Clinical assessment and acceptance criteria for continuous glucose monitoring (CGM) system performance: A proposed guideline by the IFCC Working Group on CGMEqualis AB, Uppsala, Sweden. (IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy)
Department of Clinical Chemistry, Isala Clinics, Zwolle, the Netherlands. (IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy)
Medical & Scientific Consulting, Lampertheim, Germany. (IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy)
Diabetes Research Institute of Mills-Peninsula Medical Center, San Mateo, CA, USA. (IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy)
Department of Endocrinology and Metabolism, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; Shanghai Clinical Center for Diabetes; Shanghai Diabetes Institute; Shanghai Key Laboratory of Diabetes Mellitus, Shanghai, China. (IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy)
Clinical Biochemistry Department, KAT General Hospital, Athens, Greece. (IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy)
Madras Diabetes Research Foundation (ICMR Centre of Excellence in Research) & Dr. Mohan's Diabetes Specialities Centre (IDF Centre of Excellence in Diabetes), Chennai, India. (IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy)
Vanderbilt University Medical Center, Nashville, TN, USA. (IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy)
Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK. (IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy)
Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. (IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy)
Department of Clinical Chemistry, Isala Clinics, Zwolle, the Netherlands. (IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy)
Independent Scientific Consulting, Pirna, Germany. (IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy)
University of Pittsburgh Medical School, Pittsburgh, PA, USA. (IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy)
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Diabetes Center Berne, Bern, Switzerland. (IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy)
Institut für Diabetes-Technologie Ulm GmbH, Ulm, Germany. (IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy)
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2026 (English)In: Clinica Chimica Acta, ISSN 0009-8981, E-ISSN 1873-3492, Vol. 580, article id 120728Article in journal (Refereed) Published
Abstract [en]
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.
Place, publisher, year, edition, pages
Elsevier, 2026. Vol. 580, article id 120728
Keywords [en]
Accuracy requirements, Comparator measurements, Continuous glucose monitoring, Performance assessment, Standardization, Study procedures, Traceability
National Category
Endocrinology and Diabetes
Identifiers
URN: urn:nbn:se:oru:diva-125079DOI: 10.1016/j.cca.2025.120728ISI: 001636117300001PubMedID: 41253217Scopus ID: 2-s2.0-105024331650OAI: oai:DiVA.org:oru-125079DiVA, id: diva2:2014816
Funder
NIH (National Institutes of Health)
Note
Funding Agencies:
The Institut für Diabetes Technologie Ulm GmbH received financial support from the Diabetes Center Berne, Switzerland. Elisabeth Selvin was supported by a Merit Award from the American Heart Association, NIH/NHLBI grant K24 HL152440 and NIH grants.
Erratum: Corrigendum to “Clinical assessment and acceptance criteria for continuous glucose monitoring (CGM) system performance: A proposed guideline by the IFCC working group on CGM” [Clin. Chim. Acta 580 (2026) 120728]. Stefan Pleus, Manuel Eichenlaub, Pradeep Kumar Dabla, Peter Diem, Elisabet Eriksson Boija, Marion Fokkert, Rolf Hinzmann, Johan Jendle, David C. Klonoff, Jingyi Lu, Konstantinos Makris, Viswanathan Mohan, James H. Nichols, John S. Pemberton, Elizabeth Selvin, Robbert J. Slingerland, Andreas Thomas, Nam K. Tran, Lilian Witthauer, Guido Freckmann. Clinica Chimica Acta,2026,121124. https://doi.org/10.1016/j.cca.2026.121124.(https://www.sciencedirect.com/science/article/pii/S0009898126003062)
2025-11-192025-11-192026-06-04Bibliographically approved