Glucose Reading Availability
Glucose Reading Availability
The System is designed to show a Sensor glucose reading after each scan that is performed throughout
the wear period after the start-up time. Tables 8a and 8b
each day of the wear duration.
Table 8a: Glucose Reading Capture Rate Over Wear Duration (Adult;
Table 8a: Glucose Reading Capture Rate Over Wear Duration (Adult; n=146)
Table 8b: Glucose Reading Capture Rate Over Wear Duration (Paediatric;
Table 8b: Glucose Reading Capture Rate Over Wear Duration (Paediatric; n=139)
Precision
Precision
Precision of the System was evaluated by comparing the results from two separate Sensors worn on the
same subject at the same time. Table 9a
provides data from 137 subjects in the Paediatric study. For adults, the paired absolute relative
difference (PARD) between the two Sensors was 8.1% with coefficient of variation (CV) of 5.8%. For
children ages 4-5, PARD was 6.7% with CV of 4.8%. For children ages 6-17, PARD was 8.3% with CV of
5.9%. Paired absolute difference (PAD) is a measurement of average absolute differences (in mmol/L)
between paired GM readings, while PARD is the average of absolute relative differences (in %) between
paired GM readings.
Tables 8a and 8b show the glucose reading capture rate for
Table 9a provides data from 146 subjects in the Adult study; Table 9b
ART41758-100_rev-A 3:14pm 18-JAN-2021
n=146)
n=139)
Table 9b