Table 2

Association of baseline factors and nocturnal hypoglycemia

n% Nights with hypoglycemia per subjectUnadjusted P valueModel 1*Model 2
Total1767.4 (3.7, 12.1)
Age0.050.12
    8–14 years646.3 (2.0, 11.4)
    15–24 years428.8 (3.9, 16.1)
    ≥25 years707.4 (4.6, 10.8)
Sex947.2 (3.7, 10.8)
    Female0.36
    Male827.8 (3.7, 14.2)
Severe hypoglycemia events in 6 months before to study (self-reported)0.87
    01647.2 (3.7, 12.2)
    ≥1128.3 (4.3, 10.5)
Nights with hypoglycemia during blinded use at baseline<0.001<0.001<0.001
    01026.0 (2.8, 10.5)
    ≥1689.4 (5.1, 15.9)
Home blood glucose meter measurements per day (self-reported at baseline)§0.28
    ≤5438.1 (4.1, 13.7)
    6–8788.8 (3.7, 12.2)
    >8265.4 (3.2, 12.4)
Insulin delivery
    Pump1637.4 (3.9, 12.0)0.63
    Multiple daily injections135.1 (1.8, 12.6)
A1C§<0.001<0.001<0.001
    <7.0%579.0 (5.3, 14.7)
    7.0–<8.0%728.2 (4.5, 12.0)
    ≥8.0%473.9 (1.6, 8.7)
Hypoglycemia Fear Scale score§0.110.22
    <20657.5 (3.3, 10.3)
    20–<30327.7 (4.6, 11.0)
    ≥30787.0 (3.7, 13.5)
  • Data are median (25th, 75th percentile).

  • *The multivariate regression model included all variables with P < 0.20.

  • †Multivariate regression model using backward selection keeping those variables with P < 0.05.

  • ‡From use of a blinded CGM device for 1 week at baseline, missing for 6 subjects.

  • §P value obtained by treating as continuous variable.

  • ‖Collected on a randomization form, as assessed by clinic personnel over the last 7 days. A question was added to Case Report Form after study initialization, and data were missing for 29 subjects.

  • ¶The Hypoglycemia Fear Scale consists of 15 5-point Likert scale items, with scores scaled to a 0 to 100 range with higher scores indicating more fear of hypoglycemia; missing for 1 subject.