Measures of Accuracy for Continuous Glucose Monitoring and Blood Glucose Monitoring Devices.
Measures of Accuracy for Continuous Glucose Monitoring and Blood Glucose Monitoring Devices.
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DOI：
10.1177/1932296818812062
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发表时间：
2019-05-01
影响因子：
5
通讯作者：
Levy, Brian
中科院分区：
文献类型：
--
作者：
Freckmann, Guido;Pleus, Stefan;Levy, Brian
目前，糖尿病患者可以选择两种主要的血糖测量系统：测量毛细血管内血糖的血糖监测(BGM)系统和测量间质液体葡萄糖的连续血糖监测(CGM)系统。虽然BGM和CGM系统提供不同的功能，但这两种类型的系统都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系统的精度主要是根据国际标准化组织15197：2013年的精度要求进行评估的，而CGM精度到目前为止主要是由MARD评估的，尽管通常会提供其他分析的结果，如偏差分析或误差网格分析。本综述的目的是对用于确定BGM和CGM系统的准确度的不同方法进行比较，以及在使用这些不同的准确度衡量标准来比较BGM和CGM系统的分析性能(即准确度)时应考虑的因素。此外，还讨论了精确度的现实含义及其相关性。
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.