Efficacy, safety, and legal considerations of do-it-yourself artificial pancreas systems: a position statement from italian diabetes societies

Abstract

Do-It-Yourself Artificial Pancreas Systems (DIY-APS)-which combine commercially available devices with open-source software-are increasingly used for the management of type 1 diabetes, despite a lack of formal regulatory approval in many jurisdictions, including in Italy. This position statement, endorsed by Italian diabetes societies (Associazione Medici Diabetologici, Societa Italiana di Diabetologia, and Società Italiana di Endocrinologia e Diabetologia Pediatrica) and "Diabete Italia", the national patient association, addresses the efficacy, safety, and legal implications of DIY-APS in Italy. Real-world evidence and clinical trials demonstrate that DIY-APS improves glycemic control and quality of life and reduce fear of hypoglycemia in users. This statement outlines the reasons driving patient adoption of DIY-APS, including limitations of commercial systems and the need for greater personalization. It emphasizes the ethical responsibility of healthcare professionals to support patients using DIY-APS while acknowledging the legal complexities surrounding their unregulated use. The statement concludes with recommendations to enhance education for patients and healthcare professionals and advocates for clearer regulatory pathways to ensure patient safety and optimize care.

Keywords: Adults; Automated insulin delivery (AID); Children; Diabetes; Do-it-yourself; Electronic survey; Ethical considerations; Legal framework; Open APS; Open source; Type 1 diabetes.