Patient finds open-source diabetes app improves control despite lack of FDA approval

Patient has type 1 diabetes for over 30 years and has used FDA-approved pumps and sensors that were upgraded roughly every five years. Over time his glucose control slipped despite the regulated devices.

His doctor suggested trying an open-source software platform that links the sensor to the insulin pump. The community-written code adjusts insulin delivery more precisely than the commercial apps, allowing him to meet clinical guidelines and feel much better. The program is free and runs on his iPhone.

He acknowledges the gamble of using software outside FDA oversight. The agency treats medical software as a device to ensure safety, but the approval process is expensive and slow, leaving innovative tools unregulated.