Table 2.
Results for the Changes in Out-of-Range Measurements and Glycated Hemoglobin for the Different Time Periods and Associated P Values
| n | Change | 95% CI (ITT) | P (PP) | P (ITT) | ||
|---|---|---|---|---|---|---|
| OOR | ||||||
| Baseline | ||||||
| All | 46.0 | 30 | ||||
| Group 1 | 46.0 | 15 | ||||
| Group 2 | 46.0 | 15 | ||||
| T1 | ||||||
| All | 31.0 | 28 | −14.5a | −18.0, −9.0 | <0.001 | <0.001 |
| Group 1 | 32.5 | 14 | −7.5 | −15.5, −0.5 | 0.02 | 0.02 |
| Group 2 | 29.0 | 14 | −18.0a | −25.0, −13.0 | <0.001 | <0.001 |
| T2 | ||||||
| Group 2 | 34.5 | 10 | −17.5 | −29.0, −4.0 | 0.13 | 0.02 |
| Reference T1 | 3.5 | −10.0, 21.5 | 0.43 | 0.38 | ||
| HbA1c | ||||||
| Baseline | ||||||
| All | 8.20 | 30 | ||||
| Group 1 | 8.33 | 15 | ||||
| Group 2 | 8.06 | 15 | ||||
| T1 | ||||||
| All | 7.63 | 22 | −0.60a | −0.90, −0.30 | <0.001 | <0.001 |
| Group 1 | 7.89 | 11 | −0.63a | −1.02, −0.24 | 0.005 | 0.007 |
| Group 2 | 7.37 | 11 | −0.57a | −1.10, −0.05 | 0.04 | 0.04 |
| T2 versus | ||||||
| Group 2 | 7.49 | 9 | −0.21a | −0.64, −0.22 | 0.29 | 0.09 |
| Reference T1 | 0.16 | −0.37, 0.05 | 0.11 | 0.11 | ||
P values were computed by the Wilcoxon signed-rank test for out of range (OOR) and paired t test for glycated hemoglobin (HbA1c).
a
Significant difference.
CI, confidence interval; ITT, intention to treat; PP, per protocol.