Nevin Manimala Statistics

A statistical approach for assessing the compliance of integrated continuous glucose monitoring systems with FDA accuracy requirements

Diabetes Technol Ther. 2022 Oct 28. doi: 10.1089/dia.2022.0331. Online ahead of print.


To assess the compliance of “integrated” continuous glucose monitoring (CGM) systems with U.S. Food and Drug Administration (FDA) requirements, the calculation of confidence intervals on agreement rates, i.e., the percentage of CGM measurements lying within a certain deviation of a comparator method, is stipulated. However, despite the existence of numerous approaches that could yield different results, a specific procedure for calculating confidence intervals is not described anywhere. This report therefore proposes a suitable statistical procedure to allow transparency and comparability between CGM systems. Three existing methods were applied to six datasets from different CGM performance studies. The results indicate that a bootstrap-based method that accounts for the clustered structure of CGM data is reliable and robust. We thus recommend its use for the estimation of confidence intervals of agreement rates. A software implementation of the proposed method is freely available (

PMID:36306521 | DOI:10.1089/dia.2022.0331

By Nevin Manimala

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