The PEDAP trial.
The Pediatric Artificial Pancreas (PEDAP) clinical trial was conducted to compare the efficacy and safety of closed-loop insulin delivery with standard care in children with type 1 diabetes ages 2-6. Closed-loop insulin delivery is a system that automatically delivers insulin based on real-time glucose measurements. Standard care consisted of either an insulin pump or multiple daily injections of insulin plus a continuous glucose monitor. The closed-loop insulin delivery system used in the trial was the t:slim X2 with Control-IQ Technology.
At the end of the 13-week trial, the children in the closed-loop group had a significantly higher percentage of time in the target glucose range (69%) than the children in the standard-care group (56%). This means that the children in the closed-loop group were less likely to experience high or low blood sugar levels. The results of the PEDAP clinical trial were published in the New England Journal of Medicine in March 2023.
The PEDAP clinical trial provides evidence that closed-loop insulin delivery is a safe and effective way to improve glycemic control in young children ages 2-6 with type 1 diabetes. This could lead to a significant reduction in the risk of serious complications of diabetic ketoacidosis and hypoglycemia. The study outcome is a significant step forward in the development of full closed-loop insulin delivery systems to improve the quality of life for children with type 1 diabetes.