CGM Accuracy in a Fragmented Regulatory Landscape: A Commentary on Harmonisation and Recent Evidence

Diabetes Obesity and Metabolism 2026 Open access

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Authors: Tadej Battelino, Katrien Benhalima, Emanuele Bosi, Hélène P. Hanaire, Lutz Heinemann, Sufyan Hussain, JOHAN H. JENDLE, Olga Kordonouri, Alistair Lumb, Julia Katharina Mader, Kirsten Nørgaard, Charles H. Thivolet
+2 more Amir Tirosh, Francesco Giorgino
DOI: 10.1111/dom.71098
Cited by: 1
References: 35

Abstract

accuracy | continuous glucose monitoring | diabetesThe regulatory approval processes for CGM systems market access differ across geographic regions.Currently, there is no unified protocol for how CGM performance studies should be conducted and reported.In addition, there are no harmonised performance criteria that CGM systems must meet to be considered sufficiently accurate (when these protocols are followed).This variability allows market access for CGM systems of

Fields of Study & Subjects

Auditing Earnings Management Governance Monetary Policy and Economic Impact Psychometric Methodologies and Testing

Publication details

Journal / source
Diabetes Obesity and Metabolism
Publisher
Wiley
Volume
28
Issue
9
Pages
7665–7671
Publication date
9 July 2026
Language
EN