckingham follows with a discussion of CGM in MDI. The GOLD trial and Dexcom’s DIaMonD program have firmly established CGM as beneficial in both the type 1 and type 2 populations, and have convinced many thought leaders that it is time to move away from the “pump first, then CGM” mentality. Dr. Buckingham will then explore the future landscape of CGM, and, as he was acutely involved in the testing of early sensors, we’re very curious to hear his take on where the field is going. For our money, inexpensive, discrete, factory-calibrated, disposable sensors, coupled with insulin dosing decision support, will likely be the most attractive to both payers and patients in the long run. Finally, Dr. Beck will ponder how soon CGM will replace SMBG completely. One expert recently speculated on a call that all people with diabetes in Europe will be on Abbott’s FreeStyle Libre (and not use SMBG) in just two years. While this seems overly optimistic, FDA did approve the first non-adjunctive (insulin-dosing) label claim for a CGM (Dexcom’s G5) in December, Medicare decided to cover therapeutic CGM soon after, and the fact is, people are already doing this anyway! Still, one in seven type 1s in the US use CGM, and that number is much lower in the type 2 population. At this point, most people with CGM use it non-adjunctively, but how can we get it into more hands? Dr. Kowalski chairs this session, and notably, apart from Dr. Grunberger (who has a prior engagement), all speakers will be present and participating at the July 21st meeting!
- (10:45-12:25 pm) Plenary Seven: Hypoglycemia and Diabetes. The great Dr. Simon Heller will chair this session focused on hypoglycemia, in which Dr. Bruce Buckingham will talk about the “best way” to decrease hypoglycemia in people with type 1 diabetes. Based on his experience (and the current lack of a functional glucose-responsive insulin), our guess is that his answer will be hybrid closed loop. In the 670G pivotal trial, patients were spending just <45 minutes per day <70 md/dl, and ~nine minutes per day <50 mg/dl, and, according to a Medtronic poster at ADA detailing outcomes after over a year of real-world use at the Barbara Davis Center (n=19), there have still been exactly zero incidents of severe hypoglycemia requiring assistance [though there have been nine instances of severe hyperglycemia (blood glucose > 300 mg/dl with ketones >0.6 mmol/l or symptoms of nausea, vomiting, or abdominal pain)]. We wonder what other tips Dr. Buckingham might have outside of closed loop. Dr. Moshe Phillip will also present on the role of provider-facing decision support systems in preventing hypoglycemia. His company, DreaMed, has a clinician-facing support system, Advisor Pro, in development (set to enter a pivotal study this summer, per AACE). The software will be integrated with Glooko’s platform, allowing clinicians to get advice on insulin adjustments for patients using CGM and pumps (though SMBG and MDI are in development). Preliminary pilot data shown at ATTD was promising.
- (1:25-3:40 pm) Diabetes in Special Populations. Two concurrent sessions will discuss special topics relevant to (i) pediatric diabetes care and (ii) diabetes care for adults older than 40.
- In the pediatric session, Dr. Andrea Steck (Barbara Davis Center, Aurora, CO) will discuss the feasibility of early type 1 diagnosis through antibody screening. Dr. Andrea Gerard Gonzalez (Barbara Davis Center, Aurora, CO) will present on diabetes care in minority populations, identifying specific challenges. Dr. Greg Forlenza (Barbara Davis Center, Aurora, CO) will round out the session with a discussion of hybrid closed loop systems in pediatric patients that we expect will mirror the adolescent data presented in the ADA poster. FDA’s Dr. Stayce Beck recently dispelled a misconception that adult hybrid closed loop approval must precede pediatric, stating that instead the two should occur separately and in parallel. At the Barbara Davis Center, both adults and adolescents benefit greatly from 670G, though adults appear to spend more time in auto mode and have slightly improved glycemic outcomes. Medtronic is currently enrolling for a pediatric trial (ages 2-13) of the 670G with completion expected in April 2018.
- In the adult session, Dr. Aaron Michels will begin by comparing MDI and CSII in type 1 patients. Dr. Steven Nissen will provide the cardiologist’s perspective on glucose control, a topic that has become especially pertinent since Lilly/BI’s SGLT-2 inhibitor Jardiance (empagliflozin) became the first diabetes drug with an indication for the reduction of CV death, officially inviting cardiologists into the realm of diabetes management. We hope Dr. Nissen weighs in on Novo Nordisk’s GLP-1 agonist Victoza (liraglutide) for CV risk reduction as well, as the product is now pending FDA approval of a new CV indication. Dr. George Grunberger will round out the session with a talk on diabetes micro and macrovascular complications.
- (3:20-5:00 pm) Patient/Provider Question & Answer Panels. In two concurrent sessions, one panel will feature pediatric diabetes patients while the other features adult patients. Both promise to be engaging conversations on ways to improve patient quality of life.
- The pediatric panel will be chaired by Drs. Brigitte Frohnert and Robert Slover (Barbara Davis Center, Aurora, CO) and will include three patients.
- The adult panel will be chaired by Drs. Kavita Garg (University of Colorado, Denver, CO) and Peter Gottlieb (Barbara Davis Center, Aurora, CO) and will include five patients.
- (6:30-9:00 pm) Practical Review of Therapeutic Continuous Glucose Monitoring in Clinical Practice and the Future of Dexcom Technology (sponsored by Dexcom). We expect this session to be chock full of updates. Most notably, Dexcom’s Dr. Claudia Graham will speak to the use of CGM in seniors, in a talk that will surely provide a status check on Medicare reimbursement. Following Medicare’s positive decision to cover therapeutic CGM in March, Dexcom’s 1Q17 call shared that patients on Medicare cannot get claims processed/reimbursed for Dexcom’s G5 until “final” “local coverage decisions” come through. This process was expected to wrap up before the end of 2Q17, and we hope it has for the sake of the >10,000 Medicare patients in line who have not yet been shipped sensors. Medicare-age patients are arguably one of the groups who could most benefit from CGM, given higher rates of hypoglycemia unawareness and risk of injury. Dexcom’s Mr. Peter Simpson will culminate the session with a glimpse into the future of Dexcom CGM technology. We were elated to hear of Dexcom’s recent adoption of the standardized AGP in Dexcom Clarity and G5 Android approval, and we’ll be listening for pipeline updates pertaining to the new touchscreen receiver (which we played with at ADA), one-touch inserter and G5x lower profile transmitter (under FDA review), G6 pivotal trial and PMA filing (submission expected by end of 3Q17), Verily partnership (first-gen launch by the end of 2018, second-gen by “2020-2021”), and other partners. Dr. Bruce Buckingham will be sandwiched between the two Dexcom reps discussing the practicality of therapeutic CGM intervention with Dexcom G5.
Sunday, July 16
- (8:00-10:25 am) Plenary Eight: New Therapeutic Choices for Diabetes Treatment. In this final plenary, Dr. Simon Heller will evaluate new basal insulins and their advantages over earlier products – we expect Novo Nordisk’s Tresiba (insulin degludec) and Sanofi’s Toujeo (insulin glargine U300) will feature prominently. Dr. John Buse will speak to the role of SGLT-1/2 dual inhibitors in type 1, an exciting area since phase 3 results from Lexicon’s inTandem program for sotagliflozin make this candidate the most advanced adjunct oral therapy in the pipeline for type 1 diabetes (see our coverage of inTandem1 and inTandem2 from ADA 2017). Dr. Richard Kahn will discuss the role of lifestyle modification as a support for pharmacotherapy to achieve optimal outcomes. Dr. Lori Sussel (University of Colorado, Denver, CO) will present on investigational methods to rescue residual beta cells in type 1 diabetes (see our competitive landscape on type 1 diabetes cures for the big picture on this area of research).
-- by Ann Carracher, Maeve Serino, Adam Brown, Brian Levine, Payal Marathe, and Kelly Close