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自动胰岛素输注系统的注册及真实世界研究

Registration and Real-Life Studies on Automated Insulin Delivery Systems.

作者信息

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

机构信息

Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.

University of Virginia, Charlottesville, VA, USA.

出版信息

J Diabetes Sci Technol. 2025 Jul;19(4):924-936. doi: 10.1177/19322968251334993. Epub 2025 Jul 1.


DOI:10.1177/19322968251334993
PMID:40590465
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12213531/
Abstract

INTRODUCTION: The Diabetes Control and Complications Trial (DCCT) clearly documented long-term beneficial effects on both micro- and macro-vascular complications associated with type 1 diabetes (T1D) by using intensive insulin therapy (IIT) via multiple daily injections (MDIs) or insulin pumps more than 30 year 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. MATERIALS AND METHODS: 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 (NIDDK). 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. RESULTS: In the last decade, the introduction of a many AID systems for patients with T1D has shown improvements in glycemic metrics as documented by HbA1c values, time in range (TIR), time below range (TBR), 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. CONCLUSIONS: In this review, we summarize the registration and real-life studies of US Food and Drug Administration (FDA)-approved AID systems. Real-life studies confirmed the glycemic outcomes of AID systems reported from registration studies.

摘要

引言:30多年前,糖尿病控制与并发症试验(DCCT)通过每日多次注射(MDIs)或胰岛素泵进行强化胰岛素治疗(IIT),明确记录了对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。 材料与方法:我们回顾了迄今为止报道的不同AID系统的注册和实际应用研究。许多注册研究由美国国立糖尿病、消化和肾脏疾病研究所(NIDDK)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。 结果:在过去十年中,为T1D患者引入的许多AID系统已显示出血糖指标的改善,如糖化血红蛋白(HbA1c)值、血糖达标时间(TIR)、血糖低于范围时间(TBR)和生活质量所记录的那样。大多数注册和实际应用研究表明,AID系统对所有患有T1D的年龄组都安全有效。 结论:在本综述中,我们总结了美国食品药品监督管理局(FDA)批准的AID系统的注册和实际应用研究。实际应用研究证实了注册研究报告的AID系统的血糖结果。

相似文献

[1]
Registration and Real-Life Studies on Automated Insulin Delivery Systems.

J Diabetes Sci Technol. 2025-7

[2]
Registration and Real-Life Studies on Automated Insulin Delivery Systems.

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[3]
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[4]
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[5]
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[6]
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[7]
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[8]
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[9]
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[10]
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本文引用的文献

[1]
A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes.

N Engl J Med. 2025-5-8

[2]
Cardiovascular and Renal Biomarkers in Overweight and Obese Adults with Type 1 Diabetes Treated with Tirzepatide for 21 Months.

Diabetes Technol Ther. 2025-3

[3]
Automated Insulin Delivery in Adults With Type 2 Diabetes: A Nonrandomized Clinical Trial.

JAMA Netw Open. 2025-2-3

[4]
Erratum. 7. Diabetes Technology: Standards of Care in Diabetes-2025. Diabetes Care 2025;48(Suppl. 1):S146-S166.

Diabetes Care. 2025-4-1

[5]
Insulin Titration Recommendations When Using Glucagon-Like Peptide 1 Receptor Agonist Therapy in Adults With Type 1 Diabetes.

Clin Diabetes. 2024-9-20

[6]
Effectiveness of Semaglutide and Tirzepatide in Overweight and Obese Adults with Type 1 Diabetes.

Diabetes Technol Ther. 2025-1

[7]
Effectiveness of add-on therapy with SGLT2 inhibitors or GLP-1 receptor agonists in adults with type 1 diabetes: A prospective DPV registry study.

Diabetes Obes Metab. 2025-3

[8]
Glycemic and Patient-Reported Outcomes for Users of a New, Compact Automated Insulin Delivery System: A First Report.

J Diabetes Sci Technol. 2025-3

[9]
Consensus Report on Glucagon-Like Peptide-1 Receptor Agonists as Adjunctive Treatment for Individuals With Type 1 Diabetes Using an Automated Insulin Delivery System.

J Diabetes Sci Technol. 2025-1

[10]
GLP-1 Receptor Agonist and SGLT2 Inhibitor Prescribing in People With Type 1 Diabetes.

JAMA. 2024-11-19

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