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持续葡萄糖监测和血糖监测设备的准确性测量

Measures of Accuracy for Continuous Glucose Monitoring and Blood Glucose Monitoring Devices.

作者信息

Freckmann Guido, Pleus Stefan, Grady Mike, Setford Steven, Levy Brian

机构信息

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

2 LifeScan Scotland Ltd, Inverness, Scotland, UK.

出版信息

J Diabetes Sci Technol. 2019 May;13(3):575-583. doi: 10.1177/1932296818812062. Epub 2018 Nov 19.

Abstract

Currently, patients with diabetes may choose between two major types of system for glucose measurement: blood glucose monitoring (BGM) systems measuring glucose within capillary blood and continuous glucose monitoring (CGM) systems measuring glucose within interstitial fluid. Although BGM and CGM systems offer different functionality, both types of system are intended to help users achieve improved glucose control. Another area in which BGM and CGM systems differ is measurement accuracy. In the literature, BGM system accuracy is assessed mainly according to ISO 15197:2013 accuracy requirements, whereas CGM accuracy has hitherto mainly been assessed by MARD, although often results from additional analyses such as bias analysis or error grid analysis are provided. The intention of this review is to provide a comparison of different approaches used to determine the accuracy of BGM and CGM systems and factors that should be considered when using these different measures of accuracy to make comparisons between the analytical performance (ie, accuracy) of BGM and CGM systems. In addition, real-world implications of accuracy and its relevance are discussed.

摘要

目前,糖尿病患者可在两种主要的血糖测量系统中进行选择:测量毛细血管血中葡萄糖的血糖监测(BGM)系统和测量组织间液中葡萄糖的连续血糖监测(CGM)系统。尽管BGM系统和CGM系统功能不同,但这两种系统都旨在帮助用户更好地控制血糖。BGM系统和CGM系统的另一个不同之处在于测量准确性。在文献中,BGM系统的准确性主要根据ISO 15197:2013准确性要求进行评估,而CGM的准确性迄今主要通过平均绝对相对差(MARD)进行评估,不过通常也会提供偏差分析或误差网格分析等额外分析的结果。本综述的目的是比较用于确定BGM系统和CGM系统准确性的不同方法,以及在使用这些不同的准确性测量方法对BGM系统和CGM系统的分析性能(即准确性)进行比较时应考虑的因素。此外,还讨论了准确性在现实世界中的意义及其相关性。

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