Insulin delivery characteristics and time in range at baseline, week 1, month 1, month 2, and month 3 of the trial period
| . | Period . | Mean ± SD . | P value change from baseline . |
|---|---|---|---|
| Mean TDD of insulin (units/day) | Baseline | 58.6 ± 19.1 | N/A |
| Days 1–7 | 58.2 ± 20.1 | 0.83 | |
| Days 22–28 | 60.6 ± 21.5 | 0.41 | |
| Days 50–56 | 58.9 ± 22.3 | 0.91 | |
| Days 78–84 | 60.3 ± 21.5 | 0.49 | |
| Mean basal/auto-basal insulin dose (units/day) | Baseline | 25.8 ± 8.3 | N/A |
| Days 1–7 | 27.1 ± 10.6 | 0.22 | |
| Days 22–28 | 27.0 ± 9.6 | 0.31 | |
| Days 50–56 | 26.0 ± 9.1 | 0.86 | |
| Days 78–84 | 26.7 ± 9.3 | 0.37 | |
| Mean bolus insulin (units/day) | Baseline | 32.6 ± 13.7 | N/A |
| Days 1–7 | 31.1 ± 12.9 | 0.27 | |
| Days 22–28 | 33.8 ± 14.4 | 0.44 | |
| Days 50–56 | 32.9 ± 15.8 | 0.86 | |
| Days 78–84 | 33.5 ± 15.1 | 0.59 | |
| Percentage basal/bolus split | Baseline | 45.1 ± 9.2 | N/A |
| Days 1–7 | 46.9 ± 10.3 | 0.25 | |
| Days 22–28 | 44.9 ± 9.0 | 0.87 | |
| Days 50–56 | 45.1 ± 10.8 | 0.99 | |
| Days 78–84 | 44.8 ± 10.3 | 0.82 | |
| Mean 24-h basal program for OL (units/day) | Baseline | 26.7 ± 8.8 | N/A |
| Days 1–7 | 26.8 ± 8.7 | 0.10 | |
| Days 22–28 | 26.6 ± 8.7 | 0.74 | |
| Days 50–56 | 26.9 ± 8.9 | 0.21 | |
| Days 78–84 | 27.0 ± 9.1 | 0.18 | |
| C-to-I ratio | |||
| 8 a.m. | Baseline | 7.9 ± 2.7 | N/A |
| Days 1–7 | 7.4 ± 2.5 | 0.017 | |
| Days 22–28 | 7.0 ± 2.7 | 0.0014 | |
| Days 50–56 | 6.9 ± 2.7 | <0.0001 | |
| Days 78–84 | 6.8 ± 2.8 | 0.0002 | |
| 12 p.m. | Baseline | 8.9 ± 3.3 | N/A |
| Days 1–7 | 8.4 ± 3.1 | 0.0085 | |
| Days 22–28 | 7.8 ± 2.9 | <0.0001 | |
| Days 50–56 | 7.6 ± 3.0 | <0.0001 | |
| Days 78–84 | 7.6 ± 3.1 | <0.0001 | |
| 6 p.m. | Baseline | 8.7 ± 3.4 | N/A |
| Days 1–7 | 8.1 ± 3.1 | 0.0004 | |
| Days 22–28 | 7.4 ± 2.7 | <0.0001 | |
| Days 50–56 | 7.3 ± 2.7 | <0.0001 | |
| Days 78–84 | 7.2 ± 2.6 | <0.0001 | |
| Insulin action time (min) | Baseline | 174.2 ± 51.6 | N/A |
| Days 1–7 | 171.6 ± 49.2 | 0.16 | |
| Days 22–28 | 168.4 ± 46.9 | 0.083 | |
| Days 50–56 | 169.2 ± 47.3 | 0.15 | |
| Days 78–84 | 168.4 ± 46.9 | 0.083 | |
| Percentage time in range 70–180 mg/dL | |||
| Overall | Baseline | 55.3 ± 14.9 | N/A |
| Days 1–7 | 68.4 ± 11.5 | <0.0001 | |
| Days 22–28 | 67.4 ± 10.1 | <0.0001 | |
| Days 50–56 | 70.2 ± 8.9 | <0.0001 | |
| Days 78–84 | 69.0 ± 12.0 | <0.0001 | |
| HCL Mode | Baseline | N/A | N/A |
| Days 1–7 | 69.7 ± 10.6 | N/A | |
| Days 22–28 | 69.5 ± 8.5 | N/A | |
| Days 50–56 | 71.9 ± 8.1 | N/A | |
| Days 78–84 | 71.5 ± 10.3 | N/A | |
| OL | Baseline | 55.3 ± 14.9 | N/A |
| Days 1–7 | 56.6 ± 28.1 | 0.80 | |
| Days 22–28 | 56.8 ± 25.9 | 0.75 | |
| Days 50–56 | 60.3 ± 19.7 | 0.16 | |
| Days 78–84 | 57.4 ± 28.8 | 0.67 |
| . | Period . | Mean ± SD . | P value change from baseline . |
|---|---|---|---|
| Mean TDD of insulin (units/day) | Baseline | 58.6 ± 19.1 | N/A |
| Days 1–7 | 58.2 ± 20.1 | 0.83 | |
| Days 22–28 | 60.6 ± 21.5 | 0.41 | |
| Days 50–56 | 58.9 ± 22.3 | 0.91 | |
| Days 78–84 | 60.3 ± 21.5 | 0.49 | |
| Mean basal/auto-basal insulin dose (units/day) | Baseline | 25.8 ± 8.3 | N/A |
| Days 1–7 | 27.1 ± 10.6 | 0.22 | |
| Days 22–28 | 27.0 ± 9.6 | 0.31 | |
| Days 50–56 | 26.0 ± 9.1 | 0.86 | |
| Days 78–84 | 26.7 ± 9.3 | 0.37 | |
| Mean bolus insulin (units/day) | Baseline | 32.6 ± 13.7 | N/A |
| Days 1–7 | 31.1 ± 12.9 | 0.27 | |
| Days 22–28 | 33.8 ± 14.4 | 0.44 | |
| Days 50–56 | 32.9 ± 15.8 | 0.86 | |
| Days 78–84 | 33.5 ± 15.1 | 0.59 | |
| Percentage basal/bolus split | Baseline | 45.1 ± 9.2 | N/A |
| Days 1–7 | 46.9 ± 10.3 | 0.25 | |
| Days 22–28 | 44.9 ± 9.0 | 0.87 | |
| Days 50–56 | 45.1 ± 10.8 | 0.99 | |
| Days 78–84 | 44.8 ± 10.3 | 0.82 | |
| Mean 24-h basal program for OL (units/day) | Baseline | 26.7 ± 8.8 | N/A |
| Days 1–7 | 26.8 ± 8.7 | 0.10 | |
| Days 22–28 | 26.6 ± 8.7 | 0.74 | |
| Days 50–56 | 26.9 ± 8.9 | 0.21 | |
| Days 78–84 | 27.0 ± 9.1 | 0.18 | |
| C-to-I ratio | |||
| 8 a.m. | Baseline | 7.9 ± 2.7 | N/A |
| Days 1–7 | 7.4 ± 2.5 | 0.017 | |
| Days 22–28 | 7.0 ± 2.7 | 0.0014 | |
| Days 50–56 | 6.9 ± 2.7 | <0.0001 | |
| Days 78–84 | 6.8 ± 2.8 | 0.0002 | |
| 12 p.m. | Baseline | 8.9 ± 3.3 | N/A |
| Days 1–7 | 8.4 ± 3.1 | 0.0085 | |
| Days 22–28 | 7.8 ± 2.9 | <0.0001 | |
| Days 50–56 | 7.6 ± 3.0 | <0.0001 | |
| Days 78–84 | 7.6 ± 3.1 | <0.0001 | |
| 6 p.m. | Baseline | 8.7 ± 3.4 | N/A |
| Days 1–7 | 8.1 ± 3.1 | 0.0004 | |
| Days 22–28 | 7.4 ± 2.7 | <0.0001 | |
| Days 50–56 | 7.3 ± 2.7 | <0.0001 | |
| Days 78–84 | 7.2 ± 2.6 | <0.0001 | |
| Insulin action time (min) | Baseline | 174.2 ± 51.6 | N/A |
| Days 1–7 | 171.6 ± 49.2 | 0.16 | |
| Days 22–28 | 168.4 ± 46.9 | 0.083 | |
| Days 50–56 | 169.2 ± 47.3 | 0.15 | |
| Days 78–84 | 168.4 ± 46.9 | 0.083 | |
| Percentage time in range 70–180 mg/dL | |||
| Overall | Baseline | 55.3 ± 14.9 | N/A |
| Days 1–7 | 68.4 ± 11.5 | <0.0001 | |
| Days 22–28 | 67.4 ± 10.1 | <0.0001 | |
| Days 50–56 | 70.2 ± 8.9 | <0.0001 | |
| Days 78–84 | 69.0 ± 12.0 | <0.0001 | |
| HCL Mode | Baseline | N/A | N/A |
| Days 1–7 | 69.7 ± 10.6 | N/A | |
| Days 22–28 | 69.5 ± 8.5 | N/A | |
| Days 50–56 | 71.9 ± 8.1 | N/A | |
| Days 78–84 | 71.5 ± 10.3 | N/A | |
| OL | Baseline | 55.3 ± 14.9 | N/A |
| Days 1–7 | 56.6 ± 28.1 | 0.80 | |
| Days 22–28 | 56.8 ± 25.9 | 0.75 | |
| Days 50–56 | 60.3 ± 19.7 | 0.16 | |
| Days 78–84 | 57.4 ± 28.8 | 0.67 |
N/A, not applicable.