Appendix F | Technical; Information - Dexcom G6 User Manual

Appendix F
F.1 Device Performance Characteristics
NOTE: We recommend that you review the information in this chapter with your
healthcare professional to understand how well the Dexcom G6 performs.
The Dexcom G6 (G6) uses a glucose sensor to continuously measure and monitor your
glucose levels. Once the sensor code is entered, the G6 reports glucose readings up to
every 5 minutes. The G6's performance was evaluated in clinical studies in which G6
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.
Participants wore either one or two sensors for up to 10 days. A subset of participants
wore two sensors for the precision study to compare variability of readings between
sensors. Adult participants wore their G6(s) in the abdomen only; pediatric subjects
had the choice of either abdomen or upper buttocks. Clinic session(s) took place at
the beginning (Day 1, 2), middle (Day 4, 5), and end (Day 7, 10) of the G6 lifecycle.
Depending on the participant's age, they participated in either 1, 2 or 3 clinic sessions
of varying duration.
Dexcom G6 ® System User Guide
Appendix F: Technical Information
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Technical Information
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