학술논문
Comparator Data Characteristics and Testing Procedures for the Clinical Performance Evaluation of Continuous Glucose Monitoring Systems.
Document Type
Academic Journal
Author
Eichenlaub M; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.; Pleus S; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring.; Rothenbühler M; Diabetes Center Berne, Bern, Switzerland.; Bailey TS; AMCR Institute, Escondido, California, USA.; Bally L; Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital Bern, Bern University Hospital and University of Bern, Bern, Switzerland.; Brazg R; Rainier Clinical Research Center, Renton, Washington, USA.; Bruttomesso D; Division of Metabolic Disease, Department of Medicine, University of Padua, Padua, Italy.; Diem P; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring.; Endokrinologie Diabetologie Bern, Bern, Switzerland.; Eriksson Boija E; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring.; Equalis AB, Uppsala, Sweden.; Fokkert M; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring.; Department of Clinical Chemistry, Isala Clinics, Zwolle, The Netherlands.; Haug C; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.; Hinzmann R; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring.; Roche Diabetes Care GmbH, Mannheim, Germany.; Jendle J; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring.; School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.; Klonoff DC; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring.; Diabetes Research Institute of Mills-Peninsula Medical Center, San Mateo, California, USA.; Mader JK; Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.; Makris K; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring.; Clinical Biochemistry Department, KAT General Hospital, Athens, Greece.; Moser O; Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.; Department of Exercise Physiology and Metabolism, University of Bayreuth, Bayreuth, Germany.; Nichols JH; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring.; Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Nørgaard K; Steno Diabetes Center Copenhagen, Herlev, Denmark.; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.; Pemberton J; Birmingham Women's and Children's Foundation Trust, Birmingham, United Kingdom.; Selvin E; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring.; Department of Cardiovascular and Clinical Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.; Spanou L; Department of Endocrinology, Diabetes and Metabolism, Hellenic Red Cross Hospital, Athens, Greece.; Thomas A; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring.; Independent Scientific Consulting, Pirna, Germany.; Tran NK; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring.; 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.; Diabetes Center Berne, Bern, Switzerland.; Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital Bern, Bern University Hospital and University of Bern, Bern, Switzerland.; Slingerland RJ; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring.; Department of Clinical Chemistry, Isala Clinics, Zwolle, The Netherlands.; Freckmann G; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.; IFCC Scientific Division, Working Group on Continuous Glucose Monitoring.
Source
Publisher: Mary Ann Liebert, Inc Country of Publication: United States NLM ID: 100889084 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-8593 (Electronic) Linking ISSN: 15209156 NLM ISO Abbreviation: Diabetes Technol Ther Subsets: MEDLINE
Subject
Language
English
Abstract
Comparing the performance of different continuous glucose monitoring (CGM) systems is challenging due to the lack of comprehensive guidelines for clinical study design. In particular, the absence of concise requirements for the distribution of comparator (reference) blood glucose (BG) concentrations and their rate of change (RoC) that are used to evaluate CGM performance, impairs comparability. For this article, several experts in the field of CGM performance testing have collaborated to propose characteristics of the distribution of comparator measurements that should be collected during CGM performance testing. Specifically, it is proposed that at least 7.5% of comparator BG concentrations are <70 mg/dL (3.9 mmol/L) and >300 mg/dL (16.7 mmol/L), respectively, and that at least 7.5% of BG-RoC combinations indicate fast BG changes with impending hypo- or hyperglycemia, respectively. These proposed characteristics of the comparator data can facilitate the harmonization of testing conditions across different studies and CGM systems and ensure that the most relevant scenarios representing real-life situations are established during performance testing. In addition, a study protocol and testing procedure for the manipulation of glucose levels are suggested that enable the collection of comparator data with these characteristics. This work is an important step toward establishing a future standard for the performance evaluation of CGM systems.