Dexcom G6 - Page 313

Dexcom G6
®
System User Guide
311Appendix F: Technical Information
Table 6-B. Sensor Stability Relative to YSI (Accuracy over Time
1
)
(Pediatrics*; n=165)
Wear
Period
Number
of paired
CGM-YSI
MARD
(%)
Percent
within
15/15% YSI
(%)
Percent
within
20/20% YSI
(%)
Percent
within
40/40% YSI
(%)
Beginning 6,696 10.9 76.5 88.0 99.6
Middle 6,464 9.2 84.3 94.6 99.8
End 6,169 9.6 82.3 92.4 99.8
* Includes pediatric subjects 6-17 years of age; no YSI measurements were taken for
pediatric subjects 2-5 years of age.
1
CGM readings are within 40-400 mg/dL, inclusive.
Sensor Life
Sensors can be worn for up to 10 days (238 hours; 240 hours less 2 hours warm-up
period). To estimate how long a sensor will work over 10 days, all sensors worn were
evaluated to determine how many days/hours of readings each sensor provided.
For adults, a total of 164 sensors were evaluated. Ninety-four percent (94%) of the
sensors lasted through the end of the entire wear period (e.g., Day 10) (see Figure 1-A).
Among the 164 sensors evaluated, 8 sensors (4.9%) had “early sensor shut-off” where
the sensor algorithm would have detected sensors that did not function as intended
and shut them off.
For pediatrics, a total of 210 sensors were evaluated. Seventy-seven percent (77%) of
the sensors lasted through the end of the entire wear period (e.g., Day 10) (see Figure
1-B). Among the 210 sensors evaluated, 28 sensors (13.3%) had “early sensor shut-
off” where the sensor algorithm would have detected sensors that did not function as
intended and shut them off.