Why #WeAreNotWaiting - Motivations and Self-Reported Outcomes Among Users of Open-Source Automated Insulin Delivery Systems: A Multinational Survey

Background: Automated insulin delivery (AID) systems have been shown to be safe and effective in reducing hyper- and hypoglycaemia, but are not universally available, accessible, and affordable. Therefore, user-driven open-source AID systems are becoming increasingly popular. Methods: This study investigated motivations why people with diabetes or their caregivers decide to build and use a personalised open-source AID. A cross-sectional online survey was conducted to assess personal motivations and associated self-reported clinical outcomes. Findings: Of 897 participants from 35 countries, 80·4% were adults with diabetes and 19·6% were caregivers of children with diabetes. Primary motivations to commence open-source AID included: improving glycaemic outcomes (94% of adults, 95% of caregivers), reducing acute (87%/96%) and long-term (83%/91%) complication risk, interacting less frequently with diabetes technology (81%/76%), improving their/child’s sleep quality (72%/80%), increasing their/child’s life expectancy (72%/85%), lack of commercially available AID systems (71%/70%), and unachieved therapy goals with available therapy options (68%/69%). Improving their own sleep quality was an almost universal motivator for caregivers (94%). Significant improvements, independent of age and gender, were observed in self-reported HbA1C, 7·14±1·13% (54·5±12·4 mmol/mol) to 6·24±0·64% (44·7±7·0 mmol/mol; p<0·0001); and Time-in-Range (62·96±16·18% to 80·34±9·41%; p<0·0001). Interpretation: These results highlight the unmet needs of people with diabetes, provide new insights into the evolving phenomenon of open-source AID technology, and indicate improved clinical outcomes. This study may inform healthcare professionals and policymakers about the opportunities provided by open-source AID systems.Funding: EU-H2020 grant agreement number 823902. Funding Statement: EU-H2020 grant agreement number 823902. Declaration of Interests: All authors have completed the Unified Competing Interest form and declare the following: ● KB received research grants from the Berlin Institute of Health (BIH), SPOKES Wellcome Trust, Stiftung Charite, and the German Diabetes Association (DDG). She has served as a speaker and advisory board member for Medtronic Diabetes and Hi.Health, and received fees for medical consulting and public speaking from Roche Diabetes Care, Dexcom, Medtronic Diabetes, Diabeloop, BCG Digital Ventures and Bertelsmann Stiftung; outside the submitted work. ● DL reports grants from the Robert Wood Johnson Foundation, JDRF, personal fees from Lilly, Diabeloop, Roche Diabetes Care, and Novo Nordisk and Tandem, outside the submitted work. ● JSp has served on advisory boards for Janssen, Medtronic, Roche Diabetes Care, and Sanofi Diabetes; her research group (Australian Centre for Behavioural Research in Diabetes [ACBRD]) has received honoraria for this advisory board participation and has also received unrestricted educational grants and in-kind support from Abbott Diabetes Care, AstraZeneca, Medtronic, Roche Diabetes Care, and Sanofi Diabetes. JS has also received sponsorship to attend educational meetings from Medtronic, Roche Diabetes Care, and Sanofi Diabetes, and consultancy income or speaker fees from Abbott Diabetes Care, AstraZeneca, Medtronic, Novo Nordisk, Roche Diabetes Care, and Sanofi Diabetes; all outside the submitted work. ● KR is an Advisory Board member of Lilly Diabetes Care and Abbott Diabetes Care outside the submitted work. ● KB, DL, SO, AdT and KAG are members of the open-source AID online community. All other authors have no conflict of interest to declare. Ethics Approval Statement: The survey was approved by the Charite – Universitatsmedizin Berlin Ethics Committee (EA2/140/18).