WL pre to 13 months ∆ | GEM pre to 13 months ∆ | |||||
Responders | Non-responders | P value | Responders | Non- responders | P value | |
Primary outcome variable | ||||||
HbA1c (% and (mmol/mol)) | −1.2±0.7 (−13.1±7.7) | 0.5±1.2 (5.5±13.1) | <0.001* | −1.5±1.0 (−16.4±10.9) | 0.5±1.0 (5.5±10.9) | <0.001* |
Total treatment effect (TTE) | −1.2±0.7 | 0.8±1.1 | <0.001* | −1.6±1.0 | 0.8±1.0 | <0.001* |
Secondary outcome variables | ||||||
% cardiovascular risk (UKPDS-OM2) | −2.2±4.8 | 2.5±3.7 | <0.01* | −2.8±5.3 | 1.6±7.0 | <0.001* |
Diabetes empowerment | 0.8±5.6 | −2.8±6.0 | 0.12 | 3.6±4.8 | 0.7±6.3 | 0.007* |
Diabetes distress (emotional) | 0.0±0.9 | 0.1±0.9 | 0.80 | −0.5±0.9 | 0.0±1.1 | 0.019* |
Diabetes distress (regimen) | −0.3±1.2 | −0.5±0.8 | 0.59 | −0.7±1.3 | −0.1±1.2 | 0.007* |
Depression (Patient Health Questionnaire-9) | 1.3±3.7 | −1.3±4.3 | 0.11 | −1.0±3.2 | 0.1±4.4 | 0.14 |
Medication Effect Score (MES) | 0.0±0.3 | 0.3±0.6 | 0.09 | −0.2±0.5 | 0.3±0.6 | <0.001* |
Side effect variables | ||||||
LDL (mmol/L) | −0.0665±0.4619 | 0.0443±0.7354 | 0.62 | −0.074±0.7421 | −0.0538±0.8723 | 0.90 |
HDL (mmol/L) | 0.0776±0.144 | 0.0037±0.1634 | 0.17 | 0.1204±0.1785 | 0.0199±0.1506 | 0.001* |
Triglycerides (mmol/L) | 0.324±0.542 | 0.2478±0.5099 | 0.23 | −0.0611±0.894 | −0.0925±2.1165 | 0.92 |
Total cholesterol (mmol/L) | 0.638±0.509 | 0.1416±0.7326 | 0.73 | 0.0309±0.8414 | −0.0314±1.1026 | 0.73 |
Mechanism variables | ||||||
Diabetes knowledge | 0.3±2.8 | 0.3±2.6 | 0.95 | 2.8±2.8 | 2.2±2.6 | 0.24 |
Body mass index (BMI) | −1.3±1.3 | −0.5±1.4 | 0.08 | −1.5±1.7 | −0.5±1.4 | 0.002* |
Carbohydrates Routinely Consumed (servings) | −2.7±16.7 | 1.2±16.5 | 0.82 | −17.2±16.4 | −8.7±21.5 | 0.021* |
SMBG readings (30 days) | 1.6±22.8 | 3.0±23.0 | 0.86 | 13.1±30.0 | 12.1±34.0 | 0.87 |
Glucose Monitor Satisfaction Survey (GMSS) | 0.2±0.6 | 0.0±0.6 | 0.31 | 0.4±0.6 | 0.1±0.5 | 0.007* |
*Significant with a false discovery rate of 0.05.16
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.