Association of baseline factors and nocturnal hypoglycemia
n | % Nights with hypoglycemia per subject | Unadjusted P value | Model 1* | Model 2† | |
---|---|---|---|---|---|
Total | 176 | 7.4 (3.7, 12.1) | |||
Age | 0.05 | 0.12 | |||
8–14 years | 64 | 6.3 (2.0, 11.4) | |||
15–24 years | 42 | 8.8 (3.9, 16.1) | |||
≥25 years | 70 | 7.4 (4.6, 10.8) | |||
Sex | 94 | 7.2 (3.7, 10.8) | |||
Female | 0.36 | ||||
Male | 82 | 7.8 (3.7, 14.2) | |||
Severe hypoglycemia events in 6 months before to study (self-reported) | 0.87 | ||||
0 | 164 | 7.2 (3.7, 12.2) | |||
≥1 | 12 | 8.3 (4.3, 10.5) | |||
Nights with hypoglycemia during blinded use at baseline‡ | <0.001 | <0.001 | <0.001 | ||
0 | 102 | 6.0 (2.8, 10.5) | |||
≥1 | 68 | 9.4 (5.1, 15.9) | |||
Home blood glucose meter measurements per day (self-reported at baseline)§‖ | 0.28 | ||||
≤5 | 43 | 8.1 (4.1, 13.7) | |||
6–8 | 78 | 8.8 (3.7, 12.2) | |||
>8 | 26 | 5.4 (3.2, 12.4) | |||
Insulin delivery | |||||
Pump | 163 | 7.4 (3.9, 12.0) | 0.63 | ||
Multiple daily injections | 13 | 5.1 (1.8, 12.6) | |||
A1C§ | <0.001 | <0.001 | <0.001 | ||
<7.0% | 57 | 9.0 (5.3, 14.7) | |||
7.0–<8.0% | 72 | 8.2 (4.5, 12.0) | |||
≥8.0% | 47 | 3.9 (1.6, 8.7) | |||
Hypoglycemia Fear Scale score§¶ | 0.11 | 0.22 | |||
<20 | 65 | 7.5 (3.3, 10.3) | |||
20–<30 | 32 | 7.7 (4.6, 11.0) | |||
≥30 | 78 | 7.0 (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.