Abbott FreeStyle Libre 2 User Manual page 59

† 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
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; n=144) Table 2a: Concurrence Analysis with 'LO' GM Reading (Adult; n=144)
Tables 2a and 2b 2b display the concurrence between
ART41753-100_rev-A 5:36pm 18-JAN-2021