User's Manual

Dexcom G5x System User Guide
Technical Information
311
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
1
)
- (Adult)
Day
of
Wear
Study
2
Number
of
Paired
CGM-
YSI
Mean
Absolute
Percent
Differenc
es
Median
Absolute
Percent
Differenc
es
Percen
t
Within
15/15%
YSI
Percen
t
Within
20/20%
YSI
Percen
t
Within
30/30%
YSI
Percen
t
Greater
than
40/40%
YSI
Day
1
Original
3023
16.7%
13.2%
59%
71%
86%
6%
Software
505
680
10.7%
7.9%
77%
84%
96%
2%
Day
4
Original
3108
11.4%
8.2%
77%
87%
95%
2%
Software
505
777
8.0%
6.4%
89%
96%
99%
0%
Day
7
Original
3021
11.9%
8.9%
76%
87%
95%
2%
Software
505
806
8.5%
7.2%
90%
97%
99%
0%
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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