Table 1.
Accuracy Summary Statistics for Venous Measurements According to Glucose Level Comparing Both HGMs with the Laboratory-measured Glucose Values (data from 50 subjects).
|
Overall (N=1,103 Pairs) |
By Reference Glucose Level(mg/dL) |
||||||
|---|---|---|---|---|---|---|---|
| Mean(95% confidence interval) | Median(25th–75thpercentiles) | ≤ 70 (N=162) | 71–120 (N=410) | 121–180 (N=262) | 181–240 (N=150) | > 240 (N=119) | |
| Difference* | median | ||||||
| Ultra | +0.6 (−1.4, +2.6) | +2 (−5, +7) | +4 | +2 | −1 | +1 | +1 |
| Freestyle | +1.4 (+0.1, +2.7) | +3 (−2, +8) | +4 | +5 | +2 | +1 | −8 |
| Absolute Difference† | |||||||
| Ultra | 7.8 (6.9, 8.9) | 6 (3, 10) | 5 | 5 | 6 | 7 | 13 |
| Freestyle | 7.4 (6.6, 8.2) | 6 (3, 10) | 5 | 6 | 6 | 5 | 10 |
| Relative Absolute Difference‡ | |||||||
| Ultra | 6% (6%, 7%) | 5% (2%, 9%) | 8% | 6% | 4% | 4% | 5% |
| Freestyle | 6% (6%, 7%) | 5% (2%, 9%) | 9% | 6% | 4% | 3% | 4% |
| ISO Criteria met§ | percentage | ||||||
| Ultra | 99% (98%, 99%) | N/A | 96% | 99% | 100% | 99% | 100% |
| Freestyle | 98% (97%, 99%) | 99% | 97% | 97% | 100% | 100% | |
*
Difference is the meter glucose minus the reference glucose value.
†
Absolute difference is the absolute value of the difference.
‡
Relative absolute difference is the absolute difference divided by the reference value (expressed as a percentage).
§
ISO criteria: for reference glucose value ≤75 mg/dL meter value within ±15 mg/dL and for reference glucose value >75 mg/dL meter value within ±20%.