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Comparative Study
. 2017 Nov;11(6):1226-1230.
doi: 10.1177/1932296817707292. Epub 2017 Apr 26.

Strengths and Limitations of New Approaches for Graphical Presentation of Blood Glucose Monitoring System Accuracy Data

Stefan Pleus  1 , Frank Flacke  2 , Jochen Sieber  2 , Cornelia Haug  1 , Guido Freckmann  1
Affiliations
Comparative Study

Strengths and Limitations of New Approaches for Graphical Presentation of Blood Glucose Monitoring System Accuracy Data

Stefan Pleus et al. J Diabetes Sci Technol. 2017 Nov.

Abstract

Graphical presentation of blood glucose monitoring systems' (BGMSs) accuracy typically includes difference plots (DPs). Recently, 3 new approaches were presented: radar plots (RPs), rectangle target plots (RTPs), and surveillance error grids (SEGs). BGMS data were modeled based on 3 scenarios that can be encountered in real life to highlight strengths and limitations of these approaches. Detailed assessment of BGMS data may be easier in plots with individual data points (DPs, RPs, SEGs), whereas RTPs may facilitate display of large amounts of data or comparison of BGMS. SEGs have the advantage of assessing clinical risk. The selection of a specific type depends mostly on the kind of information sought (eg, accuracy in specific concentration intervals, lot-to-lot variability, clinical risk) as there is no "absolute best" approach.

Keywords: difference plot; radar plot; rectangle target plot; surveillance error grid.

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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: SP and CH are employees of IDT. FF and JS are employees of Sanofi-Aventis GmbH, Frankfurt, Germany. 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, Berlin-Chemie, Becton-Dickinson, Dexcom, LifeScan, Menarini Diagnostics, Novo Nordisk, Roche, Sanofi, Sensile, and Ypsomed.

Figures

Figure 1.
Figure 1.
BGMS showing a high level of accuracy. More than 95% of individual results are within ±10 mg/dl (at glucose concentrations <100 mg/dl) or within ±10% (at glucose concentrations ≥100 mg/dl).
Figure 2.
Figure 2.
Concentration dependency of BGMS results. Model data in part A and part B have similar bias and imprecision, as presented in RTP, but measurement error in part A is concentration-dependent.
Figure 3.
Figure 3.
Variation in bias and imprecision between test strip lots.
Figure 4.
Figure 4.
Display of 6 test strip lots instead of 3 test strip lots.
See this image and copyright information in PMC

References

    1. International Organization for Standardization. In vitro diagnostic test systems—requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. ISO 15197:2013.
    1. Pleus S, Baumstark A, Rittmeyer D, Jendrike N, Haug C, Freckmann G. Performance of two updated blood glucose monitoring systems: an evaluation following ISO 15197:2013. Curr Med Res Opin. 2016;32(5):847-855. - PubMed
    1. Freckmann G, Link M, Schmid C, Pleus S, Baumstark A, Haug C. System accuracy evaluation of different blood glucose monitoring systems following ISO 15197:2013 by using two different comparison methods. Diabetes Technol Ther. 2015;17(9):635-648. - PubMed
    1. Link M, Schmid C, Pleus S, et al. System accuracy evaluation of four systems for self-monitoring of blood glucose following ISO 15197 using a glucose oxidase and a hexokinase-based comparison method. J Diabetes Sci Technol. 2015;14(9):1041-1050. - PMC - PubMed
    1. Pleus S, Link M, Baumstark A, Haug C, Freckmann G. Evaluating clinical accuracy of four blood glucose monitoring systems using surveillance error grids. Diabetes Technol Ther. 2015;17(S1):A86.

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