From Patient Initiative to Scientific Innovation: Clinical and Psychosocial Impact of Open-Source Automated Insulin Delivery Systems

Type 1 Diabetes (T1D) is a complex chronic condition, with significant impact on physical and mental health. Automated insulin delivery (AID) systems, which combine continuous glucose monitoring and insulin pumps with algorithms for insulin dosing, represent a major innovation in diabetes care. Even before commercial systems became available, a community of people with diabetes (PwD) behind the hashtag #WeAreNotWaiting developed their own digital, open-source solutions for automated insulin dosing. Both real-world studies and randomized controlled trials (RCTs) have shown that these systems are safe and effective. However, since open-source systems are developed and used at the user’s own risk, they are not subject to the same regulatory processes as commercial AID systems. Research to date has primarily focused on clinical outcomes, while little attention has been paid to the psychosocial impact and user perspectives of open-source AID. Furthermore, a direct comparison of the effectiveness of open-source and commercial systems is lacking, limiting the understanding of their impact on the reality of PwD's lives. This dissertation, conducted as part of the OPEN project (“Outcomes of Patients' Evidence with Novel, Do-it-Yourself Artificial Pancreas Technology”, H2020-MSCA-RISE-2018, Grant-ID 823902), addresses this gap through the following studies: (i) A systematic review of real-world studies compared clinical outcomes of both commercial and open-source AID systems and found that both commercial and open-source AID systems can significantly improve time in range and decrease hemoglobin A1c levels, without increasing the risk of severe hypoglycemia. (ii) A quantitative analysis of quality of life (QoL) and psychological well-being used validated questionnaires in children with T1D using open-source AID and showed significantly higher diabetes-related QoL, improved well-being, and better sleep compared to users of other treatment methods. (iii) A qualitative analysis of the users’ lived experience, based on personal narratives, reported positive impacts on physical and emotional health, including QoL and sleep quality. The community was an important source of support, while challenges were primarily related to obtaining hardware and setting up open-source AID systems. Across different methodological approaches, the three studies consistently demonstrate that open-source AID systems can improve both clinical and psychosocial outcomes. Future research should incorporate psychosocial outcomes to better understand the broader impact of interventions on patients' lives.