Variables | WL Mean (SD) | GEM Mean (SD) | P value | ||||
Pre | Follow-up | Pre | Follow-up | WL to GEM | WL | GEM | |
Primary outcome variable | |||||||
HbA1c (%) | 8.24 (0.99) | 7.93 (1.39) | 8.36 (1.33) | 7.39 (1.31) | 0.005* | 0.055 | <0.001* |
Secondary benefit variables | |||||||
Cardiovascular risk (United Kingdom Prospective Diabetes Study Outcomes Model 2, UKPDS-OM2) (%) | 15 (11) | 14 (10) | 14 (12) | 11 (8) | 0.003* | 0.171 | <0.001* |
Diabetes empowerment | 30.6 (3.8) | 31.7 (4.8) | 30.0 (4.6) | 33.1 (4.9) | 0.073 | 0.096 | <0.001* |
Diabetes distress (Emotional) | 2.26 (1.05) | 2.14 (1.04) | 2.35 (1.11) | 2.12 (1.10) | 0.629 | 0.303 | 0.002 |
Diabetes distress (Regimen) | 3.14 (1.11) | 2.79 (1.24) | 3.07 (1.35) | 2.48 (1.27) | 0.175 | 0.078 | <0.001* |
PHQ-9 (depression symptoms) | 4.61 (4.28) | 4.10 (4.76) | 4.38 (4.75) | 3.62 (4.81) | 0.683 | 0.541 | 0.038* |
Side effect variables | |||||||
LDL (mmol/L) | 5.74 (1.88) | 5.57 (1.65) | 5.63 (2.06) | 5.70 (2.00) | 0.335 | 0.427 | 0.579 |
HDL (mmol/L) | 2.37 (0.48) | 2.43 (0.48) | 2.39 (0.56) | 2.54 (0.68) | 0.528 | 0.002* | <0.001* |
Triglycerides (mmol/L) | 7.99 (5.72) | 7.22 (3.05) | 9.99 (7.94) | 8.27 (4.55) | 0.513 | 0.383 | 0.816 |
Total cholesterol (mmol/L) | 9.34 (1.96) | 9.18 (1.80) | 9.62 (2.42) | 9.58 (2.37) | 0.403 | 0.402 | 0.832 |
Total fats/day (g) (ASA24) | 105.8 (41.2) | 101.9 (42.2) | 83.3 (29.3) | 85.1 (31.7) | 0.598 | 0.664 | 0.741 |
Proteins (g) (ASA24) | 104.2 (29.6) | 97.1 (29.1) | 83.9 (26.0) | 85.4 (28.0) | 0.335 | 0.427 | 0.579 |
Mechanism variables | |||||||
Diabetes knowledge | 14.2 (2.7) | 14.5 (3.7) | 14.6 (3.0) | 17.2 (2.9) | <0.001* | 0.690 | <0.001* |
BMI | 34.9 (7.1) | 34.2 (6.8) | 34.9 (6.0) | 33.6 (6.1) | 0.013 | 0.005* | <0.001* |
Carbohydrates (serving) (CRC) | 32.5 (14.3) | 29.0 (12.1) | 34.9 (16.7) | 18.2 (14.8) | <0.001 | 0.050 | <0.001* |
Carbohydrates/day (g)(ASA24) | 236 (66) | 208 (68) | 214 (80) | 148 (67.9) | 0.001 | 0.178 | <0.001* |
Calories/day (ASA24) | 2292 (580) | 2111 (617) | 1953 (595) | 1710 (561) | 0.061 | 0.756 | <0.001* |
Steps/day (Fitbit) | 7438 (3434) | 7669 (3455) | 6599 (2961) | 7156 (3392) | 0.698 | 0.368 | 0.012* |
Hours active (Fitbit) | 7.14 (2.82) | 7.50 (2.65) | 7.62 (2.51) | 8.31 (2.71) | 0.538 | 0.041 | 0.006* |
∆BG from MMTT (0–60 min) (mmol/L) | 4.66 (1.57) | 5.04 (1.79) | 4.42 (1.73) | 4.18 (1.73) | 0.021 | 0.082 | 0.090 |
Self-monitoring of blood glucose (SMBG): Count in past 30 days | 15.4 (22.6) | 18.7 (20.0) | 10.1 (18.4) | 28.5 (29.2) | 0.056 | 0.143 | <0.001* |
Glucose monitoring satisfaction | 3.32 (0.47) | 3.60 (0.62) | 3.36 (0.52) | 3.73 (0.51) | 0.267 | 0.003 | <0.001* |
Medication Effect Score | 1.06 (0.74) | 1.17 (0.90) | 1.19 (0.81) | 1.18 (0.80) | 0.227 | 0.223 | 0.768 |
*Significant with a false discovery rate of 0.05.25
ASA24, Automated Self-Administered 24-hour dietary recall; BG, blood glucose; BMI, body mass index; CRC, Carbohydrate Routine Consumption scale; GEM, glycemic excursion minimization; HDL, high-density lipoprotein; LDL, low-density lipoprotein; MMTT, mixed meal tolerance test; PHQ-9, Patient Health Questionnaire-9; WL, weight loss.