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Publications

Journal Article Ahead of print

PubMed: 40773023 DOI: 10.1007/s00592-025-02559-3

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

Acta Diabetol

Authors: Concetta Irace, Roberta Assaloni, Angelo Avogaro, Riccardo Candido, Valentino Cherubini, Sara Coluzzi, Ilaria Dicembrini, Paolo Di Bartolo, Sergio Di Molfetta, Roberto Franceschi, Elena Frattolin, Valeria Grancini, Vincenzo Guardasole, Daniela Marcello, Matteo Neri, Stefano Nervo, Ivana Rabbone, Alessandro Rapellino, Antonietta Maria Scarpitta, Davide Tinti, Maddalena Trombetta, Angela Zanfardino, Andrea Scaramuzza

Affiliations

  • Department of Health Science, University Magna Græcia, Catanzaro, Italy.
  • Diabetes and Diabetic Foot Treatment Center, ASUGI, Monfalcone-Gorizia, Monfalcone, Italy.
  • Department of Medicine, University of Padova, Padua, Italy.
  • Department of Medical Surgical and Health Sciences, University of Trieste, Trieste, Italy.
  • Department of Women's and Children's Health, Salesi Hospital, Ancona, Italy.
  • Endocrinology and Metabolism Unit, ASL, Pescara, Italy.
  • Experimental Clinical Biomedical Sciences 'Mario Serio' Department, University of Florence, Florence, Italy.
  • Ravenna Diabetes Clinic, Dept of Specialistic Medicines of Ravenna, Romagna Local Healthcare Authority of Romagna, Ravenna, Italy.
  • Endocrinology Unit, University Hospital "Consorziale Policlinico", Bari, Italy.
  • Centre for Medical Sciences - CISMed, University of Trento, Trento, Italy.
  • Udine, Italy.
  • Endocrinology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
  • Department of Translational Medical Sciences, Federico II University Hospital, Naples, Italy.
  • School of Economic Sciences, University of Firenze, Florence, Italy.
  • Chieti, Italy.
  • Padua, Italy.
  • Division of Pediatrics, Department of Health Sciences, Università del Piemonte Orientale, Novara, Italy.
  • Department of Interventional Radiology and Neuroradiology, San Giovanni Bosco Hospital, 10154, Piazza del Donatore di Sangue, 3, Turin, Italia.
  • Unit of Endocrine and Metabolic Diseases "Paolo Borsellino" Hospital, ASP Trapani, Marsala, Italy.
  • Department of Pediatrics, A.O.U. Città Della Salute E Della Scienza di Torino, Turin, Italy.
  • Division of Endocrinology, Diabetes and Metabolic Diseases, Department of Medicine, University Hospital of Verona, Verona, Italy.
  • Department of the Woman, of the Child and of the General and Specialized Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy.
  • Division of Pediatrics, Pediatric Diabetes, Endocrinology and Nutrition, Azienda Socio Sanitaria Territoriale (ASST) Cremona, Largo Priori 1, 26100, Cremona, Italy.

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.

MeSH

Diabetes Mellitus, Pancreas, Artificial, Safety, Pancreas, Software