User`s guide

Dexcom G4 PLATINUM (Pediatric) System User’s Guide | 177
Overall, the System reads, on average, 2.2% lower (Mean Percent
Difference) than SMBG values and 15.3% absolute different (Mean
Absolute Percent Difference) than the SMBG values. The Median
Percent Difference shows that half of the time the System reads +0.9%
or less than the SMBG values and the Median Absolute Percent
Difference shows that half of the time the System reads about 11.1% or
less different than SMBG values (Table 12).
Sensor Stability Relative to SMBG
Sensors can be worn for up to 7 days. Performance was estimated
by calculating the percentage of system readings within various
percentages of the SMBG values at each day of the sensor wear period
(Table 13). The average and median of the absolute percent differences
are included in the tables.
Table 13. Sensor Stability Relative to SMBG (Accuracy
over Time, Pediatric Study)
Day of
Wear
Number
of paired
CGM-
SMBG
Mean
Absolute
Percent
Differences
(%)
Median
Absolute
Percent
Differences
(%)
Percent
within
15/15%
SMBG
Percent
within
20/20%
SMBG
Percent
within
30/30%
SMBG
Percent
within
40/40%
SMBG
Percent
greater
than
40/40%
SMBG
Day 1 3216 18.8 14.2 53% 65% 81% 90% 10%
Day 2 2148 16.2 12.4 60% 74% 87% 94% 6%
Day 3 1977 15.2 11.0 63% 76% 89% 95% 5%
Day 4 2830 14.0 10.9 66% 79% 91% 96% 4%
Day 5 1768 15.4 10.7 67% 78% 90% 95% 5%
Day 6 1704 14.3 9.8 68% 79% 90% 96% 4%
Day 7 2675 12.4 9.2 72% 83% 94% 97% 3%
Adverse Events
No serious adverse events or device-related serious adverse events