A clinical trial, funded by the NIDDK, at four pediatric diabetes centers in the United States has found that a new artificial pancreas is safe and effective at managing blood glucose levels in children as young as age six with type 1 diabetes.

The artificial pancreas, also known as closed-loop control, is an “all-in-one” diabetes management system that tracks blood glucose levels using a continuous glucose monitor (CGM) and automatically delivers insulin when needed using an insulin pump. The system replaces reliance on testing by fingerstick or CGM with the delivery of insulin by multiple daily injections or a pump controlled by the patient or caregiver.

The study enrolled 101 children between ages 6 and 13 and assigned them to either the experimental group, which used the new artificial pancreas system, or to the control group, which used a standard CGM and separate insulin pump. Check-ins and data collection were conducted every other week for four months and study participants were instructed to continue their daily lives so that the researchers could best understand how the system works in the children’s typical routines.

As a result, the study found that youth using the artificial pancreas system had a 7% improvement in keeping blood glucose in range during the daytime, and a 26% improvement in nighttime control compared to the control group. Nighttime control is of particular importance for people with type 1 diabetes, as severe, unchecked hypoglycemia can lead to a seizure, coma, or even death. The overall time-in-range goal for the artificial pancreas reflected a nearly 11% improvement, which translated to 2.6 more hours per day in range.

“Fewer than 1 in 5 children with type 1 diabetes are able to successfully keep their blood glucose in a healthy range with current treatment, which may have serious consequences on their long-term health and quality of life,” said Guillermo Arreaza-Rubín, MD, director of NIDDK’s Diabetes Technology Program and project scientist for the study. “Earlier research showed that the system tested in this study was safe and effective for people ages 14 and older. This trial now shows us this system works in a real-world setting with younger children.”

This four-month study was part of a series of trials conducted in the International Diabetes Closed-Loop (iDCL) Study, which is one of four major research efforts funded by NIDDK through the Special Statutory Funding Program for Type 1 Diabetes Research to test and refine advanced artificial pancreas systems. The results of this study were published on August 26 in the New England Journal of Medicine. For more information, view the full NIH press release.