F • Technical Information; Device Performance Summary - Dexcom G7 User Manual

F • Technical Information

Device performance summary

Dexcom assessed device performance in a clinical study with 482 participants. The
adult (18 years and older) and pediatric (2 to 17 years old) participants all had type 1
or type 2 diabetes.
Participants wore G7 devices for up to 10.5 days on both their arm and abdomen.
Pediatrics aged 2 to 6 may have worn a device on their upper buttocks instead of their
arm or abdomen.
Each participant attended up to three clinic sessions during the beginning, middle, or
end of the 10.5 day wear period to have their blood glucose measured every 15
minutes with a laboratory reference method, the Yellow Springs Instrument 2300
STAT Plus™ Glucose Analyzer (or a blood glucose meter for pediatrics aged 2 to 6).
The G7 device was compared to the laboratory reference method to evaluate accuracy
in participants aged 7 years and older.
Accuracy
When LOWER is better
Adults
8.7%
Beginning: 10.1%
Middle: 7.6%
End: 8.1%
F • Technical Information |
Performance Metrics*
Overall Accuracy
Mean ARD% (MARD), 40–400 mg/dL
(% average absolute difference versus
reference glucose across the range of
glucose levels)
Accuracy Over Time
Mean ARD% (MARD), 40–400 mg/dL
Dexcom G7 User Guide
Pediatrics
8.5%
Beginning: 9.9%
Middle: 7.4%
End: 7.6%
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