Table 2

Between- and within-group differences in clinical parameters and quality-of-life scores at visit 1 and visit 2 with respect to baseline values

DID groupStandard groupP
Between groups*Within DID†Within standard†
Baseline3 months6 monthsBaseline3 months6 months3 months vs. 06 months vs. 03 months vs. 06 months vs. 03 months vs. 06 months vs. 0
n6763
A1C (%)8.2 ± 0.8−0.5 ± 0.8−0.4 ± 0.98.4 ± 0.7−0.4 ± 0.6−0.5 ± 10.950.68<0.0001<0.0001<0.00010.0002
FBG (mg/dl)182.8 ± 85.6−1.7 ± 105−22 ± 99.8176.9 ± 68.43.8 ± 94.715.5 ± 90.80.830.130.920.130.810.39
Systolic blood pressure (mmHg)121.5 ± 12.8−1.8 ± 13.7−0.8 ± 8.6119.2 ± 11.50.4 ± 110.7 ± 11.50.190.710.630.600.700.51
Diastolic blood pressure (mmHg)74.4 ± 7.5−2.4 ± 7.9−1.3 ± 6.574.1 ± 7.6−2.3 ± 6.8−1.1 ± 7.60.830.890.00040.160.010.27
Total cholesterol (mg/dl)179.5 ± 29.9−3.8 ± 29.1−3.6 ± 32.3184.3 ± 343.1 ± 26.62.7 ± 28.90.150.330.960.470.310.42
HDL cholesterol (mg/dl)57.6 ± 15.30.9 ± 9.41.6 ± 8.561.1 ± 16.4−1.7 ± 9.84.8 ± 10.30.490.140.570.110.150.0005
LDL cholesterol (mg/dl)101.9 ± 28−0.8 ± 26.4−3.4 ± 29.1105.8 ± 27.45.7 ± 23.30.3 ± 27.60.260.790.181.00.050.05
Triglycerides (mg/dl)94.5 ± 54.9−10.7 ± 48.8−10.7 ± 56.179.9 ± 541.9 ± 43.78.2 ± 43.40.060.040.300.170.690.15
Weight (kg)69.9 ± 11.8−0.1 ± 3.80.7 ± 3.669.4 ± 11.90.7 ± 1.91.5 ± 2.30.150.220.300.160.006<0.0001
DTSQ‡
    Score26.7 ± 4.41.8 ± 3.63.4 ± 4.227.5 ± 4.80.6 ± 3.91 ± 40.20.040.0090.00020.430.17
    Hyperglycemia3.6 ± 1.6−1 ± 1.4−0.4 ± 1.73.1 ± 1.3−0.3 ± 1.70.2 ± 1.80.050.190.00060.210.230.50
    Hypoglycemia2.3 ± 1.10.4 ± 1.30.5 ± 1.72.5 ± 1.5−0.2 ± 1.6−0.1 ± 1.70.080.160.190.120.510.76
SF-36‡
    Physical functioning90 ± 13.3−3.3 ± 16.84.3 ± 12.394.1 ± 8.3−0.7 ± 11.80.2 ± 7.30.950.220.280.100.760.89
    Role physical72.5 ± 36.28.7 ± 38.07.1 ± 43.085.8 ± 27.6−12.1 ± 38.20 ± 28.30.050.270.260.490.090.96
    Bodily pain78.4 ± 21.53.9 ± 18.3−2.2 ± 23.971.2 ± 19.2−2.5 ± 21.410 ± 25.50.350.090.290.510.670.04
    General health56 ± 23.34.8 ± 8.96.5 ± 16.861.4 ± 16.4−2.8 ± 13.1−4.6 ± 14.70.020.020.0090.060.300.08
    Vitality57.8 ± 15.84.3 ± 10.58.2 ± 17.966.7 ± 15.7−5.1 ± 13.90.3 ± 14.10.020.10.040.040.070.91
    Social functioning73.3 ± 17.30.9 ± 16.04.5 ± 23.176.3 ± 20.34.3 ± 19.83.3 ± 22.20.530.80.820.350.220.42
    Role emotional60 ± 36.514.9 ± 40.417.9 ± 52.583.9 ± 27.8−4 ± 22.6−4 ± 35.50.020.050.070.140.330.51
    Mental health68.7 ± 16.3−0.3 ± 10.94 ± 19.270.8 ± 14.9−1.4 ± 12.1−0.8 ± 12.80.670.230.820.330.590.73
    Physical component score50.3 ± 8.91.3 ± 6.60.6 ± 7.350.6 ± 4.9−1.7 ± 7.01 ± 4.90.090.770.390.720.270.27
    Mental component score43.5 ± 10.62.2 ± 8.14.2 ± 12.548.1 ± 8.1−0.3 ± 6.8−0.8 ± 10.20.180.140.160.110.840.70
  • Data are means ± SD. 3 months and 6 months columns show the mean variation at visit 1 and visit 2 with respect to baseline (0) values.

  • *P values refer to the Mann-Whitney U test.

  • P values refer to the Wilcoxon signed-rank test.

  • ‡Questionnaires were administered to a subgroup of 60 patients (30 in the DID group and 30 in the standard group).