Table 2.
Primary and secondary outcomes of the 12-week randomized study: S&P versus AID
| Run-in | 12-Week study | AID effect Mean (95% CI) | ||||
|---|---|---|---|---|---|---|
| Outcome | S&P (n = 22) | AID (n = 49) | S&P (n = 22) | AID (n = 49) | P value | |
| Primary outcome: SG reading <70 mg/dL (%time) | 10.3 ± 5.5 | 9.4 ± 4.2 | 6.8 ± 3.5 | 2.8 ± 1.4 | −3.7 (−4.8, −2.6) | <0.001 |
| Secondary outcomes, SG reading, mg/dL (%time)* | ||||||
| 70–180 | 61.5 ± 15.6 | 61.2 ± 11.9 | 64.2 ± 13.3 | 74.4 ± 8.9 | +8.6 (5.2, 12.1) | <0.001 |
| >180 | 28.1 ± 15.8 | 29.3 ± 13.3 | 28.9 ± 13.6 | 22.8 ± 8.9 | −5.3 (−8.7, −1.8) | 0.004 |
| Mean | 148.3 ± 26.0 | 150.7 ± 23.3 | 151.9 ± 22.7 | 147.9 ± 12.9 | −2.9 (−8.9, 3.1) | 0.342 |
| <54 | 3.3 ± 2.8 | 3.1 ± 2.1 | 1.5 ± 1.2 | 0.6 ± 0.5 | −0.8 (−1.2, −0.5) | Not tested |
Data are reported as mean ± SD unless otherwise indicated.
Hierarchical analysis.