ArticleJournal of diabetes science and technology2017
Do the New FDA Guidance Documents Help Improving Performance of Blood Glucose Monitoring Systems Compared With ISO 15197?
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 10 papers.
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Who cites it
10 citing papers in PubMed.
- 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
- Technologies for Diabetes Self-Monitoring: A Scoping Review and Assessment Using the REASSURED Criteria.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
- Glucose biosensors in clinical practice: principles, limits and perspectives of currently used devices.Theranostics · 2022Review
- Evaluation of Precision and Bias Specifications Required to Achieve the 2018 FDA Guidance Criteria for Glucose Meter Performance Using Simulation Models.Journal of diabetes science and technology · 2020Article
- Accuracy and stability of an arterial sensor for glucose monitoring in a porcine model using glucose clamp technique.Scientific reports · 2020Article
- 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
- 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
- Impact of Glucose Measuring Systems and Sample Type on Diagnosis Rates of Diabetes Mellitus.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018Article
- Self-measurement of Blood Glucose and Continuous Glucose Monitoring - Is There Only One Future?European endocrinology · 2018Review
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Recently, the Food and Drug Administration (FDA) published guidance documents for point-of-care testing (POCT) and over-the-counter (OTC) blood glucose monitoring systems (BGMS). These are expected to improve weaknesses of the already established ISO 15197:2013 standard accuracy evaluation for OTC BGMS; however, the proposed criteria and procedures rather raise new questions. As an example, the OTC guidance stipulates tighter accuracy criteria in the low glycemic range than the POCT guidance for no obvious reason. Furthermore, a clear definition of requirements for the reference method is missing under consideration of the strict accuracy criteria. External surveillance of BGMS after introduction to the market is an issue that is addressed neither in the FDA documents, nor in ISO 15197, but in the Clinical and Laboratory Standards Institute (CLSI) guideline POCT12-A3.
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