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Clinical Performance Evaluation of Continuous Glucose Monitoring Systems: A Scoping Review and Recommendations for Reporting.
Freckmann, Guido; Eichenlaub, Manuel; Waldenmaier, Delia; Pleus, Stefan; Wehrstedt, Stephanie; Haug, Cornelia; Witthauer, Lilian; Jendle, Johan; Hinzmann, Rolf; Thomas, Andreas; Eriksson Boija, Elisabet; Makris, Konstantinos; Diem, Peter; Tran, Nam; Klonoff, David C; Nichols, James H; Slingerland, Robbert J.
Afiliación
  • Freckmann G; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring.
  • Eichenlaub M; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
  • Waldenmaier D; 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.
  • Wehrstedt S; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
  • Haug C; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
  • Witthauer L; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
  • Jendle J; Diabetes Center Berne, Bern, Switzerland.
  • Hinzmann R; Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital Bern, Bern University Hospital and University of Bern, Bern, Switzerland.
  • Thomas A; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring.
  • Eriksson Boija E; School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
  • Makris K; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring.
  • Diem P; Roche Diabetes Care GmbH, Mannheim, Germany.
  • Tran N; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring.
  • Klonoff DC; Pirna, Germany.
  • Nichols JH; IFCC Scientific Division - Working Group on Continuous Glucose Monitoring.
  • Slingerland RJ; Equalis AB, Uppsala, Sweden.
J Diabetes Sci Technol ; 17(6): 1506-1526, 2023 11.
Article en En | MEDLINE | ID: mdl-37599389
The use of different approaches for design and results presentation of studies for the clinical performance evaluation of continuous glucose monitoring (CGM) systems has long been recognized as a major challenge in comparing their results. However, a comprehensive characterization of the variability in study designs is currently unavailable. This article presents a scoping review of clinical CGM performance evaluations published between 2002 and 2022. Specifically, this review quantifies the prevalence of numerous options associated with various aspects of study design, including subject population, comparator (reference) method selection, testing procedures, and statistical accuracy evaluation. We found that there is a large variability in nearly all of those aspects and, in particular, in the characteristics of the comparator measurements. Furthermore, these characteristics as well as other crucial aspects of study design are often not reported in sufficient detail to allow an informed interpretation of study results. We therefore provide recommendations for reporting the general study design, CGM system use, comparator measurement approach, testing procedures, and data analysis/statistical performance evaluation. Additionally, this review aims to serve as a foundation for the development of a standardized CGM performance evaluation procedure, thereby supporting the goals and objectives of the Working Group on CGM established by the Scientific Division of the International Federation of Clinical Chemistry and Laboratory Medicine.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Glucemia / Diabetes Mellitus Tipo 1 Tipo de estudio: Guideline / Risk_factors_studies / Systematic_reviews Límite: Humans Idioma: En Revista: J Diabetes Sci Technol Asunto de la revista: ENDOCRINOLOGIA Año: 2023 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Glucemia / Diabetes Mellitus Tipo 1 Tipo de estudio: Guideline / Risk_factors_studies / Systematic_reviews Límite: Humans Idioma: En Revista: J Diabetes Sci Technol Asunto de la revista: ENDOCRINOLOGIA Año: 2023 Tipo del documento: Article Pais de publicación: Estados Unidos