ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2018
User Performance Evaluation of Four Blood Glucose Monitoring Systems Applying ISO 15197:2013 Accuracy Criteria and Calculation of Insulin Dosing Errors.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02916576 (User Performance Evaluation of Contour® Plus One, Accu-Chek® Performa Connect, FreeStyle Optium Neo and OneTouch® Select Plus Blood Glucose Monitoring Systems Following ISO 15197), which is not on this map. Cited by 8 papers.
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The trial behind it
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User Performance Evaluation of Contour® Plus One, Accu-Chek® Performa Connect, FreeStyle Optium Neo and OneTouch® Select Plus Blood Glucose Monitoring Systems Following ISO 15197:2013; EN ISO 15197:2015
Who cites it
8 citing papers in PubMed, 19 citations in OpenAlex.
- Nanostructured electrode materials and flexible-substrate engineering for wearable multi-analyte biosensors in diabetes monitoring and personalized care: a comprehensive review.Journal of materials science. Materials in medicine · 2026Review
- Practices for glucose measurement with a glucometer in a population of diabetic patients. An observational study.Scientific reports · 2026Observational
- Reply to Pemberton and Brown.The American journal of clinical nutrition · 2025Article
- Accuracy of a novel calibratable real-time continuous glucose monitoring device based on FreeStyle libre in- and out-of-hospital.Frontiers in endocrinology · 2025Article
- Evaluation of System Accuracy, Precision, Hematocrit Influence, and User Performance of Two Blood Glucose Monitoring Systems Based on ISO 15197:2013/EN ISO 15197:2015.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024Article
- No Result: A Neglected Glucose Meter Metric.Journal of diabetes science and technology · 2022Article
- Self-Monitoring of Blood Glucose as an Integral Part in the Management of People with Type 2 Diabetes Mellitus.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2022Article
- Flash glucose monitoring in type 1 diabetes: A comparison with self-monitoring blood glucose.Journal of diabetes investigation · 2020Article
Corrections and comments
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe international standard ISO 15197:2013 requires a user performance evaluation to assess if intended users are able to obtain accurate blood glucose measurement results with a self-monitoring of blood glucose (SMBG) system. In this study, user performance was evaluated for four SMBG systems on the basis of ISO 15197:2013, and possibly related insulin dosing errors were calculated. Additionally, accuracy was assessed in the hands of study personnel.
methodsAccu-Chek
resultsIn the hands of lay-users three systems fulfilled ISO 15197:2013 accuracy criteria with the investigated test strip lot showing 96% (A), 100% (B), and 98% (C) of results within the defined limits. All systems fulfilled minimum accuracy criteria in the hands of study personnel [99% (A), 100% (B), 99.5% (C), 96% (D)]. Measurements with all four systems were within zones of the consensus error grid and surveillance error grid associated with no or minimal risk. Regarding calculated insulin dosing errors, all 99% ranges were between dosing errors of - 2.7 and + 1.4 units for measurements in the hands of lay-users and between - 2.5 and + 1.4 units for study personnel. Frequent lay-user errors were not checking the test strips' expiry date and applying blood incorrectly.
conclusionsData obtained in this study show that not all available SMBG systems complied with ISO 15197:2013 accuracy criteria when measurements were performed by lay-users.
trial registrationThe study was registered at ClinicalTrials.gov (NCT02916576).
fundingAscensia Diabetes Care Deutschland GmbH.
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