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实时与间断扫描式连续血糖监测系统的准确性比较分析。

Comparative Accuracy Analysis of a Real-time and an Intermittent-Scanning Continuous Glucose Monitoring System.

机构信息

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.

Dexcom Inc., San Diego, CA, USA.

出版信息

J Diabetes Sci Technol. 2021 Mar;15(2):287-293. doi: 10.1177/1932296819895022. Epub 2019 Dec 17.

Abstract

BACKGROUND

Currently, two different types of continuous glucose monitoring (CGM) systems are available: real time (rt) CGM systems that continuously provide glucose values and intermittent-scanning (is) CGM systems. This study compared accuracy of an rtCGM and an isCGM system when worn in parallel.

METHODS

Dexcom G5 Mobile (DG5) and FreeStyle Libre (FL) were worn in parallel by 27 subjects for 14 days including two clinic sessions with induced glucose excursions. The percentage of CGM values within ±20% or ±20 mg/dL of the laboratory comparison method results (YSI 2300 STAT Plus, YSI Inc., Yellow Springs, OH, United States; glucose oxidase based) or blood glucose meter values and mean absolute relative difference (MARD) were calculated. Consensus error grid and continuous glucose error grid analyses were performed to assess clinical accuracy.

RESULTS

Both systems displayed clinically accurate readings. Compared to laboratory comparison method results during clinic sessions, DG5 had 91.5% of values within ±20%/20 mg/dL and a MARD of 9.5%; FL had 82.5% of scanned values within ±20%/20 mg/dL and an MARD of 13.6%. Both systems showed a lower level of performance during the home phase and when using the blood glucose meter as reference.

CONCLUSION

The two systems tested in this study represent two different principles of CGM. DG5 generally provided higher accordance with laboratory comparison method results than FL.

摘要

背景

目前,有两种不同类型的连续血糖监测(CGM)系统:实时(rt)CGM 系统,可连续提供血糖值,以及间歇扫描(is)CGM 系统。本研究比较了两种系统在同时佩戴时的准确性。

方法

27 名受试者同时佩戴 Dexcom G5 Mobile(DG5)和 FreeStyle Libre(FL),共佩戴 14 天,包括两次诊所就诊期间的葡萄糖波动。将 CGM 值与实验室比较方法(YSI 2300 STAT Plus,YSI Inc.,Yellow Springs,OH,美国;葡萄糖氧化酶法)或血糖仪值之间的差异在±20%或±20mg/dL 内的百分比以及平均绝对相对差异(MARD)进行计算。使用一致性误差网格和连续血糖误差网格分析来评估临床准确性。

结果

两种系统均显示出准确的读数。与诊所就诊期间的实验室比较方法结果相比,DG5 有 91.5%的读数在±20%/20mg/dL 内,MARD 为 9.5%;FL 有 82.5%的扫描值在±20%/20mg/dL 内,MARD 为 13.6%。两种系统在家庭阶段和以血糖仪作为参考时,性能水平均较低。

结论

本研究中测试的两种系统代表了两种不同的 CGM 原理。DG5 通常比 FL 更符合实验室比较方法的结果。

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