Dexcom G5 User Manual page 295

Sensor Stability
Relative to YSI
Sensors can be worn for up to 7 days. Performance was estimated 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 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-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 Study, 36 subjects wore two systems. 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. In
the Original Pediatric Study, all subjects wore two systems. Results 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 and Software 505
Pediatric Studies, so precision data was not collected.
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.
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Dexcom G5 Mobile System User Guide
Technical Information