Dexcom G7 - Page 151

Sensor Stability
Sensors can be worn for up to 10 days plus a 12-hour grace period. Performance was
estimated by calculating the percentage of sensor readings within 15 mg/dL or 15%
(15/15%), 20 mg/dL or 20% (20/20%), and 40 mg/dL or 40% (40/40%) of the YSI
values at the beginning (Day 1, 2), middle (Day 4, 7), and end (the second half of Day
10, the first half of Day 11) of the G7 lifecycle. For blood glucose values less than 70
mg/dL, the absolute difference in mg/dL between the two glucose results was
calculated. For values greater than or equal to 70 mg/dL, the absolute difference (%)
relative to the YSI values was calculated. In addition, the mean absolute relative
difference (MARD) shows the average amount the sensor readings differ from the YSI
glucose. The MARD values included in Table 6-A and 6-B show G7 is highly accurate
over the 10.5-day life of the sensor.
Table 6-A. Sensor stability relative to YSI (accuracy over time
1
) (adults; n=308)
Wear
period
Number of paired
CGM-YSI
MARD
(%)
Percent within
15/15% YSI
(%)
Percent within
20/20% YSI
(%)
Percent within
40/40% YSI
(%)
Beginning 14,280 9.9 82.7 91.1 99.0
Middle 13,210 7.2 91.8 96.9 99.9
End 11,703 7.2 91.8 96.4 99.8
1
CGM readings are within 40 to 400 mg/dL, inclusive.
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