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


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

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).

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%.

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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Available from: Manuela Link, Apr 22, 2014
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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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    ABSTRACT: Use of blood glucose (BG) meters in the self-monitoring of blood glucose (SMBG) significantly lowers the risk of diabetic complications. With several BG meters now commercially available, the International Organization for Standardization (ISO) ensures that each BG meter conforms to a set degree of accuracy. Although adherence to ISO guidelines is a prerequisite for commercialization in Europe, several BG meters claim to meet the ISO guidelines yet fail to do so on internal validation. We conducted a study to determine whether the accuracy of the GlucoRx Nexus TD-4280 meter, utilized by our department for its cost-effectiveness, complied with ISO guidelines. 105 patients requiring laboratory blood glucose analysis were randomly selected and reference measurements were determined by the UniCel DxC 800 clinical system. Overall the BG meter failed to adhere to the ≥95% accuracy criterion required by both the 15197:2003 (overall accuracy 92.4%) and 15197:2013 protocol (overall accuracy 86.7%). Inaccurate meters have an inherent risk of over-and/or underestimating the true BG concentration, thereby risking patients to incorrect therapeutic interventions. Our study demonstrates the importance of internally validating the accuracy of BG meters to ensure that its accuracy is accepted by standardized guidelines.
    Full-text · Article · Oct 2014 · Disease markers
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    • "These elements alone or when combined can significantly impact BG measurement accuracy with POC glucose monitoring devices[2]. Since inaccurate systems bear the risk of false therapeutic decisions, standardized and regular evaluation of BG meters and test strips should be requested in order to ensure adherenceJ Med Diagn Meth ISSN: 2168-9784 JMDM, an open access journal to accuracy and quality standards[6]. The use of glucose meters like SensoCard for blood glucose monitoring in DM patients is increasing from time to time in Ethiopia. "
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    ABSTRACT: Introduction: Diabetes mellitus is a cause of morbidity, disability and mortality worldwide. Glucose measurement by glucose meter is one of the diagnosing and monitoring tools of diabetes mellitus. However, the accuracy of this instrument is in question. Therefore, the aim of this study was to assess the accuracy of SensoCard glucose meter comparing with reference glucose oxidase method at University of Gondar Hospital, Gondar, Ethiopia. Methods: A prospective cross-sectional study was conducted in March, 2014. A total of 122 (equal number of type 1 and II) diabetic mellitus patients were selected by consecutive sampling technique. Glucose value was determined by SensoCard glucose meter and reference glucose oxidase method. The data were entered and analyzed using SPSS version 20 and Analyse-it version 3.76.1 softwares. Correlation coefficient and bias were calculated to observe the agreement of the glucose meter result with the comparative method. The minimum accuracy of Sensocard was determined based ISO 15197:2003 and ISO 15197:2013 criteria. Results: Sixty three (51.6%) participants were females. The mean age was 46.16 ± 15.5. The mean serum glucose value measured by reference method was 164.78 ± 86.33 mg/dl and the mean capillary blood glucose value measured by SensoCard glucose meter was 161.19 ± 78.1 mg/dl. There was no statistically significant difference between the means of SensoCard glucose meter and reference method glucose value (p-value=0.052). The correlation coefficient between the two methods was 0.975. The SensoCard glucose meter underestimated the overall glucose value from the reference method glucose value by a bias of 3.59. Conclusion: SensoCard did not fulfill the minimum accuracy requirements of ISO 15197:2003 and ISO 15197:2013. Further study should be undertaken including hypoglycemic and normoglycemic individuals to see the accuracy of SensoCard in low and normal levels of blood glucose in addition to high blood glucose level in diabetes mellitus patients.
    Full-text · Article · Sep 2014
    • "In lieu of these errors, accuracy is always a concern when using glucometers. The ISO: 15197 standards discuss quality standards in blood glucose monitoring devices and the accuracy requirements for glucometers.[24] This standard states that 95% of comparative results between a laboratory reference and the glucometer must fall within a bias of 15% for results greater than 100 mg%. "
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    ABSTRACT: Blood glucose monitoring has evolved over the last century. The concept of adequate glycemic control and minimum glycemic variability requires an ideal, accurate and reliable glucose monitoring system. The search for an ideal blood glucose monitoring system still continues. This review explains the various blood glucose monitoring systems with special focus on the monitoring systems like self- monitored blood glucose (SMBG) and continuous glucose monitoring system (CGMS). It also focuses on the newer concepts of blood glucose monitoring and their incorporation in routine clinical management of diabetes mellitus.
    No preview · Article · Dec 2013
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