Dexcom G7 User Manual page 152

Table 6-B. Sensor stability relative to YSI (accuracy over time
n=122)
Wear Number of paired
period CGM-YSI
Beginning 3,378
Middle 3,341
End 1,349
* Includes pediatric subjects 7-17 years of age; no YSI measurements were taken for
pediatric subjects 2-6 years of age.
1
CGM readings are within 40 to 400 mg/dL, inclusive.
Sensor Life
Subjects wore multiple sensors during the study. Prior to insertion, subjects and
caregivers cleaned hands and insertion sites with soap and water, allowing both to
fully dry. An alcohol wipe was then used to wipe the insertion site. The site was
allowed to fully dry. After insertion, gentle pressure was applied to the sensor for 10
seconds, the adhesive patch was rubbed 3 times, and overpatches were applied.
Sensors are designed to be worn for up to 10 days with an optional 12-hour grace
period. Some sensors may not survive the full 10 days for a variety of reasons. To
estimate how long a sensor will work over the intended use life of 10 days, sensors
worn were evaluated to determine how many days and hours of readings each sensor
provided.
For adults, a total of 315 sensors were evaluated. 80.5% of the sensors lasted through
the end of the entire 10-day wear period (see Figure 1-A). Among the 315 sensors
evaluated, 38 sensors (12.1%) possibly had early sensor shut-off where the sensor
algorithm would have detected sensors that did not function as intended and shut
them off.
E • Technical Information |
Percent within
MARD
15/15% YSI
(%)
9.9
6.8
6.8
Dexcom G7 User Guide
Percent within
20/20% YSI
(%)
80.1 90.4
93.8 98.1
92.4 96.2
1
) (pediatrics*;
Percent within
40/40% YSI
(%) (%)
98.3
100.0
99.9
145