Freestyle Libre 14 day User Manual page 121

Agreement with 'LO' and 'HI' CGM Reading against YSI Reference
The System reports glucose concentrations between 40 and 500 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 500 mg/dL, it will report as 'HI' . Table 8 displays the concurrence between
the CGM and YSI reference glucose when CGM reads 'LO' . For example, in the clinical study, when
CGM reading was 'LO' , YSI glucose values were less than 40 mg/dL 0.0% of the time, equal to or above
40 mg/dL 100.0% of the time, above 50 mg/dL 83.3% of the time, above 60 mg/dL 55.6% of the
time, above 70 mg/dL 33.3% of the time, and above 80 mg/dL 22.2% of the time.
Table 8: Concurrence Analysis with 'LO' CGM Reading
% of CGM points in YSI range
Number of CGM points in YSI range
Table 9 displays the concurrence between the CGM and YSI reference glucose when CGM reads 'HI' .
For example, in the clinical study, when CGM reading was 'HI' , YSI glucose values were less than or
equal to 200 mg/dL 0% of the time, above 200 mg/dL 100% of the time, above 300 mg/dL 100% of
the time, above 400 mg/dL 100% of the time, and above 500 mg/dL 7.7% of the time.
Table 9: Concurrence Analysis with 'HI' CGM Reading
% of CGM points in YSI range
Number of CGM points in YSI range
YSI (mg/dL)
<40 ≥40 >50
0.0 100.0 83.3
0 18 15
YSI (mg/dL)
≤200 >200
0.0 100.0
0 13
>60 >70
55.6 33.3
10 6
>300 >400 >500
100.0 100.0
13 13
N
>80
22.2
4 18
N
7.7
1 13
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