DTM 2016 (Diabetes Technology Meeting)

November 10-12, 2016; Bethesda, MD; Preview – Draft

November 10-12, 2016 – Bethesda North Marriot Hotel – Bethesda, MD



Conference Website

From Thursday November 10 to Saturday November 12, the diabetes tech world will descend on Bethesda’s North Marriott Hotel for the 16th annual Diabetes Technology Meeting. Wow! We remember the very first one, back in the day! Sessions we’re most looking forward to include (i) patient-generated health data and precision medicine (Verily, IBM Watson, Tidepool, and Glooko – none of these companies would’ve been here even five years ago!); (ii) a powerhouse CGM industry update session (Abbott, Dexcom, Medtronic, Roche, Arkray – this has been a highlight at this conference for the past several years); (iii) regulatory initiatives in diabetes technology, including FDA’s Dr. Courtney Lias on BGM; (iv) artificial pancreas algorithm innovations (including Drs. Moshe Phillip, Claudio Cobelli, and Bill Tamborlane); and (v) sessions on social media, diabetes apps, and insulin delivery (including OpenAPS user Rachel Sandlain, the masterful Dr. Joyce Lee, and DiabetesMine’s Amy Tenderich).

The Thursday pre-conference workshops will include a rapid-fire session on implanted CGM sensors (including Senseonics, GlySens, Profusa, Biorasis, Capillary Biomedical, and investor perspectives); a slew of talks on reimbursement and competitive bidding; discussion of diabetes metrics for glycemic control and glucose monitors; and a session on biomarkers.

Keep scrolling for a chronological, session-by-session overview of what is sure to be an insight-packed gathering, and check out our report from DTM 2015 for a reminder of how impactful and update-rich this meeting can be!

Thursday, November 10 (Pre Conference)

  • (8:00 am – 11:30 am) Workshop A: Implanted Sensors. The pre-conference events will begin with two concurrent workshops, each consisting of two “panel” sessions (see below). Each panel will contain a 30-minute Q&A session after the panelists have spoken.
    • (8:00 am – 9:35 am) Panel 1: Long-term Implantable Glucose Sensors. Dr. Joseph Lucisano (Glysens, San Diego, CA) will dive right in at 8:05 am to provide an update on clinical experience with Glysens’ long-term fully implantable CGM. We had the opportunity to speak with the Glysens team down in San Diego during AADE – the company has two, small, ongoing clinical trials, which have demonstrated strong signal stability over 12-months of use, with minimal monthly drift (one calibration per month) and a MARD of 15%. The session will also include full results from Senseonics’ 90-day US pivotal trial (PRECISE II) of the implantable Eversense CGM. Moments before the 2Q16 call in August, Senseonics released topline accuracy results indicating an impressive 8.8% MARD vs. YSI. We look forward to hearing more about safety, sensor durability, and (hopefully) patient-reported outcomes. Profusa and Biorasis will also speak about their implantable sensors, among others. Cost, form factor, and hassle will be critical drivers of CGM market expansion, and the bar is rising for implantable systems to keep up with rapid innovation at Abbott, Dexcom, and Medtronic. Still, there is plenty of penetration runway for many products to succeed in the field. We wonder what CGM will look like in ten years, and which of these companies is best positioned to address the future market.
    • (9:55 am – 11:30 am) Panel 2: Market Opportunities, Financial Issues, and Exit Strategy. Glysens CEO Mr. Bill Markle will share customer preference data for the company’s implanted CGM (presumably the T1D Exchange data we heard in our meeting at AADE – the dQ&A data was much more limited). The highly regarded Dr. Tim Goodnow (CEO/President of Senseonics) will then focus on how implanted technologies can address new market challenges. Capillary Biomedical’s Mr. Paul Strasma will follow and discuss the value proposition of implants (separately, the company is JDRF funded to work on a seven-day infusion set catheter). The session will be bookended by an exploration of the ever-crucial investor perspective from Fenix Group’s Mr. Matthew Maryniak.
  • (8:00 am – 11:30 am) Workshop B: Biomarkers for Diabetes
    • (8:00 am – 9:35 am) Panel 1: Update on Established Biomarkers. A big part of this session will focus on CGM-based metrics, such as time in range and any number of possible hypoglycemia measurements. Dr. Pratik Choudhary (King’s College London, UK) will overview some of these metrics, while UVA’s Dr. Boris Kovatchev will give an update on eA1c (estimated A1c). The latter was the focus of a JDST paper published a year ago, and for a couple years has been part of Sanofi’s MyStar Extra meter outside the US. In addition, UCLA’s Dr. Andrew Drexler and MedStar’s Dr. Michelle Magee will discuss measurement, interpretation, and clinical utility of blood ketones and A1c, respectively. Everyone agrees that outcomes beyond A1c are needed (see the August FDA Workshop), though gaining consensus will be the key task ahead.
    • (9:55 am – 11:30 am) Panel 2: Emerging Biomarkers. UCSF’s Dr. Gerold Grodsky and NIH’s Dr. Guillermo Arreaza-Rubín will moderate the second half of the biomarker session, which will focus on biomarkers of the future. Hypoglycemia expert Dr. Brian Frier (University of Edinburgh, UK) will call for a new definition of hypoglycemia, perhaps building on Dr. Simon Heller’s presentation from August’s FDA workshop. Other talks in the session will touch on noninvasive glucose measurement; C-peptide and proinsulin; and an overview of innovations in electrochemical sensors, methods, and analytes.
  • (12:30 pm ­– 4:00 pm) Workshop C: Coding, Coverage, Reimbursement, & Competitive Bidding
    • (12:30 pm – 2:05 pm) Panel 1: Coding and Coverage. The great Dr. Barry Ginsberg (Diabetes Technology Consultants, Wyckoff, New Jersey) and Dexcom’s smart Dr. Claudia Graham will moderate this critical panel (see Dr. Graham’s insightful update on CGM reimbursement from EASD). Roche’s Bruce Taylor will kick off the session with an overview of the coding and coverage landscape for diabetes products. Next, Arkray’s Jerry Gomez will explain how reimbursement affects patient choice. The remaining two talks are forward-looking: powerhouse Ms. Patty Telgener (Emerson Consultants, Excelsior, Minnesota) will discuss the impact of healthcare reform on reimbursement for new technologies, while Ms. Erika Miller (Cavarocchi, Ruscio, Dennis Associates, Washington, DC) will evaluate the pros and cons of a new CPT code for CGM. CGM is undoubtedly center stage in the reimbursement discussion. As of last month, it was approved for reimbursement in Germany for patients on intensive insulin therapy and a number of other countries cover CGM partially or fully, but Medicare still denies coverage. Abbott’s FreeStyle Libre has gained impressive traction in Europe with primarily a cash-pay model (200,000+ users as of 3Q16), and we’ll be interested to see how it comes into the US market (real-time version submitted in 3Q16).
    • (2:25 pm – 4:00 pm) Panel 2: Reimbursement and the Competitive Bidding Process by CMS. The session opens with patient perspectives from Ms. Christel Marchand Aprigliano and Mr. Bennet Dunlap (Diabetes Patient Advocacy Coalition) – this will be terrific to hear patient perspectives on policy. Related talks in this session will come from esteemed Drs. Gary Puckerin (National Minority Quality Forum, Washington, DC) and David Marrero (formerly Indiana University School of Medicine, Indianapolis, IN – now UA Center for Border Health at the University of Arizona Health Sciences). Dr. Puckerin will focus on diabetes safety monitoring in the competitive bidding program, while Dr. Marrero will lay out the anticipated impacts of competitive bidding on health outcomes. The CMS program, intended to make blood glucose strips more affordable and accessible for patients, actually appears to have had the opposite effect thus far. A Diabetes Care paper published earlier in March suggests that the program has (unsurprisingly) led to reduced access to glucose testing supplies, potentially driving increased mortality in competitive bidding test sites. Competitive bidding has also crushed the BGM market: in 3Q16, pooled revenue from the Abbott, J&J, and Roche totaled just ~$1.2 billion, falling 1% YOY and at least the 15th quarter in a row with a loss.
  • (12:30 ­pm – 4:00 pm) Workshop D: Metrics for Diabetes
    • (12:30 pm – 2:05 pm) Panel 1: Metrics for Describing Performance of a Monitor. JDRF’s Dr. Vincent Crabtree and FDA’s Dr. Courtney Lias will team up to moderate this panel. We can’t wait to hear Ms. Annika Jimenez, Dexcom’s SVP of Data, speak about borrowing from big data technologies to drive better ruse and interpretation of CGM. She joined Dexcom’s leadership last year and brings Big Data experience from Silicon Valley. The session will also feature three talks on BGM: Ascencia’s Dr. David Simmons on the relationship between BGM and CGM, Biomedical Informatics Consultants’ Dr. David Rodbard on the best metrics of glycemia provided by a BGM, and Roche’s Dr. Rolf Hinzmann on the best way to describe the accuracy of blood glucose meters. Earlier this month, FDA finalized guidances updating SMBG (home use) and point-of-care (healthcare facilities) BGM accuracy and study requirements. Perhaps most notable is the call for tighter accuracy on the SMBG side – good news for patients and HCPs, but not necessarily a positive for innovation in industry.
    • (2:25 pm – 4:00 pm) Panel 2: New Metrics for Control. This is yet another session one to keep an eye on for discussion of outcomes beyond A1c. Medtronic’s Dr. Robert Vigersky will kick of the session with a discussion of the glucose pentagon, which combines five elements of glycemia: A1c; SD; time >160 mg/dl; AUC > 160 mg/dl; and mean glucose (see his AADE 2016 talk). Dr. Alexander Fleming (Kinexum, Harpers Ferry, WV), formerly of FDA, will follow with his own talk on composite metrics for clinical trials. And last but not least, UVA’s algorithm expert Dr. Marc Breton will suggest some long-term metrics. We’re not sure what to expect from this last one, but assume it will focus on combining CGM and perhaps A1c data.

Friday, November 11

  • (8:00 am – 9:25 am) Session 1: Patient-Generated Health Data for the Precision Medicine Initiative. We can hardly wait for the first session of the meeting – just look at the lineup! Moderated by NIH’s Dr. Judith Fradkin (who spoke about NIH’s Precision Medicine Initiative at ADA), the 85 minutes will include talks from Verily’s Dr. Howard Zisser, IBM Watson’s CSO Dr. Shahram Ebadollahi (he gave an outstanding, mind-blowing talk at ATTD 2016), Tidepool CEO Mr. Howard Look, and Glooko CEO Mr. Rick Altinger. We have not heard Dr. Zisser speak publicly since he joined Verily in April, and we’ll be keenly listening for even a shred of updates on the Sanofi/Verily joint venture (“Onduo”), the partnership with Dexcom (bandage-like CGM, with first gen on track to launch in 2018) and Novartis (glucose-sensing contact lens; no recent updates). Dr. Ebadollahi will hopefully share more on Sugar.IQ, Medtronic’s pattern recognition app with IBM Watson (commercial version demoed for the first time a few weeks ago). Mr. Look will then delve into the benefits of Tidepool’s open source platform that enables an ecosystem of diabetes apps and research. To round out the session, Mr. Altinger will talk about leveraging patient-generated data and decision support to deliver personalized recommendations. Glooko, fresh off a merger with Diasend, will hopefully have an update on its exciting insulin dose titration tools (see our ATTD 2016 coverage).
  • (9:45 am – 11:55 am) Session 2: Regulatory Initiatives in Diabetes Technology. We will hear “news” from FDA’s Dr. Courtney Lias on glucose monitoring regulation (presumably October’s final guidance for BGM accuracy and study requirements) and preliminary results from the DTS BGM surveillance program from Ms. Joan Lee Parkes. UCLA’s Ms. Sarah Blenner will touch on her JAMA letter about the privacy of diabetes apps. Three talks in this session will pertain to cybersecurity: Blackberry’s Mr. David Kleidermacher on DTSec (DTS cybersecurity standard published in May), J&J’s Mr. Colin Morgan on insulin pump cybersecurity (following Animas’ recent announcement that the Ping has a low-risk vulnerability), and an FDA perspective from Dr. Suzanne Schwartz. This issue continues to get lots of press attention, which presents a challenge: what are the unintended consequences of publicizing this issue, particularly if the absolute risk is low? There is a risk to everything, and as Mr. Radcliffe wrote, “Removing an insulin pump from a diabetic over this risk is similar to never taking an airplane because it might crash.” For those with malicious intent, there are easier ways than RF hacking to harm someone with diabetes wearing a pump. Still, cybersecurity is a must-have, particularly as Bluetooth connectivity becomes standard in pumps.
  • (12:50 pm – 1:55 pm) Session 3: Use of Mobile Apps to Increase Adherence. In an ideal world, apps improve care by closing the feedback loop – collecting data passively, giving patients feedback on their behaviors, and providing doctors with context. We’ll hear from Canary Health’s Dr. Adam Kaufman on digital diabetes self-management support (recently released six-month data from a trial type 2 diabetes), King’s College Dr. Pratik Choudhary on the European perspective, and a psychological perspective from Vanderbilt’s Dr. Shelagh Mulvaney.
  • (2:15 pm – 4:00 pm) Session 4: Artificial Pancreas – Recent Innovations in Algorithms. The star-studded cast in this session includes Drs. Moshe Phillip (Schneider Children’s Medical Center of Israel), Claudio Cobelli (University of Padova, Italy), Patrick Keith-Hynes (TypeZero Technologies, Charlottesville, VA), Mr. Nick Oliver (Imperial College, UK), and William Tamborlane (Yale School of Medicine, New Haven, CT). On the heels of the MiniMed 670G FDA approval last month, there are a slew of first-gen systems moving ahead (see our automated insulin delivery competitive landscape), but where do algorithms need to go? We will hear about more adaptive algorithms, combining two schools of thought into one algorithm (Medtronic/DREAM’s work on the 690G), TypeZero’s inControl algorithm (licensed by Tandem in July), multi-variable algorithms, and adding an “adaptive bolus calculator.” The session will wrap up with Dr. Tamborlane’s expert opinion on how to translate hybrid closed-loop technology into better care for type 1 diabetes patients. A few things are for sure: (i) clinicians need to know what to expect and how these systems will work; (ii) the paradigm of diabetes care may change once these systems are widely adopted (e.g., less focus on basal insulin titration); and (iii) managing patients’ expectations will be critical. We can’t wait to hear what Dr. Tamborlane has to say about using “hybrid closed loop” most effectively and managing the same issues that come up with CGM and insulin pumps (kinking, adhesive issues, infusion sets, etc.). We believe the overnight control offered by hybrid closed loop will be a gamechanger for the vast majority of patients, even those who are highly engaged (assuming alarms are not annoying are the user interface is well done).

Saturday, November 12

  • (8:00 am – 10:00 am) Session 5: New Drugs. Dr. Jessica Castle (Oregon Health and Science University, Portland, Oregon) will begin by presenting on glucagon. Glucagon is, of course, particularly relevant today as groups in Boston (Beta Bionics) and Montreal push toward dual hormone closed loop systems. The rest of the session will be on insulins, as Drs. David Kerr, Tim Heise, and Lutz Heinemann elaborate on optimizing basal insulin, novel rapid acting insulins, and biosimilar insulin, respectively. We’re particularly interested to hear about the rapid acting insulins – new developments in this department could shoot hopes for future 100% closed loop systems through the roof.
  • (10:20 am – 12:00 pm) Session 6: New Insulins and Delivery Systems. Former AADE Educator of the year Dr. Deborah Greenwood will moderate this powerhouse session, which will begin with Dr. Lutz Heinemann’s talk on infusion set advances. The highly regarded Dr. John Pickup (King’s College, London, UK) will then delve into the land of patch pumps, where Insulet is currently the leader, but many other companies are trying to scale (Cellnovo, Kaleido) or bring something to market (Roche). We’re also excited to hear from young OpenAPS user Ms. Rachel Sandlain – the DIY automated insulin delivery system has received increasing airtime at conferences, and most recently, substantially reduced the form factor burden with the iOS app Loop (see picture below; it now requires just one additional device (a RileyLink) that turns Medtronic pump RF into Bluetooth; the G5 data goes straight into the app from the transmitter). We’ll be interested to hear what Dr. Heinemann discusses on the infusion set front, where the competitive pressure has risen now that BD/Medtronic just began a limited launch of MiniMed Pro-set with FlowSmart technology (including a new Quik-serter). Medtronic has five other infusion set projects slated to launch over the next three years, included an extended wear set and two different combo CGM-insulin delivery sets. 

  • (1:00 pm – 2:35 pm) Session 7: New Developments in Needle Sensor CGMs. Abbott, Dexcom, Medtronic, and Roche will all show their latest and greatest in a session that has become a highlight of DTM. Abbott’s Scott Harper will share new FreeStyle Libre data, though we’re not sure from what study (the recently completed accuracy study in pregnant women?). Libre has of course taken flight in the EU, where there are over 200,000 users as of the 3Q16 earnings call. Dexcom’s Peter Simpson will talk about “pushing the boundaries in CGM performance,” perhaps related to the 10-day wear G6 sensor (one calibration per day after startup; pivotal starting ASAP as of 2Q16). Meanwhile, Medtronic’s Mr. Brian Kannard will talk about new developments in sensor technology (see its packed CGM pipeline as of the June Analyst Meeting), and Roche’s Dr. Guenther Schmelzeisen-Redeker will provide new data on the Accu-Chek Insight CGM system. Preliminary data from the ongoing Roche pivotal trial presented at EASD (n=36 patients) suggested an MARD of 10.5% over seven-day wear. Arkray’s Mr. Shinjiro Sekimoto also returns this year to provide accuracy data on his company’s novel CGM with direct electron transfer technology. Arkray emerged on the scene at DTM 2014 and we heard more details last year at DTM 2015; we’re still not sure how far this is from market.
  • (2:55 pm – 4:20 pm) Session 8: Social Media. Who better to give talks about social media than experts Dr. Joyce Lee (University of Michigan, Ann Arbor, MI) and DiabetesMine founder Ms. Amy Tenderich? Dr. Lee has a long history with the Nightscout community and will reference this to speak about DIY innovation, including a compelling survey shared last fall and a subsequent April publication in JAMA. Ms. Tenderich will then discuss how social media affects adoption and use of technology; we wonder what takeaways she’ll leave for industry. A positive online sentiment from influencers clearly gives a new product tailwind, though it is not all that matters (e.g., Afrezza) – how should companies engage on this front? How should they develop products, leveraging lead users (e.g., Nightscout, OpenAPS), but designing for the masses? Abbott’s FreeStyle Libre has arguably done the best job of navigating the online community in recent memory – EU bloggers helped drive early adoption of the product. Last but not least, Sansum’s Dr. David Kerr will talk about the “Diabetes Village” and why people with diabetes need to be heard.
  • (4:30 pm – 4:50 pm) Session 9: Live Demonstration. Continuing with the tradition of DTM closing with live product demonstrations, the meeting will be capped off by a demo of Neurometrix’s Quell. The well-designed pain relief product has seen very encouraging uptake to date, driving 65% YOY growth in 3Q16. Perhaps the demo will bring an early look at the company’s upcoming pipeline – a new product could launch at CES in January.

-- by Brian Levine, Adam Brown, and Kelly Close