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Clinical Performance Evaluation of Continuous Glucose Monitoring Systems : A Scoping Review and Recommendations for Reporting

Freckmann, Guido (författare)
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
Eichenlaub, Manuel (författare)
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
Waldenmaier, Delia (författare)
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
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Pleus, Stefan (författare)
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
Wehrstedt, Stephanie (författare)
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
Haug, Cornelia (författare)
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
Witthauer, Lilian (författare)
Diabetes Center Berne, Bern, Switzerland; Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital Bern, Bern University Hospital and University of Bern, Bern, Switzerland
Jendle, Johan, 1963- (författare)
Örebro universitet,Institutionen för medicinska vetenskaper,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
Hinzmann, Rolf (författare)
Roche Diabetes Care GmbH, Mannheim, Germany,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
Thomas, Andreas (författare)
Pirna, Germany,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
Eriksson Boija, Elisabet (författare)
Equalis AB, Uppsala, Sweden,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
Makris, Konstantinos (författare)
Clinical Biochemistry Department, KAT General Hospital, Athens, Greece,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
Diem, Peter (författare)
Endokrinologie Diabetologie Bern, Bern, Switzerland,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
Tran, Nam (författare)
Department of Pathology and Laboratory Medicine, University of California Davis Health, Sacramento, CA, USA
Klonoff, David C. (författare)
Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
Nichols, James H. (författare)
IVanderbilt University Medical Center, Nashville, TN, USA,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
Slingerland, Robbert J. (författare)
epartment of Clinical Chemistry, Isala Clinics, Zwolle, the Netherlands,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
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 (creator_code:org_t)
Sage Publications, 2023
2023
Engelska.
Ingår i: Journal of Diabetes Science and Technology. - : Sage Publications. - 1932-2968. ; 17:6, s. 1506-1526
Relaterad länk:
https://urn.kb.se/re...
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https://doi.org/10.1...
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  • Forskningsöversikt (refereegranskat)
Abstract Ämnesord
Stäng  
  • 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.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)

Nyckelord

Accuracy
clinical performance evaluation
continuous glucose monitoring
study design

Publikations- och innehållstyp

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