Table 2.
Glycemic Outcomes at Baseline and Over 6 Months Follow-Up
| Baseline (n = 447) | Over 6 months follow-up (n = 558) | Change from baseline to follow-up difference (95% CI)a | Pa | |
|---|---|---|---|---|
| Hours of CGM data, mean ± SD | 1852 ± 923 (77 ± 38 days) | 3815 ± 816 (159 ± 34 days) | — | — |
| Primary outcomesb | ||||
| Percent time in range 70–180 mg/dL, mean ± SD | 67% ± 16% | 73% ± 13% | 6.6% (5.9% to 7.4%) | <0.001 |
| Percent time >180 mg/dL, mean ± SD | 29% ± 17% | 24% ± 14% | −6.2% (−7.0% to −5.4%) | <0.001 |
| Mean glucose (mg/dL), mean ± SD | 155 ± 29 | 147 ± 23 | −10 (−11 to −8) | <0.001 |
| Percent time <70 mg/dL, median (IQR) | 2.9% (1.3%, 5.2%) | 2.8% (1.3%, 4.7%) | −0.2% (−0.4% to −0.1%) | 0.002 |
| Percent time <54 mg/dL, median (IQR) | 0.40% (0.13%, 0.96%) | 0.36% (0.15%, 0.85%) | −0.05% (−0.09% to −0.03%) | <0.001 |
| HbA1c mean ± SD, % (mmol/mol)c | 6.8 ± 1.0 | 6.5 ± 0.8 | −0.33% (−0.40% to −0.26%) | <0.001 |
| 51 ± 10.9 | 48 ± 8.7 | [−3.6 (−4.4 to −2.80)] | ||
| Secondary continuous outcomes,d median (IQR) | ||||
| Percent time in range 70–140 mg/dL | 44% (35%, 57%) | 52% (42%, 61%) | 6.7% (6.0% to 7.5%) | <0.001 |
| Percent time >250 mg/dL | 6% (2%, 13%) | 5% (2%, 9%) | −1.8% (−2.2% to −1.5%) | <0.001 |
| High blood glucose index | 6.1 (3.6, 9.1) | 4.9 (3.2, 7.1) | −1.2 (−1.4 to −1.0) | <0.001 |
| AUC >180 mg/dL | 13 (6, 23) | 10 (5, 17) | −3.3 (−4.0 to −2.7) | <0.001 |
| Low blood glucose index | 0.9 (0.5, 1.4) | 0.9 (0.5, 1.4) | 0.01 (−0.03 to 0.04) | 0.67 |
| AOC <70 mg/dL | 0.3 (0.1, 0.5) | 0.2 (0.1, 0.5) | −0.03 (−0.04 to −0.01) | <0.001 |
| Rate of hypoglycemia events per week (<54 mg/dL)d,e | 0.8 (0.2, 2.0) | 0.7 (0.3, 1.7) | −0.16 (−0.19 to −0.13) | <0.001 |
| Glucose coefficient of variation (%), median (IQR) | 37% (33%, 41%) | 37% (33%, 40%) | −0.3% (−0.6% to −0.0%) | 0.05 |
| Glucose standard deviation (mg/dL), median (IQR) | 57 (48, 68) | 54 (45, 62) | −3.5 (−4.1 to −2.9) | <0.001 |
| Secondary binary outcomes,dn (%) | ||||
| Time in range 70–180 mg/dL >70% | 198 (44%) | 353 (63%) | 21% (17% to 25%) | <0.001 |
| Time below 70 mg/dL <4% | 275 (62%) | 379 (68%) | 6% (2% to 9%) | 0.001 |
| Time below 54 mg/dL <1% | 341 (76%) | 452 (81%) | 5% (2% to 9%) | 0.002 |
| Time in range 70–180 mg/dL >70% plus time below 70 mg/dL <4% | 97 (22%) | 209 (37%) | 17% (13% to 21%) | <0.001 |
| Time in range 70–180 mg/dL >70% plus time below 54 mg/dL <1% | 144 (32%) | 274 (49%) | 19% (15% to 23%) | <0.001 |
| HbA1c < 7.0% (<53 mmol/mol)c | 220 (58%) | 332 (75%) | 19% (14% to 23%) | <0.001 |
| HbA1c improvement from baseline ≥0.5% (≥5.5 mmol/mol)c | — | 178 (40%) | — | — |
For continuous outcomes, P-values estimated from paired t-test or Wilcoxon signed-rank test using complete-case analysis (n = 447 for CGM analysis and n = 335 for HbA1c analysis) and CIs for the mean or median difference are reported. For the rate of hypoglycemia events per week, P-value estimated from a Poisson regression model and CI for difference in event rates is reported. For binary outcomes, P-values estimated from McNemar's test and Wald CIs for the difference in proportions are reported.
Hierarchical approach used to control for the family-wise error rate.
For HbA1c outcomes n = 378 at baseline and n = 443 at follow-up.
P-values and CIs adjusted using the adaptive Benjamini–Hochberg procedure to control the false discovery rate.
A hypoglycemic event was defined as at least 15 continuous minutes with CGM readings <54 mg/dL. The end of an event was defined as at least 15 continuous minutes with CGM readings ≥70 mg/dL.
AOC, area over the curve; AUC, area under the receiver operating characteristic curve; CGM, continuous glucose monitoring; CI, confidence interval; IQR, interquartile range.