TABLE 3.
Variable | DCR baseline | DCR 12 weeks | Change | p‐value a | E‐TRE baseline | E‐TRE 12 weeks | Change | p‐value a | p‐value b |
---|---|---|---|---|---|---|---|---|---|
Average sensor glucose | 95.8 (9.0) | 93.2 (9.2) | −2.5 (12.0) | 0.430 | 90.5 (10.2) | 92.7 (11.1) | 2.1 (11.9) | 0.278 | 0.187 |
Standard deviation | 15.8 (3.6) | 14.0 (2.7) | −1.8 (3.7) | 0.022 | 13.6 (3.9) | 13.0 (3.0) | −0.6 (3.0) | 0.474 | 0.228 |
Coefficient of variation | 0.16 (0.03) | 0.15 (0.03) | −0.01 (0.03) | 0.041 | 0.15 (0.03) | 0.14 (0.03) | −0.01 (0.03) | 0.177 | 0.566 |
Daytime average sensor glucose | 97.0 (8.6) | 94.4 (10.8) | −2.6 (11.9) | 0.396 | 92.0 (10.3) | 94.6 (11.5) | 2.7 (11.2) | 0.195 | 0.131 |
Nighttime average sensor glucose | 92.8 (11.9) | 90.5 (7.3) | −2.3 (13.4) | 0.564 | 87.3 (10.9) | 88.3 (10.7) | 1.0 (13.8) | 0.533 | 0.396 |
MAGE | 35.2 (8.6) | 29.8 (6.5) | −5.4 (7.3) | 0.002 | 29.1 (9.6) | 28.6 (8.3) | −0.6 (7.0) | 0.801 | 0.030 |
Glucose | 77.2 (16.9) | 80.4 (6.8) | 3.2 (19.3) | 0.386 | 81.2 (7.0) | 83.7 (5.5) | 2.2 (4.3) | 0.532 | 0.879 |
Insulin | 7.8 (4.9) | 5.9 (3.7) | −1.9 (3.2) | 0.022 | 8.3 (4.8) | 6.8 (3.3) | −1.8 (2.8) | 0.057 | 0.817 |
HOMA‐IR | 1.6 (1.1) | 1.2 (0.7) | −0.4 (0.7) | 0.025 | 1.7 (1.1) | 1.4 (0.7) | −0.3 (0.6) | 0.111 | 0.666 |
A1c | 5.4 (0.3) | 5.4 (0.4) | 0.0 (0.3) | 0.234 | 5.2 (0.3) | 5.2 (0.4) | 0.0 (0.2) | 0.601 | 0.618 |
Note: Mean (standard deviation) are presented. Bold values indicates statistical significance p < 0.05.
Abbreviations: A1c, hemoglobin A1c; HOMA‐IR, homeostatic model assessment of insulin resistance; MAGE, mean amplitude of glycemic excursions; METs, metabolic equivalents.
p‐value calculated from weight‐adjusted mixed model tests whether baseline differs from Week 12 within each randomized group.
p‐value calculated from randomized group × time interaction of weight‐adjusted mixed model tests whether the changes in each outcome from baseline to week 12 differed by randomized group.