Variables | M(SD) baseline to 13 months ∆ | P value level | |||
WL | GEM | WL versus GEM | WL | GEM | |
Sample size | 36 | 123 | |||
Primary outcome variables | |||||
HbA1c (% and (mmol/mol)) | −0.2±1.3 (−2.2±14.2) | −0.5±1.4 (−5.5±15.3) | 0.33 | 0.33 | <0.001* |
Secondary outcome variables | |||||
% cardiovascular risk (UKPDS-OM2) | 0.6±4.7 | −0.7±6.5 | 0.21 | 0.47 | 0.26 |
Diabetes empowerment | −1.3±6.0 | 2.2±5.7 | 0.005* | 0.28 | <0.001* |
Diabetes distress (emotional) | 0.1±0.9 | −0.3±1.0 | 0.21 | 0.76 | 0.009* |
Diabetes distress (regimen) | −0.4±1.0 | −0.4±1.3 | 0.93 | 0.03 | 0.001* |
Depression (Patient Health Questionnaire-9) | −0.2±4.2 | −0.4±3.9 | 0.60 | 0.79 | 0.22 |
Side effect variables | |||||
LDL (mmol/L) | 0±0.6346 | −0.0647±0.8012 | 0.65 | 1.00 | 0.401 |
HDL (mmol/L) | 0.0345±0.1579 | 0.0723±0.1726 | 0.24 | 0.20 | <0.001* |
Triglycerides (mmol/L) | 0.1581±0.5269 | −0.0761±1.593 | 0.89 | 0.08 | 0.61 |
Total cholesterol (mmol/L) | 0.1092±0.6419 | 0.0011±0.9714 | 0.73 | 0.31 | 0.99 |
Mechanism variables | |||||
Diabetes knowledge | 0.3±2.6 | 2.5±2.7 | <0.001* | 0.57 | <0.001* |
Body mass index (BMI) | −0.9±1.4 | −1±1.6 | 0.56 | 0.001* | <0.001* |
Carbohydrates Routinely Consumed (servings) | −1.8±16.3 | −13.3±19 | <0.01* | 0.57 | <0.001* |
SMBG readings (30 days) | 2.4±22.5 | 12.6±31.8 | 0.18 | 0.53 | <0.001* |
Glucose Monitor Satisfaction Survey (GMSS) | 0.9±0.6 | 0.3±0.5 | 0.04 | 0.44 | <0.001* |
Medication Effect Score (MES) | 0.1±0.5 | 0±0.6 | 0.24 | 0.11 | 0.44 |
*P value levels were calculated with a false discovery rate of 0.05.
GEM, glycemic excursion minimization; HDL, high-density lipoprotein; LDL, low-density lipoprotein; SMBG, self-monitoring of blood glucose; UKPDS-OM2, UK Prospective Diabetes Study Outcomes Model 2; WL, weight loss.