Concurrence Analysis With ‘Lo’ Cgm Reading; Concurrence Analysis With ‘Hi’ Cgm Reading - Abbott FreeStyle Libre 3 User Manual

DOC44383_rev-C 1:14pm 22-SEP-2021
reference glucose when CGM reads 'LO'. For example, in the Adult subject group,
when CGM reading was 'LO', YSI glucose values were less than 50 mg/dL 20.0% of
the time, less than 60 mg/dL 40.0% of the time, less than 70 mg/dL 40.0% of the
time, less than 80 mg/dL 80.0% of the time, and equal to or above 80 mg/dL 20.0%
of the time.
Table 2a: Concurrence Analysis with 'LO' CGM Reading (Adult; n=200)
Table 2b: Concurrence Analysis with 'LO' CGM Reading (Pediatric*; n=168)
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
Tables 2c and 2d display the concurrence between the CGM and YSI reference
glucose when CGM reads 'HI'. In the Adult subject group, when CGM reading was
'HI', YSI glucose values were above 350 mg/dL 97.6% of the time, above 300 mg/dL
100.0% of the time, above 250 mg/dL 100.0% of the time, and less than or equal to
250 mg/dL 0.0% of the time.
Table 2c: Concurrence Analysis with 'HI' CGM Reading (Adult; n=200)
Table 2d: Concurrence Analysis with 'HI' CGM Reading (Pediatric; n=168)