Freestyle LibreLink Manuel D'utilisation page 46

ART41361-001_rev-A 2:18 pm 30 aug 2019
Agreement with BG Levels
Agreement between the System and capillary blood glucose values (BG) as measured by the Reader's
built-in meter was characterised by using paired System GM and BG value. The accuracy of GM versus BG
value was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and
40% for BG values 4.44 mmol/L and above, and within 0.83 mmol/L, 1.11 mmol/L, 1.67 mmol/L and
2.22 mmol/L for values below 4.44 mmol/L. The results are presented in Table 4 for BG values. Overall,
86.9% of results were within ±1.11 mmol/L / 20% of BG values.
Table 4: Number and Percent of Results within BG Values*
* Comparison to BG was performed using the Reader's built-in blood glucose meter. Different performance may be expected when compared to
other models of blood glucose meters.
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 GM and the BG value. Table 5 shows the overall absolute difference measure.
Overall, the Mean Absolute Relative Difference was 11.4% for the comparison with BG value. The Median
Absolute Relative Difference shows that half of the time the System was within 9.1% of the BG value.
Table 5: Difference Measures with BG Value *
* Comparison to BG was performed using the Reader's built-in blood glucose meter. Different performance may be expected when compared to
other models of blood glucose meters.
Concurrence of System and Reference (GM vs. YSI)
The percentage of concurring glucose values (GM vs. YSI) in each glucose reference range is presented for
each GM range in Table 6. For example, when the System glucose results were within the 4.5 to
6.7 mmol/L range, actual blood glucose values were less than 2.2 mmol/L 0.0% of the time, between 2.2
and 3.3 mmol/L 0.1% of the time, between 3.4 and 4.4 mmol/L 2.7% of the time, between 4.5 and
6.7 mmol/L 67.9% of the time, between 6.7 and 8.9 mmol/L 28.0% of the time, between 8.9 and
11.1 mmol/L 1.2% of the time, between 11.2 and 13.9 mmol/L 0.1% of the time and above 13.9 mmol/L
0.0% of the time.
Table 6: Concurrence Analysis by Glucose Level