A Statistical Approach for Assessing the Compliance of Integrated Continuous Glucose Monitoring Systems with Food and Drug Administration Accuracy Requirements
Authors' conclusion
The results indicate that a bootstrap-based method that accounts for the clustered structure of CGM data is reliable and robust.
Study context
- Population
- Six data sets from different continuous glucose monitoring (CGM) performance studies6 data sets
- Comparison
- Three existing methods for calculating CIs of agreement rates
- Outcome
- CI estimation of agreement rates (ARs)
Methodological detailsSoftware implementation of the proposed method freely available (https://github.com/IfDTUlm/CGM_Performance_Assessment)
- Software implementation of the proposed method freely available (https://github.com/IfDTUlm/CGM_Performance_Assessment)
Main finding
As reported in the abstract
- A bootstrap-based method that accounts for the clustered structure of CGM data is reliable and robust
Original publication
A Statistical Approach for Assessing the Compliance of Integrated Continuous Glucose Monitoring Systems with Food and Drug Administration Accuracy Requirements. Diabetes Technol Ther. Published 28 February 2023. doi:10.
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