Executive Summary

The Dexcom G5 Mobile System is designed for non-adjunctive use in the treatment of diabetes mellitus.

Overview

The system consists of a sensor, transmitter, receiver, and mobile app, providing continuous glucose monitoring.

The system is intended to replace fingerstick glucose testing for diabetes management.

Clinical Studies

Clinical studies and simulation studies were conducted to evaluate the system’s performance and safety.

Results from these studies are included in the briefing materials.

Patient and Clinician Education

Revised instructions and education materials are provided for patients and clinicians.

These materials aim to ensure safe and effective use of the system.

Manual:

Download: Dexcom G5 Mobile CONTINUOUS GLUCOSE MONITORING SYSTEM Advisory Committee Briefing Materials

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