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

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.

Keywords: ISO 15197; MARD; accuracy; blood glucose monitoring; continuous glucose monitoring; performance.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Blood Glucose / analysis*
  • Blood Glucose Self-Monitoring / instrumentation
  • Blood Glucose Self-Monitoring / standards
  • Device Approval
  • Diabetes Mellitus / blood*
  • Diabetes Mellitus / diagnosis
  • Guideline Adherence
  • Humans
  • Medical Device Legislation
  • Reproducibility of Results
  • Sensitivity and Specificity
  • United States
  • United States Food and Drug Administration

Substances

  • Blood Glucose