Freestyle Libre 2 Manuel D'utilisation page 60

glucose values < 3.9 mmol/L , the difference in mmol/L between the GM and YSI blood glucose values
was calculated. For values ≥ 3.9 mmol/L , the relative difference (%) to the YSI blood glucose values was
calculated. The results categorised within GM glucose ranges are presented in Tables 1b and 1c
results categorised within YSI glucose ranges are presented in Tables 1d and 1e
Table 1b: Table 1b: Accuracy to YSI within GM Glucose Ranges (Adult; n=144) Accuracy to YSI within GM Glucose Ranges (Adult; n=144)
† System range is 2.2 - 22.2 mmol/L.
Table 1c: Accuracy to YSI within GM Glucose Ranges (Paediatric*; n=129) Table 1c: Accuracy to YSI within GM Glucose Ranges (Paediatric*; n=129)
* Includes children 6–17 years of age. No YSI measurements were obtained for children 4–5 years of age.
† System range is 2.2 - 22.2 mmol/L.
Table 1d: Accuracy to YSI within YSI Glucose Ranges (Adult; n=144) Table 1d: Accuracy to YSI within YSI Glucose Ranges (Adult; n=144)
Table 1e: Accuracy to YSI within YSI Glucose Ranges (Paediatric*; n=129) Table 1e: Accuracy to YSI within YSI Glucose Ranges (Paediatric*; n=129)
* Includes children 6–17 years of age. No YSI measurements were obtained for children 4–5 years of age.
Agreement with 'LO' and 'HI' GM Reading against YSI Reference Agreement with 'LO' and 'HI' GM Reading against YSI Reference
The System reports glucose concentrations between 2.2 and 22.2 mmol/L. When the System determines
that glucose level is below 2.2 mmol/L, it will report as 'LO'. When the System determines that glucose
level is above 22.2 mmol/L, it will report as 'HI'. Tables 2a and
Tables 1d and 1e.
Tables 2a and 2b 2b display the concurrence between
ART41758-100_rev-A 3:14pm 18-JAN-2021
Tables 1b and 1c. The