Recovery of Hypoglycemia Awareness in Long-StandingType 1 Diabetes: A Multicenter 2 3 2 Factorial Randomized Controlled Trial Comparing Insulin Pump WithMultiple Daily Injections and Continuous With Conventional Glucose Self-Monitoring (HypoCOMPaSS)

A total of 96 participants (mean diabetes duration 29 years) were randomized. Overall, biochemical hypoglycemia (£3.0 mmol/L) decreased (536 63 to 246 56 min/24 h; P = 0.004 [t test]) without deterioration in HbA1c. Hypoglycemia awareness improved (5.16 1.1 to 4.16 1.6; P = 0.0001 [t test]) with decreased SH (8.96 13.4 to 0.8 6 1.8 episodes/patient-year; P = 0.0001 [t test]). At 24 weeks, there was no significant difference in awareness comparing CSII with MDI (4.16 1.6 vs. 4.26 1.7; difference 0.1; 95% CI20.6 to 0.8) and RTwith SMBG (4.36 1.6 vs. 4.06 1.7; difference20.3; 95% CI21.0 to 0.4). Between-groups analyses demonstrated comparable reductions in SH, fear of hypoglycemia, and insulin doses with equivalent HbA1c. Treatment satisfactionwas higherwith CSII thanMDI (326 3 vs. 296 6; P = 0.0003 [t test]), but comparable with SMBG and RT (30 6 5 vs. 30 6 5; P = 0.79 [t test]).