Effect of sensor-augmented insulin pump therapy and automated insulin suspension vs standard insulin pump therapy on hypoglycemia in patients with type 1 diabetes: a randomized clinical trial.

摘要: Importance Hypoglycemia is a critical obstacle to the care of patients with type 1 diabetes. Sensor-augmented insulin pump automated low-glucose suspension has potential reduce incidence major hypoglycemic events. Objective To determine severe and moderate hypoglycemia sensor-augmented compared standard therapy. Design, Setting, Participants A randomized clinical trial involving 95 diabetes, recruited from December 2009 January 2012 in Australia. Interventions Patients were only or for 6 months. Main Outcomes Measures The primary outcome was combined (hypoglycemic seizure coma) (an event requiring assistance treatment). In subgroup, counterregulatory hormone responses assessed using clamp technique. Results Of randomized, 49 assigned standard-pump (pump-only) therapy 46 group. mean (SD) age 18.6 (11.8) years; duration 11.0 (8.9) therapy, 4.1 (3.4) years. baseline rate events pump-only group 20.7 vs 129.6 per 100 patient months After treatment, rates decreased 28 16 175 35 adjusted patient-months 34.2 (95% CI, 22.0-53.3) 9.5 5.2-17.4) ratio 3.6 1.7-7.5; P Conclusions Relevance reduced Trial Registration anzctr.org.auIdentifier:ACTRN12610000024044