TABLE 1.
Treatment Effects
| Parameter (units) | Children (6-17.9 years) | Adults (≥18 years) | ||
|---|---|---|---|---|
| SoC | Tubeless AID | SoC | Tubeless AID | |
| Base case | ||||
| Change in baseline A1c (%), mean (SD) | 0.000 | -0.690 (0.640) | 0.000 | -0.360 (0.510) |
| NSHE <70 mg/dL (per 100 patient-years) event rate | 28,226 | 27,062 | 29,145 | 17,461 |
| NSHE <54 mg/dL (per 100 patient-years) event rate | 5,607 | 5,398 | 6,569 | 3,131 |
| SHE 1 (requiring nonmedical assistance) (per 100 patient-years) event rate | 18.0 | 3.6 | 29.5 | 7.2 |
| DKA (per 100 patient-years) event rate | 13.2 | 3.6 | 10.3 | 0.0 |
| TBR ≥4% | ||||
| Change in baseline A1c (%), mean (SD) | 0.000 | -0.430 (0.600) | 0.000 | -0.270 (0.410) |
| NSHE <70 mg/dL (per 100 patient-years) event rate | 71,113 | 47,812 | 59,438 | 29,360 |
| NSHE <54 mg/dL (per 100 patient-years) event rate | 21,384 | 12,894 | 15,867 | 5,529 |
| SHE 1 (requiring nonmedical assistance) (per 100 patient-years) event rate | 18.0 | 18.0 | 29.5 | 13.2 |
| DKA (per 100 patient-years) event rate | 13.2 | 0.0 | 10.3 | 0.0 |
| A1c ≥8% | ||||
| Change in baseline A1c (%), mean (SD) | 0.000 | -1.180 (0.600) | 0.000 | -0.840 (0.690) |
| NSHE <70 mg/dL (per 100 patient-years) event rate | 18,614 | 21,855 | 24,705 | 12,517 |
| NSHE <54 mg/dL (per 100 patient-years) event rate | 4,773 | 4,371 | 6,361 | 2,868 |
| SHE 1 (requiring nonmedical assistance) (per 100 patient-years) event rate | 18.0 | 0.0 | 29.5 | 0.0 |
| DKA (per 100 patient-years) event rate | 13.2 | 9.6 | 10.3 | 0.0 |
A1c = hemoglobin A1c; AID = automated insulin delivery; DKA = diabetes ketoacidosis; NSHE = severe hypoglycemic event; SHE = severe hypoglycemic event; SoC = standard of care; TBR = time below range.