News from ATTD 2019


#1

Dr. Lutz Heinemann on Diabetes Tech in 2025: Lower Cost CGM (<$2-$3/day), More CGM in Type 2, Telemedicine, Decision Support; ~3,000 Patients on DIY AID Systems Globally

Science Consulting Neuss CEO Dr. Lutz Heinemann kicked off ATTD 2019 in fantastic fashion, headlined by his predictions for diabetes tech in 2025:

  • For type 1, he anticipates: (i) the availability of cheap and reliable CGM with an <8% MARD and ~<$3/day; (ii) “affordable” AID systems at ~$11/day; (iii) “doc on demand” providers via telemedicine as part of patients’ standard care; and (iv) most therapeutic aspects of care facilitated by data download to the cloud and clinical decision support systems (CDSS). No surprises there, though we’d be interested to know the assumptions behind AID at $11 per day (~$330 per month, ~$4,000 per year) – if that estimate includes CGM and insulin, it’s a massive step down in costs relative to current systems.
  • For type 2, Dr. Heinemann expects: (i) SMBG to be widely replaced by CGM with <10% MARD and ~<$2/day (implying a different lower-cost, slightly less accurate product than for type 1); (ii) increasing uptake of once- weekly basal insulins; and (iii) wide use of CDSS (clinical decision support systems – we’re trying to help everyone get used to this new-ish abbreviation).
  • Supporting these claims, Dr. Heinemann gave several take-home trends:
    • Declining numbers of endocrinologists and diabetologists are at odds with the rising diabetes epidemic, necessitating the transfer of responsibility to machines and algorithms. 80% of diabetes-related procedures are routine tasks, which clinical decision support systems could primarily undertake, allowing physicians to add their own recommendations informed by their relationships with patients and patient circumstances. Notably, algorithms could also be used to detect the ~one-fifth of patients that require direct and fuller attention of a physician. As Dr. Heinemann pointed out, these algorithms aren’t necessarily intended to enable the treatment of more patients within the same period of time, but rather to empower providers with more time to talk to each patient. Given the trends in numbers of providers, this is still a concern – who is going to take care of everyone with diabetes?
    • While better devices have pushed major success in the ~$2.9 billion CGM market , Dr. Heinemann characterizes current CGM systems as still “miles off from ideal.” To this end, he labelled cost, sensor wear time, pain, and skin reactions as major areas of improvement, as well as the establishment of an accuracy standard such as that seen already with SMBG systems. (iCGM is sort of the de facto accuracy standard now, as we assume all companies will move to that over time given the regulatory and speed advantages. We also think that due to arrows, accuracy overall is less important to some patients.) Looking to the future, Dr. Heinemann was particularly excited about the Dexcom and Verily “G7,” slated to launch in late 2020, followed by a full rollout in 2021 (per JPM). However, he was skeptical that the project will stick to this timeline to launch it next year (he did not mention the broader rollout in 2021). At JPM, CEO Mr. Kevin Sayer shared that Dexcom expects to “finalize” G7 this year and provide “very clear timing” on the plan. With the amended Verily collaboration agreement and consistency between 3Q18 and the Investor Day, we think things are feeling clearer on this next major pipeline launch. Dexcom often gets products approved faster than expected, though given the massive organizational disruption for G6, there is a lot to get ready for G7.
  • Dr. Heinemann asserted that ~3,000 people globally are currently using DIY insulin systems (Loop, OpenAPS, or Android APS). We’ve previously heard an estimate of ~2,000 Loop users, and this sounds in the ballpark taking into account all three systems. It also shows the great desire for more advanced and personalized AID; as Dr. Heinemann put it, “people with diabetes won’t wait for innovation.” That said, the DIY movement has also started to make regulatory waves, with Tidepool and Jaeb beginning an observational, virtual study of Loop last month to support FDA submission. (Adam is in this study and just mailed back the A1c kit – very cool!)
  • Dr. Heinemann also pointed to the environmental waste associated with diabetes products , showing a full trash bag from diabetes product waste accumulated in just two weeks. To this end, he highlighted that each Dexcom G6 inserter creates 80 g of plastic waste and each Abbott FreeStyle Libre sensor 71 g. For the latter, this equates to over 1 billion pounds of plastic created each year (!) – assuming 1.3 million users inserting two sensors per month. Further data from Dr. Heinemann on this topic are currently under review for the Journal of Diabetes Science and Technology .

  • What about exciting therapy innovation? Dr. Heinemann specifically pointed to glucose-responsive, or smart, insulin (GRI) – while he doesn’t believe a product will reach the market soon, he does anticipate that GRI may pose a threat to diabetes technologies such as a fully closed-loop. We think the prospects of GRI are a bit long-term (10+ years out) to make a judgment call at this point. After the first-ever clinical candidate was discontinued by Merck due to inadequate phase 1 results, GRI has experienced somewhat of a renaissance with investment from JDRF and Novo NordiskSanofi has also made some major investments. Still, development of an effective GRI does comes with wide-ranging technical challenges that are currently unsolved, as was highlighted in a 2016 JDRF/Helmsley Charitable Trust gathering on smart insulin. Perhaps most importantly, a molecule must be programmed sensitively toward a narrow and physiologically appropriate glucose range, which is no small feat; cost and insulin receptor kinetics are also key. We’d bet on no technology emerging for at least the next decade.
  • Digitalization will continue to change our world dramatically. According to Rock Health, investment in digital health surpassed $8 billion in 2018, and with major companies such as Google and Apple beginning to venture even further, diabetes technology is ripe for disruption (as it has been for many years). For these companies, according to Dr. Heinemann, digital health is a market of the future.

– by Adam Brown, Ann Carracher, Brian Levine, Payal Marathe, Peter Rentzepis, Maeve Serino, and Kelly Close


#2

LifeScan Symposium: Physician Focus Groups on Future of SMBG; Bastian Hauck Delivers a Patient’s Perspective on SMBG; Prof. Barnard’s Sage Advice for Manufacturers

In a LifeScan-sponsored symposium, UCSD’s Dr. Steve Edelman, Prof. Katharine Barnard, and dedoc’s Mr. Bastian Hauck overviewed the future of BGM: In short, it’s not going anywhere for most patients, and the future of fingersticks has to be based in consumer-centric design, seamless connectivity, and decision support. (That sounds a lot like CGM!)

  • Dr. Edelman kicked off the presentations with a summary of findings from TCOYD-, CWD-, and ISPAD-sponsored focus groups that took part at ATTD and ADA 2018; participating clinicians (many with diabetes) were asked to ruminate on the future role of SMBG. Dr. Edelman hopes to publish these findings soon. Unsurprisingly, the clinicians expect that BGM will remain in high demand for individuals who can’t access CGM in the US, many type 2s who won’t need to rely on CGM 24/7, as well as the majority of the world – particularly countries like China and India – for many years to come. When asked what type of evidence they’d look for to justify the usage and reimbursement of connected BGM, respondents underscored a desire for real-world, pragmatic data, changes in patient behaviors/attitudes, as well as a slew of clinical/economic outcomes (A1c improvements reductions in hypoglycemia and/or ER visits/hospitalizations, and improvements in time-in-range).The clinicians emphasized a need for decision support tools, structured testing vs. “worthless testing,” highly usable technology for patients and healthcare providers, as well as adding minimal burden in terms of healthcare team time and staff. On this last point, Dr. Edelman commented, “A big mistake a lot of companies make is assuming physicians have a lot of time to learn new things.” Provider have less time than ever – alongside rising burnout – and the big hope is for clinical decision support tools to simplify visits. Alongside that is remote/virtual care “clinics” and coaches, which might be able to fill the gaps.
  • Mr. Hauck, speaking only from notes and without slides, rattled off a list of desires for BGM in the era of CGM.
    • “Make blood glucose meters sexy. I want one I really like to carry around… . If you were producing cellphones the way you produce BGMs right now, everyone in here would be out of business, because I wouldn’t buy it…design matters.” At the outset of his talk, he recalled a 2012 talk in which he warned manufacturers in attendance, “If you don’t watch out, if you don’t design your next BGM with consumers in mind, my next BGM will be my iPhone.”
    • “For me it’s really about open data; data that goes flawlessly, fluently, seamlessly from users to payers, to providers, and back. From hardware, software, to the cloud and back … I have an appointment with my diabetologist every three months here. That’s not because I need to see her every three months – maybe I do in two months, or not for next six months. I only go to get insulin. It’d be much smarter to have a pattern recognition algorithm that calls me when an algorithm detects something is not quite right with my blood glucoses.”
    • He wondered why we don’t have automatic bolus calculators for MDI, whereas we do for pumps. Of course, Companion Medical’s InPen is available in the US and CE marked, with a planned 2019 launch, but only ~2,000 people are using InPen in the US. It’s still early days for MDI dose capture, though Lilly’s and Novo Nordisk’s entries in the near-term could change that in a hurry.
    • “EHR; I don’t understand why it’s not working. All of this data should be in the EHR, along with all kinds of other data.”
    • “The interface of tomorrow will not be an app, something you click on, look at and push buttons . It’ll be something between cloud and messenger, Siri and Alexa…maybe a reminder on the fridge, on the TV when I sit down to watch a movie, or maybe on my alarm clock if it’s something I need to do when going to bed. The great thing about open data is it’s kind of everywhere. The idea of a ‘Homespital’ – a mix of being in the home and in hospital all the time, 24/7. That’s the perfect integrated solution for diabetes management.”
    • “I don’t see why we couldn’t do something like trends/curves/alarms/reminders in something as simple as BGM. It won’t be as good as CGM, but it could be better than what we have now.”
  • Prof. Barnard reiterated many of Dr. Edelman and Mr. Hauck’s points, and added a few particularly poignant musings. For one, she noted the absurdity in the fact that when we have a new tool that promises to reduce burden for patients, “we make them jump through all kinds of hoops to get it…it’s a bit weird. We shouldn’t be making people jump through hoops to take care of their healthcare needs.” Prof. Barnard also advised manufacturers that “one size fits nobody very well, but a single device with a broad range of functionality fits many, many people.” (FreeStyle Libre is probably the best recent example of the latter.)
  • Head of Portfolio Strategy Mr. David DeJonghe and Clinical Affairs Director Dr. Mike Grady doubled down on their presentations from the EASD symposium , highlighting the CE-marked One Touch Verio Reflect (with the Blood Sugar Mentor; launched in France and Germany) and recent data supporting One Touch strip accuracy and outcomes data. To his talk, Mr. DeJonghe added that the One Touch Reveal app is approaching two million downloads. The Mentor meter’s messages are basic pattern recognition, but they are far better than most people get (since most don’t download or look at data). For example, if the meter finds that a user has been high each of the last four days in the evening, it will notify her and her healthcare provider, and ask her if anything has changed (i.e., eating high-carb lunches, eating late lunches, large/unnecessary mid-afternoon snacks, less activity than before, etc.). If it detects hyperglycemia, it might suggest a walk, and if it detects a low or near-low, it will recommend juice and offer to set a reminder to re-check blood glucose in 15 minutes.
  • According to Dr. Grady, LifeScan makes five billion strips per year – ~33% of the world’s annual production!

– by Adam Brown, Ann Carracher, Brian Levine, Payal Marathe, Peter Rentzepis, Maeve Serino, and Kelly Close