Dexcom G4 PLATINUM User Manual page 97

Table 8. Sensor Stability (Accuracy
Number of
Day of
Study paired CGM-
2
Wear
Original
Day 1
Advanced
Original
Day 4
Advanced
Original
Day 7
Advanced
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as
Sensor Stability
Sensors can be worn for up to 7 days. To verify sensor performance over time, 72 subjects were evaluated
with the System across the 7-day wear period while 50 subjects were evaluated with the
Original
System across the 7-day wear period. Performance was estimated by calculating the percentage
Advanced
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 at the beginning (Day 1), middle (Day 4) and end (Day 7) of
the System lifecycle. The average and median of the absolute percent differences are included in Table 8
showing consistent accuracy and sensor stability over the 7-day life of the sensor.
Precision of System Readings
In the Study, 36 subjects wore two Systems. This was to look at how similarly two Systems
Original
function on the same subject (sensor precision). Precision was evaluated by comparing the glucose
readings from the two Systems worn on the same subject at the same time. Results showed that System
readings from the two sensors generally agreed with each other within 9% (absolute percent difference) with
a 7% coefficient of variation. Only one System was worn in the
collected in this study.
Sensor Life
Sensors may be worn for up to 7 days (168 hours). To estimate how long a sensor will work over 7 days,
108 sensors were evaluated with the
sensor provided. Ninety-four percent (94%) of the sensors lasted until Day 7 (145-168 hours). There were 6
(6%) sensors that ended early, four of which lasted more than 3 days.
For the Study, 51 sensors were evaluated to determine how many days/hours of readings each
Advanced
sensor provided. Ninety-eight percent (98%) of the sensors lasted until Day 7 (145-168 hours). There was 1
(2%) sensor that ended early, which lasted until day 5 of the sensor wear.
1
Mean Absolute
Percent
YSI Differences
3023 16.7%
680 10.7%
3108 11.4%
777 8.0%
3021 11.9%
806 8.5%
Study to determine how many days/hours of readings each
Original
over Time)
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%
(SW10050) or
Original
Advanced
97
Percent Percent
within within
20/20% 30/30%
YSI YSI
71% 86%
84% 96%
87% 95%
96% 99%
87% 95%
97% 99%
(SW10505).
Advanced
Study so precision data was not
Percent
greater
than
40/40% YSI
6%
2%
2%
0%
2%
0%