Freestyle Libre User Manual page 61

Concurrence of System and Reference (CGM vs. YSI)
The percentage of concurring glucose values (CGM vs. YSI) in each glucose reference range is
presented for each CGM range in Table 6. For example, in the clinical study, when the System glucose
results were within the 81 to 120 mg/dL range, actual blood glucose values were less than 40 mg/dL
0% of the time, between 40 and 60 mg/dL 0.2% of the time, between 61 and 80 mg/dL 5.6% of the
time, between 81 and 120 mg/dL 75.9% of the time, between 121 and 160 mg/dL 17.6% of the time,
between 161 and 200 mg/dL 0.6% of the time, between 201 and 250 mg/dL 0.1% of the time and
above 250 mg/dL 0% of the time.
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Table 6: Concurrence Analysis by Glucose Level
YSI Glucose Level (mg/dL)
CGM
81- 121- 161- 201-
(mg/dL)
<40* 40-60 61-80
120 160 200 250
<40 0.0 19.0 61.9 19.0 0.0 0.0
40-60
0.7 25.2 58.7 15.4 0.0 0.0
61-80
0.0 7.3 45.8 46.3 0.6 0.0
81-120 0.0 0.2 5.6 75.9 17.6 0.6
121-160 0.0 0.0 0.1 13.2 72.0 14.3
161-200 0.0 0.0 0.0 0.3 21.9 67.5 10.2
201-250 0.0 0.0 0.0 0.0 0.9 28.8 64.5
251-300 0.0 0.0 0.0 0.0 0.0 0.3 41.2 53.4
301-350 0.0 0.0 0.0 0.0 0.0 0.0
351-400 0.0 0.0 0.0 0.0 0.0 0.0
401-500 0.0 0.0 0.0 0.0 0.0 0.0
>500 0.0 0.0 0.0 0.0 0.0 0.0
* Levels out of system dynamic range.
N
251- 301- 351- 401-
>500*
300 350 400 500
0.0 0.0 0.0 0.0 0.0 0.0 21
0.0 0.0 0.0 0.0 0.0 0.0 143
0.0 0.0 0.0 0.0 0.0 0.0 356
0.1 0.0 0.0 0.0 0.0 0.0 1222
0.4 0.0 0.0 0.0 0.0 0.0 1435
0.1 0.0 0.0 0.0 0.0 1087
5.7 0.0 0.0 0.0 0.0 905
5.2 0.0 0.0 0.0 386
1.2 55.3 40.6 2.9 0.0 0.0 170
0.0 3.6 66.1 30.4 0.0 0.0 56
0.0 0.0 25.0 33.3 41.7 0.0 12
0.0 0.0 0.0 0.0 0.0 0.0 0
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