Article

System Accuracy Evaluation of 43 Blood Glucose Monitoring Systems for Self-Monitoring of Blood Glucose according to DIN EN ISO 15197

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
Journal of diabetes science and technology 09/2012; 6(5):1060-75. DOI: 10.1177/193229681200600510

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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    • "Regarded as the international standard, manufacturers of BG monitors for SMBG must provide documentation highlighting conformity to these ISO guidelines in order to obtain the Conformitè Européenne (CE) mark required for distribution of their products within the European Economic Area (EEA). Nevertheless, previously conducted evaluation studies have shown that several manufacturers have displayed the CE mark yet have not met such accuracy requirements [22] [23]. Furthermore, whether such BG monitors comply with the newly ISO 15197:2013 criteria remains of topical interest and is yet to be established as existing literature has only been able to utilise a draft version and not the final protocol. "
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