The DiabetesMine Innovation Summit: Delivering on the Promise of Diabetes Technology
By Nancy Liu, Adam Brown, and Kelly Close
Twitter summary: Lots of learning from #dbminesummit on using tech to improve lives of people with #diabetes, great talk from FDA, +more!
This year’s DiabetesMine Innovation Summit took place in November at the Stanford School of Medicine. The summit called on all attendees to focus on “Delivering on the Promise of Diabetes Technology,” an area certainly ripe for discussion! Participants discussed the hefty challenges of creating “life-friendly” medical devices, understanding the impact of technology, and increasing access for patients.
New Apps to Deal with Diabetes Data
On the theme of leveraging technology and data, we saw some very exciting new developments at Tidepool, a non-profit in the Bay Area. The organization’s goal is to create open-source diabetes management apps, all built on the same underlying software platform. The hope is to use the information from open source development – think Wikipedia! – to build better technology for people with diabetes. Tidepool’s CEO Howard Look (a parent of a child with type 1 and a very smart new leader in the field) discussed two apps in development: blip and Nutshell.
blip is a web-based program intended to be a “hub for diabetes data.” The application will take data from many devices (meters, CGMs, pumps, and even activity monitors) and aggregate in one dynamic, sleek online interface (see example pictures here). The platform’s integration goals are quite ambitious – “imagine seeing data from a Medtronic pump and a Dexcom CGM together, in one place.” Historically, that has not been possible without a lot of extra work. Healthcare providers, family members, and anyone else will be able to use the blip to communicate and annotate logged events. Mr. Look showcased the app – while his daughter experienced a low blood sugar, he logged the event details on blip. His wife soon commented (she was out of the house), helping troubleshoot and uncovering the cause of the low (over-bolusing and taking the dog for a walk). His daughter’s healthcare provider even checked in and asked if everything was okay. We were impressed with the interface and the seamless communication it enabled. blip is being tested at the University of California, San Francisco and Tidepool is in talks with the FDA. If you would like to learn more and sign up for a pilot study, click here.
Meanwhile, Tidepool’s Mr. Brandon Arbiter discussed Nutshell, spurred by the blousing challenges of tricky restaurant meals (and not getting it right much of the time). Mr. Arbiter realized that he often goes to the same restaurants, typically ordering the same meals. With the Nutshell mobile app, patients/caregivers would “check in” to their favorite restaurants and log the meal they ate, insulin info, and blood glucose values. (Tidepool is working to make this as easy as possible.) Upon returning to the same venue, patients/caregivers would use the app to look back, assess their previous performance, and dose better for the same meal (what Tidepool calls “situational recall”). It’s a simple use of data, but one that is very powerful and could help patients improve their mealtime dosing. Nutshell now exists in “proof of concept” form and Tidepool is gearing up to release a “minimum viable product.” More details are here.
Notably, both blip and Nutshell are built on Tidepool’s open-source and open-data platform, which can be used on different devices and is freely available to patients, parents, doctors, and researchers. You can view screenshots of the apps as well as Mr. Look’s full presentation at here.
What Patients Want
The summit also featured winners of DiabetesMine’s Patient Voices contest, which called on patient advocates to create short videos about the current state of diabetes technology and what they consider to be the biggest unmet needs. Patients shared their views on how to create better human-centered design for diabetes technology, reduce the mental burden on device users, and access more shareable, integrated, and actionable data. The nine-minute 2013 Patient Voices Contest video is on YouTube (highly recommended) and you can learn more about the contest on the DiabetesMine website. If you have ideas, make sure to enter the 2014 Patient Voices contest! Some of the most interesting winners included:
Simon Carter: Creator of a new blood glucose prediction system called ManageBGL.com.
Melissa Lee: Presented an idea for an “Insu-litmus” test to help gauge whether insulin is still effective.
Kyle McClain: Creator of Gludi, a logging app designed to be “breathtakingly simple.”
Scott Strange: Discussed the need to emphasize the mental and emotional side of diabetes
We also saw the results of the Patient Voices Survey at the summit, where nearly 800 diabetes patients contributed their opinions on current and future diabetes technology. One of the most notable results we saw were how participants ranked the most important quality of life improvements as having fewer glucose highs and lows, feeling in control of their care, and reducing the daily hassle of devices. Hear hear! You can view the full results of the survey here.
An Update from the FDA
Dr. Courtney Lias, Director for the Division of Chemistry and Toxicology Devices at the FDA, delivered a great keynote address that gave us hope that the FDA will be more attuned to the needs of patients in the future – this was by far one of the best speeches we’ve ever heard from the FDA. Her talk clearly recognized the ongoing issues that people with diabetes face, including, “long term health risks due to glycemic variability” and “quality of life challenges.” This was encouraging, since the agency has historically placed a major focus on A1c above all other measures.
Dr. Lias also acknowledged that patients are unhappy with the accuracy of blood glucose meters, which the FDA is unhappy about too. With this in mind, it was great to see the FDA recently published recommendations (“guidance”) that will tighten blood glucose meter accuracy – look to our next issue for more details on the guidance. Though the requirements are still in draft form, the accuracy bar to get a meter approved will eventually get much higher, particularly in the hypoglycemia range (meter values will need to be within 15% of the true reference value).
Her discussion of blood glucose meters addressed post-approval safety as well – Dr. Lias noted that the FDA device division receives more adverse event reports for blood glucose meters than for any other device. Though surprising at first, this is due to the large number of people who use meters and the dangerous dosing errors related to insulin. That said, we were happy to hear her specifically mention the Diabetes Technology Society’s new blood glucose meter surveillance program, which would monitor the quality and accuracy of strips/meters following FDA approval. Though this program is in the early stages, Dr. Lias seemed optimistic. For more information, please read our update from the Diabetes Technology Society’s September 9 Meeting.
Her presentation followed with a great Q&A:
Q: CMS has started competitive bidding for glucose strips. How do you work with CMS to see if making this decision is a good idea? Won’t it drive good players out of the marketplace?
A: We’re starting to talk to CMS on that issue. Larger companies are concerned in the area of glucose test strips – that the policy will drive people to the off-brand meters. From their point-of-view, off-brand meters are not as high quality. One thing that spurred on the proposal for the surveillance program is that industry wants something that will prove that strips on the market are as safe as when they were cleared. What’s happening a lot is companies are sending data to get their meters cleared, but they’re good lots. Then, they are modifying the manufacturing processes to cut corners. It’s difficult for us to inspect factories in China. We have engaged CMS on this issue. At this point in time, CMS says that if a device is cleared by the FDA, it should be okay. That’s still ongoing, and we’ll see how that turns out. The surveillance program is another way to say these devices don’t meet the standards. We’ll have to talk more.
Q: My nine-year-old is dreaming of the Animas Vibe. How come Europe has all the devices? How is their process different?
A: We cannot clear or approve a device that is not sent to us. Often, companies haven’t done the clinical studies. Often, companies are putting devices on the market in Europe while gathering the data for safety and effectiveness. A lot of times they haven’t sent the data to us.
Q: What are your thoughts on endpoints in trials such as “time in zone”? A1c is necessary but not sufficient…
A: In our final artificial pancreas guidance, we emphasized flexibility. We try to tie an endpoint for what makes sense to what’s going on. A1c as a safety endpoint is easy to measure. But we are not tied to A1c being the only endpoint for effectiveness. If someone had a lot of glycemic variability, spent less time under 70, or had more time in range, we can all agree there is some benefit to that. We try to work with investigators and companies to make sure that the endpoint makes sense.
Heated Discussions between Payers and Patients
One of the main challenges that the summit identified was the conflicted technology agenda among patients, industry, and payers. We were pleased to see a diverse gathering of patient advocates, industry representatives, and an impressive payer panel that included representatives from Aetna, Capital Blue Cross, Kaiser Permanente, Humana, and the State of Arkansas to speak about innovation.
During a heated discussion, many patient advocates vented their frustrations with restrictive insurance coverage, puzzling reimbursement policies, and bureaucratic interactions with insurers. The conversation reached a climax when one patient expressed how “[payers] don’t give a **** about me!” Patient advocate Kelly Close emphasized that companies operate in a competitive environment with extremely low profit margins. Unfortunately, it can be a challenge for payers to cover more expensive technologies that have a longer payback period, especially when patients can switch insurance every few years. We salute the DiabetesMine Summit for bringing payers into the room, since they are often absent from the discussion. We hope that the lines remain open so that patients and payers can work together to address gaps in diabetes care coverage.