Dexcom G6 Integrated Continuous Glucose Monitoring (CGM) System

The Dexcom G6 Continuous Glucose Monitoring System is an integrated continuous glucose monitoring system (iCGM). It is indicated for the management of diabetes in persons age 2 years and older.

The 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.

The table(s) below describes devices that are interoperable with the Dexcom G6. The G6 components are not cleared to connect to other medical devices or non-medical device technologies in the United States. Interoperable use of the G6 is reserved for Dexcom and the devices in the table(s) below.

Data from collaborator devices and products must be verified by those collaborator devices and products. Users should confirm data and connections with their collaborator devices and products.

TANDEM T:SLIM X2 WITH BASAL-IQ TECHNOLOGY
Purpose of the Interface	To display Dexcom iCGM information (e.g., glucose readings) on the Tandem's t:slim X2 pump to be used for diabetes treatment decisions and to suspend insulin delivery based on iCGM sensor readings.
Anticipated Users	People 6 years and older with diabetes mellitus requiring insulin.
Whether the iCGM connection controls another device	The iCGM readings do not control the pump. They provide CGM inputs to the pump’s algorithm.
Specifications for the iCGM interface	The iCGM and pump are paired to communicate via a secure Bluetooth protocol.

TANDEM T:SLIM X2 WITH CONTROL-IQ TECHNOLOGY
Purpose of the Interface	To display Dexcom iCGM information (e.g., glucose readings) on Tandem Diabetes Care's t:slim X2 pump which includes an embedded algorithm that automates basal insulin delivery, including delivery of automatic correction boluses (up to one/hour) based on iCGM sensor readings.
Anticipated Users	14 years and older with diabetes mellitus requiring insulin.
Whether the iCGM connection controls another device	The iCGM readings do not control the pump. They provide CGM inputs to the pump’s algorithm.
Specifications for the iCGM interface	The iCGM and pump are paired to communicate via a secure Bluetooth protocol.

For testing, standards and further information on the interoperability between the iCGM and other digitally connected medical devices, please see the other devices’ Summary of Safety and Effectiveness (available from the manufacturer or through https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm.

Dexcom G6 Pro Continuous Glucose Monitoring System (G6 Pro System)

The Dexcom G6 Pro Continuous Glucose Monitoring System (Dexcom G6 Pro System) is a real time continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. The Dexcom G6 Pro System may also be used as a retrospective glucose recording device indicated for assessing glycemic variability in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. The Dexcom G6 Pro System is an integrated continuous glucose monitoring system (iCGM). The Dexcom G6 Pro System is also intended to autonomously communicate with digitally connected devices. The table below describes the devices that are interoperable with the Dexcom G6 Pro System. The Dexcom G6 Pro System is not intended to interface with automated insulin dosing (AID) systems. Only compatible display devices (https://www.dexcom.com/compatibility) can be used to view real time data.

AUTHORIZED DATA EXTRACTION DEVICE
Purpose of the Interface	The authorized data extractio n device is a medical device data system that allows healthcare professionals to check system status, download and upload retrospective iCGM data.
Anticipated Users	Authorized healthcare professionals.
Whether the iCGM connection controls another device	The iCGM connection does not control the authorized data extraction device.
Specifications for the iCGM interface	The iCGM communicates with an authorized data extraction device via a secure Bluetooth communication protocol.

Dexcom G6 Glucose Program Continuous Glucose Monitoring System

The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is an integrated continuous glucose monitoring system (iCGM). Is it indicated for the management of diabetes in persons age 2 years and older without significant risk of severe hypoglycemia.

The Dexcom Glucose Program System is also intended to autonomously communicate with digitally connected devices. The Dexcom Glucose Program System can be used alone or in conjunction with digitally connected devices or services for the purpose of managing diabetes.

The table below describes devices that are interoperable with the Dexcom Glucose Program System. Interoperable use of the Dexcom Glucose Program System is reserved for Dexcom and the devices, non-devices, and services listed below. The Dexcom Glucose Program System is not intended to interface with automated insulin dosing (AID) systems, or other systems whose risk profile requires patient alarms.

	THIRD PARTY WELLNESS COACH CHAT	COMPATIBLE FITNESS TRACKERS – SEE DEXCOM.COM/COMPATIBILITY FOR MORE INFORMATION
Purpose of the Interface	The third-party wellness coach chat provides encouragement, education, and motivation regarding their diabetes management.	Users of the Dexcom Glucose Program System can view iCGM data on a compatible fitness tracker. This interface is not intended to replace information provided by the primary display mechanism (mobile app).
Anticipated Users	Persons age 2 years and older without significant risk of severe hypoglycemia	Persons age 2 years and older without significant risk of severe hypoglycemia with a compatible fitness tracker.
Whether the iCGM connection controls another device	The iCGM connection does not control the third party wellness coaching chat.	The iCGM connection does not control the compatible fitness tracker.
Specifications for the iCGM interface	The iCGM and coaching chat are incorporated into the Dexcom Glucose Program App. The chat interface is accessible only to authorized third party partners.	The iCGM and compatible fitness tracker communicate via a secure Bluetooth communication protocol.