20.500.12556/DiRROS-28435 International clinical opinion on transparency, standardisation, and calibration alignment in the performance evaluation of systems for continuous glucose monitoring Continuous glucose monitoring (CGM) is now central to diabetes management, yet variation in how respective medical products are evaluated limits meaningful comparison between CGM systems. Three barriers currently constrain reliable interpretation of glucose-derived measures. The first is limited transparency: in several regulatory settings, particularly those using Conformité Européenne marking, clinical-study reports, reference-method information and analytical documentation required for market authorisation are not publicly accessible. The second barrier is heterogeneity in study procedures. Existing evaluations use different reference-glucose methods, sampling strategies, glucose-manipulation protocols and participant characteristics, leading to accuracy estimates that cannot be interpreted consistently across systems. The third barrier is calibration alignment. Even with full transparency and aligned procedures, CGM systems may differ because their calibration algorithms are trained on distinct reference-glucose datasets, influencing reported glucose ranges, automated insulin-delivery behaviour and interpretation during device transitions. A modified Delphi process involving clinicians, laboratory scientists, and researchers identified these issues as the principal determinants of comparability. During this process, the International Federation of Clinical Chemistry and Laboratory Medicine released a validated framework for performance evaluation of CGM systems, providing a unified approach to reference-method selection, dynamic in-clinic testing, and structured reporting. Adoption would reduce procedural variability but does not resolve calibration-alignment differences. This international clinical opinion proposes a pathway towards internationally interpretable CGM evaluation: immediate transparency of clinical evidence, routine declaration of calibration alignment, and progressive adoption of validated standardised procedures. These steps provide a foundation for reliable interpretation and globally comparable assessment of CGM technologies. continuous glucose monitoring CGM diabetes management evaluation true false true Angleški jezik Ni določen Neznano 2026-03-19 09:28:14 2026-03-19 09:28:15 2026-03-26 03:43:11 0000-00-00 00:00:00 2026 0 0 Nasl. z nasl. zaslona; Opis vira z dne 13. 2. 2026; str. 2551-2565 issue 4 Vol. 28 2026 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 616.379 1463-1326 10.1111/dom.70460 268352003 RAZ_Pemberton_John_S._2026.pdf RAZ_Pemberton_John_S._2026.pdf 1 3BFC416FA32E1BFFF8EFAAE2B11FF802 b1d101287faa50d4f1d8514d9185c4cb96ee85583b3f53a79140f3dd55ffd60a ccd6a1fe-236d-11f1-8070-001a4af901a5 https://dirros.openscience.si/Dokument.php?lang=slv&id=42092 https://dom-pubs.pericles-prod.literatumonline.com/doi/10.1111/dom.70460 0 e1f531d4-236d-11f1-8070-001a4af901a5 https://dirros.openscience.si/Dokument.php?lang=slv&id=42093 Univerzitetni klinični center Ljubljana 0 0 0