Nayna Aggarwal interviews Sheela Hedge on her experience moderating the DiabetesMine™ D-Data Exchange Industry Forum Panel at this year’s American Diabetes Association (ADA) conference.
Nayna: Sheela, thank you for joining today. We’re excited to hear about the panel that you moderated at the ADA conference recently.
Sheela: It was a panel that was organized by DiabetesMine, a very active blog in the type 1 diabetes space. Amy Tenderich, who authors the blog, is a proponent of open data sharing. This panel was an opportunity to bring together the companies that are shaping the future of data sharing in the diabetes space. The panel included executives from Animas, Medtronic, Dexcom, Insulet, Roche, and Tandem. It was a very productive dialog.
Nayna: We’d love to hear a little bit about some of the issues around data sharing from both the patient perspective and the provider perspective.
Sheela: A big conundrum in diabetes, especially if you are a diabetes patient on insulin pump therapy, is that you need to manage several devices. You’ve got an insulin pump. You’ve got a continuous glucose meter. You’ve got a blood glucose meter. And none of those devices interface or interact with each other.
The patient and the healthcare provider are faced with the daunting challenge of getting data out of those devices and piecing those data together in order to make effective treatment decisions. That’s the crux of the problem.
In this field, patients have been the biggest advocates, pushing companies to work together to make devices talk to each other and to create data aggregation and visualization tools that can streamline care management.
Nayna: Are you seeing excitement from care providers around being able to access the data, or are there challenges there as well?
Sheela: It’s a good question, because we all think it would be great to have more data and give physicians more data to help with treatment decision making. But actually, physicians only have so much time and ability to pay attention to data. The last thing they want is data overload.
What physicians would welcome are smart and streamlined ways of sharing the most important data in order to make a fast decision in a 10‑minute visit with a patient. Physicians do welcome decision support tools; what they don’t welcome is just mounds of data without any type of analytics or aggregation.
Nayna: As companies look to develop platforms or applications to enable this data sharing, there is more and more talk about open source platforms. What is your view on those platforms?
Sheela: I think there is an “open source movement.” This has been driven by the patient community. What we have seen are type 1 patients who are savvy with programming hacking devices, taking data out, and creating open source platforms.
It’s good on one hand, because this action has really pushed companies to start investing in partnerships to share data.
On the flip side, when you’re in an open source environment, who ultimately is accountable? If there’s some data that is critical to a treatment decision, but for whatever reason, the technology fails, the data is erroneous and the patient makes a bad decision, who does the patient call? Who’s going to fix that problem?
In the healthcare field, you want to make sure that no harm is done to patients. You want to make sure safeguards are in place, and ultimately you want to make sure there’s accountability. Companies at this panel said that they would support open sourcing if there were clear guidelines and accountable sources.
Nayna: Are there certain companies that come to mind as you think about open data sharing that are at the forefront of that effort?
Sheela: Dexcom. A lot of the movement around open source actually has been propelled by the CGM data that Dexcom provides. It’s immensely valuable data, and they’ve got the most accurate sensor out there.
Night Scout is an application based on Dexcom CGM data where parents or caregivers can look at their loved ones’ CGM data on the cloud through a web or smartphone portal. It’s a very important example that allows better management of people who have T1D.
Nayna: What’s the FDA’s role in data sharing? Have they taken a position on this particular topic?
Sheela: Absolutely. Companies have been working with FDA over the last several years to get more guidance in this area, which has been gray area for a long time. The FDA published guidelines around mobile health applications late last year and earlier this year.
These guidelines provide more clarity by distinguishing different categories of mobile health solutions. There’s a low risk category, and then there are other data applications that might result in an action, such as control of a pump. Those are high‑risk, so they fall in another bucket. Then there’s a category in‑between that falls under “enforcement discretion.”
Just by delineating these categories and providing less rigorous regulatory requirements in those applications that are low‑risk, FDA has given some freedom back to companies – helping them expedite decision making and move forward with software applications that were previously held up.
One panelist commented that getting more clarity around this middle “enforcement discretion” category will be important for the industry as more cases come to bear.
Nayna: Were there questions around how the FDA determined or defined high‑risk versus low‑risk? Was that a collaborative effort with industry?
Sheela: It absolutely was. Many of the companies on this panel worked with the FDA, including Roche and J&J. The companies have been at the table during all of these decisions and pushing for this.
There were several comments from panelists and the audience that FDA has actually been extraordinarily fast. This is one area where we absolutely would commend the FDA for how quickly they’ve responded to industry and patient concerns.
Nayna: It sounds like a great step forward. Any last thoughts on the panel that you think we should discuss?
Sheela: It was a great forum this year because we had panelists representing industry and an audience made up of patients and advocates and even hackers who have been really responsible for getting these companies’ attention. It was actually a very productive dialog between those two groups. Some of the panelists admitted that they were moving too slow and they actually thanked the patients and the advocates for bringing these issues to their attention.
Companies do have to think about regulatory issues and safety, they reminded the audience, but there has been a lot of advances in their thinking, there’s been more guidance from FDA, so in the future everyone’s bullish in terms of how much more innovation we’ll see in data visualization, data aggregation, and data analytics. There are more and more partnerships occurring, even within the panel itself. Insulet has partnered with Tidepool and Glooko, which are two third‑party data visualization solutions. Medtronic announced that they’re starting their first partnership ever in the space. To date they’ve always been insular, focused just on their proprietary CareLink system. They announced at ADA that they are partnering with Glooko. I actually think it’s a very exciting time for this space and we’re looking forward to seeing what the next few years bring.
Opinions expressed here are solely those of the authors and do not reflect the views of Health Advances LLC, its management, or affiliates