E • Technical Information | Dexcom G7 User Guide 125
E • Technical Information
Device performance characteristics
NOTE: We recommend you review the information in this chapter with your healthcare
provider to understand how well the Dexcom G7 Continuous Glucose Monitoring
System (G7) performs.
G7 uses a glucose sensor to continuously measure and monitor your glucose levels.
G7 reports glucose readings (sensor readings) every 5 minutes. G7’s performance
was evaluated in a clinical study in which sensor readings were assessed against
blood glucose values tested by a comparator method for subjects 7 years of age and
older, and by fingerstick blood glucose meter for pediatric subjects 2 to 6 years of age.
The performance characteristics of G7 presented in the following sections conform to
the guidance for devices in the same classification.
Clinical study overview
To demonstrate the performance of G7, a prospective clinical study (Study 1) was
conducted at 12 centers across the United States. The study included both adult (18
years and older) and pediatric (2 to 17 years) participants. The study evaluated G7
performance, in terms of its safety, effectiveness, and precision. The study enrolled a
total of 482 participants with 87.3% having Type 1 diabetes mellitus and 12.7%
having Type 2 diabetes mellitus who were on either intensive insulin therapy (10.6%)
or non-intensive insulin therapy (2.1%).
Adult participants wore up to two G7s on the upper arm and pediatric subjects wore
up to two G7s on the upper arm and/or upper buttocks. A subset of participants wore
two sensors at the same wear location for the precision study to compare variability of
readings between sensors. Participants wore the sensors for up to 10.5 days with at
least one clinic session at the beginning (Day 1, 2), middle (Day 4, 7), and end (the
second half of Day 10 or the first half of Day 11) of the G7 lifecycle. Depending on the
participant’s age, they participated in either 1, 2, or 3 clinic sessions of varying
duration.
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