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Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA) : A Novel Approach for the Statistical Accuracy Assessment of Continuous Glucose Monitoring Systems
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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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- Stephan, Peter (författare)
- Mannheim, 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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- Rothenbühler, Martina (författare)
- Diabetes Center Berne, Bern, Switzerland
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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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- Hinzmann, Rolf (författare)
- Roche Diabetes Care GmbH, Mannheim, Germany,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring (WG-CGM)
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- Thomas, Andreas (författare)
- Pirna, Germany,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring (WG-CGM)
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- Jendle, Johan, 1963- (författare)
- Örebro universitet,Institutionen för medicinska vetenskaper,Pir Department of Medical Sciences, Örebro University, Örebro, Sweden,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring (WG-CGM)
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- Diem, Peter (författare)
- Endokrinologie Diabetologie Bern, Bern, Switzerland,IFCC Scientific Division - Working Group on Continuous Glucose Monitoring (WG-CGM)
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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 (WG-CGM)
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(creator_code:org_t)
- 2022-11-03
- 2024
- Engelska.
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Ingår i: Journal of Diabetes Science and Technology. - : Diabetes Technology Society. - 1932-2968. ; 18:4, s. 857-865
- 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
- BACKGROUND: The accuracy of continuous glucose monitoring (CGM) systems is crucial for the management of glucose levels in individuals with diabetes mellitus. However, the discussion of CGM accuracy is challenged by an abundance of parameters and assessment methods. The aim of this article is to introduce the Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA), a new approach for a comprehensive characterization of CGM point accuracy which is based on the U.S. Food and Drug Administration requirements for "integrated" CGM systems.METHODS: The statistical concept of tolerance intervals and data from two approved CGM systems was used to illustrate the CG-DIVA.RESULTS: The CG-DIVA characterizes the expected range of deviations of the CGM system from a comparison method in different glucose concentration ranges and the variability of accuracy within and between sensors. The results of the CG-DIVA are visualized in an intuitive and straightforward graphical presentation. Compared with conventional accuracy characterizations, the CG-DIVA infers the expected accuracy of a CGM system and highlights important differences between CGM systems. Furthermore, it provides information on the incidence of large errors which are of particular clinical relevance. A software implementation of the CG-DIVA is freely available (https://github.com/IfDTUlm/CGM_Performance_Assessment).CONCLUSIONS: We argue that the CG-DIVA can simplify the discussion and comparison of CGM accuracy and could replace the high number of conventional approaches. Future adaptations of the approach could thus become a putative standard for the accuracy characterization of CGM systems and serve as the basis for the definition of future CGM performance requirements.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Nyckelord
- FDA iCGM requirements
- accuracy
- continuous glucose monitoring
- deviation intervals
- sensor-to-sensor variability
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- ref (ämneskategori)
- art (ämneskategori)
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- Av författaren/redakt...
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Eichenlaub, Manu ...
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Stephan, Peter
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Waldenmaier, Del ...
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Pleus, Stefan
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Rothenbühler, Ma ...
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Haug, Cornelia
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Hinzmann, Rolf
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Thomas, Andreas
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Jendle, Johan, 1 ...
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Diem, Peter
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Freckmann, Guido
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MEDICIN OCH HÄLS ...
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Journal of Diabe ...
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Örebro universitet