Table 1

Changes from baseline to 13 months for the WL and GEM groups, and statistical significance for changes from baseline, both within and between groups

VariablesM(SD) baseline to 13 months ∆P value level
WLGEMWL versus GEMWLGEM
Sample size36123
Primary outcome variables
 HbA1c (% and (mmol/mol))−0.2±1.3 (−2.2±14.2)−0.5±1.4 (−5.5±15.3)0.330.33<0.001*
Secondary outcome variables
% cardiovascular risk (UKPDS-OM2)0.6±4.7−0.7±6.50.210.470.26
Diabetes empowerment−1.3±6.02.2±5.70.005*0.28<0.001*
Diabetes distress (emotional)0.1±0.9−0.3±1.00.210.760.009*
Diabetes distress (regimen)−0.4±1.0−0.4±1.30.930.030.001*
Depression (Patient Health Questionnaire-9)−0.2±4.2−0.4±3.90.600.790.22
Side effect variables
LDL (mmol/L)0±0.6346−0.0647±0.80120.651.000.401
HDL (mmol/L)0.0345±0.15790.0723±0.17260.240.20<0.001*
Triglycerides (mmol/L)0.1581±0.5269−0.0761±1.5930.890.080.61
Total cholesterol (mmol/L)0.1092±0.64190.0011±0.97140.730.310.99
Mechanism variables
Diabetes knowledge0.3±2.62.5±2.7<0.001*0.57<0.001*
Body mass index (BMI)−0.9±1.4−1±1.60.560.001*<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±22.512.6±31.80.180.53<0.001*
Glucose Monitor Satisfaction Survey (GMSS)0.9±0.60.3±0.50.040.44<0.001*
Medication Effect Score (MES)0.1±0.50±0.60.240.110.44
  • *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.