Freestyle LIBRE PRO - Page 31

Agreement with ‘LO’ or ‘HI’ GM 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 GM and
YSI reference glucose when GM reads ‘LO’. For example, when GM reads ‘LO’ you can expect that YSI
glucose values were less than 40 mg/dL 16.7% of the time, between 40 and 50 mg/dL 0.0% of the
time, between 51 and 60 mg/dL 0.0% of the time, between 61 and 70 mg/dL 16.7% of the time,
between 71 and 80 mg/dL 0.0% of the time, and above 80 mg/dL 66.7% of the time.
Table 8: Concurrence Analysis with LO GM Reading
GM Glucose Level
(mg/dL)
YSI (mg/dL)
N
<40 40-50 51-60 61-70 71-80 >80
<40 (LO) 16.7 0.0 0.0 16.7 0.0 66.7 6
Table 9 displays the concurrence between the GM and YSI reference glucose when GM reads ‘HI’. For
example, when GM reads ‘HI’ you can expect that YSI glucose values were less than 200 mg/dL 0.0%
of the time, between 200 and 300 mg/dL 0.0% of the time, between 301 and 400 mg/dL 0.0% of the
time, between 401 and 500 mg/dL 100% of the time, and above 500 mg/dL 0.0% of the time.
Table 9: Concurrence Analysis with HI GM Reading
GM Glucose Level
(mg/dL)
YSI (mg/dL)
N
<200 200-300 301-400 401-500 >500
>500 (HI) 0.0 0.0 0.0 100.0 0.0 2
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