November 2-4, 2017 – Bethesda North Marriott Hotel – Bethesda, MD
At this year’s DTM – the 17th annual edition! – things will start off quickly with several strong workshops on Thursday:
- Reimbursement of diabetes technology – What’s the latest on 670G, Medicare CGM, and digital DPP reimbursement?
- Advances in insulin delivery – Dr. Bruce Buckingham on why we need smart pens, Voluntis on decision support, and Insulet/Lilly on U500 delivered via pump (will we get a first look at phase 3 data?).
- Developments in glucose monitoring – including CGM in type 2, an Asian perspective on new tech (Dr. Koji Sode), contact lens work from Oregon State (new to us), an examination of new endpoints (continuing the Beyond A1c movement), and more.
And that’s only day one!
On Friday and Saturday, we’ll attend ten different sessions, and we’re particularly excited for:
- A CGM “panel discussion” with Abbott, ARKRAY, Dexcom, Medtronic, Pacific Diabetes Technologies, and Senseonics – we’re not sure if each company will present a pipeline update (typical in the past), or if the whole group will be on stage at once for a broad Q&A.
- Artificial intelligence for decision support – Verily’s Dr. Howard Zisser on Google’s retinopathy work, Drs. Boris Kovatchev and Moshe Phillip on decision support for physicians and patients.
- Automated insulin delivery algorithms – Updates on the four major NIH-funded pivotal AID trials, 670G performance views from Yale’s Dr. Jennifer Sherr, Insulet’s Dr. Trang Ly on OmniPod Horizon, UVA’s Drs. Stacey Anderson and Ananda Basu, and an update from Bigfoot’s Ms. Jen Block.
- Augmented reality, a first-ever DTM session!
- Novel insulins – Dr. Zhen Gu on smart insulin, IP delivery from Harvard’s fantastic Dr. Frank Doyle, Diasome’s Dr. Doug Muchmore on hepatic-directed insulin, TJU on new catheters, and Dr. Lutz Heinemann on biosimilars.
- DTS’ BGM Surveillance Program – FDA’s Dr. Alberto Gutierrez is a moderator, along with Dr. Klonoff. How will the important study results carry forward?
We’re elated to see a slew of FDA viewpoints represented once again, including Drs. Courtney Lias (glucose monitoring), Stayce Beck (direct-to-consumer marketing), Alain Silk (post-market surveillance), and Seth Carmody (privacy for diabetes devices).
Get a snapshot of all the DTM 2017 sessions below!
Thursday, November 2
- (8:00 – 11:40 am) Workshop A: Reimbursement
- (8:00 – 9:35 am) Panel 1: Glucose, CGM, Artificial Pancreas. Emerson Consultants’ very smart Ms. Patty Telgener will pick up where she left off at last year’s DTM, providing updates on the current status of CGM and automated insulin delivery reimbursement. And boy are there updates! A lot has changed since she last took to the podium a year ago: The first hybrid closed loop system, Medtronic’s MiniMed 670G, is on the market and seems to be reimbursed (Anthem being a notable exception, ruling that it is “investigational and not medically necessary”), and Medicare finally granted reimbursement for therapeutic CGM (currently only Dexcom G5). We imagine that Abbott’s FreeStyle Libre – just approved in the US – will also receive Medicare reimbursement status at some point, given the fingerstick replacement label. We’ll also hear from Dr. Paul Radensky (McDermott Will & Emery LLP, Washington, DC) on new regulatory policies and Dr. Allan Glass (Endocrine Society, Bethesda, MD), who will dive even deeper into CGM reimbursement.
- (10:00 – 11:40 am) Panel 2: Other Technologies: Pumps, Mobile Apps. Dr. Bruce Quinn leads off this session with discussion on pump reimbursement, hopefully touching on the potential to break free of the cumbersome four-year reimbursement cycle for durable pumps. Omada Health VP of Sales Mr. Robert Guigley and McKinsey’s Mr. Pablo Salazar will discuss the ins and outs of digital health reimbursement. To us, it feels like early days for coverage of diabetes/digital health, as hardware/software/services combinations continue to evolve. mySugr obtained reimbursement for its “mySugr bundle” from two large payers in Germany and is in discussions with other insurance companies worldwide. Meanwhile, companies like Omada and Livongo have had success approaching self-insured employers. Players like One Drop have gone more of a direct-to-consumer route, but are quickly pivoting to focus on payers. Of note, CMS declined to reimburse digitally-delivered DPP for now, though there are allowances for a limited number of virtual make-up sessions. We see a lot of potential in digital DPP, especially for those living in remote and rural areas. Hopefully we’ll receive some good news on this front – CMMI (Center for Medicare & Medicaid Innovation) is reportedly proceeding with a large-scale pilot to generate data to support opening up reimbursement for digital programs.
- (8:00 – 11:35 am) Workshop B: Advances in Insulin Delivery
- (8:00 – 9:40 am) Panel 1: Accurate Insulin Dosing. The session will culminate with a presentation by Lilly’s Ms. Jennal Johnson and Insulet Medical Director Dr. Trang Ly on pump delivery of U500 insulin – we’re crossing our fingers for a first look at the much-anticipated phase 3 data of the Lilly U500 Omnipod PDM in type 2 patients (VIVID; n=416, primary outcome: Change in A1c at 26 weeks), which Dr. Ly hinted is “really exciting” at AADE. Earlier, Yale’s Dr. Jennifer Sherr will kick off the session with a discussion of “uncontrolled diabetes.” Perhaps she will share insight on the 670G’s ability to help those with high A1c’s – her AADE and CDTM were quite positive on the hybrid closed loop. Meanwhile, Dr. Andreas Pfutzner (Pfützner Science & Health Institute, Mainz, Germany) and Voluntis’ Ms. Ellie Strock will both discuss insulin decision support software. The basal insulin titration landscape has pretty much sprouted entirely in the past year, with at least three apps FDA cleared – Voluntis’ Insulia, Amalgam Rx’s iSage Rx, and Sanofi’s My Dose Coach. Still, we have yet to see any broadly launch – what’s taking so long?
- (9:55 – 11:35 am) Panel 2: Technologies for Insulin/Pen Delivery. Stanford’s legendary Dr. Bruce Buckingham will provide a clinician’s perspective on why we need smart pens – the need is obvious to us, as Dr. Irl Hirsch has said repeatedly, given the dearth of insulin dose data from MDIs. The smart pen competitive landscape has been heating up, with Novo Nordisk quietly piloting its connected Echo pen at 10 clinics in Sweden, Companion Medical’s Bluetooth-enabled InPen still slated for a 2017 US launch, Sanofi piloting Common Sensing’s GoCap with One Drop, and Bigfoot acquiring Timesulin. Dr. Lutz Heinemann will then ask “What ever happened to inhaled insulin?” Mannkind has had some nice recent victories, as it just announced a $61 million stock offering, received an important label update for Afrezza (faster onset/offset), and has initiated an RCT with One Drop (coaching+Afrezza). Capillary Biomedical’s Dr. Jeffrey Joseph returns to DTM to discuss advances in insulin delivery – his team is working on long-term implantable intraperitoneal insulin delivery and subcutaneous infusion sets (via JDRF grant).
- (12:30 – 4:10 pm) Workshop C: Social Media for Diabetes – Communications and Advertising
- (12:30 – 2:10 pm) Panel 1: How Social Media can Promote Health Behavior. In a session moderated by two AADE past-presidents – Ms. Malinda Peeples and Dr. Deborah Greenwood – we’ll hear from UCLA’s Dr. David Ahn on some of the benefits of social media, and then later from Harvard’s Ms. Elissa Weitzman on the safety of online communities. One of the main themes at this year’s AADE was that social media and the Diabetes Online Community (DOC) can be enormously beneficial for patients, yet providers are still largely in the dark about this valuable resource (we remember being shocked when only about a third of the audience at an AADE session on social support networks indicated familiarity with the DOC). What will it take to expand HCP adoption?
- (2:30 – 4:10 pm) Panel 2: Advertising on Social Media. Ascensia CEO Michael Kloss will open this panel with a discussion on advertising for diabetes products on social media – now that is a unique topic! Next, FDA’s amazing Diabetes Branch Chief, Dr. Stayce Beck, will present the Agency’s policies on direct-to-consumer advertising – we can’t believe how many domains in which she and her whole team are fluent! We’ll also hear from Novo Nordisk’s Mr. Michael Bachner on online advertising, as well as a legal perspective from Mr. Michael Ryan of McDermott Will & Emery.
- (12:30 – 2:10 pm) Workshop D: Developments in Glucose Monitoring
- (12:30 – 4:10 pm) Panel 1: Technology. FDA’s Dr. Courtney Lias will share views on the Agency’s current technology policies. We’re blown away by Dr. Lias’s continued commitment to the diabetes community and remain impressed by all the hard work the FDA is doing to support the rapidly expanding world of technology – she, Dr. Stayce Beck, and team were recently recognized for their hard work and devotion with a “Sammie” Service to America Medal. Duke University School of Medicine’s Dr. Eugene Wright will discuss CGM use in type 2, a topic which we’re pleased to see is gaining significant traction. Data from Dexcom’s DIaMonD study of CGM in type 2 patients on MDI was published in the Annals of Internal Medicine in August and a Dexcom-sponsored and Jaeb Center-run study of CGM in type 2s on basal insulin is in the works. Meanwhile, Abbott has strong potential to drive into type 2 diabetes with the less expensive FreeStyle Libre sensor. Widespread type 2 adoption of CGM is still gated by cost/reimbursement, device complexity, and awareness (among other things), but we’re optimistic about the long term potential – particularly given pipeline plans for smaller, cheaper, factory-calibrated sensors and paired value-added software. The panel also includes a presentation on new sensors from Asia, as well as an update from Oregon State University on contact lenses to measure glucose – we’re not sure if this is Verily/Novartis’ work or an academic effort.
- (2:30 – 4:10 pm) Panel 2: New End Points for Diabetes Technology Clinical Trials. Dr. David Rodbard will discuss glycemic variability (he had a big hand in developing the Ambulatory Glucose Profile), along with Diasome’s Dr. Doug Muchmore on defining hypoglycemia, and Kinexum’s Dr. Zan Fleming on new endpoints and adaptive designs for clinical trials. Plus, NIDDK Director Dr. Judith Fradkin is a co-moderator. Notably, 66% of the panel participated in July’s diaTribe Foundation-organized consensus conference on glycemic outcomes beyond A1c. Much was agreed on at that meeting, including the set of standardized, core CGM metrics that should be measured and reported in clinical trials that use CGM. For a preview of the discussion, see our write-up from a breakout session at the consensus conference in which Dr. Lori Laffel, Prof. Philip Home, and peers deliberated about use of CGM in trials and how to persuade FDA to adopt hypoglycemia as a surrogate outcome metric. We’re excited to see this critical mission front and center at DTM!
Friday, November 3
- (8:00 – 9:55 am) Session 1: Artificial Intelligence for Decision Support. Dr. Jonathan Clark of the National Space Biomedical Research Institute will deliver the day’s keynote address. He is a six-time Space Shuttle crew surgeon and board-certified in neurology and aerospace medicine – whoa, we hope this talk connects some new dots in diabetes. Following the address, UVA’s Dr. Boris Kovatchev will discuss decision support based on SMBG or CGM data. We wonder if he’ll mention TypeZero and Senseonics’ recent R&D agreement to use Eversense implantable CGM data in decision support systems – in August, Senseonics hinted that a pivotal trial would be announced soon. Next, Dr. Moshe Phillip, who told us over email that DreaMed’s clinician-facing Advisor Pro decision support system was to begin a pivotal trial in September, will detail how decision support systems impact the lives of both providers and patients (We expect it will save time, surface hidden insights more quickly, and allow providers to focus on other things that matter to people with diabetes.) The panel will wrap up with Verily Diabetes Lead Dr. Howard Zisser on deep learning to diagnose diabetic retinopathy. Google published a paper in JAMA in December 2016 demonstrating that its algorithm detected retinopathy and macular edema from retinal fundus photos with over 90% sensitivity and specificity. IBM Watson and IDx are among the other companies active in this area. Dr. Judith Fradkin gave an inspiring talk at this year’s ADA regarding the massive potential these screening tools have to greatly reduce burden and improve outcomes.
- (10:15 – 11:55 am) Session 2: Privacy for Diabetes Device. This panel of noted leaders, including Lucia Savage, newly minted Chief Privacy and Regulatory Officer at Omada Health, HHS's Ms. Rachel Seeger, and Dr. Seth Carmody of the FDA, will discuss the importance of privacy given the increasing amount of health data stored and shared on devices.
- (12:55 – 2:20 pm) Session 3: Augmented Reality. University of Utah’s Dr. Bryan Gibson kicks of this first-ever DTM session on AR with a look into how virtual reality (VR) might impact the emotional reaction to diabetes data. In July, his lab put out a call for people with type 2 diabetes to participate in a study: Participants will “see/experience how well [their] blood sugar is under control, how blood sugar varies throughout the day, and what it would be like to have diabetic eye disease.” Perhaps VR could be leveraged in this way to help data more effectively translate to action. Coresights’ Mr. Ben Barone (“Measure and Reduce Stress with VR Biofeedback”) and Suggestic CEO Mr. Victor Chapela (whose food-focused app was just crowned winner of the Health 2.0 Launch! Competition) will also present. There is definite potential for VR/AR in diabetes, especially in novel education for both patients and providers.
- (2:40 – 4:20 pm) Session 4: Artificial Pancreas – Recent Innovations in Algorithms. A late addition to the lineup, Bigfoot Biomedical Director of Clinical Innovation Ms. Jen Block will present the results of the company’s first closed loop feasibility study (n=50), as well as the Bigfoot approach to developing and testing its automated insulin delivery system (the day prior, Chief Engineer Mr. Lane Desborough will present a poster on the strong predictive power of Bigfoot’s in-silico simulations). As a reminder, the system will undergo a pivotal trial in 2018 and a “2020” launch is possible, per CEO Mr. Jeffrey Brewer. NIH’s Dr. Guillermo Arreaza-Rubin will hopefully provide updates on the NIH Artificial Pancreas Consortium’s four closed loop trials: (i) IDCL with Tandem/Dexcom/TypeZero’s system in the US (the main phase doesn’t appear to have begun) and Roche/Senseonics/TypeZero’s system in Europe (beginning in early 2018); (ii) DAN05 (Cambridge; possibly underway); (iii) 670G vs. next-gen Medtronic pump with automatic correction boluses (IDC-Schneider Children’s; possibly underway); and (iv) BU/MGH’s bihormonal pivotal trial (starting in the beginning of 2019). We’re also looking forward to updates on UVA’s AP project from Dr. Stacey Anderson and Insulet’s Horizon MPC algorithm from Dr. Trang Ly. As of EASD, the Insulet system had been tested in in 113 patients (n=7,104 hours). A five-day hotel study (n=48), the third IDE study, was expected to wrap up this month, so we might see topline data. The ever-insightful Prof. Katharine Barnard will also discuss intra-peritoneal artificial pancreas systems, which she last discussed at the JDRF-Helmsley Charitable Trust Closed Loop Intra-Peritoneal Infusion Workshop in April. There, she discussed psychosocial concerns, which we would expect her to focus on at this meeting as well.
Saturday, November 4
- (8:00 – 10:30 am) Session 5: Novel Insulins. Profil’s Dr. Eric Zijlstra will discuss insulins in the pipeline, after which Harvard’s Dr. Frank Doyle will discuss intraperitoneal insulin delivery. For a refresher on this topic, don’t pass up on our coverage of April’s IP AP Workshop – we remain IP insulin delivery skeptics, but look forward to seeing another potential option, assuming it is cost-effective, small enough, and hits a segment of the market that cannot/will not benefit from subcutaneous approaches. We’ll also receive updates on Diasome’s (recipient of “up to $30 million” from Medicxi, JDRF T1D Fund, and others) hepatic-directed insulin candidate, and on biosimilar insulin from Dr. Lutz Heinemann. In December, Lilly and BI launched Basaglar in the US, and we’ll be interested to hearing Dr. Heinemann’s view of how the “biosimilar” glargine is being received. UNC’s brilliant Dr. Zhen Gu will wrap up the session with a discussion on smart insulin, perhaps showing new data on his glucose-responsive insulin patch, for which his lab received a $5.8 million investment in June.
- (10:20 am – 12:00 pm) Session 6: Assessment of Diabetes Technology. FDA’s Dr. Alain Silk will give his valuable perspective on post-market surveillance, with hopefully some commentary on outcomes from DTS’ notable BGM study (see our July coverage). We wonder if Dr. Silk will discuss the FDA’s recently released guidance on use of real world data, which can be used to support post market surveillance, or the National Evaluation System for health Technology (NEST). Returning to DTM, Dr. John Pickup will provide a meta-analysis of the current state of diabetes technology. Last year, he provided an insightful and entertaining overview of patch pumps, and at ATTD in February, he presented a meta-analysis of pumps in type 2 patients. For the second time in this meeting, we’ll hear from Dr. Katharine Barnard on IP insulin delivery. Lastly, University of Colorado’s Dr. Brett McQueen will discuss cost efficiency in diabetes technology, a topic that will arguably become the biggest driver of this field in the years to come.
- (1:00 – 1:20 pm) Session 7: DTS Surveillance Program for Cleared BGM. Quesgen’s Mr. Michael John will discuss the results of DTS’ surveillance program, a well-designed, rigorous study which found that only six of 18 popular BGMs received the seal of approval for accuracy. We wonder if the panel will discuss possible solutions like follow-up studies, providing insurance coverage only for meters that received a seal, etc. One of the scariest realizations from the study was that ~68% of the Medicare mail order BGM market in 2016 was for meters that didn’t pass the accuracy bar in DTS’ evaluation. We hope the data reminds patients, providers, payers, and regulators that not all BGMs are created equal, and not all deliver real-world performance in line with the data submitted to the FDA. We also point out of course that not everyone agrees with the research and then of course it's also true that other items that no one is doing anything about also throws off results like poor carb counting and hand washing.
- (1:35 – 2:45 pm) Session 8: Continuous Insulin Monitoring. Sansum’s Dr. David Kerr will open the session by explaining the clinical need for “continuous insulin monitoring.” We agree, depending on what this term actually means. For pumpers, Continuous Insulin Monitoring could give automated insulin delivery algorithms far more data on how the system is actually performing (e.g., is the insulin actually going into the tissue? Is there an occlusion?). For MDIs, tracking insulin use could drive dose titration and decision support. We’ll also hear from ASU’s Dr. Jeffrey La Belle on Electrochemical Impedance spectroscopy for continuous insulin monitoring and Aptitude’s Dr. B Scott Ferguson on a point of care insulin monitoring device for improved diabetes management. We’ll be interested to see how these speakers define this topic and where they see the most value potential.
- (3:05 – 4: 15 pm) Session 9: CGM. In the last big session of this year’s DTM – one of our favorites every year – we’ll hear from five diabetes companies on their current CGM efforts. The session is listed as a “panel discussion,” implying all speakers will get on stage for a broad Q&A. If so, that would be a departure from past years, where we heard major updates from the different manufacturers in individual presentations. We’re not surprised to see Roche absent, given the step back on its own Accu-Chek Insight CGM.
- Abbott’s Dr. Tim Dunn will be able to discuss FreeStyle Libre more openly, following the victory of FDA approval in September. It’s possible he’ll present more real-world data from the >55,000-strong FreeStyle Libre user cohort (previously shown at ATTD and ADA).
- Dexcom’s Mr. Peter Simpson will hopefully provide a first look at G6 pivotal data and/or a pipeline update for 2018 and beyond. Per Dexcom’s 2Q17 call, the G6 pivotal was wrapping up and a submission was expected by the end of September. Will we see the pivotal accuracy data following the pre-pivotal data from last year’s DTM (MARD of 8.1% on one calibration per day after startup; n=49)? We also hope to hear more about the Verily partnership and plans for the first and second-gen sensors – there have not been material updates in some time.
- Senseonics’ Dr. Andrew DeHennis will hopefully provide a glance into real-world Eversense data from Europe, or perhaps early data on the potential for a factory calibrated 90-180 day sensor. The 90-day version of Eversense remains under FDA review, with previous guidance hoping for a 4Q17 approval. If the company has an FDA advisory committee – which it expects to, but has not yet been announced – a 2017 approval feels increasingly unlikely at this stage.
- Medtronic’s Dr. Robert Vigersky may give an update on the current sensor shortage and manufacturing capacity, and perhaps an idea of when FDA approval for the Guardian Connect mobile CGM may come through. We’re particularly excited for this to launch in the US, as it will do so alongside the Sugar.IQ pattern-recognition app. Guardian Connect remains under FDA review, and given the sensor shortage, we imagine a launch wouldn’t happen in the US until early 2018.
- Pacific Diabetes Technologies’ (PDT) Dr. Bob Cargill will discuss the team’s exciting efforts to combine CGM sensing/insulin infusion in a single catheter. We last heard in July 2016 that human studies were to begin in the first part of 2017. Interestingly, PDT discovered that phenol (insulin preservative) interferes with accurate CGM sensing ~30% of the time, driving an alarmingly high false peak and subsequent sensor poisoning. The team has changed its sensor to an osmium-based chemistry biased at 180 mV, and no longer sees this effect. We look forward to hearing an update!
- Arkray’s Mr. Shinjiro Sekimoto will return to DTM for the fourth consecutive year. At last year’s meeting he shared limited progress on the company’s glucose dehydrogenase-dependent DiET CGM. Clinical trials in the US and Japan were predicted to begin between 1Q17 and 2018, though we’re not too optimistic.
- (4:30 pm –) Session 10: Live Demonstration. Dr. Sammy Choi will demonstrate real-time CGM in active US soldiers – whoa! We doubt we’ll see live streams from actively-deployed individuals on the big screen (that’d be cool) and we’re not even sure if the title refers to people with diabetes, but we’re curious nonetheless!
--by Maeve Serino, Brian Levine, Adam Brown, and Kelly Close