A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes

This multicenter, randomized, open label trial evaluated the efficacy and safety of a closed loop insulin delivery system (artificial pancreas) in children aged 6–13 years with type 1 diabetes. Participants were assigned in a 3:1 ratio to either the closed loop group (n=78) or a sensor-augmented insulin pump (control group; n=23). Over 16 weeks, the closed loop group showed a significant increase in the percentage of time with glucose levels in the target range (70–180 mg/dL) compared to the control group (mean adjusted difference: 11 percentage points; 95% CI, 7 to 14; P<0.001), equivalent to 2.6 additional hours per day in range. Hypoglycemia was infrequent in both groups, with no episodes of severe hypoglycemia or diabetic ketoacidosis. The closed loop system demonstrated robust efficacy across diverse baseline characteristics, highlighting its potential to improve glycemic outcomes in pediatric type 1 diabetes.

This multicenter, randomized, open label trial evaluated the efficacy and safety of a closed loop insulin delivery system (artificial pancreas) in children aged 6–13 years with type 1 diabetes. Participants were assigned in a 3:1 ratio to either the closed loop group (n=78) or a sensor-augmented insulin pump (control group; n=23). Over 16 weeks, the closed loop group showed a significant increase in the percentage of time with glucose levels in the target range (70–180 mg/dL) compared to the control group (mean adjusted difference: 11 percentage points; 95% CI, 7 to 14; P<0.001), equivalent to 2.6 additional hours per day in range. Hypoglycemia was infrequent in both groups, with no episodes of severe hypoglycemia or diabetic ketoacidosis. The closed loop system demonstrated robust efficacy across diverse baseline characteristics, highlighting its potential to improve glycemic outcomes in pediatric type 1 diabetes.