Freestyle Libre 2 Manuel D'utilisation page 61

the GM and YSI reference glucose when GM reads 'LO'. For example, in the Adult study, when GM
reading was 'LO', YSI glucose values were less than 2.8 mmol/L 20.0% of the time, less than 3.3 mmol/L
40.0% of the time, less than 3.9 mmol/L 40.0% of the time, less than 4.4 mmol/L 80.0% of the time, and
equal to or above 4.4 mmol/L 20.0% of the time.
Table 2a: Concurrence Analysis with 'LO' GM Reading (Adult; Table 2a: Concurrence Analysis with 'LO' GM Reading (Adult; n=144)
Table 2b: Concurrence Analysis with 'LO' GM Reading (Paediatric*; n=129) Table 2b: Concurrence Analysis with 'LO' GM Reading (Paediatric*; n=129)
* Includes children 6–17 years of age. No YSI measurements were obtained for children 4–5 years of age.
Tables 2c Tables 2c and 2d and 2d display the concurrence between the GM and YSI reference glucose when GM reads
'HI'. In the Adult study, when GM reading was 'HI', YSI glucose values were above 22.2 mmol/L 34.4% of
the time, above 19.4 mmol/L 97.5% of the time, above 16.7 mmol/L 100.0% of the time, above
13.9 mmol/L 100.0 % of the time, and below or equal to 13.9 mmol/L 0.0% of the time.
Table 2c: Concurrence Analysis with 'HI' GM Reading (Adult; Table 2c: Concurrence Analysis with 'HI' GM Reading (Adult; n=144)
Table 2d: Concurrence Analysis with 'HI' GM Reading (Paediatric; n=129) Table 2d: Concurrence Analysis with 'HI' GM Reading (Paediatric; n=129)
Concurrence of System and Reference (GM vs. YSI) Concurrence of System and Reference (GM vs. YSI)
The percentage of concurring glucose values (GM vs. YSI) in each glucose reference range is presented
for each GM range in Tables 3a and 3b Tables 3a and 3b and for each YSI range in Tables
the Adult study, when the System glucose readings were within the 4.5 and 6.7 mmol/L range, actual
blood glucose values were between 2.2 and 3.3 mmol/L 0.2% of the time, between 3.4 and 4.4 mmol/L
10.9% of the time, between 4.5 and 6.7 mmol/L 70.0% of the time, between 6.7 and 8.9 mmol/L 17.9% of
the time, between 8.9 and 11.1 mmol/L 0.9% of the time, and between 11.2 and 13.9 mmol/L 0.1% of the
time.
Table 3a: Concurrence Analysis by GM Glucose Level (Adult; Table 3a: Concurrence Analysis by GM Glucose Level (Adult; n=144)
ART41758-100_rev-A 3:14pm 18-JAN-2021
n=144)
n=144)
Tables 3c and 3d 3c and 3d. For example, in
n=144)