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

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.

SUBMITTER: Pleus S

PROVIDER: S-EPMC5951044 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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

Pleus Stefan S Flacke Frank F Sieber Jochen J Haug Cornelia C Freckmann Guido G

Journal of diabetes science and technology 20170426 6

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 ...[more]

PMID: 28443344

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| S-EPMC10979678 | biostudies-literature

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Project description:BackgroundAs blood glucose monitoring system (BGMS) accuracy is based on comparison of BGMS and laboratory reference glucose analyzer results, reference instrument accuracy is important to discriminate small differences between BGMS and reference glucose analyzer results. Here, we demonstrate the important role of reference glucose analyzer accuracy in BGMS accuracy evaluations.MethodsTwo clinical studies assessed the performance of a new BGMS, using different reference instrument procedures. BGMS and YSI analyzer results were compared for fingertip blood that was obtained by untrained subjects' self-testing and study staff testing, respectively. YSI analyzer accuracy was monitored using traceable serum controls.ResultsIn study 1 (N = 136), 94.1% of BGMS results were within International Organization for Standardization (ISO) 15197:2013 accuracy criteria; YSI analyzer serum control results showed a negative bias (-0.64% to -2.48%) at the first site and a positive bias (3.36% to 6.91%) at the other site. In study 2 (N = 329), 97.8% of BGMS results were within accuracy criteria; serum controls showed minimal bias (<0.92%) at both sites.ConclusionsThese findings suggest that the ability to demonstrate that a BGMS meets accuracy guidelines is influenced by reference instrument accuracy.

| S-EPMC4928230 | biostudies-literature

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| S-EPMC4667333 | biostudies-literature

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