User-driven open-source artificial pancreas systems and patient-reported outcomes: A missed opportunity?

Aim: This paper aims to highlight the attributes of engagement and urgency to act to control diabetes demonstrated by open-source artificial pancreas system users with the view that increased user involvement in research and practice can capitalize on these self-management traits; and to outline the challenges of researching outcomes in the context of unlicensed therapies. Methods: A group of technically minded people with type 1 diabetes have reverse-engineered commercially available diabetes devices to help them achieve the diabetes outcomes they desire. Although studies have reported improved biomedical outcomes with these artificial pancreas systems, there are only a few studies examining patient-reported outcomes. Results: The investigation of patient-reported outcomes for open-source artificial pancreas system users has been hampered by the rapid advances in the technology, the lack of randomized controlled trials and the ethical challenges of researching unregulated technologies. There is an on-going debate about the most appropriate types of measures to evaluate patient-related outcomes. Conclusions: The early adopters of open-source artificial pancreas systems exhibit many of the characteristics that predict optimal diabetes outcomes through engagement and urgency regarding self-management. These qualities should be harnessed to improve research in this and other areas of diabetes management.