Freestyle Libre 2 Manuel D'utilisation page 66

20%, and 40% of the YSI value was calculated. For values < 3.9 mmol/L, the percentage of readings
within 0.83 mmol/L, 1.11 mmol/L, and 2.2 mmol/L of the YSI value was calculated. The percentage of
System readings within YSI values for the first 12 hours of a Sensor wear is presented in Table 6c
Table 6a: Sensor Accuracy Relative to YSI over the wear duration (Adult; n=144) Table 6a: Sensor Accuracy Relative to YSI over the wear duration (Adult; n=144)
Table 6b: Sensor Accuracy Relative to YSI over the wear duration (Paediatric*; Table 6b: Sensor Accuracy Relative to YSI over the wear duration (Paediatric*; n=129)
* Includes children 6–17 years of age. No YSI measurements were obtained for children 4–5 years of age.
Table 6c: Sensor Accuracy Relative to YSI over the First 12 Hours of Sensor Wear Table 6c: Sensor Accuracy Relative to YSI over the First 12 Hours of Sensor Wear
Sensor Wear Duration Sensor Wear Duration
The Sensor can be worn for up to 14 days. To estimate how long a Sensor will work over the wear
duration, 146 Sensors were evaluated in the Adult study and 139 Sensors were evaluated in the
Paediatric study to determine how many days of readings each Sensor provided. Of the 146 Sensors in
the Adult study, 71.1% lasted until the final day of use. In the Paediatric study, 78.1% of the Sensors
lasted until the final day of use. Tables 7a and 7b
for the Adult & Paediatric studies.
Table 7a: Sensor Survival Rate Over Wear Duration (Adult; Table 7a: Sensor Survival Rate Over Wear Duration (Adult; n=146)
Table 7b: Sensor Survival Rate Over Wear Duration (Paediatric; n=139) Table 7b: Sensor Survival Rate Over Wear Duration (Paediatric; n=139)
Tables 7a and 7b display the data for each day in the wear duration
ART41758-100_rev-A 3:14pm 18-JAN-2021
Table 6c.
n=146)
n=129)