New study finds artificial pancreas system safe for children as young as 6 with type 1 diabetes

Four pediatric diabetes centers in the country found during a clinical trial that a new artificial pancreas system is safe for children as young as six years old who have type one diabetes.

The artificial pancreas system automatically monitors and regulates blood glucose levels, the National Institute of Health announced in a press release. The trail was funded by the National Institute of Diabetes and Digestive and Kidney Disease, part of the NIH.

“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,” Dr. Guillermo Arreaza-Rubín, director of NIDDK’s Diabetes Technology Program and project scientist for the study, said in the press release. “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.”

The artificial pancreas is a diabetes management system that the NIH describes as “all-in-one” as it tracks blood glucose levels and through an insulin pump automatically delivers insulin if needed. A continuous glucose monitor (CGM) is used in the artificial pancreas. It replaces fingerstick or a CGM which delivers insulin through several daily injections or a pump controlled by either the patient or a caregiver.

The study, published in the New England Journal of Medicine, comprised of 101 children between ages 6 and 13 over a course of four months. Some of the children were assigned to an experimental group or to a control group.

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 the insulin when needed via an insulin pump. The system replaces testing by fingerstick or CGM with delivery of insulin by multiple daily injections or a pump controlled by the patient or caregiver.

The study enrolled 101 children between ages six and 13 and assigned them to either the experimental group, which used the new artificial pancreas system or to the control group which used the CGM and an insuling pump.

The participants were asked to continue in their daily lives so the artificial pancreas could be understood during children’s routines.

The study saw a 7% improvement in keeping blood glucose in range in the children using the artificial pancreas during the day and a 26% improvement in the nighttime. The NIH indicated that nighttime control of blood glucose is important as unchecked hypoglycemia can result in seizure, coma or death.

“The improvement in blood glucose control in this study was impressive, especially during the overnight hours, letting parents and caregivers sleep better at night knowing their kids are safer,” Protocol Chair Dr. R. Paul Wadwa, professor of pediatrics at the Barbara Davis Center for Childhood Diabetes at the University of Colorado, Aurora (CU), said in the press release. “Artificial pancreas technology can mean fewer times children and their families have to stop everything to take care of their diabetes. Instead, kids can focus on being kids.”