Yale School of Medicine, New Haven, CT.
Science & Co, Kaarst, Germany.
Diabetes Care. 2022 Dec 1;45(12):3058-3074. doi: 10.2337/dci22-0018.
A technological solution for the management of diabetes in people who require intensive insulin therapy has been sought for decades. The last 10 years have seen substantial growth in devices that can be integrated into clinical care. Driven by the availability of reliable systems for continuous glucose monitoring, we have entered an era in which insulin delivery through insulin pumps can be modulated based on sensor glucose data. Over the past few years, regulatory approval of the first automated insulin delivery (AID) systems has been granted, and these systems have been adopted into clinical care. Additionally, a community of people living with type 1 diabetes has created its own systems using a do-it-yourself approach by using products commercialized for independent use. With several AID systems in development, some of which are anticipated to be granted regulatory approval in the near future, the joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association has created this consensus report. We provide a review of the current landscape of AID systems, with a particular focus on their safety. We conclude with a series of recommended targeted actions. This is the fourth in a series of reports issued by this working group. The working group was jointly commissioned by the executives of both organizations to write the first statement on insulin pumps, which was published in 2015. The original authoring group was comprised by three nominated members of the American Diabetes Association and three nominated members of the European Association for the Study of Diabetes. Additional authors have been added to the group to increase diversity and range of expertise. Each organization has provided a similar internal review process for each manuscript prior to submission for editorial review by the two journals. Harmonization of editorial and substantial modifications has occurred at both levels. The members of the group have selected the subject of each statement and submitted the selection to both organizations for confirmation.
几十年来，人们一直寻求一种能够管理需要强化胰岛素治疗的糖尿病患者的技术解决方案。过去 10 年，能够集成到临床护理中的设备有了实质性的增长。由于连续血糖监测系统的可靠性，我们已经进入了一个可以根据传感器葡萄糖数据来调节胰岛素泵胰岛素输送的时代。在过去的几年中，第一种自动化胰岛素输送（AID）系统已获得监管部门的批准，并已在临床护理中得到采用。此外，一个由 1 型糖尿病患者组成的社区已经通过使用商业化的独立产品采用 DIY 方法创建了自己的系统。随着几个 AID 系统的开发，其中一些预计在不久的将来将获得监管部门的批准，欧洲糖尿病研究协会和美国糖尿病协会的联合糖尿病技术工作组已经创建了这份共识报告。我们回顾了当前的 AID 系统，特别关注其安全性。最后，我们提出了一系列有针对性的建议。这是该工作组发布的一系列报告中的第四份报告。该工作组由两个组织的执行委员会联合委托撰写，第一份关于胰岛素泵的声明于 2015 年发表。最初的作者团队由美国糖尿病协会提名的三名成员和欧洲糖尿病研究协会提名的三名成员组成。后来又增加了一些额外的作者，以增加多样性和专业知识范围。在提交给两个期刊进行编辑审查之前，每个组织都对每份手稿进行了类似的内部审查过程。在两个层面都进行了编辑和实质性修改的协调。该小组的成员选择了每个声明的主题，并将选择提交给两个组织确认。
