ArticleJournal of diabetes science and technology2015
System Accuracy Evaluation of Four Systems for Self-Monitoring of Blood Glucose Following ISO 15197 Using a Glucose Oxidase and a Hexokinase-Based Comparison Method.
Article in Journal of diabetes science and technology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01789021 (Analytical Performance Evaluation of Blood Glucose Monitoring Systems), which is not on this map. Cited by 17 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Analytical Performance Evaluation of Blood Glucose Monitoring Systems
Who cites it
17 citing papers in PubMed.
- Quality assessment of glucose measurement with regard to epidemiology and clinical management of diabetes mellitus in Germany.Frontiers in molecular biosciences · 2024Article
- 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
- Haematological and biochemical reference intervals for wild green turtles (Conservation physiology · 2022Article
- Evidence From a Long-Term, Systematic Post-Market Surveillance Program: Clinical Performance of a Hematocrit-Insensitive Blood Glucose Test Strip.Journal of diabetes science and technology · 2021Article
- Analysis of "Capillary and Venous Blood Glucose Accuracy in Blood Glucose Meters Versus Reference Standards: The Impact of Study Design on Accuracy Evaluations".Journal of diabetes science and technology · 2019Article
- Article
- User Performance Evaluation of Four Blood Glucose Monitoring Systems Applying ISO 15197:2013 Accuracy Criteria and Calculation of Insulin Dosing Errors.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018Article
- Polysaccharide IV fromFrontiers in endocrinology · 2018Article
- Introduction of a Novel Smartphone-Coupled Blood Glucose Monitoring System.Journal of diabetes science and technology · 2017Article
- Strengths and Limitations of New Approaches for Graphical Presentation of Blood Glucose Monitoring System Accuracy Data.Journal of diabetes science and technology · 2017Article
- Do the New FDA Guidance Documents Help Improving Performance of Blood Glucose Monitoring Systems Compared With ISO 15197?Journal of diabetes science and technology · 2017Article
- Analysis of "Accuracy and User Performance Evaluation of a New, Wireless-Enabled Blood Glucose Monitoring System That Links to a Smart Mobile Device".Journal of diabetes science and technology · 2017Article
- Comparative Accuracy of 17 Point-of-Care Glucose Meters.Journal of diabetes science and technology · 2017Article
- Mobile technology for self-monitoring of blood glucose among patients with type 2 diabetes mellitus.mHealth · 2017Article
- The Rationale for Continuous Glucose Monitoring-based Diabetes Treatment Decisions and Non-adjunctive Continuous Glucose Monitoring Use.European endocrinology · 2016Review
- Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy: Relevant Differences Among ISO 15197:2003, ISO 15197:2013, and Current FDA Recommendations.Journal of diabetes science and technology · 2015Review
- Use of oral healthcare facilities for the screening of hyperglycaemia in dental patients with undiagnosed type-2 diabetes mellitus in Andhra Pradesh, India.Journal of oral and maxillofacial pathology : JOMFPArticle
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7 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundThe standard ISO (International Organization for Standardization) 15197 is widely accepted for the accuracy evaluation of systems for self-monitoring of blood glucose (SMBG). Accuracy evaluation was performed for 4 SMBG systems (Accu-Chek Aviva, ContourXT, GlucoCheck XL, GlucoMen LX PLUS) with 3 test strip lots each. To investigate a possible impact of the comparison method on system accuracy data, 2 different established methods were used.
methodsThe evaluation was performed in a standardized manner following test procedures described in ISO 15197:2003 (section 7.3). System accuracy was assessed by applying ISO 15197:2003 and in addition ISO 15197:2013 criteria (section 6.3.3). For each system, comparison measurements were performed with a glucose oxidase (YSI 2300 STAT Plus glucose analyzer) and a hexokinase (cobas c111) method.
resultsAll 4 systems fulfilled the accuracy requirements of ISO 15197:2003 with the tested lots. More stringent accuracy criteria of ISO 15197:2013 were fulfilled by 3 systems (Accu-Chek Aviva, ContourXT, GlucoMen LX PLUS) when compared to the manufacturer's comparison method and by 2 systems (Accu-Chek Aviva, ContourXT) when compared to the alternative comparison method. All systems showed lot-to-lot variability to a certain degree; 2 systems (Accu-Chek Aviva, ContourXT), however, showed only minimal differences in relative bias between the 3 evaluated lots.
conclusionsIn this study, all 4 systems complied with the evaluated test strip lots with accuracy criteria of ISO 15197:2003. Applying ISO 15197:2013 accuracy limits, differences in the accuracy of the tested systems were observed, also demonstrating that the applied comparison method/system and the lot-to-lot variability can have a decisive influence on accuracy data obtained for a SMBG system.
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