Technical Information; Device Performance Characteristics; Clinical Study Overview - Dexcom G6 Pro User Manual

Appendix G: Technical Information
The device performance described in this section are from studies
conducted for the Dexcom G6 CGM System (G6). The performance of
the G6 is relevant because the G6 Pro uses the same sensor
and transmitter.
NOTE: We recommend that you review the information in this
chapter with your patient to understand how well the Dexcom G6
systems perform.
G.1 Device Performance Characteristics
The G6 uses a glucose sensor to continuously measure and monitor
your patient's glucose levels. After the sensor warmup is complete, the
G6 reports glucose readings every 5 minutes. The G6's performance
was evaluated in clinical studies in which G6 Pro readings were
assessed against blood glucose values tested by a laboratory reference
method for subjects 6 years of age and older and by fingerstick
blood glucose meter for pediatric subjects 2 to 5 years of age. The
performance characteristics of the G6 presented in the following
sections conform to the guidance for devices in the
same classification.

Clinical Study Overview

To demonstrate the performance of the G6, two prospective clinical
studies were conducted at 11 centers across the United States. The
studies included both adult (18 years and older) and pediatric (2 to
17 years) participants. The studies evaluated the G6 performance, in
terms of its safety, effectiveness, and precision. The studies enrolled a
total of 380 participants with 99% having type 1 diabetes mellitus and
1% having insulin using type 2 diabetes mellitus.
G6 Pro User Guide
Appendix G: Technical Information
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