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Comparative Study
. 2012 Sep 1;6(5):1060-75.
doi: 10.1177/193229681200600510.

System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197

Guido Freckmann  1 , Christina Schmid, Annette Baumstark, Stefan Pleus, Manuela Link, Cornelia Haug
Affiliations
Comparative Study

System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197

Guido Freckmann et al. J Diabetes Sci Technol. .

Abstract

Background: The accuracy of systems for self-monitoring of blood glucose is important, as reliable measurement results are a prerequisite for therapeutic decisions.

Methods: This system accuracy evaluation study was performed according to DIN EN ISO 15197:2003 for 43 Conformité Européenne (CE)-labeled blood glucose (BG) monitoring systems. Measurement results of each system were compared with results of the designated comparison method (manufacturer's measurement procedure): glucose oxidase method (YSI 2300 glucose analyzer) or hexokinase method (Hitachi 917/ cobas 501).

Results: Complete assessment according to the International Organization for Standardization (ISO) standard was performed for 34 out of 43 systems, and 27 (79.4%) meet the requirements of the standard, i.e., ≥95% of their results showed at least the minimum acceptable accuracy. For 9 of the 43 systems, complete accuracy assessment was not performed due to an oxygen sensitivity (manufacturer's labeling). The bias (according to Bland and Altman) of all 43 evaluated systems ranged from -14.1% to +12.4%.

Conclusions: From the 34 systems completely assessed, 7 systems did not fulfill the minimal accuracy requirements of the ISO standard. The CE mark apparently does not guarantee that all BG systems provide accuracy according to the standard. Because inaccurate systems bear the risk of false therapeutic decisions, regular and standardized evaluation of BG meters and test strips should be requested in order to ensure adherence to quality standards.

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Figures

Figure 1A
Figure 1A
Difference plots of 43 BG systems. Black lines, system accuracy in accordance with DIN EN ISO 15197:2003; dashed lines, system overall accuracy determination according to the current draft revision of ISO 15197. For 9 BG systems with oxygen dependency (as mentioned in the manufacturer’s labeling), data of modified blood samples were excluded from overall system accuracy evaluation. For these 9 systems, the boundaries of concentration categories, including only unprepared blood samples (BG concentration ≥50 and <400 mg/dl) and categories that may include prepared blood samples (BG concentration <50 and ≥400 mg/dl), are marked by dashed perpendicular lines.
Figure 1B
Figure 1B
Difference plots of 43 BG systems. Black lines, system accuracy in accordance with DIN EN ISO 15197:2003; dashed lines, system overall accuracy determination according to the current draft revision of ISO 15197. For 9 BG systems with oxygen dependency (as mentioned in the manufacturer’s labeling), data of modified blood samples were excluded from overall system accuracy evaluation. For these 9 systems, the boundaries of concentration categories, including only unprepared blood samples (BG concentration ≥50 and <400 mg/dl) and categories that may include prepared blood samples (BG concentration <50 and ≥400 mg/dl), are marked by dashed perpendicular lines.
Figure 1C
Figure 1C
Difference plots of 43 BG systems. Black lines, system accuracy in accordance with DIN EN ISO 15197:2003; dashed lines, system overall accuracy determination according to the current draft revision of ISO 15197. For 9 BG systems with oxygen dependency (as mentioned in the manufacturer’s labeling), data of modified blood samples were excluded from overall system accuracy evaluation. For these 9 systems, the boundaries of concentration categories, including only unprepared blood samples (BG concentration ≥50 and <400 mg/dl) and categories that may include prepared blood samples (BG concentration <50 and ≥400 mg/dl), are marked by dashed perpendicular lines.
Figure 2
Figure 2
Bias according to Bland and Altman. Error bars represent 95% limits of agreement (≈ 1.96 × standard deviation). For the calculation of the bias of each system, only data of 180 unprepared blood samples (BG concentrations ≥50 and <400 mg/dl) were included. a: Accu-Chek® Mobileand Accu-Chek® Performa were both tested with different test strip chemistries. The test strip chemistry was either maltose dependent (left) or maltose independent (right). b: GlucoHexal® test strip lot was recalled from the market in June 2010, after at least 11 months’ availability on the market.
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