CGM Accuracy in a Fragmented Regulatory Landscape: A Commentary on Harmonisation and Recent Evidence
Year: 2026
Type: article
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
Source: Diabetes Obesity and Metabolism
DOI: 10.1111/dom.71098
Institutions: University of Ljubljana, Ljubljana University Medical Centre, Universitair Ziekenhuis Leuven, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Université Toulouse III - Paul Sabatier, Centre Hospitalier Universitaire de Toulouse, King's College London, Guy's and St Thomas' NHS Foundation Trust, Kings Health Partners, Örebro University, Kinderkrankenhaus auf der Bult, NIHR Oxford Biomedical Research Centre, Oxford Centre for Diabetes, Endocrinology and Metabolism, Oxford University Hospitals NHS Trust, Medical University of Graz, University of Copenhagen, Copenhagen University Hospital, Steno Diabetes Center Copenhagen, Tel Aviv University, Sheba Medical Center, Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari, University of Bari Aldo Moro
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,380
OpenAlex ID: W7167811449