Table 1.
Summary of clinical metrics
| SAP run-in |
Week 4 AP vs. SAP run-in |
Week 8 AP vs. SAP run-in |
Week 12 AP vs. SAP run-in |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean ± SD | Mean ± SD | Estimate | 95% CI | P | Mean ± SD | Estimate | 95% CI | P | Mean ± SD | Estimate | 95% CI | P | |
| Primary outcome | |||||||||||||
| HbA1c, % | 7.0 ± 0.8 | 6.8 ± 0.6 | −0.2 | −0.4, −0.1 | 0.008 | 6.7 ± 0.5 | −0.3 | −0.5, −0.2 | <0.001 | 6.7 ± 0.6 | −0.3 | −0.5, −0.2 | <0.001 |
| Secondary outcomes | |||||||||||||
| Overall control | |||||||||||||
| BGRI | 5.9 ± 2.4 | 5.5 ± 2.6 | −0.4 | −1.2, 0.5 | 0.40 | 6.1 ± 3.3 | 0.2 | −0.7, 1.0 | 0.70 | 6.3 ± 3.1 | 0.4 | 0.5, 1.3 | 0.35 |
| Glucose | |||||||||||||
| Mean, mg/dL | 141.9 ± 20.1 | 146.4 ± 17.8 | −0.6 | −1.3, 10.4 | 0.12 | 149.6 ± 21.0 | 7.7 | 1.9, 13.5 | 0.01 | 152.5 ± 20.7 | 10.9 | 5.0, 16.7 | <0.001 |
| SD, mg/dL | 49.2 ± 9.8 | 47.2 ± 11.2 | −2.0 | −5.7, 1.7 | 0.29 | 49.2 ± 14.2 | 0.1 | −3.6, 3.8 | 0.95 | 49.0 ± 13.1 | −0.1 | −3.8, 3.7 | 0.98 |
| CV glucose | 34.6 ± 4.7 | 32.1 ± 4.9 | −2.6 | −4.4, −0.8 | 0.005 | 32.5 ± 6.0 | −2.1 | −3.9, −0.3 | 0.021 | 31.9 ± 5.9 | −2.7 | −4.5, −0.9 | 0.004 |
| % Time | |||||||||||||
| 70–180 mg/dL | 73.9 ± 12.2 | 76.7 ± 10.8 | 2.8 | −1.0, 6.6 | 0.15 | 74.1 ± 13.2 | 0.2 | −3.6, 4.0 | 0.91 | 72.6 ± 13.2 | −1.3 | −5.2, 2.5 | 0.49 |
| 80–140 mg/dL | 46.2 ± 11.0 | 47.1 ± 11.2 | 0.9 | −2.6, 4.5 | 0.60 | 47.4 ± 13.1 | 1.2 | −2.4, 4.7 | 0.51 | 44.2 ± 13.1 | −2.0 | −5.6, 1.6 | 0.26 |
| % Time overnight | |||||||||||||
| 70–180 mg/dL | 73.1 ± 17.9 | 77.9 ± 14.3 | 4.9 | −1.2, 10.9 | 0.116 | 76.3 ± 16.6 | 3.3 | −2.8, 9.3 | 0.29 | 69.5 ± 20.2 | −3.5 | −9.7, 2.6 | 0.26 |
| 80–140 mg/dL | 45.7 ± 16.1 | 46.4 ± 18.6 | 0.7 | −5.7, 7.1 | 0.83 | 48.7 ± 17.6 | 3.1 | −3.3, 9.4 | 0.34 | 40.9 ± 20.4 | −4.6 | −11.0, 1.8 | 0.16 |
| Hypoglycemia | |||||||||||||
| LBGI | 1.3 ± 0.9 | 0.7 ± 0.4 | −0.6 | −0.8, −0.4 | <0.001 | 0.6 ± 0.4 | −0.6 | −0.8, −0.4 | <0.001 | 0.6 ± .4 | −0.7 | −0.9, −0.5 | <0.001 |
| % Time | |||||||||||||
| <50 mg/dL | 0.6 ± 0.8 | 0.2 ± 0.2 | −0.4 | −0.6, −0.2 | <0.001 | 0.2 ± 0.3 | −0.4 | −0.6, −0.2 | <0.001 | 0.2 ± 0.3 | −0.4 | −0.6, −0.2 | <0.001 |
| <60 mg/dL | 2.0 ± 2.2 | 0.7 ± 0.7 | −1.3 | −1.8, −0.8 | <0.001 | 0.7 ± 0.8 | −1.3 | −1.8, −0.8 | <0.001 | 0.7 ± 0.8 | −1.4 | −1.9, −0.8 | <0.001 |
| <70 mg/dL | 5.0 ± 4.2 | 2.0 ± 1.6 | −3.0 | −4.0, −2.0 | <0.001 | 1.9 ± 1.6 | −3.1 | −4.1, −2.1 | <0.001 | 1.9 ± 2.0 | −3.1 | −4.1, −2.1 | <0.001 |
| % Time overnight | |||||||||||||
| <70 mg/dL | 4.1 ± 4.3 | 0.9 ± 1.4 | −3.2 | −4.3, −2.1 | <0.001 | 0.7 ± 1.1 | −3.4 | −4.6, −2.3 | <0.001 | 1.1 ± 1.9 | −3.1 | −4.2, −1.9 | <0.001 |
| Hyperglycemia | |||||||||||||
| HBGRI | 4.7 ± 2.8 | 4.9 ± 2.7 | 0.2 | −0.7, 1.1 | 0.65 | 5.4 ± 3.4 | 0.8 | −0.1, 1.7 | 0.089 | 5.7 ± 3.3 | 1.1 | 0.2, 2.0 | 0.019 |
| % Time | |||||||||||||
| >180 mg/dL | 21.1 ± 13.5 | 21.3 ± 11.3 | 0.2 | −3.8, 4.1 | 0.94 | 24.0 ± 13.5 | 2.9 | −1.0, 6.8 | 0.147 | 25.5 ± 13.7 | 4.5 | 0.5, 8.5 | 0.027 |
| >250 mg/dL | 4.1 ± 4.5 | 4.3 ± 5.7 | 0.2 | −1.8, 2.2 | 0.84 | 5.6 ± 7.7 | 1.6 | −0.4, 3.6 | 0.125 | 5.6 ± 7.2 | 1.6 | −0.4, 3.6 | 0.124 |
| >300 mg/dL | 1.0 ± 1.5 | 1.2 ± 2.9 | 0.2 | −0.9, 1.2 | 0.76 | 1.9 ± 4.2 | 0.9 | −0.2, 1.9 | 0.107 | 1.8 ± 3.1 | 0.7 | −0.3, 1.8 | 0.17 |
Shown are repeated-measures comparisons between the SAP run-in week and the 4th, 8th, and 12th week of AP use. HbA1c was collected at the start of the AP (end of SAP run-in week) and again at the end of the 4th, 8th, and 12th week of AP use. Statistically significant changes are highlighted in bold.
BGRI, blood glucose risk index; CV, coefficient of variation; HBGRI, high blood glucose risk index; LBGI, low blood glucose index.