Table 2

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.