Table 4.
Additional Efficacy Continuous Glucose Monitoring Outcomes
| Baseline |
Follow-up (at or over 13 weeks) |
Adjusted difference, BP minus SC (95% CI)a | P a | |||
|---|---|---|---|---|---|---|
| BP (N = 107) | SC (N = 54) | BP (N = 106) | SC (N = 54) | |||
| Hours of CGM data, median (IQR) | 334 (321, 336) | 334 (326, 336) | 2022 (1887, 2062) | 2114 (2063, 2136) | ||
| Time 70–140 mg/dL, mean ± SD | 33% ± 15% | 32% ± 16% | 42% ± 7% | 34% ± 14% | 7% (5% to 9%) | <0.001 |
| Time 70–120 mg/dL, mean ± SD | 21% ± 12% | 20% ± 12% | 26% ± 5% | 22% ± 10% | 3% (2% to 5%) | <0.001 |
| Time <60 mg/dL, median (IQR) | 0.5% (0.1%, 1.1%) | 0.3% (0.1%, 0.8%) | 0.7% (0.4%, 1.0%) | 0.5% (0.2%, 1.0%) | 0.0% (−0.1% to 0.2%) | 0.46 |
| Area over the curve <70 mg/dL,b median (IQR) | 0.15 (0.03, 0.29) | 0.08 (0.02, 0.25) | 0.18 (0.10, 0.27) | 0.13 (0.05, 0.24) | 0.01 (−0.02 to 0.04) | 0.49 |
| Low blood glucose index, median (IQR) | 0.49 (0.20, 0.86) | 0.39 (0.18, 0.66) | 0.58 (0.42, 0.80) | 0.43 (0.27, 0.79) | 0.05 (−0.03 to 0.13) | 0.22 |
| Hypoglycemic event rate per week,c median (IQR) | 0.50 (0.00, 1.08) | 0.00 (0.00, 1.02) | 0.66 (0.25, 1.14) | 0.36 (0.16, 1.01) | 0.00 (−0.07 to 0.16) | 0.34 |
| Time >300 mg/dL, median (IQR) | 3.1% (0.6%, 9.8%) | 4.0% (0.5%, 14.1%) | 1.2% (0.6%, 2.4%) | 2.6% (0.7%, 9.0%) | −1.2% (−1.9% to −0.6%) | <0.001 |
| Area under the curve >180 mg/dL,b median (IQR) | 20.8 (11.3, 37.7) | 24.9 (10.1, 47.8) | 12.1 (8.6, 16.0) | 20.7 (11.0, 38.5) | −6.1 (−8.9 to 3.6) | <0.001 |
| High blood glucose index, median (IQR) | 8.8 (5.6, 13.3) | 10.2 (5.1, 15.9) | 6.1 (5.0, 7.3) | 8.8 (5.6, 13.3) | −2.0 (−2.8 to −1.3) | <0.001 |
| Hyperglycemic event rate per week (≥15 min >300 mg/dL),d median (IQR) | 3.0 (0.6, 6.0) | 3.8 (0.5, 7.6) | 1.4 (0.9, 2.4) | 2.5 (0.7, 6.7) | −0.7 (−1.3 to −0.3) | 0.002 |
| Hyperglycemic event rate per week (≥90 min >300 mg/dL in 120 min),e median (IQR) | 1.0 (0.0, 3.1) | 1.5 (0.0, 5.0) | 0.5 (0.2, 0.9) | 0.9 (0.3, 3.1) | −0.5 (−0.8 to −0.2) | <0.001 |
| Mean of daily difference, mean ± SD | 27 ± 12 | 28 ± 12 | 17 ± 6 | 25 ± 9 | −8 (−9 to −6) | <0.001 |
| Blood glucose risk index,f median (IQR) | 9.4 (6.5, 14.1) | 10.5 (5.5, 16.2) | 6.9 (5.5, 7.7) | 9.3 (6.2, 13.9) | −2.0 (−2.8 to −1.3) | <0.001 |
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. Multiple comparisons were adjusted using the Benjamini-Hochberg adaptive false discovery rate correction procedure.
Area over the curve 70 mg/dL is calculated as the average magnitude of CGM glucose values below 70 mg/dL. Area over the curve 180 mg/dL is calculated as the average magnitude of CGM glucose values above 180 mg/dL.
A CGM-measured hypoglycemic event is defined as ≥15 consecutive minutes with a CGM sensor value <54 mg/dL. The hypo event ends when there are ≥15 consecutive minutes with a CGM sensor value ≥70 mg/dL, at which point the participant becomes eligible for another hypoglycemic event.
A CGM-measured hyperglycemic event is defined as ≥15 consecutive minutes with a CGM glucose value >300 mg/dL. The hyper event ends when there are ≥15 consecutive minutes with a CGM glucose value ≤250 mg/dL, at which point the participant becomes eligible for another hyper event.
A CGM-measured hyperglycemic event is defined as ≥90 cumulative minutes with a CGM sensor value >300 mg/dL within a 120-min period. The hyper event ends when there are ≥15 consecutive minutes with a CGM sensor value ≤180 mg/dL, at which point the participant becomes eligible for another hyperglycemic event.
Blood glucose risk index = low blood glucose index + high blood glucose index.