新型连续血糖监测设备在糖尿病患者中的表现。

IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM
Julia K Mader, Delia Waldenmaier, Wiebke Mueller-Hoffmann, Katrin Mueller, Michael Angstmann, Gerhard Vogt, Cosima C Rieger, Manuel Eichenlaub, Thomas Forst, Guido Freckmann
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引用次数: 0

摘要

背景在这项多中心研究中,对新型连续血糖监测(CGM)系统的性能进行了评估:方法:成年糖尿病患者参与研究。他们每人在上臂佩戴 CGM 系统的三个传感器长达 14 天。在四次门诊期间,经常与毛细血管血糖(BG)样本进行对比测量。主要终点是 20/20 一致率 (AR):CGM 读数在 ±20 mg/dL 范围内的百分比(血糖值结果):对 48 名参与者和 139 个传感器的数据进行了分析。在诊疗过程中,20/20 一致率为 90.5%,误差率为 9.2%。血糖范围为 180 毫克/分升时,20/20 AR 分别为 94.3%、89.0% 和 92.5%。在传感器佩戴时间的初期、中期和末期,20/20 AR 分别为 92.8%、91.5% 和 85.9%。14 天存活率为 82.4%。插入传感器后的疼痛和出血量均在预期范围内。根据研究结果,该设备的使用是安全的:与毛细血管血糖测量相比,该系统表现出良好的性能。在整个测量范围内,尤其是在低血糖范围内,以及在传感器的整个佩戴时间内,都能显示出这种准确性。这项研究结果支持该设备的非联合使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Performance of a Novel Continuous Glucose Monitoring Device in People With Diabetes.

Background: In this multicenter study, performance of a novel continuous glucose monitoring (CGM) system was evaluated.

Methods: Adult participants with diabetes were included in the study. They each wore three sensors of the CGM system on the upper arms for up to 14 days. During four in-clinic visits, frequent comparison measurements with capillary blood glucose (BG) samples were performed. The primary endpoint was the 20/20 agreement rate (AR): the percentage of CGM readings within ±20 mg/dL (at BG values <100 mg/dL) or ±20% (at BG values ≥100 mg/dL) of the comparator. Further evaluations included mean absolute relative difference (MARD) and 20/20 AR in different BG ranges and across the wear time.

Results: Data from 48 participants and 139 sensors were analyzed. During in-clinic sessions the 20/20 AR was 90.5% and the MARD was 9.2%. For BG ranges <70, 70-180, and >180 mg/dL, 20/20 AR was 94.3%, 89.0%, and 92.5%, respectively. At the beginning, middle, and end of sensor wear time, 20/20 AR was 92.8%, 91.5%, and 85.9%, respectively. The 14-day survival probability was 82.4%. Pain and bleeding after sensor insertion were within the expected range. Based on the study outcome, the use of the device is regarded as safe.

Conclusions: The system showed a good performance compared to capillary BG measurements. This level of accuracy could be shown over the entire measurement range, especially in the low glycemic range, and the whole wear time of the sensors. The results of this study are supporting a non-adjunctive use of the device.

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来源期刊
Journal of Diabetes Science and Technology
Journal of Diabetes Science and Technology Medicine-Internal Medicine
CiteScore
7.50
自引率
12.00%
发文量
148
期刊介绍: The Journal of Diabetes Science and Technology (JDST) is a bi-monthly, peer-reviewed scientific journal published by the Diabetes Technology Society. JDST covers scientific and clinical aspects of diabetes technology including glucose monitoring, insulin and metabolic peptide delivery, the artificial pancreas, digital health, precision medicine, social media, cybersecurity, software for modeling, physiologic monitoring, technology for managing obesity, and diagnostic tests of glycation. The journal also covers the development and use of mobile applications and wireless communication, as well as bioengineered tools such as MEMS, new biomaterials, and nanotechnology to develop new sensors. Articles in JDST cover both basic research and clinical applications of technologies being developed to help people with diabetes.
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