ArticleJournal of diabetes science and technology2017
Accuracy Evaluation of 19 Blood Glucose Monitoring Systems Manufactured in the Asia-Pacific Region: A Multicenter Study.
Article in Journal of diabetes science and technology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed.
- A Survey of the Current Practice for Testing for Neonatal Hypoglycaemia in Aotearoa, New Zealand.Journal of paediatrics and child health · 2025Article
- Metabolic, Hematological, and Functional Health in Adults with Down Syndrome and Significance of Parental Health Literacy: A Cross-Sectional Study.Healthcare (Basel, Switzerland) · 2025Article
- Quality assessment of glucose measurement with regard to epidemiology and clinical management of diabetes mellitus in Germany.Frontiers in molecular biosciences · 2024Article
- Comparative Study Between Blood Glucose Meters in a Maternity Center.Women's health reports (New Rochelle, N.Y.) · 2024Article
- Blood glucose monitoring devices: current considerations.Australian prescriber · 2023Review
- Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus.Diabetes care · 2023Review
- Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus.Clinical chemistry · 2023Article
- A Nanotechnology-Based Approach to Biosensor Application in Current Diabetes Management Practices.Nanomaterials (Basel, Switzerland) · 2023Review
- A Simulation Study to Assess the Effect of Analytic Error on Neonatal Glucose Measurements Using the Canadian Pediatric Society Position Statement Action Thresholds.Journal of diabetes science and technology · 2020Article
- System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015.BMJ open diabetes research & care · 2020Article
- Assessment of System Accuracy, Intermediate Measurement Precision, and Measurement Repeatability of a Blood Glucose Monitoring System Based on ISO 15197.Journal of diabetes science and technology · 2019Article
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Authors and funding
7 authors.
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Abstract
backgroundSystem accuracy of current blood glucose monitors (BGMs) in the market has already been evaluated extensively, yet mostly focused on European and North American manufacturers. Data on BGMs manufactured in the Asia-Pacific region remain to be established. In this study, we sought to assess the accuracy performance of 19 BGMs manufactured in the Asia-pacific region.
methodsA total of 19 BGMs were obtained from local pharmacies in China. The study was conducted at three hospitals located in the Asia-Pacific region. Measurement results of each system were compared with results of the reference instrument (YSI 2300 PLUS Glucose Analyzer), and accuracy evaluation was performed in accordance to the ISO 15197:2003 and updated 2015 guidelines. Radar plots, which is a new method, are described herein to visualize the analytical performance of the 19 BGMs evaluated. Consensus error grid is a tool for evaluating the clinical significance of the results.
resultsThe 19 BGMs resulted in a satisfaction rate between 83.5% and 100.0% within ISO 15197:2003 error limits, and between 71.3% and 100.0% within EN ISO 15197:2015 (ISO 15197:2013) error limits.
conclusionsOf the 19 BGMs evaluated, 12 met the minimal accuracy requirement of the ISO 15197:2003 standard, whereas only 4 met the tighter EN ISO 15197:2015 (ISO 15197:2013) requirements. Accuracy evaluation of BGMs should be performed regularly to maximize patient safety.
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