ArticleJournal of diabetes science and technology2012
System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197.
Article in Journal of diabetes science and technology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 91 papers.
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91 citing papers in PubMed.
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- Current and future therapies to treat impaired awareness of hypoglycemia.Frontiers in pharmacology · 2023Review
- Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems.Journal of diabetes science and technology · 2022Article
- Clinical Study of a High Accuracy Green Design Blood Glucose Monitor Using an Innovative Optical Transmission Absorbance System.Journal of diabetes science and technology · 2022Article
- Mean Absolute Relative Difference of Blood Glucose Monitoring Systems and Relationship to ISO 15197.Journal of diabetes science and technology · 2022Article
- Do We Need the Replacement of YSI 2300? A View from the Clinical Laboratory.Journal of diabetes science and technology · 2022Article
- Evaluation of Glycemic Index of Six Different Samples of Commercial and Experimental Pasta Differing in Wheat Varieties and Production Processes.Foods (Basel, Switzerland) · 2021Article
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31 more citing papers are in PubMed but not listed here.
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6 authors.
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Abstract
backgroundThe accuracy of systems for self-monitoring of blood glucose is important, as reliable measurement results are a prerequisite for therapeutic decisions.
methodsThis 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).
resultsComplete 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%.
conclusionsFrom 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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