Until recently, evidence on the safety and effectiveness of these systems has been lacking, as has evidence on the lived experiences of people using open-source artificial pancreases.
To address this gap, an international team of interdisciplinary researchers co-founded the OPEN project in 2019, with the aim of examining the experienced outcomes of the users of open-source AID, and the implications for more widespread use among people with diabetes.
They found significant improvements across all participants in self reported clinical outcomes regardless of age and gender. The most significant transformation was in relation to quality of life. There was almost universal consensus among participants that these systems were life changing and brought with them improvements in sleep quality that had previously been unimaginable. As highlighted by a parent of a 12-year old boy from the UK, 3 years old at diagnosis, using the ‘Loop’ system: “If I could give my pancreas to my son, I would. This is the next best available option.” However, participants also highlighted the multiple challenges of building such systems, with sourcing the necessary components, lack of confidence in one's own technology knowledge and skills, perceived time and energy required to build a system as well as fear of losing healthcare provider support highlighted as major barriers towards uptake. The support of the wider diabetes community was seen as key overcoming some of these barriers.
In 2020, OPEN teamed up with 48 medical experts and 4 legal experts across 25 countries to create a consensus statement on the safe and ethical use of open-source AID systems, which currently has no regulatory approval in clinical practice. The consensus statement, which has been endorsed by several international professional diabetes organisations—including the International Diabetes Federation and International Society for Pediatric and Adolescent Diabetes—is published in the Lancet Diabetes & Endocrinology. This is the first time that international guidance on open source AID has been provided to healthcare professionals. These guidelines will be particularly important in providing both education and reassurance to healthcare providers who are increasingly encountering open-source AID in their clinical practice. It is anticipated that this, alongside other localised guidance, can support policy makers in dealing with the legal and regulatory dilemmas that open-source innovation presents to formal healthcare systems, now and in the future.
