Freestyle Libre - 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.
Table 6: Concurrence Analysis by Glucose Level
CGM
(mg/dL)
YSI Glucose Level (mg/dL)
N
<40* 40-60 61-80
81-
120
121-
160
161-
200
201-
250
251-
300
301-
350
351-
400
401-
500
>500*
<40 0.0 19.0 61.9 19.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 21
40-60 0.7 25.2 58.7 15.4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 143
61-80 0.0 7.3 45.8 46.3 0.6 0.0 0.0 0.0 0.0 0.0 0.0 0.0 356
81-120 0.0 0.2 5.6 75.9 17.6 0.6 0.1 0.0 0.0 0.0 0.0 0.0 1222
121-160 0.0 0.0 0.1 13.2 72.0 14.3 0.4 0.0 0.0 0.0 0.0 0.0 1435
161-200 0.0 0.0 0.0 0.3 21.9 67.5 10.2 0.1 0.0 0.0 0.0 0.0 1087
201-250 0.0 0.0 0.0 0.0 0.9 28.8 64.5 5.7 0.0 0.0 0.0 0.0 905
251-300 0.0 0.0 0.0 0.0 0.0 0.3 41.2 53.4 5.2 0.0 0.0 0.0 386
301-350 0.0 0.0 0.0 0.0 0.0 0.0 1.2 55.3 40.6 2.9
0.0
0.0 170
351-400 0.0 0.0 0.0 0.0 0.0 0.0 0.0 3.6 66.1 30.4
0.0
0.0 56
401-500 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 25.0 33.3 41.7
0.0
12
>500 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0
* Levels out of system dynamic range.
113 114
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