The Need for Standardization of Continuous Glucose Monitoring Performance Evaluation: An Opinion by the International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Continuous Glucose MonitoringWorking Group on Continuous Glucose Monitoring, Scientific Division, The International Federation of Clinical Chemistry and Laboratory Medicine, Milano, Italy; Lampertheim, Germany.
Working Group on Continuous Glucose Monitoring, Scientific Division, The International Federation of Clinical Chemistry and Laboratory Medicine, Milano, Italy; Diabetes Research Institute of Mills-Peninsula Medical Center, San Mateo, CA, USA.
Working Group on Continuous Glucose Monitoring, Scientific Division, The International Federation of Clinical Chemistry and Laboratory Medicine, Milano, Italy; Clinical Biochemistry Department, KAT General Hospital, Athens, Greece.
Working Group on Continuous Glucose Monitoring, Scientific Division, The International Federation of Clinical Chemistry and Laboratory Medicine, Milano, Italy; Vanderbilt University Medical Center, Nashville, TN, USA.
Working Group on Continuous Glucose Monitoring, Scientific Division, The International Federation of Clinical Chemistry and Laboratory Medicine, Milano, Italy; Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.
Working Group on Continuous Glucose Monitoring, Scientific Division, The International Federation of Clinical Chemistry and Laboratory Medicine, Milano, Italy; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Working Group on Continuous Glucose Monitoring, Scientific Division, The International Federation of Clinical Chemistry and Laboratory Medicine, Milano, Italy; Department of Clinical Chemistry, Isala Clinics, Zwolle, The Netherlands.
Working Group on Continuous Glucose Monitoring, Scientific Division, The International Federation of Clinical Chemistry and Laboratory Medicine, Milano, Italy; Independent Scientific Consulting, Pirna, Germany.
Working Group on Continuous Glucose Monitoring, Scientific Division, The International Federation of Clinical Chemistry and Laboratory Medicine, Milano, Italy; Department of Pathology and Laboratory Medicine, University of California Davis Health, Sacramento, CA, USA.
Working Group on Continuous Glucose Monitoring, Scientific Division, The International Federation of Clinical Chemistry and Laboratory Medicine, Milano, Italy; Diabetes Center Berne, Bern, Switzerland; Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital Bern, University of Bern, Bern, Switzerland.
Working Group on Continuous Glucose Monitoring, Scientific Division, The International Federation of Clinical Chemistry and Laboratory Medicine, Milano, Italy; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
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2024 (English)In: Journal of Diabetes Science and Technology, E-ISSN 1932-2968, article id 19322968241296097Article in journal (Refereed) Epub ahead of print
Abstract [en]
Metrics derived from continuous glucose monitoring (CGM) systems are often discordant between systems. A major cause is that CGM systems are not standardized; they use various algorithms and calibration methods, leading to discordant CGM readings across systems. This discordance can be addressed by standardizing CGM performance assessments: If manufacturers aim their CGM systems at the same target, then CGM readings will align across systems. This standardization should include the comparator device, sample origin, and study procedures. With better aligned CGM readings, CGM-derived metrics will subsequently also align better between systems.
Place, publisher, year, edition, pages
Diabetes Technology Society , 2024. article id 19322968241296097
Keywords [en]
IFCC, continuous glucose monitoring, standardization
National Category
Endocrinology and Diabetes
Identifiers
URN: urn:nbn:se:oru:diva-117360DOI: 10.1177/19322968241296097ISI: 001355575000001PubMedID: 39540398Scopus ID: 2-s2.0-85208928538OAI: oai:DiVA.org:oru-117360DiVA, id: diva2:1914008
Note
Funding:
Financial support was provided by Diabetes Center Berne.
2024-11-182024-11-182025-01-20Bibliographically approved