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The Dexcom G6 Pro Continuous Glucose Monitoring 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 is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the real-time Dexcom G6 Pro System results should be based on the glucose trends and several sequential readings over time. 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. Retrospective interpretation of data recorded by the Dexcom G6 Pro System should be conducted solely by a healthcare professional. The Dexcom G6 Pro System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom G6 Pro System is also intended to interface with digitally connected devices. The Dexcom G6 Pro System can be used alone or in conjunction with these digitally connected medical devices or assessing glycemic variability.

The Dexcom G6 Pro Continuous Glucose Monitoring (G6 Pro) System is a continuous glucose monitor that offers an introduction to CGM for users who would benefit from the supervision of their qualified Healthcare Professional (HCP) during early or initial use of CGM. The predicate of the Dexcom G6 Pro CGM System is the Dexcom G6 CGM System. G6 Pro consists of three main components: a sensor/applicator delivery system, a transmitter, and a mobile application (app). The sensor/applicator is identical to the sensor/applicator used in the G6 CGM System (K191450). The sensor is a small and flexible wire inserted into subcutaneous tissue where it converts glucose into electrical current. The G6 Pro Transmitter is connected to the sensor and is worn on the body. It samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm. The G6 Pro Transmitter's firmware includes an auto-start feature which enables the transmitter to start a session immediately upon attachment of the transmitter to the on-body wearable. The G6 Pro Transmitter can be used as a retrospective CGM data logger and it can also send realtime estimated glucose values to the G6 Mobile Application. The HCP selects which type of CGM session the patient receives (retrospective vs. real-time). The G6 Pro Transmitter Firmware supports a single-use 10-day sensor session per transmitter. The G6 App displays the current glucose reading (updated every 5 minutes) and glucose trends (up to 24 hours) from the transmitter.