Proposed minimum requirements for market approval of continuous glucose monitoring ( CGM ) systems: A viewpoint from the IFCC working group on CGM
Authors:
- Stefan PleusSPStefan Pleus
- Manuel EichenlaubMEManuel Eichenlaub
- Peter DiemPDPeter Diem
- Marion FokkertMFMarion Fokkert
- Rolf HinzmannRHRolf Hinzmann
- Johan JendleJJJohan Jendle
- David C. KlonoffDKDavid C. Klonoff
- Konstantinos MakrisKonstantinos Makris
- James H. NicholsJNJames H. Nichols
- John PembertonJPJohn Pemberton
- Elizabeth SelvinESElizabeth Selvin
- 28 April 2025
- journal article
- letter
- Published by Wiley in Diabetes, Obesity and Metabolism
- Vol. 27 (7) , 4039-4042
Abstract
No abstract availableKeywords
This publication has 10 references indexed in Scilit:
- Recommendations on the Collection of Comparator Measurement Data in the Performance Evaluation of Continuous Glucose Monitoring SystemsJournal of Diabetes Science and Technology, 2025
- Performance of Three Continuous Glucose Monitoring Systems in Adults With Type 1 DiabetesJournal of Diabetes Science and Technology, 2025
- Minimum expectations for market authorization of continuous glucose monitoring devices in Europe—‘ eCGM ’ compliance statusDiabetes, Obesity and Metabolism, 2024
- Comparator Data Characteristics and Testing Procedures for the Clinical Performance Evaluation of Continuous Glucose Monitoring SystemsDiabetes Technology & Therapeutics, 2024
- Effect of Arterialization on Venous Blood Glucose Concentrations and Implications for Observed Continuous Glucose Monitoring AccuracyDiabetes Technology & Therapeutics, 2024
- Clinical Performance Evaluation of Continuous Glucose Monitoring Systems: A Scoping Review and Recommendations for ReportingJournal of Diabetes Science and Technology, 2023
- A Statistical Approach for Assessing the Compliance of Integrated Continuous Glucose Monitoring Systems with Food and Drug Administration Accuracy RequirementsDiabetes Technology & Therapeutics, 2023
- Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA): A Novel Approach for the Statistical Accuracy Assessment of Continuous Glucose Monitoring SystemsJournal of Diabetes Science and Technology, 2022
- Improving the Bias of Comparator Methods in Analytical Performance Assessments Through RecalibrationJournal of Diabetes Science and Technology, 2022
- Fundamental Importance of Reference Glucose Analyzer Accuracy for Evaluating the Performance of Blood Glucose Monitoring Systems (BGMSs)Journal of Diabetes Science and Technology, 2016