Table 1

Baseline characteristics

OverallAge-group
8–14 years15–24 years≥25 years
n176644270
Age (years)25.6 ± 15.611.6 ± 2.019.6 ± 3.242.1 ± 11.4
Diabetes duration (years)14.7 ± 12.56.1 ± 3.110.2 ± 5.125.4 ± 13.2
Sex
    Female94 (53)34 (53)21 (50)39 (56)
    Male82 (47)30 (47)21 (50)31 (44)
Severe hypoglycemia events in 6 months before study (self-reported)
    0164 (93)61 (95)39 (93)64 (91)
    ≥112 (7)3 (5)3 (7)6 (9)
Nights with hypoglycemia during blinded use at baseline*
    0102 (60)42 (67)21 (51)39 (59)
    ≥168 (40)21 (33)20 (49)27 (41)
Home blood glucose meter measurements per day (self-reported at baseline)6.8 ± 2.36.8 ± 2.06.0 ± 2.17.1 ± 2.5
    ≤543 (29)12 (23)16 (52)15 (23)
    6–878 (53)31 (60)12 (39)35 (55)
    >826 (18)9 (17)3 (10)14 (22)
Insulin delivery
    Pump163 (93)57 (89)38 (90)68 (97)
    Multiple daily injections13 (7)7 (11)4 (10)2 (3)
A1C7.4 ± 0.97.6 ± 1.07.6 ± 0.87.1 ± 0.8
    <7.0%57 (32)17 (27)11 (26)29 (41)
    7.0–<8.0%72 (41)22 (34)16 (38)34 (49)
    ≥8.0%47 (27)25 (39)15 (36)7 (10)
Hypoglycemia Fear Scale score28 ± 1825 ± 1729 ± 1831 ± 18
    <2065 (37)27 (42)15 (36)23 (33)
    20–<3032 (18)14 (22)8 (19)10 (14)
    ≥3078 (45)22 (35)19 (45)37 (53)
  • Data are means ± SD or n (%).

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

  • †Collected on 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 0–100 range with higher scores indicating more fear of hypoglycemia; missing for 1 subject.