Dexcom G5 User Manual page 292

Calibration Stability
The system must be calibrated every 12 hours. To demonstrate performance
of the system over a 12-hour calibration period, systems were evaluated to
verify that performance remains consistent over the 12-hour calibration period.
Systems were evaluated in 2-hour increments after calibration. Performance
was estimated at each 2-hour interval and stratified by glucose values by
calculating the percentage of system readings within 15 mg/dL or 15%, 20
mg/dL or 20%, 30 mg/dL or 30%, 40 mg/dL or 40% and greater than 40 mg/dL
or 40% of the YSI values in Table 7-A and 7-B.
Table 8-A. Sensor Stability Relative to YSI (Accuracy Over Time
Day
2
of Study
Wear
Original
Day
1
Software 505
Original
Day
4
Software 505
Original
Day
7
Software 505
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as
Software 505 (SW10505).
Dexcom G5 Mobile System User Guide
Technical Information
Number
Mean
of
Absolute
Paired
Percent
CGM-
Differences
YSI
3023 16.7%
680 10.7%
3108 11.4%
777 8.0%
3021 11.9%
806 8.5%
Median Percent
Absolute Within
Percent 15/15%
Differences YSI
13.2% 59%
7.9% 77%
8.2% 77%
6.4% 89%
8.9% 76%
7.2% 90%
Original
1
) - (Adult)
Percent Percent
Within Within
20/20% 30/30%
YSI YSI
71% 86%
84% 96%
87% 95%
96% 99%
87% 95%
97% 99%
(SW10050) or
Percent
Greater
than
40/40%
YSI
6%
2%
2%
0%
2%
0%
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