Abbott FreeStyle Libre 2 User Manual page 198

Agreement with 'LO' and 'HI' CGM Reading against YSI Reference
The System reports glucose concentrations between 40 and 400 mg/dL. When the System
determines that glucose level is below 40 mg/dL, it will report as 'LO' . When the System determines
that glucose level is above 400 mg/dL, it will report as 'HI' . Tables 2a and 2b display the
concurrence between the CGM and YSI reference glucose when CGM reads 'LO' . For example, in the
Adult study, 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=144)
CGM-
Reference
Pairs
n
Cumulative % 20.0
Table 2b: Concurrence Analysis with 'LO' CGM Reading (Pediatric*; n=129)
CGM-
Reference
Pairs
n
Cumulative %
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
<50 <60
1 2
40.0
<50 <60
0 1
0.0 50.0
YSI (mg/dL)
<70 <80
2 4
40.0 80.0
YSI (mg/dL)
<70 <80
2 2
100.0 100.0
N
≥80
1 5
20.0
N
≥80
0 2
0.0
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