Table 2.
Sensor Accuracy for the Whole Glucose Range and Stratified According to Capillary Glucose During the Three Closed-Loop Home Studies
| Whole range (1.1–27.8 mmol/L) | Euglycemia (3.9–10.0 mmol/L) | Hyperglycemia (>10.0 mmol/L) | Hypoglycemia (<3.9 mmol/L) | |
|---|---|---|---|---|
| Number of glucose sensor–capillary pairs | 10,647 | 6,223 | 3,410 | 1,014 |
| Mean capillary glucose (mmol/L) | 8.6±3.9 | 6.9±1.7 | 13.3±2.8 | 3.2±0.5 |
| Mean AD | 1.0±1.0 | 0.9±0.8 | 1.3±1.2 | 0.9±0.8 |
| Median AD | 0.8 (0.4, 1.4) | 0.7 (0.3, 1.2) | 1.0 (0.4, 1.8) | 0.7 (0.4, 1.2) |
| Mean ARD | 14.2±15.5 | 13.9±13.3 | 9.8±8.8 | 30.6±28.7 |
| Median ARD (%) | 10.0 (4.5, 18.4) | 10.4 (4.7, 18.6) | 7.8 (3.4, 13.7) | 22.8 (11.2, 41.2) |
| Bias | 0.04 (1.44) | 0.08 (1.3) | −0.25 (1.7) | 0.7 (0.9) |
| ISO criteria (%)a | 70.0 | 67.5 | 78.7 | 55.7 |
Data are mean±SD or median (interquartile range) values as indicated.
a
International Organization for Standardization (ISO) 15197:2013 15/15% limits.
AD, absolute difference; ARD, absolute relative difference.