Table 2.
Primary analysis of HbA1c* at 1 Year
| More Frequent Cohort | Annual Cohort | |||
|---|---|---|---|---|
|
| ||||
| Control N=424 | Intervention N=423 | Control N=292 | Intervention N=312 | |
| Baseline HbA1c (%) | ||||
| Median (25th, 75th percentile) | 8.0 (7.2, 9.0) | 8.2 (7.3, 9.3) | 8.0 (7.1, 9.1) | 8.0 (7.2, 9.3) |
| Mean ± SD | 8.3 ± 1.6 | 8.5 ± 1.7 | 8.2 ± 1.5 | 8.4 ± 1.7 |
| One Year HbA1c† (%) | ||||
| Median (25th, 75th percentile) | 7.9 (7.0, 9.0) | 8.0 (7.0, 9.1) | 8.0 (7.0, 9.2) | 7.9 (7.1, 9.2) |
| Mean ± SD | 8.2 ± 1.7 | 8.2 ± 1.6 | 8.2 ± 1.6 | 8.3 ± 1.8 |
|
| ||||
| Change in HbA1c from baseline (%) | ||||
| Median (25th, 75th percentile) | −0.1 (−0.6, +0.5) | −0.1 (−0.8, +0.5) | 0.0 (−0.6, +0.5) | −0.1 (−0.6, +0.5) |
| Mean ± SD | −0.1 ± 1.5 | −0.3 ± 1.4 | 0.0 ± 1.1 | −0.1 ± 1.6 |
| Mean Difference (Intervention – Control) ± Standard Error‡ | −0.09 ± 0.09 | −0.05 ± 0.09 | ||
| 95% Confidence Interval‡ | (−0.29, + 0.12) | (−0.27, +0.18) | ||
| P-value‡ | 0.35 | 0.63 | ||
|
| ||||
| % with HbA1c < 7.0% | 97 (23%) | 97 (23%) | 70 (24%) | 69 (22%) |
| % with HbA1c > 10.0% | 47 (11%) | 61 (14%) | 34 (12%) | 44 (14%) |
| % with relative decrease in HbA1c ≥ 10% | 90 (21%) | 106 (25%) | 50 (17%) | 64 (21%) |
| % with absolute decrease in HbA1c ≥ 0.5% | 131 (31%) | 154 (36%) | 83 (28%) | 92 (29%) |
| % with absolute increase in HbA1c ≥ 0.5% | 112 (26%) | 110 (26%) | 76 (26%) | 78 (25%) |
*
From central lab measurement.
More Frequent Cohort:
- †1 year HbA1c missing for 10 control, 5 intervention
- ‡From a repeated measures model adjusting for baseline HbA1c and correlation between patients within site, assuming the correlation is the same for any pair of patients at a given site, and the within site correlation is the same at all sites. P-value from same model adjusting for additional potential confounders (race, education level, income) = 0.29
Annual Cohort:
- †1 year HbA1c missing for 8 control, 8 intervention
- ‡From a repeated measures model adjusting for baseline HbA1c and correlation between patients within site, assuming the correlation is the same for any pair of patients at a given site, and the within site correlation is the same at all sites. Pvalue from same model adjusting for additional potential confounders (race, education level, income) = 0.44