Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA): A Novel Approach for the Statistical Accuracy Assessment of Continuous Glucose Monitoring Systems.

ABSTRACT:

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

SUBMITTER: Eichenlaub M 

PROVIDER: S-EPMC11307236 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature