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

机译:连续血糖监测和血糖监测设备的精度测量

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摘要

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.
机译:当前,糖尿病患者可以在两种主要的葡萄糖测量系统之间进行选择:测量毛细血管内葡萄糖的血糖监测(BGM)系统和测量组织液中葡萄糖的连续葡萄糖监测(CGM)系统。尽管BGM和CGM系统提供不同的功能,但两种类型的系统均旨在帮助用户实现更好的血糖控制。 BGM和CGM系统的另一个不同之处是测量精度。在文献中,BGM系统准确性主要根据ISO 15197:2013准确性要求进行评估,而CGM准确性迄今为止主要由MARD进行评估,尽管通常会提供其他分析(例如偏差分析或误差网格分析)得出的结果。这篇综述的目的是提供用于确定BGM和CGM系统准确性的不同方法的比较,以及在使用这些不同的准确性度量方法进行BGM分析性能(即准确性)之间的比较时应考虑的因素。和CGM系统。此外,还讨论了准确性及其相关性在现实世界中的含义。

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