Dexcom G5 MOBILE User Manual page 320

included in Tables 8-A and 8-B showing consistent accuracy and sensor stability over the 7-day life of
the sensor.
Relative to SMBG (Pediatric Study)
Performance was also estimated by calculating the percentage of system readings within various
percentages of the SMBG values at each day of the sensor wear period (Table 8-C). The average and
median of the absolute percent differences are included in the table.
Precision of System Readings
A subset of subjects wore two Systems at the same time. This was to look at how similarly two
Systems 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.
In the Original Adult
from the two sensors generally agreed with each other within 9% (absolute percent difference) with
a 7% coefficient of variation. In the
showed that System readings from the two sensors generally agreed with each other within 10%
(absolute percent difference) with a 7% coefficient of variation. Only one System was worn in the
Software 505 Adult
Sensor Life
Sensors may be worn for up to 7 days (168 hours). To estimate how long a sensor will work over
7 days, all sensors worn were evaluated to determine how many days/hours of readings each
sensor provided.
Original Adult
In the
lasted until Day 7 (145-168 hours). There were 6 (6%) sensors that ended early, four of which lasted
more than 3 days.
Software 505 Adult
In 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.
In the Original Pediatric
lasted until Day 7 (145-168 hours).
Software 505 Pediatric
In the
sensors lasted until Day 7 (145-168 hours).
Dexcom G5 Mobile System User Guide
Technical Information
Study, 36 subjects wore two Systems. Results showed that System readings
Original Pediatric
Software 505 Pediatric
and
Study, 108 sensors were evaluated. Ninety-four percent (94%) of the sensors
Study, 51 sensors were evaluated. Ninety-eight percent (98%) of the
Study, 351 sensors were evaluated. Eighty-five percent (85%) of the sensors
Study, 77 sensors were evaluated. Ninety-four percent (94%) of the
Study, all subjects wore two Systems. Results
Studies so precision data was not collected.
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