Clinical assessment and acceptance criteria for continuous glucose monitoring (CGM) system performance: A proposed guideline by the IFCC Working Group on CGM
Continuous glucose monitoring (CGM) systems are essential tools for modern diabetes care. However, the assessment of their analytical performance has been hindered by a lack of standardization. This poses challenges for the field, as the choice of study procedures and evaluation methods can influence the observed performance, further complicating the comparisons between CGM systems and confounding the interpretation and use of CGM metrics as research outcomes. To address this issue, the Working Group on CGM of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has developed a comprehensive guideline for the clinical assessment of CGM systems. The guideline defines requirements for study design and procedures, characteristics of comparator measurements, minimum requirements for accuracy, and performance characterization.
Authors
- L. Witthauer (ORCID: https://orcid.org/0000-0001-9459-875X)
- Manuel Eichenlaub (ORCID: https://orcid.org/0000-0003-2150-3160)
- James H. Nichols (ORCID: https://orcid.org/0000-0002-3652-1612)
- Konstantinos Makris (ORCID: https://orcid.org/0000-0002-7896-9028)
- Elizabeth Selvin (ORCID: https://orcid.org/0000-0001-6923-7151)
- Stefan Pleus (ORCID: https://orcid.org/0000-0003-4629-7754)
- Marion Fokkert (ORCID: https://orcid.org/0000-0002-4687-1157)
- Viswanathan Mohan (ORCID: https://orcid.org/0000-0001-5038-6210)
- Peter Diem (ORCID: https://orcid.org/0000-0002-1190-9880)
- Rolf Hinzmann (ORCID: https://orcid.org/0000-0002-8419-4740)
- Jingyi Lu (ORCID: https://orcid.org/0000-0003-1105-4189)
- Robbert J. Slingerland (ORCID: https://orcid.org/0000-0002-8583-376X)
- Elisabet Eriksson Boija
- JOHAN H. JENDLE (ORCID: https://orcid.org/0000-0003-1025-1682)
- John Pemberton (ORCID: https://orcid.org/0000-0002-0730-7879)
- Pradeep Kumar Dabla (ORCID: https://orcid.org/0000-0003-1409-6771)
- Nam K. Tran (ORCID: https://orcid.org/0000-0003-1565-0025)
- Guido Freckmann (ORCID: https://orcid.org/0000-0002-0406-9529)
- Andreas Thomas (ORCID: https://orcid.org/0000-0002-6549-2793)
- David Charles Klonoff (ORCID: https://orcid.org/0000-0001-6394-6862)
Institutions
- Uppsala Monitoring Centre (SE)
- Johns Hopkins University (US)
- Universität Ulm (DE)
- Örebro University (SE)
- University Hospital of Bern (CH)
- Kantonsarchäologie (CH)
- Mills Peninsula Health Services (US)
- Scientific Consulting Group (US)
- University of Pittsburgh Medical Center (US)
- Dr. Mohan's Diabetes Specialities Centre (IN)
- Shanghai Sixth People's Hospital (CN)
- Isala (NL)
- KAT General Hospital of Attica (GR)
- Birmingham Women’s and Children’s NHS Foundation Trust (GB)
- Govind Ballabh Pant Hospital (IN)
- Oldham Council (GB)
- Vanderbilt University Medical Center (US)
Publication Details
- Journal
- Clinica Chimica Acta
- Published
- 2025-11-20
- DOI
- https://doi.org/10.1016/j.cca.2025.120728
- Citations
- 6
- Primary Topic
- Diabetes Management and Research
- Type
- article
- Field-Weighted Citation Impact
- 7.77