Department of Diabetes, Endocrinology, Nutritional Medicine, and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.
Department of Cardiology, Inselspital, Bern University Hospital, Bern, Switzerland.
Diabetes Obes Metab. 2024 Oct;26(10):4753-4766. doi: 10.1111/dom.15849. Epub 2024 Aug 14.
To conduct a systematic review and meta-analysis, within the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, evaluating CE-marked high-risk devices for glucose management.
We identified interventional and observational studies evaluating the efficacy and safety of eight automated insulin delivery (AID) systems, two implantable insulin pumps, and three implantable continuous glucose monitoring (CGM) devices. We meta-analysed randomized controlled trials (RCTs) comparing AID systems with other treatments.
A total of 182 studies published between 2009 and 2024 were included, comprising 166 studies on AID systems, six on insulin pumps, and 10 on CGM devices; 26% reported industry funding; 18% were pre-market; 37% had a comparator group. Of the studies identified, 29% were RCTs, 24% were non-randomized trials, and 47% were observational studies. The median (interquartile range) sample size was 48 (28-102), age 34.8 (14-44.2) years, and study duration 17.5 (12-26) weeks. AID systems lowered glycated haemoglobin by 0.5 percentage points (absolute mean difference [MD] = -0.5; 21 RCTs; I = 86%) and increased time in target range for sensor glucose level by 13.4 percentage points (MD = 13.4; 14 RCTs; I = 90%). At least one safety outcome was assessed in 71% of studies.
High-risk devices for glucose monitoring or insulin dosing, in particular AID systems, improve glucose control safely, but evidence on diabetes-related end-organ damage is lacking due to short study durations. Methodological heterogeneity highlights the need for developing standards for future pre- and post-market investigations of diabetes-specific high-risk medical devices.
在协调医疗器械研究和证据（CORE-MD）项目中，进行系统评价和荟萃分析，评估具有高风险的 CE 标志的葡萄糖管理医疗器械。
我们确定了评估八种自动胰岛素输送（AID）系统、两种植入式胰岛素泵和三种植入式连续血糖监测（CGM）设备的疗效和安全性的干预性和观察性研究。我们对比较 AID 系统与其他治疗方法的随机对照试验（RCT）进行了荟萃分析。
共纳入了 2009 年至 2024 年期间发表的 182 项研究，其中包括 166 项关于 AID 系统的研究、6 项关于胰岛素泵的研究和 10 项关于 CGM 设备的研究；26%的研究报告了行业资助；18%为上市前研究；37%有对照组。在所确定的研究中，29%为 RCT，24%为非随机试验，47%为观察性研究。研究样本量中位数（四分位距）为 48（28-102）岁，年龄 34.8（14-44.2）岁，研究持续时间 17.5（12-26）周。AID 系统使糖化血红蛋白降低了 0.5 个百分点（绝对平均差值 [MD] = -0.5；21 项 RCT；I = 86%），并使传感器血糖水平目标范围内的时间增加了 13.4 个百分点（MD = 13.4；14 项 RCT；I = 90%）。71%的研究评估了至少一种安全性结果。
用于葡萄糖监测或胰岛素给药的高风险设备，特别是 AID 系统，可安全地改善血糖控制，但由于研究持续时间较短，缺乏与糖尿病相关的终末器官损伤的证据。方法学异质性突出表明需要为未来糖尿病高风险医疗器械的上市前和上市后研究制定标准。
