Table 2 —

Comparison of mean scores for primary dependent variables across baseline and follow-up periods

VariableBaseline6-month follow-up12-month follow-upTime P levelsContrast 1*P levelsContrast 2P levels
Improved recognition of BG levels
 % Detection low BG34 ± 2944 ± 3044 ± 27F = 3.5 P < 0.005t = 2.4 P = 0.002t = 0.5 NS
 % Detection high BG51 ± 2455 ± 2653 ± 27F = 3.1 P < 0.001t = 1.7 P < 0.05t = 0.9 NS
 Accurate estimates38 ± 1145 ± 1546 ± 15F = 13.6 P < 0.001t = 4.3 P < 0.001t = 0.6 NS
Reduced extreme BG fluctuations§
 BG risk index13.9 ± 4.413.3 ± 6.013.0 ± 5.2F = 2.1 P = 0.002t = 3.7 P = 0.001t = 0.01 NS
 HbA1c10.2 ± 2.010.2 ± 2.010.2 ± 1.9F = 0.1 NSt = 0.0 NSt = 0.5 NS
Improved judgment
 % Decision to raise low BG50 ± 2759 ± 3458 ± 30F = 3.6 P < 0.005t = 2.6 P = 0.01t = 2.2 P < 0.5
 % Decision to lower high BG53 ± 2654 ± 3060 ± 28F = 5.2 P < 0.001t = 3.3 P < 0.001t = 2.2 P < 0.05
 % Decision not to drive when low48 ± 3350 ± 3651 ± 31F = 2.0 P < 0.01t = 2.7 P < 0.005t = 0.3 NS
Reduction of negative consequences
 DKA (total no.)700
 Severe hypoglycemia  (mean episodes/month)1.6 ± 2.01.2 ± 1.91.1 ± 2.0F = 3.9 P < 0.002t = 2.3 P = 0.002t = 0.8 NS
 Motor vehicle violations  (mean violations/month)0.09 ± 0.270.03 ± 0.090.03 ± 0.15F = 5.4 P < 0.001t = 2.8 P = 0.001t = 0.4 NS
Improvement in psychologial parameters#
 Hypoglycemia fear survey–worry22 ± 9.617.5 ± 10.717.4 ± 9.9F = 21.2 P < 0.001t = 5.2 P < 0.002t = 0.8 NS
 DQOL–impact46.3 ± 8.744.0 ± 7.743.8 ± 8.3F = 6.7 P < 0.005t = 3.1 P < 0.005t = 1.0 NS
 DQOL–worry18.3 ± 7.616.5 ± 8.716.2 ± 8.5F = 11.7 P < 0.001t = 4.3 P < 0.001t = 0.8 NS
 BDI–total6.9 ± 5.65.8 ± 5.76.1 ± 6.2F = 2.4 P = 0.09t = 1.6 P = 0.11t = 0.6 NS
 DAS–diabetes conflict19.1 ± 8.718.5 ± 8.318.9 ± 8.7F = 0.5 NSt = 0.5 NSt = 0.7 NS
 Knowledge43.2 ± 4.246.8 ± 3.346.3 ± 3.5F = 61.7 P < 0.001T = 8.2 P < 0.001t = 1.4 NS
  • Data are means ± SD unless otherwise indicated.

  • *

    * Contrast 1 compared the 6-month baseline with the 6- and 12-month follow-up data to determine whether there was a long-term benefit of BGAT-2;

  • contrast 2 compared posttreatment (assessment 3, Fig. 1);

  • F = 4.0, P < 0.01, MANOVA;

  • §

    § no MANOVA was performed because only one variable, BG risk index, was hypothesized to change;

  • F = 2.7, P = 0.05, MANOVA;

  • F = 4.5, P < 0.005, MANOVA;

  • #

    # F =14.9, P < 0.0001, MANOVA.