As their famous rallying cry states, the patients behind the Nightscout project for creating a do-it-yourself mobile technology for diabetes management are not waiting for approval from the FDA. But that doesn't mean they aren't seeking it, or that they haven't been in contact with the regulatory organization to make sure Nightscout is as safe as it can be.
In a new editorial published in the Journal of the American Medical Association, Dr. Joyce Lee and Emily Hirschfield of the University of Michigan, as well as Nightscout Foundation President James Wedding, wrote about some of the triumphs and challenges the now-two-year-old patient-led initiative has faced.
"The Nightscout Project is an example of a patient-designed, technology-driven collaborative health innovation. However a number of important legal, regulatory, and cultural challenges must be addressed by patients, caregivers, and the health care ecosystem," the authors wrote.
In the JAMA piece, authors share that the Nightscout Facebook group, where software and instructions for building a mobile CGM interface were made available, grew from 40 members to more than 15,000 members in 18 months. In the face of the rapid growth, and the fact that said growth didn't slow down even when companies like Dexcom began offering official, FDA-cleared alternatives, Nightscout leaders decided to meet with the FDA to discuss their patient safety responsibilities.
"The FDA emphasized the need for a single entity, even if the entity is nontraditional, to be responsible for ensuring the safety and effectiveness of the project, which includes the reviewing and testing of code before public release, monitoring safety, detailing how quickly problems are identified and addressed in the system, tracking the code updates, and identifying the responsible party for these updates," the editorial explains. "The group has embarked on this process, but to date, there is no systematic measurement or monitoring of these events inside the community except for the unstructured information being shared by the Facebook group."
In addition to safety concerns, there are liability concerns, as no single person is responsible for the collaboratively-created code and there's no obvious recourse for any one endangered by it. And questions have arisen about whether the Nightscout project and projects like it should escape FDA regulation simply because they are given away for free rather than sold.
"The Nightscout community leadership has engaged with the FDA on a regular basis with the hope of receiving approval for Nightscout for monitoring purposes, which would reflect an important milestone for patient-driven design," the editorial concludes. "In addition, a collaborative approach to patient-driven research is being explored jointly by the community with researchers. As the Nightscout Project continues to develop and unfold, the questions it raises should lead to greater opportunities for patients and their families to help drive innovation in the health care delivery system."