In a recent editorial in the Journal of the American Medical Association, members of the NightScout project described their experience as a group of patients & caregivers who built a diabetes app & remote monitoring platform for implantable continuous glucose monitors (CGM).
For those not familiar with the NightScout project, it started out with a parent who wanted to remotely monitor their the data from their diabetic child’s CGM. The parent basically wrote software that would enable remote viewing of the CGM data on his smartphone.
After sharing his own success on social media, other diabetic patients and their loved ones began collaborating with him. They made the code open-source, published detailed instructions online, and even developed software to display CGM data on the Apple Watch. Years later, Dexcomm and Medtronic caught up with apps to let patients view their CGM data on their smartphones or smartwatches.
In a recent JAMA editorial, members of the NightScout Foundation and their collaborators described both the genesis of their work and their experience navigating complex issues of patient safety as well as government regulations.
As they note, getting set up to use Nightscout’s app to monitor CGM data isn’t a trivial task – its a complicated process with a lot of potential points for error. To help, the Nightscout community set up a Facebook group, which has no grown to more than 15,000 members in the US, that offers technical assistance and even in-person install sessions.
In 2014, they contacted the FDA to discuss some of these issues and, among the several issues they discuss in the editorial, two were particularly interesting.
The first is the regulatory and safety issues around Nightscout’s work. As they note, most of the early adopters were computer scientists, engineers, and others with a deep technical skill set. As they’ve grown, that its increasingly being adopted by people who don’t necessarily have the same depth of knowledge. Apparently since the software is not being sold, it wouldn’t fall under the FDA’s Mobile Medical Application guidance.
Nonetheless, the FDA emphasized the importance of having single entity overseeing software developing, vetting updates, and tracking safety issues as well as their resolution. And while the Nightscout Foundation does some of that, there isn’t yet a mechanism to track safety issues with the software beyond the Facebook group.
The second is liability for errors. As open source software with contributions from many volunteer contributors, its not clear whether Nightscout’s many developers would potentially be liable if someone were to be harmed through this software. Its not even clear who actually owns the code or if anyone does.
The Nightscout project is pioneering uncharted territory, where a group of well-intentioned people (rather than a billon dollar pharmaceutical of device company) have built something to benefit a community of patients. In addition to advancing the tools available for diabetic patients, their experience could help guide others interested in tackling any number of challenges in medicine.