ArticleJournal of diabetes science and technology2019
Assessment of System Accuracy, Intermediate Measurement Precision, and Measurement Repeatability of a Blood Glucose Monitoring System Based on ISO 15197.
Article in Journal of diabetes science and technology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed.
- Laser-Assisted Self-Monitoring of Blood Glucose: Analytical Performance, Clinical Accuracy, and Usability of the HandyRay-Glu System.Diagnostics (Basel, Switzerland) · 2026Article
- Quality assessment of glucose measurement with regard to epidemiology and clinical management of diabetes mellitus in Germany.Frontiers in molecular biosciences · 2024Article
- Getting More Information From Glucose Meter Evaluations.Journal of diabetes science and technology · 2019Article
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Authors and funding
6 authors.
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Abstract
backgroundAnalytical quality of blood glucose monitoring systems (BGMS) is an important aspect for many diabetes patients. Sufficiently high analytical quality is required for adequate diabetes therapy.
methodsIn this study, system accuracy and measurement precision of a BGMS were assessed based on ISO 15197:2013. For system accuracy, this standard requires a specific glucose distribution and at least 95% of results obtained with the BGMS in capillary blood to fall within ±15 mg/dl or ±15% (at glucose concentrations <100 mg/dl or ≥100 mg/dl, respectively) of corresponding comparison method results, and at least 99% of results to be found within clinically acceptable consensus error grid (CEG) zones A and B. Based on ISO 15197:2013, intermediate measurement precision, using control solution, and measurement repeatability, using venous blood samples, were analyzed by calculation of standard deviations (SDs) and coefficients of variation (CV) at glucose concentrations <100 mg/dl or ≥100 mg/dl, respectively, although ISO 15197:2013 does not specify acceptance criteria.
resultsThe BGMS fulfilled system accuracy requirements with ≥99% of results within ±15 mg/dl or ±15% of the comparison method results, and 100% of results in CEG zones A and B. Intermediate measurement precision analysis showed SD ≤2.2 mg/dl and CV ≤2.3%. Analysis of measurement repeatability showed SD ≤2.1 mg/dl and CV ≤2.4%.
conclusionSystem accuracy requirements of ISO 15197:2013 were fulfilled by the BGMS. As ISO 15197:2013 does not specify precision requirements, precision analysis results were compared with those reported for other BGMS in the literature and found to be similar.
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