Clinical assessment and acceptance criteria for continuous glucose monitoring (CGM) system performance: A proposed guideline by the IFCC Working Group on CGM.

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Title: Clinical assessment and acceptance criteria for continuous glucose monitoring (CGM) system performance: A proposed guideline by the IFCC Working Group on CGM.
Authors: Pleus S; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Institut für Diabetes-Technologie Ulm GmbH, Ulm, Germany. Electronic address: stefan.pleus@idt-ulm.de., Eichenlaub M; Institut für Diabetes-Technologie Ulm GmbH, Ulm, Germany., Dabla PK; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Department of Biochemistry, Govind Ballabh Pant Institute of Postgraduate Medical Education & Research, New Delhi, India., Diem P; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Endokrinologie Diabetologie Bern, Bern, Switzerland., Eriksson Boija E; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Equalis AB, Uppsala, Sweden., Fokkert M; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Department of Clinical Chemistry, Isala Clinics, Zwolle, the Netherlands., Hinzmann R; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Medical & Scientific Consulting, Lampertheim, Germany., Jendle J; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, 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, Italy; Diabetes Research Institute of Mills-Peninsula Medical Center, San Mateo, CA, USA., Lu J; 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., Makris K; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Clinical Biochemistry Department, KAT General Hospital, Athens, Greece., Mohan V; 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., Nichols JH; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Vanderbilt University Medical Center, Nashville, TN, USA., Pemberton JS; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK., Selvin E; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Slingerland RJ; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Department of Clinical Chemistry, Isala Clinics, Zwolle, the Netherlands., Thomas A; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Independent Scientific Consulting, Pirna, Germany., Tran NK; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; University of Pittsburgh Medical School, Pittsburgh, PA, USA., Witthauer L; 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., Freckmann G; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Institut für Diabetes-Technologie Ulm GmbH, Ulm, Germany.
Corporate Authors: Working Group on Continuous Glucose Monitoring of the IFCC Scientific Division
Source: Clinica chimica acta; international journal of clinical chemistry [Clin Chim Acta] 2026 Jan 30; Vol. 580, pp. 120728. Date of Electronic Publication: 2025 Nov 16.
Publication Type: Journal Article; Practice Guideline
Journal Info: Publisher: Elsevier Country of Publication: Netherlands NLM ID: 1302422 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-3492 (Electronic) Linking ISSN: 00098981 NLM ISO Abbreviation: Clin Chim Acta Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Clinical assessment and acceptance criteria for continuous glucose monitoring (CGM) system performance: A proposed guideline by the IFCC Working Group on CGM.
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  Data: <searchLink fieldCode="AU" term="%22Pleus+S%22">Pleus S</searchLink>; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Institut für Diabetes-Technologie Ulm GmbH, Ulm, Germany. Electronic address: stefan.pleus@idt-ulm.de.<br /><searchLink fieldCode="AU" term="%22Eichenlaub+M%22">Eichenlaub M</searchLink>; Institut für Diabetes-Technologie Ulm GmbH, Ulm, Germany.<br /><searchLink fieldCode="AU" term="%22Dabla+PK%22">Dabla PK</searchLink>; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Department of Biochemistry, Govind Ballabh Pant Institute of Postgraduate Medical Education & Research, New Delhi, India.<br /><searchLink fieldCode="AU" term="%22Diem+P%22">Diem P</searchLink>; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Endokrinologie Diabetologie Bern, Bern, Switzerland.<br /><searchLink fieldCode="AU" term="%22Eriksson+Boija+E%22">Eriksson Boija E</searchLink>; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Equalis AB, Uppsala, Sweden.<br /><searchLink fieldCode="AU" term="%22Fokkert+M%22">Fokkert M</searchLink>; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Department of Clinical Chemistry, Isala Clinics, Zwolle, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Hinzmann+R%22">Hinzmann R</searchLink>; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Medical & Scientific Consulting, Lampertheim, Germany.<br /><searchLink fieldCode="AU" term="%22Jendle+J%22">Jendle J</searchLink>; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.<br /><searchLink fieldCode="AU" term="%22Klonoff+DC%22">Klonoff DC</searchLink>; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Diabetes Research Institute of Mills-Peninsula Medical Center, San Mateo, CA, USA.<br /><searchLink fieldCode="AU" term="%22Lu+J%22">Lu J</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Makris+K%22">Makris K</searchLink>; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Clinical Biochemistry Department, KAT General Hospital, Athens, Greece.<br /><searchLink fieldCode="AU" term="%22Mohan+V%22">Mohan V</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Nichols+JH%22">Nichols JH</searchLink>; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Vanderbilt University Medical Center, Nashville, TN, USA.<br /><searchLink fieldCode="AU" term="%22Pemberton+JS%22">Pemberton JS</searchLink>; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.<br /><searchLink fieldCode="AU" term="%22Selvin+E%22">Selvin E</searchLink>; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.<br /><searchLink fieldCode="AU" term="%22Slingerland+RJ%22">Slingerland RJ</searchLink>; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Department of Clinical Chemistry, Isala Clinics, Zwolle, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Thomas+A%22">Thomas A</searchLink>; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Independent Scientific Consulting, Pirna, Germany.<br /><searchLink fieldCode="AU" term="%22Tran+NK%22">Tran NK</searchLink>; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; University of Pittsburgh Medical School, Pittsburgh, PA, USA.<br /><searchLink fieldCode="AU" term="%22Witthauer+L%22">Witthauer L</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Freckmann+G%22">Freckmann G</searchLink>; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring, Italy; Institut für Diabetes-Technologie Ulm GmbH, Ulm, Germany.
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  Data: <searchLink fieldCode="JN" term="%221302422%22">Clinica chimica acta; international journal of clinical chemistry</searchLink> [Clin Chim Acta] 2026 Jan 30; Vol. 580, pp. 120728. <i>Date of Electronic Publication: </i>2025 Nov 16.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier%22">Elsevier </searchLink><i>Country of Publication: </i>Netherlands <i>NLM ID: </i>1302422 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1873-3492 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2200098981%22">00098981 </searchLink><i>NLM ISO Abbreviation: </i>Clin Chim Acta <i>Subsets: </i>MEDLINE
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        Value: 10.1016/j.cca.2025.120728
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