Akturk Halis Kaan, Brown Sue A, Beck Roy W, Sherr Jennifer L, Bergenstal Richard M, Kovatchev Boris P, Vigersky Robert, Breton Marc D, Hovorka Roman, Klonoff David C, Garg Satish K
Barbara Davis Center for Diabetes, University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado, USA.
University of Virginia, Charlottesville, Virginia, USA.
Diabetes Technol Ther. 2025 Jul;27(S3):S48-S59. doi: 10.1089/dia.2025.0130.
The Diabetes Control and Complications Trial (DCCT) clearly documented long-term beneficial effects on both micro- and macrovascular complications associated with type 1 diabetes (T1D) by using intensive insulin therapy (IIT) via multiple daily injections or insulin pumps more than 30 years ago. IIT, both during the DCCT and with translation into clinical practice, has been demonstrated to increase the risk of severe hypoglycemia and weight gain. Automated insulin delivery (AID) systems have become the standard of care in T1D management in the developed countries. We reviewed the registration and real-life studies for different AID systems reported to date. Many of the registration studies were sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases. A systematic literature search was conducted using the MEDLINE (PubMed) database. Studies with the longest duration and/or with the largest number of participants were included. In the last decade, the introduction of many AID systems for patients with T1D has shown improvements in glycemic metrics as documented by hemoglobin A1c values, time in range, time below range, and quality of life. Most of the registration and real-life studies have shown safe and effective use of AID systems for all age groups living with T1D. In this review, we summarize the registration and real-life studies of U.S. Food and Drug Administration-approved AID systems. Real-life studies confirmed the glycemic outcomes of AID systems reported from registration studies.
30多年前，糖尿病控制与并发症试验（DCCT）通过每日多次注射或胰岛素泵进行强化胰岛素治疗（IIT），明确记录了其对1型糖尿病（T1D）相关微血管和大血管并发症的长期有益影响。在DCCT期间以及转化为临床实践后，IIT已被证明会增加严重低血糖和体重增加的风险。自动胰岛素输送（AID）系统已成为发达国家T1D管理的护理标准。我们回顾了迄今为止报道的不同AID系统的注册研究和实际应用研究。许多注册研究由美国国立糖尿病、消化和肾脏疾病研究所赞助。使用MEDLINE（PubMed）数据库进行了系统的文献检索。纳入了持续时间最长和/或参与者数量最多的研究。在过去十年中，许多针对T1D患者的AID系统的引入已显示出血红蛋白A1c值、血糖达标时间、血糖低于目标范围的时间和生活质量等血糖指标有所改善。大多数注册研究和实际应用研究表明，AID系统对所有T1D患者年龄组的使用都是安全有效的。在本综述中，我们总结了美国食品药品监督管理局批准的AID系统的注册研究和实际应用研究。实际应用研究证实了注册研究报告的AID系统的血糖结果。
