Proposed minimum requirements for market approval of continuous glucose monitoring (CGM) systems: A viewpoint from the IFCC working group on CGM.
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| Title: | Proposed minimum requirements for market approval of continuous glucose monitoring (CGM) systems: A viewpoint from the IFCC working group on CGM. |
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| Authors: | Pleus S; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring, Milano, Italy.; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany., Eichenlaub M; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany., Eriksson Boija E; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring, Milano, Italy.; Equalis AB, Uppsala, Sweden., Diem P; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring, Milano, Italy.; Endokrinologie Diabetologie Bern, Bern, Switzerland., Fokkert M; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring, Milano, Italy.; Department of Clinical Chemistry, Isala Clinics, Zwolle, The Netherlands., Hinzmann R; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring, Milano, Italy.; Lampertheim, Germany., Jendle J; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring, Milano, Italy.; School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden., Klonoff DC; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring, Milano, Italy.; Diabetes Research Institute of Mills-Peninsula Medical Center, San Mateo, California, USA., Makris K; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring, Milano, Italy.; Clinical Biochemistry Department, KAT General Hospital, Athens, Greece., Nichols JH; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring, Milano, Italy.; Vanderbilt University Medical Center, Nashville, Tennessee, USA., Pemberton J; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring, Milano, Italy.; Birmingham Women's and Children's Foundation Trust, Birmingham, UK., Selvin E; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring, Milano, Italy.; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Slingerland RJ; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring, Milano, Italy.; Department of Clinical Chemistry, Isala Clinics, Zwolle, The Netherlands., Thomas A; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring, Milano, Italy.; Independent Scientific Consulting, Pirna, Germany., Tran NK; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring, Milano, Italy.; Department of Pathology and Laboratory Medicine, University of California Davis Health, Sacramento, California, USA., Witthauer L; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring, Milano, Italy.; Diabetes Center Berne, Bern, Switzerland.; Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital Bern, Bern University Hospital and University of Bern, Bern, Switzerland., Freckmann G; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring, Milano, Italy.; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany. |
| Corporate Authors: | Working Group on Continuous Glucose Monitoring of the IFCC Scientific Division |
| Source: | Diabetes, obesity & metabolism [Diabetes Obes Metab] 2025 Jul; Vol. 27 (7), pp. 4039-4042. Date of Electronic Publication: 2025 Apr 28. |
| Publication Type: | Letter |
| Journal Info: | Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 100883645 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1463-1326 (Electronic) Linking ISSN: 14628902 NLM ISO Abbreviation: Diabetes Obes Metab Subsets: MEDLINE; In Process |
| Database: | MEDLINE Ultimate |
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| ISSN: | 1463-1326 |
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| DOI: | 10.1111/dom.16420 |
