Freestyle Libre User Manual page 60

Table 4: Number and Percent of Results within BG Values*
CGM Glucose Number of Within
Level CGM-Reference ±15% /
(mg/dL) Pairs ±15mg/dL
Overall 3680 72.8
40-50
23 47.8
51-80 288 65.6
81-180
1722 71.7
181-300 1193 75.0
301-400
362 76.8
401-500 92 78.3
* Comparison to BG was performed using the FreeStyle Libre Reader's built-in blood glucose meter. Different
performance may be expected when compared to other models of blood glucose meters.
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Within Within Within Outside
±20% / ±30% / ±40% / ±40% /
±20mg/dL ±30mg/dL ±40mg/dL ±40mg/dL
84.3 95.0 98.0 2.0
73.9 87.0 95.7 4.3
77.1 89.6 97.6 2.4
82.9 94.7 97.4 2.6
87.3 96.2 98.4 1.6
87.8 97.2 99.2 0.8
85.9 95.7 98.9 1.1
Overall Accuracy against BG values
Accuracy was measured by comparing the absolute relative difference between the System and BG
values. The absolute relative difference measures the level of disagreement between the System
and the BG value, but does not tell you whether the System glucose value was, on average, higher
or lower than the BG glucose value. The Mean Absolute Relative Difference gives an indication of
the average percent disagreement between the CGM and the BG value. Table 5 shows the overall
absolute difference measure. Overall the Mean Absolute Relative Difference was 12.1% for the
comparison with BG value. The Median Absolute Relative Difference shows that half of the time the
System was within 9.4% of the BG value.
Table 5: Difference Measures with BG Value *
Number of Median Absolute Relative
CGM-Reference Pairs Difference
3680 9.4%
* Comparison to BG was performed using the FreeStyle Libre Reader's built-in blood glucose meter. Different
performance may be expected when compared to other models of blood glucose meters.
Mean Absolute Relative
Difference
12.1%
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