Table 2.
Key Efficacy Outcomes
| Baseline |
Follow-up (at or over 13 weeks) |
Adjusted difference, BP minus SC (95% CI)b | P b | |||
|---|---|---|---|---|---|---|
| BP (N = 107)a | SC (N = 54)a | BP (N = 107)a | SC (N = 54)a | |||
| Overall | ||||||
| HbA1c (%), mean ± SD | 7.6 ± 1.2 | 7.6 ± 1.2 | 7.1 ± 0.6 | 7.5 ± 0.9 | −0.5 (−0.6 to −0.3) | <0.001 |
| Mean glucose (mg/dL), mean ± SD | 179 ± 41 | 186 ± 42 | 157 ± 12 | 174 ± 30 | −16 (−20 to −11) | <0.001 |
| Time 70–180 mg/dL, mean ± SD | 56% ± 19% | 53% ± 21% | 69% ± 8% | 58% ± 17% | 11% (8% to 13%) | <0.001 |
| Time >180 mg/dL, mean ± SD | 42% ± 20% | 45% ± 21% | 28% ± 9% | 40% ± 18% | −11% (−13% to −8%) | <0.001 |
| Time >250 mg/dL, median (IQR) | 11.0% (4.9%, 23.0%) | 13.2% (3.8%, 32.0%) | 5.4% (3.4%, 7.7%) | 10.4% (4.3%, 23.6%) | −3.6% (−5.5% to −2.1%) | <0.001 |
| Time <70 mg/dL, median (IQR) | 1.7% (0.5%, 2.8%) | 1.3% (0.4%, 2.6%) | 1.9% (1.1%, 2.8%) | 1.5% (0.6%, 2.7%) | 0.1% (−0.2% to 0.4%) | 0.51 |
| Time <54 mg/dL, median (IQR) | 0.21% (0.02%, 0.57%) | 0.11% (0.00%, 0.37%) | 0.33% (0.14%, 0.52%) | 0.18% (0.08%, 0.58%) | 0.02% (−0.04% to 0.08%) | 0.33 |
| SD (mg/dL), mean ± SD | 62 ± 16 | 65 ± 18 | 54 ± 9 | 61 ± 14 | −7 (−9 to −4) | <0.001 |
| Coefficient of variation (%), mean ± SD | 35% ± 6% | 35% ± 5% | 34% ± 4% | 35% ± 5% | −0.8% (−1.9% to 0.4%) | 0.17 |
| Daytime (06:00 − 23:59) | ||||||
| Mean glucose (mg/dL), mean ± SD | 181 ± 40 | 186 ± 41 | 159 ± 12 | 175 ± 30 | ||
| Time 70–180 mg/dL, mean ± SD | 55% ± 19% | 53% ± 20% | 67% ± 8% | 57% ± 17% | ||
| Time >180 mg/dL, mean ± SD | 43% ± 20% | 45% ± 21% | 30% ± 8% | 41% ± 18% | ||
| Time >250 mg/dL, median (IQR) | 11.8% (4.9%, 24.2%) | 14.1% (4.8%, 31.8%) | 6.0% (4.1%, 9.2%) | 10.9% (3.3%, 22.8%) | ||
| Time <70 mg/dL, median (IQR) | 1.6% (0.4%, 3.0%) | 1.6% (0.4%, 2.5%) | 1.8% (0.9%, 3.0%) | 1.4% (0.6%, 2.5%) | ||
| Time <54 mg/dL, median (IQR) | 0.13% (0.00%, 0.60%) | 0.10% (0.00%, 0.43%) | 0.29% (0.10%, 0.53%) | 0.16% (0.05%, 0.46%) | ||
| SD (mg/dL), mean ± SD | 63 ± 16 | 65 ± 18 | 55 ± 8 | 61 ± 14 | ||
| Coefficient of variation (%), mean ± SD | 35% ± 6% | 35% ± 6% | 35% ± 4% | 35% ± 5% | ||
| Nighttime (00:00 − 05:59) | ||||||
| Mean glucose (mg/dL), mean ± SD | 174 ± 45 | 185 ± 51 | 150 ± 17 | 173 ± 33 | ||
| Time 70–180 mg/dL, mean ± SD | 59% ± 23% | 55% ± 26% | 75% ± 12% | 59% ± 20% | ||
| Time >180 mg/dL, mean ± SD | 38% ± 23% | 44% ± 26% | 23% ± 12% | 39% ± 20% | ||
| Time >250 mg/dL, median (IQR) | 7.4% (1.7%, 22.6%) | 10.8% (2.5%, 31.8%) | 3.4% (1.2%, 6.2%) | 9.5% (3.3%, 20.4%) | ||
| Time <70 mg/dL, median (IQR) | 1.2% (0.1%, 3.5%) | 0.6% (0.0%, 1.9%) | 1.9% (1.2%, 2.9%) | 1.1% (0.5%, 3.0%) | ||
| Time <54 mg/dL, median (IQR) | 0.00% (0.00%, 0.84%) | 0.00% (0.00%, 0.20%) | 0.38% (0.17%, 0.63%) | 0.19% (0.05%, 0.45%) | ||
| SD (mg/dL), mean ± SD | 57 ± 19 | 60 ± 19 | 49 ± 11 | 59 ± 15 | ||
| Coefficient of variation (%), mean ± SD | 33% ± 7% | 32% ± 7% | 32% ± 5% | 34% ± 6% | ||
One SC participant missing baseline HbA1c. Five BP participants and one SC participant missing 13-week HbA1c. One BP participant with missing follow-up CGM data. Median amount of CGM data for analyses was 334 (IQR 321, 336) h at baseline and 2022 (IQR 1887, 2062) during follow-up in the BP group and 334 (IQR 326, 336) and 2114 (IQR 2063, 2136), respectively in the SC group.
All statistical testing is for superiority. P-values and 95% CIs are from mixed-effect models adjusting for baseline value of the metric, age at randomization, and site (random effect). Missing data were handled using direct likelihood analyses. Due to a skewed distribution, % time >250, <70, and <54 mg/dL were transformed using a rank normal transformation. Multiple comparisons were adjusted using the Benjamini-Hochberg adaptive false discovery rate correction procedure.
CI, confidence interval.