Digital innovations in healthcare up until recently have typically followed a ‘top-down’ pathway, with device manufacturers leading the design and production of technology-enabled solutions and patients involved only as users of the end-product. However, this is now being disrupted by the increasing influence and popularity of more ‘bottom-up’ and patient-led open source initiatives. A leading example is the growing movement of people with diabetes who create their own “Do-it-Yourself Artificial Pancreas Systems (“DIY APS”) through remote-control of medical devices with an open source algorithm. The DIY APS community has created a safety-focused reference algorithm and an implementation of a hybrid closed loop system. Based on the prediction of glucose levels, the system constantly and automatically adjusts basal insulin levels, in order to keep glucose levels inside a safe range night and day.
DIY AP systems are not CE-marked or FDA-approved systems or devices. They are not been manufactured or sold anywhere in the world. However, the algorithm and source code are made open source and are publicly available.