Table 2

Clinical variables, differences between the groups after 12 months in the full analysis set

FBA versus RCCC versus RCFBA versus CC
HbA1c
NGSP %
0.0 (0.1) p=0.792
7.8 (0.7) vs 7.9 (0.8)*
n=40 vs 45
−0.1 (0.1) p=0.522
7.8 (0.7) vs 7.9 (0.8)*
n=48 vs 45
0.0 (0.0) p=0.754
7.8 (0.7) vs 7.8 (0.7)*
n=40 vs 48
HbA1c, mmol/mol−0.4 (1.3)
61.8 (7.9) vs 62.7 (8.7)*
p=0.792
n=40 vs 45
−0.8 (1.2)
61.8 (7.3) vs 62.7 (8.7)*
p=0.522
n=48 vs 45
0.4 (0.3)
61.8 (7.9) vs 61.8 (7.3)*
p=0.754
n=40 vs 48
Total cholesterol, mmol/L0.09 (0.06) p=0.131
n=40 vs 46
0.05 (0.06) p=0.376
n=48 vs 46
0.01 (0.06) p=0.846
n=40 vs 48
HDL cholesterol, mmol/L−0.01 (0.02) p=0.658
n=40 vs 46
0.00 (0.02) p=0.962
n=48 vs 46
−0.01 (0.02) p=0.547
n=40 vs 48
LDL cholesterol, mmol/L0.04 (0.04) p=0284
n=40 vs 46
0.07 (0.05) p=0.159
n=48 vs 46
−0.04 (0.05) p=0.400
n=40 vs 48
Non-HDL cholesterol, mmol/L0.08 (0.05) p=0.107
n=40 vs 46
0.05 (0.05) p=0.328
n=48 vs 46
0.02 (0.05) p=0.610
n=40 vs 48
Triglycerides, mmol/L−0.03 (0.04) p=0.418
n=40 vs 44
−0.08 (0.04) p=0.054
n=48 vs 44
0.05 (0.04) p=0.194
n=40 vs 48
Systolic blood pressure, mm Hg−0.42 (1.36) p=0.756
n=40 vs 45
−0.14 (1.24) p=0.913
n=48 vs 45
0.12 (1.34) p=0.928
n=40 vs 48
Diastolic blood pressure. mm Hg0.12 (0.86) p=0.887
n=40 vs 45
−0.14 (0.84) p=0.867
n=48 vs 45
0.12 (0.88) p=0.888
n=40 vs 48
Body weight, kg−0.23 (0.5) p=0.680
n=40 vs 45
−0.22 (0.60) p=0.713
n=48 vs 45
0.05 (0.56) p=0.935
n=40 vs 48
hs-CRP, mg/L0.19 (0.35) p=0.586
n=41 vs 46
0.35 (0.32) p=0.278
n=47 vs 46
−0.13 (0.39) p=0.735
n=41 vs 47
Insulin dose,
IU/kg body weight
0.03 (0.02) p=0.079
n=37 vs 42
0.01 (0.02) p=0.625 n=44 vs 420.03 (0.02) p=0.161
n=37 vs 44
Hypoglycemia
Number of events per month
0.39 (0.06) p=0.000
n=35 vs 42
0.05 (0.07) p=0.437
n=44 vs 42
0.35 (0.06) p=<0.000
n=35 vs 44
Albumin/Creatinine ratio, mg/mmol−0.73 (0.76) p=0.339
n=40 vs 41
−0.00 (0.78) p=0.995
n=48 vs 41
−0.32 (0.82) p=0.699
n=40 vs 48
  • Data shown as means (SD) unless otherwise stated. All analyses were adjusted for baseline values. The analysis of lipids and blood pressure does not include data from subjects who changed the dose or type of cholesterol/hypertension-lowering medication during the study period.

  • *Mean (SD) HbA1c at 12 months.

  • CC, carbohydrate counting; FBA, food-based advice; HbA1c, glycated hemoglobin A1c; HDL, high-density lipoprotein; hs-CRP, high-sensitivity C reactive protein; LDL, low-density lipoprotein; NGSP, National Glycohemoglobin Standardization Program; RC, routine care.