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Clinical Performanc...
Clinical Performance Evaluation of Continuous Glucose Monitoring Systems : A Scoping Review and Recommendations for Reporting
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- 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
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- Eichenlaub, Manuel (författare)
- Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
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- 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
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- Wehrstedt, Stephanie (författare)
- Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
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- Haug, Cornelia (författare)
- Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
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- 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
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- Jendle, Johan, 1963- (författare)
- Örebro universitet,Institutionen för medicinska vetenskaper,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
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- Hinzmann, Rolf (författare)
- Roche Diabetes Care GmbH, Mannheim, Germany,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
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- Thomas, Andreas (författare)
- Pirna, Germany,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
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- Eriksson Boija, Elisabet (författare)
- Equalis AB, Uppsala, Sweden,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
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- Makris, Konstantinos (författare)
- Clinical Biochemistry Department, KAT General Hospital, Athens, Greece,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
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- Diem, Peter (författare)
- Endokrinologie Diabetologie Bern, Bern, Switzerland,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
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- Tran, Nam (författare)
- Department of Pathology and Laboratory Medicine, University of California Davis Health, Sacramento, CA, USA
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- Klonoff, David C. (författare)
- Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
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- Nichols, James H. (författare)
- IVanderbilt University Medical Center, Nashville, TN, USA,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
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- 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.
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Ingår i: Journal of Diabetes Science and Technology. - : Sage Publications. - 1932-2968. ; 17:6, s. 1506-1526
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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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
- ref (ämneskategori)
- for (ämneskategori)
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- Av författaren/redakt...
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Freckmann, Guido
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Eichenlaub, Manu ...
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Waldenmaier, Del ...
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Pleus, Stefan
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Wehrstedt, Steph ...
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Haug, Cornelia
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Witthauer, Lilia ...
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Jendle, Johan, 1 ...
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Hinzmann, Rolf
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Thomas, Andreas
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Eriksson Boija, ...
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Makris, Konstant ...
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Diem, Peter
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Tran, Nam
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Klonoff, David C ...
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Nichols, James H ...
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Slingerland, Rob ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Endokrinologi oc ...
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Journal of Diabe ...
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Örebro universitet