Freestyle LIBRE PRO - Page 28

Agreement with BG Levels
Agreement between the System and capillary FreeStyle Precision blood glucose values (BG) was
characterized by using paired System Glucose Measurements (GM) and BG reference.
The accuracy of GM versus BG reference was assessed by calculating the percentage of System
readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and
15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL. The results are presented
in Table 5. Overall 79.4% of results were within ±20 mg/dL / 20% of BG reference. Please note
that dierent blood glucose meters have dierent levels of performance compared to the meter
used in this study. The performance presented here is not representative of a comparison to all
blood glucose meters.
Table 5: Number and Percent of Results within BG Reference*
BG
Glucose
Level
(mg/dL)
Number
of GM-
Reference
Pairs
Within
±15% /
±15 mg/dL
Within
±20% /
±20 mg/dL
Within
±30% /
±30 mg/dL
Within
±40% /
±40 mg/dL
Outside
±40% /
±40 mg/dL
Overall 11918 66.5 79.4 93.4 97.9 2.1
40-50 152 57.2 66.4 86.8 92.8 7.2
51-80 841 68.4 80.6 93.6 98.1 1.9
81-180 6397 65.7 78.5 92.6 97.4 2.6
181-300 3719 66.5 80.2 94.1 98.7 1.3
301-400 695 71.7 83.5 97.3 99.3 0.7
401-500 114 81.6 90.4 97.4 99.1 0.9
* Comparison to BG was performed using the FreeStyle Precision blood glucose meter. Dierent performance
may be expected when compared to other models of blood glucose meters.
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