User's Guide

Dexcom G6 System User Guide

Chapter 2: Indications for Use and Safety Statements

Safety Statements in Chapters

Each chapter shows applicable indications, contraindications, precautions, and

warnings. Some chapters have multiple Safety Statements; others have none. The

same statement may be repeated in several chapters.

2.3 Dexcom G6 Safety Statements

Indications for Use

The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real

time, continuous glucose monitoring device indicated for the management of diabetes

in persons age 2 years and older.

The Dexcom G6 System is intended to replace fingerstick blood glucose testing for

diabetes treatment decisions. Interpretation of the Dexcom G6 System results should

be based on the glucose trends and several sequential readings over time. The Dexcom

G6 System also aids in the detection of episodes of hyperglycemia and hypoglycemia,

facilitating both acute and long-term therapy adjustments.

The Dexcom G6 System is also intended to autonomously communicate with digitally

connected devices, including automated insulin dosing (AID) systems. The Dexcom

G6 System can be used alone or in conjunction with these digitally connected medical

devices for the purpose of managing diabetes.

Contraindication

• No MRI/CT/Diathermy – MR Unsafe

Don’t wear your CGM (sensor, transmitter, receiver, or smart device) for magnetic

resonance imaging (MRI), computed tomography (CT) scan, or high-frequency

electrical heat (diathermy) treatment.

The G6 hasn’t been tested in those situations. The magnetic fields and heat could

damage the components of the G6, which may cause it to display inaccurate G6

sensor glucose readings (G6 readings) or may prevent alerts. Without G6 readings

or alarm/alert notifications, you might miss a severe low or high glucose event.

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