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高风险CE标记医疗器械的临床证据用于控制葡萄糖:系统性审查和元分析
Arjola Bano1,2,3, Juri Künzler1, Faina Wehrli1
1Department of Diabetes, Endocrinology, Nutritional Medicine, and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.
Diabetes, obesity & metabolism
|August 14, 2024
概括
自动化胰岛素输送系统和连续血糖监测设备可以安全地改善血糖控制. 然而,关于糖尿病并发症的长期数据有限,需要对高风险医疗器械进行标准化研究协议.
科学领域:
- 医疗器械 医疗器械
- 内分泌学 在内分泌学.
- 糖尿病管理 糖尿病管理
背景情况:
- 高风险的医疗设备,包括自动胰岛素输送系统 (AID),胰岛素和持续血糖监测 (CGM) 设备,对于糖尿病管理至关重要.
- 具有CE标志的设备需要严格的有效性和安全性评估.
结论:
- 具有CE标志的高风险设备,特别是AID系统,在改善血糖控制方面证明了安全性和有效性.
- 有限证据表明,由于研究时间短,糖尿病导致的末端器官损伤是有限的.
- 方法的异质性强调了在未来的设备调查中需要标准化的协议.
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