Table 1—

Patient characteristics at randomization

CharacteristicsControlIntervention
n1615
Age (years)44 (32.3–46.8)41.8 (24.4–52.7)
Sex (% women)11 (68.8)10 (66.7)
Diabetes duration (years)17.2 (10.1–27.1)16.9 (14.6–27.4)
BMI (kg/m2)25.9 (22.3–30.6)26 (25–28.6)
Creatinine (mg/dl)*0.9 (0.8–1.1)1.0 (0.9–1.4)
HbA1c
 Percent8.8 ± 1.229.1 ± 1.3
 Distribution (%)8.3 (7.8–9.7)8.8 (8.3–9.7)
 >10.5%5 (31.3)5 (33.3)
Goal range
 80–120 mg/dl (4.4–6.7 mmol/l)9 (56.3)9 (60)
 100–140 mg/dl (5.5–7.8 mmol/l)7 (43.7)†6 (40)
Insulin pump5 (31.3)5 (33.3)
Hypoglycemic unawareness7 (43.8)5 (33.3)
Daily insulin units
 Total dose47 ± 1950 ± 14
 Total basal dose25 ± 1226 ± 10
 Total bolus dose23 ± 1025 ± 6
  • Data are means ± SD, n (%), or median (IQR).*To convert to Système International (SI) units (μmol/l), multiply values by 88.4; †one patient had a glucose goal range of 90–150 mg/dl (5–8.3 mmol/l).