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 (2023). Clinical Performance Evaluation of Continuous Glucose Monitoring Systems: A Scoping Review and Recommendations for Reporting. Journal of diabetes science and technology, 17(6), pp. 1506-1526. Diabetes Technology Society 10.1177/19322968231190941

Full text not available from this repository.

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.

Item Type:	Journal Article (Review Article)
Division/Institute:	04 Faculty of Medicine > Department of Gynaecology, Paediatrics and Endocrinology (DFKE) > Clinic of Endocrinology, Diabetology and Clinical Nutrition
UniBE Contributor:	Witthauer, Lilian
Subjects:	600 Technology > 610 Medicine & health
ISSN:	1932-2968
Publisher:	Diabetes Technology Society
Language:	English
Submitter:	Pubmed Import
Date Deposited:	21 Aug 2023 15:33
Last Modified:	02 Nov 2023 00:14
Publisher DOI:	10.1177/19322968231190941
PubMed ID:	37599389
Uncontrolled Keywords:	accuracy clinical performance evaluation continuous glucose monitoring study design
URI:	https://boris.unibe.ch/id/eprint/185628