Submitting Continuous Glucose Monitoring Data in Clinical Trials

Issue Date: May 6, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s):
Status: Final

Submitting Continuous Glucose Monitoring Data in Clinical Trials

This document provides technical specifications for submitting continuous glucose monitoring (CGM) data in clinical trials to support a marketing application for a drug or biological product. In general, FDA’s guidance documents do not establish legally enforceable responsibilities.

Download the Guidance Document

Submitting Continuous Glucose Monitoring Data in Clinical Trials

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