Department of Paediatric Endocrinology and Diabetes, Charité-Universitätsmedizin Berlin, Berlin, Germany; Institute of Medical Informatics, Charité-Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany.
Stanford Diabetes Research Center, Stanford University School of Medicine, Stanford University, Stanford, CA, USA.
Lancet Diabetes Endocrinol. 2022 Jan;10(1):58-74. doi: 10.1016/S2213-8587(21)00267-9. Epub 2021 Nov 13.
Open-source automated insulin delivery systems, commonly referred to as do-it-yourself automated insulin delivery systems, are examples of user-driven innovations that were co-created and supported by an online community who were directly affected by diabetes. Their uptake continues to increase globally, with current estimates suggesting several thousand active users worldwide. Real-world user-driven evidence is growing and provides insights into safety and effectiveness of these systems. The aim of this consensus statement is two-fold. Firstly, it provides a review of the current evidence, description of the technologies, and discusses the ethics and legal considerations for these systems from an international perspective. Secondly, it provides a much-needed international health-care consensus supporting the implementation of open-source systems in clinical settings, with detailed clinical guidance. This consensus also provides important recommendations for key stakeholders that are involved in diabetes technologies, including developers, regulators, and industry, and provides medico-legal and ethical support for patient-driven, open-source innovations.
开源自动化胰岛素输送系统，通常被称为 DIY 自动化胰岛素输送系统，是用户驱动创新的范例，由受糖尿病直接影响的在线社区共同创造和支持。它们在全球范围内的使用率持续增加，目前估计全球有数千名活跃用户。真实世界中用户驱动的证据不断增加，为这些系统的安全性和有效性提供了新的见解。本共识声明有两个目的。首先，它从国际视角对当前证据进行了回顾，对技术进行了描述，并讨论了这些系统的伦理和法律问题。其次，它为开源系统在临床环境中的实施提供了急需的国际医疗保健共识，并提供了详细的临床指导。该共识还为涉及糖尿病技术的利益相关者（包括开发者、监管机构和行业）提供了重要建议，并为患者驱动的开源创新提供了医学法律和伦理支持。
