Irace Concetta, Assaloni Roberta, Avogaro Angelo, Candido Riccardo, Cherubini Valentino, Coluzzi Sara, Dicembrini Ilaria, Di Bartolo Paolo, Di Molfetta Sergio, Franceschi Roberto, Frattolin Elena, Grancini Valeria, Guardasole Vincenzo, Marcello Daniela, Neri Matteo, Nervo Stefano, Rabbone Ivana, Rapellino Alessandro, Scarpitta Antonietta Maria, Tinti Davide, Trombetta Maddalena, Zanfardino Angela, Scaramuzza Andrea
Department of Health Science, University Magna Græcia, Catanzaro, Italy.
Diabetes and Diabetic Foot Treatment Center, ASUGI, Monfalcone-Gorizia, Monfalcone, Italy.
Acta Diabetol. 2025 Aug 7. doi: 10.1007/s00592-025-02559-3.
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.
自行组装人工胰腺系统（DIY-APS）——将市售设备与开源软件相结合——尽管在包括意大利在内的许多司法管辖区缺乏正式的监管批准，但越来越多地用于1型糖尿病的管理。本立场声明得到了意大利糖尿病学会（意大利糖尿病医生协会、意大利糖尿病学会和意大利儿内分泌与糖尿病学会）以及全国患者协会“意大利糖尿病”的认可，阐述了DIY-APS在意大利的疗效、安全性和法律影响。真实世界证据和临床试验表明，DIY-APS可改善血糖控制和生活质量，并减少使用者对低血糖的恐惧。本声明概述了促使患者采用DIY-APS的原因，包括商业系统的局限性以及对更大个性化的需求。它强调了医疗保健专业人员支持使用DIY-APS患者的道德责任，同时承认其不受监管使用所涉及的法律复杂性。声明最后提出了加强对患者和医疗保健专业人员教育的建议，并倡导建立更清晰的监管途径，以确保患者安全并优化护理。
