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

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

Guido Freckmann  1 , Stefan Pleus  1 , Mike Grady  2 , Steven Setford  2 , Brian Levy  3
Affiliations
Review

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

Guido Freckmann et al. J Diabetes Sci Technol. 2019 May.

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.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: GF is general manager of the IDT (Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany), which carries out clinical studies on the evaluation of BG meters and medical devices for diabetes therapy on its own initiative and on behalf of various companies. GF/IDT have received speakers’ honoraria or consulting fees from Abbott, Ascensia, Bayer, LifeScan, Menarini Diagnostics, Metronom Health, Novo Nordisk, Roche, Sanofi, Sensile, and Ypsomed. SP is employee of IDT. MG and SS are employees of LifeScan Scotland Ltd. BL is employee of LifeScan Inc.

Figures

Figure 1.
Figure 1.
Modeled data (n = 600) for a glucose monitoring system with (A) MARD 4.8%, 99.3% of results within accuracy limits of ISO 15197, and no bias, medium precision; (B) MARD 10.0%, 99.3% of results within accuracy limits of ISO 15197, and medium bias, high precision; (C) 10.0% MARD, 81.5% of results within accuracy limits of ISO 15197, and positive bias, low precision; (D) MARD 10.0%, 99.3% of results within accuracy limits of ISO 15197, and negative bias, high precision.
Figure 2.
Figure 2.
Modeled data (n = 600) for a glucose monitoring system showing constant bias and glucose-concentration-dependent variability.
See this image and copyright information in PMC

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