Table 3

Hypoglycemia awareness, SH, and patient-reported outcomes in MDIs vs. CSII and SMBG vs. RT comparisons at 24-week end point

Insulin comparisonMonitoring comparison
MDICSIIP value*SMBGRTP value*
SH
 Annualized rate1.0 ± 2.10.6 ± 1.70.340.9 ± 2.10.8 ± 1.80.95
0 [0–0] (n = 47)0 [0–0] (n = 43)0 [0–0] (n = 44)0 [0–0] (n = 46)0.92
 Proportion affected (%)23 (n = 47)16 (n = 43)0.39921 (n = 44)20 (n = 46)0.92**
IAH
 Gold*4 [3–5]4 [3–5.5]0.7564 [3–5]4 [3–6]0.42
(2–7)(1–7)(1–7)(1–7)
4.1 ± 1.6 (n = 45)4.2 ± 1.7 (n = 40)4.3 ± 1.6 (n = 42)4.0 ± 1.7 (n = 43)
 Clarke4 [2–5]3 [2–4]0.3053 [2–4]3 [2–4]0.83
(0–7)(0–6)(0–6)(0–7)
3.3 ± 1.8 (n = 41)3.0 ± 1.6 (n = 39)3.3 ± 1.6 (n = 39)3.1 ± 1.8 (n = 41)
 HypoA-Q9 [5.5–12]10 [6–12.5]0.60110 [5–12]9 [6–12]0.83
(0–19)(0–18)(0–16)(3–14)
8.9 ± 4.3 (n = 44)9.4 ± 4.2 (n = 40)9.2 ± 4.1 (n = 40)9.0 ± 4.4 (n = 44)
Fear of hypoglycemia and treatment satisfaction
 HFS II–Total45 ± 25 (n = 46)44 ± 23 (n = 41)0.82445 ± 24 (n = 42)45 ± 25 (n = 45)0.96
 HFS II–Behavior21 ± 10 (n = 46)20 ± 10 (n = 41)0.61321 ± 9 (n = 42)20 ± 11 (n = 45)0.94
 HFS II–Worry25 ± 17 (n = 46)24 ± 17 (n = 41)0.98525 ± 17 (n = 42)24 ± 17 (n = 45)0.98
 DTSQ–Total satisfaction29 ± 6 (n = 45)32 ± 3 (n = 39)<0.00130 ± 5 (n = 41)30 ± 5 (n = 43)0.79
 DTSQ2–Perceived frequency of hyperglycemia3 ± 1.293 ± 1.010.2483 ± 1.173 ± 1.180.70
 DTSQ3–Perceived frequency of hypoglycemia3 ± 1.133 ± 1.250.2403 ± 1.093 ± 1.270.75
  • Data are median [interquartile range] (range) or mean ± SD. Number with available data denoted by n number in parentheses. Number completing DTSQ2 and DTSQ3 in each group are the same as those completing DTSQ–Total satisfaction questions.

  • †Mann-Whitney U test.

  • *Two-sample t test between groups at week 24 (except **χ2 test).