Open-source diabetes app developer Nightscout detailed their development process, including crowdsourcing and their talks with the FDA in a new editorial from the Journal of the American Medical Association.
In the article, NightScout foundation prez James Wedding and Dr. Joyce Lee and Emily Hirschfield from the University of Michigan discuss the patient-led initiative during its 2-years in development.
NightScout is an open-source software program that hacks into a Dexcom Inc. (NSDQ:DXCM) monitor and uploads its data to the internet. The information can then be relayed to smart phones and devices, allowing diabetic patients to monitor their blood sugar levels wherever they are.
In the JAMA article, the authors detail the growth from a 40-member Facebook group to a whopping 15,000 members after 18 months, seeing continued growth despite larger CGM companies coming forward to offer official, FDA-approved alternatives, as well as their interactions with the FDA.
“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 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,” Authors write in the editorial.
Despite being open-sourced and crowd-developed, liability and safety concerns loom – but no one group or person can be held responsible for the collaborative project. Questions around this topic were discussed between leaders of the project and the FDA, the editorial authors wrote.
“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. 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,” authors concluded.