Table 2.
HbA1c and CGM-Derived Endpoints of Glycemic Control.
| MDI+RT-CGM group | AHCL group | Model-based treatment effect | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Run-in | Study | Run-in | Study | ||||||
| N | Value | N | Value | N | Value | N | Value | ||
| HbA1c, % | 5 | 9.46 ± 0.6 | 5 | 8.9 ± 1.1 | 8 | 8.9 ± 0.5 | 7 | 7.2 ± 1.0 | — |
| Change in HbA1c from baseline, percentage points | - | - | 5 | −0.6 ± 1.3 | - | - | 7 | −1.7 ± 1.0 | −1.1 (−2.2 to 0.0; P = .0508) |
| TIR, % | |||||||||
| >250 mg/dL (13.9 mmol/L) a | 4 | 20.7 ± 6.1 | 5 | 21.6 ± 9.3 | 7 | 22.8 ± 11.7 | 8 | 6.3 ± 5.2 | −16.0 (−26.0 to −6.2; P = .0051) |
| >180 mg/dL (>10.0 mmol/L) a | 4 | 53.9 ± 9.9 | 5 | 50.9 ± 15.6 | 7 | 55.2 ± 15.8 | 8 | 24.0 ± 13.5 | −28.5 (−45.3 to −11.6; P = .0043) |
| 70-180 mg/dL (3.9-10.0 mmol/L) a | 4 | 43.9 ± 9.6 | 5 | 46.4 ± 12.5 | 7 | 42.1± 15.3 | 8 | 73.6 ± 13.7 | 28.8 (12.3-45.3; P = .0035) |
| <70 mg/dL (3.9 mmol/L) b | 4 | 2.2 ± 2.5 | 5 | 2.7 ± 3.1 | 7 | 2.7 ± 3.0 | 8 | 2.4 ± 2.0 | −0.6 (−2.6 to 1.4; noninferiority met) |
| <54 mg/dL (3.0 mmol/L) c | 4 | 0.3 ± 0.4 | 5 | 1.0 ± 1.6 | 7 | 0.9 ± 1.4 | 8 | 0.5 ± 0.7 | −0.7 (−2.0 to 0.6; non-inferiority met) |
| Mean of SG, mg/dL | 4 | 191.8 ± 14.6 | 5 | 191.1 ± 26.4 | 7 | 194.6 ± 25.8 | 8 | 147.3 ± 20.8 | −46.9 (−73.8 to −20.0; P = .0034) |
| Standard deviation of SG, mg/dL | 4 | 70.1 ± 5.3 | 5 | 68.9 ± 7.4 | 7 | 67.2 ± 8.2 | 8 | 52.6 ± 12.7 | −16.2 (−31.1 to −1.2; P = .0372) |
| Users achieving HbA1c <7.0%, % (n/N) d | 5 | 0.0 (0/5) | 5 | 0.0 (0/5) | 8 | 0.0 (0/8) | 7 | 42.9 (3/7) | 0.0 (0.0 to 3.18; P = .2045) |
| Users achieving GMI <7.0%, % (n/N) d | 4 | 0.0 (0/4) | 5 | 20.0 (1/5) | 7 | 0.0 (0/7) | 8 | 62.5 (5/8) | 0.18 (0.0 to 3.0; P = .2657) |
| Users achieving TIR >70%, % (n/N) d | 4 | 0.0 (0/4) | 5 | 0.0 (0/5) | 7 | 0.0 (0/7) | 8 | 62.5 (5/8) | 0.0 (0.0 to 1.31; P = .0754) |
| Users achieving TBR <4%, % (n/N) d | 4 | 75.0 (3/4) | 5 | 80.0 (4/5) | 7 | 71.4 (5/7) | 8 | 75.0 (6/8) | 1.3 (0.0 to 98.0; P = .9999) |
Values are mean ± SD unless otherwise stated. The model-based treatment effect is the estimated treatment effect (AHCL group minus MDI + RT-CGM group) from the repeated-measures model.
Abbreviations: AHCL, advanced hybrid closed loop; CI, confidence interval; GMI, glucose management indicator; HbA1c, glycated hemoglobin; MDI + RT-CGM, multiple daily injections of insulin + real-time continuous glucose monitoring; SG, sensor glucose; TBR, time spent below range; TIR, time in range.
Model-based treatment effect (95% CI; P value for superiority test).
Model-based treatment effect (97.5% confidence limit; noninferiority met), noninferiority is met when the 97.5% upper confidence limit is less than the noninferiority margin of 5%.
Model-based treatment effect (97.5% confidence limit; noninferiority met), noninferiority is met when the 97.5% upper confidence limit is less than the noninferiority margin of 2%.
Post hoc analysis with odds ratio treatment effect estimates based on the Fisher exact test.