Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes

This 6 month randomized, multicenter trial evaluated the efficacy and safety of a closed loop insulin delivery system (artificial pancreas) compared to a sensor augmented pump in patients with type 1 diabetes. A total of 168 patients were assigned in a 2:1 ratio to either the closed loop group (n=112) or the control group (n=56). The primary outcome was the percentage of time spent within the target glucose range (70–180 mg/dL). Results showed that the closed loop system significantly increased time in the target range by 11 percentage points (71% vs. 59%, P<0.001), equivalent to 2.6 more hours per day. Secondary outcomes, including reduced hyperglycemia and hypoglycemia, also favored the closed loop system. Glycated hemoglobin levels improved in the closed loop group (0.33 percentage points, P=0.001). The system was used 90% of the time with minimal adverse events, though one case of diabetic ketoacidosis occurred due to pump failure. The trial demonstrated that closed loop control is effective and safe for improving glycemic outcomes in type 1 diabetes.

This 6 month randomized, multicenter trial evaluated the efficacy and safety of a closed loop insulin delivery system (artificial pancreas) compared to a sensor augmented pump in patients with type 1 diabetes. A total of 168 patients were assigned in a 2:1 ratio to either the closed loop group (n=112) or the control group (n=56). The primary outcome was the percentage of time spent within the target glucose range (70–180 mg/dL). Results showed that the closed loop system significantly increased time in the target range by 11 percentage points (71% vs. 59%, P<0.001), equivalent to 2.6 more hours per day. Secondary outcomes, including reduced hyperglycemia and hypoglycemia, also favored the closed loop system. Glycated hemoglobin levels improved in the closed loop group (0.33 percentage points, P=0.001). The system was used 90% of the time with minimal adverse events, though one case of diabetic ketoacidosis occurred due to pump failure. The trial demonstrated that closed loop control is effective and safe for improving glycemic outcomes in type 1 diabetes.