Table 3.
Additional Efficacy Binary Outcomes
| Follow-up (at or over 13 weeks) |
Adjusted difference, BP minus SC (95% CI)b | P b | ||
|---|---|---|---|---|
| BP (N = 107),a N (%) | SC (N = 54),a N (%) | |||
| HbA1c <7.0% | 43 (42) | 15 (28) | 14% (4% to 27%) | 0.008 |
| HbA1c <7.5% | 76 (75) | 23 (43) | 28% (18% to 38%) | <0.001 |
| HbA1c <8.0% | 97 (95) | 41 (77) | 16% (8% to 24%) | <0.001 |
| HbA1c >9.0% | 0 (0) | 6 (11) | 36% (−23% to 91%) | 1.00 |
| HbA1c improvement from baseline >0.5% | 44 (43) | 9 (17) | 25% (19% to 30%) | <0.001 |
| HbA1c improvement from baseline >1.0% | 23 (23) | 2 (4) | 18% (8% to 24%) | 0.009 |
| HbA1c relative improvement from baseline >10% | 32 (31) | 2 (4) | 26% (17% to 33%) | 0.002 |
| HbA1c improvement from baseline >1.0% or HbA1c <7.0% | 58 (57) | 16 (31) | 26% (11% to 39%) | <0.001 |
| Time 70–180 mg/dL >70% | 50 (47) | 17 (31) | 12% (3% to 21%) | 0.01 |
| Time 70–180 mg/dL improvement from baseline ≥5% | 78 (74) | 28 (52) | 26% (17% to 36%) | <0.001 |
| Time 70–180 mg/dL improvement from baseline ≥10% | 72 (68) | 24 (44) | 29% (20% to 39%) | <0.001 |
| Time <70 mg/dL <4% | 93 (88) | 43 (80) | 10% (2% to 19%) | 0.01 |
| Time <54 mg/dL <1% | 92 (87) | 44 (81) | 9% (2% to 16%) | 0.01 |
| Mean glucose <154 mg/dL and time <54 mg/dL <1% | 42 (40) | 12 (22) | 15% (8% to 22%) | <0.001 |
| Time 70–180 mg/dL >70% and time <54 mg/dL <1% | 46 (43) | 12 (22) | 20% (11% to 28%) | <0.001 |
| HbA1c <7.0% for participants with baseline HbA1c >7.5% | N = 44, 9 (20) | N = 26, 1 (4) | 28% (−1% to 53%) | 0.06 |
| Improvement in HbA1c >0.5% without an increase in time <54 mg/dL by >0.5% or improvement in time <54 mg/dL by >0.5% without an increase in HbA1c by >0.5% | 47 (46) | 11 (21) | 20% (11% to 28%) | <0.001 |
| Improvement in time 70–180 mg/dL by >10% without an increase in time <54 mg/dL by >0.5% or improvement in time <54 mg/dL by >0.5% without a decrease in time 70–180 mg/dL by >10% | 55 (52) | 13 (24) | 27% (17% to 37%) | <0.001 |
a
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.
b
P-values are from a logistic regression model adjusting for the baseline value of the metric, age at randomization, and site (random effect). A 95% CI for the treatment group adjusted risk difference (BP minus SC) was produced using parametric bootstrapping. Multiple comparisons were adjusted using the Benjamini-Hochberg adaptive false discovery rate correction procedure.