Introduction
This document outlines the statistical analysis plan for the evaluation of the updated continuous glucose monitoring (CGM) form factor in adults, adolescents, and pediatrics.
Background
The study aims to evaluate the performance of the updated CGM system in different age groups.
The study design includes subjects aged 14-80 years and 2-13 years, with a focus on sensor accuracy and safety evaluation.
Statistical Methods
The analysis will involve center pooling, handling of missing data, and adjustments for multiple comparisons.
The primary objective is to evaluate the accuracy of the CGM system, with secondary objectives including safety evaluation and health outcomes analyses.
Manual:
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