Dexcom G5 Mobile - Page 324

Dexcom G5 Mobile System User Guide
322Technical Information
Table 10-B. System Readings Within Wear Days (Pediatric)
Statistic
Study
1
Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7
All
Days
2
Mean
Original 97% 96% 96% 95% 94% 94% 92% 95%
Software 505 96% 96% 95% 96% 93% 95% 93% 95%
Median
Original 99% 99% 99% 99% 99% 99% 98% 99%
Software 505 99% 98% 99% 99% 97% 97% 98% 98%
Standard
Deviation
Original 6% 10% 9% 12% 14% 14% 17% 12%
Software 505 9% 6% 12% 10% 15% 7% 12% 11%
1
Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505).
2
A total of 108 sensors were included with the Original Study and 77 sensors were included with the
Software 505 Study.
Number of Readings Provided
The System is capable of providing a reading up to every 5 minutes, or up to 288 readings per day.
For a variety of reasons, the System may not display a glucose reading and readings are “skipped.”
Tables 9-A and 9-B estimate the number of readings you can expect to receive from the System over
the entire 7-day period after calibration. Tables 10-A and 10-B show the number of readings you can
expect to receive from the System within each system wear day.
For the Software 505 Adult Study (SW10505), 96% of Systems provided between 1,497 and 1,992
valid glucose readings (or more than 75% of the expected number of readings) as seen in Table 9-A.
Adjusted within each system wear-day, the System in the Software 505 Adult Study provided an
average of 98% of all expected glucose readings (288) as seen in Table 10-A.