Table 1.
Glycemic Outcomes During Postmeal Periods
| Run-in | 670G arm | AHCL arm | Baseline-adjusted difference between AHCL and 670G (95% CI) [P-value]a |
|
|---|---|---|---|---|
| No. of participants | 98 | 112 | 112 | |
| No. of meals per participant | 67 ± 20 | 229 ± 29 | 229 ± 27 | |
| Meal size (g) | 46 ± 16 | 46 ± 16 | 44 ± 15 | |
| Baseline glucose at start of meal (mg/dL) | 181 ± 30 | 175 ± 23 | 167 ± 23 | |
| Insulin on board at start of meal (U)b | 9.1 ± 3.4 | 9.1 ± 3.1 | 9.3 ± 3.1 | |
| Peak glucose (mg/dL) | 241 ± 30 | 235 ± 23 | 231 ± 23 | |
| Time to peak (minutes) | 73 ± 15 | 78 ± 12 | 82 ± 12 | |
| Nadir glucose (mg/dL) | 128 ± 24 | 124 ± 14 | 121 ± 16 | |
| Glucose excursion (peak—baseline; mg/dL) | 59 ± 15 | 61 ± 13 | 64 ± 13 | 1.7 (−0.6 to 4.1) [0.10] |
| Overall glucose control | ||||
| Mean glucose (mg/dL) | 185 ± 27 | 180 ± 19 | 177 ± 20 | 1.8 (−0.4 to 4.0) [0.10] |
| % Time in the target range (70–180 mg/dL) | 49% ± 15% | 53% ± 11% | 54% ± 11% | −0.8% (−2.1% to 0.4%) [0.12] |
| % Time in the tight target range (70–140 mg/dL) | 28% ± 11% | 29% ± 8% | 30% ± 9% | −0.1% (−1.4% to 1.1%) [0.85] |
| Glycemic variability | ||||
| Coefficient of variation | 35% ± 5% | 36% ± 4% | 36% ± 3% | 0.0% (−0.7% to 0.7%) [0.96] |
| Hypoglycemia | ||||
| % Time <70 mg/dL | 2.2% ± 1.9% | 2.1% ± 1.4% | 2.1% ± 1.5% | −0.1% (−0.4% to 0.2%) [0.48] |
| % Time <54 mg/dLb | 0.46% ± 0.52% | 0.49% ± 0.39% | 0.46% ± 0.34% | −0.05% (−0.13% to 0.03%) [0.13] |
| Hyperglycemia | ||||
| % Time >180 mg/dL | 49% ± 16% | 45% ± 11% | 44% ± 12% | 1.0% (−0.4% to 2.3%) [0.12] |
| % Time >250 mg/dL | 18% ± 12% | 15% ± 9% | 14% ± 9% | 1.0% (0.0% to 1.9%) [0.05] |
Values are reported as mean ± SD.
Baseline-adjusted difference is the mean outcome in AHCL minus mean outcome in 670G estimated from a repeated measures least squares regression model adjusting for baseline glucose at start of meal, period, prestudy 670G system use, and HbA1c at randomization as fixed effects. The model includes three time points: (1) baseline, (2) period 1 outcome, and (3) period 2 outcome. Nominal (uncorrected) P-values were adjusted for multiple comparisons using the Two Stage Benjamini-Hochberg adaptive false discovery rate procedure.
Summary statistics winsorized at the 10th and 90th percentiles to account for skewness.
AHCL, advanced hybrid closed-loop; CI, confidence interval; SD, standard deviation.