A clinical trial at four pediatric diabetes centers in the United States showed that a new artificial pancreas system — which tracks and controls blood glucose levels automatically — is safe and successful in controlling blood glucose levels in children as young as six with type 1 diabetes. The trial was sponsored by the National Diabetes and Digestive and Kidney Diseases Institute (NIDDK), one of the national health institutes.
"With current care, less than 1 in 5 children with type 1 diabetes can effectively maintain their blood glucose within a safe range, which can have significant implications for their long-term health and quality of life," said Guillermo Arreaza-Rubín, M.D. , director of NIDDK 's Diabetes Research Program and study project scientist. This trial now tells that this device works with younger children in a real-world environment.
The artificial pancreas, also known as closed-loop regulation, is an all-in-one diabetes management system that uses a continuous glucose monitor (CGM) to track blood glucose levels and automatically delivers the insulin when required using an insulin pump.
The research enrolled 101 children aged 6 to 13 and allocated them either to the experimental group using the new artificial pancreas device, or to the control group using a normal CGM and separate insulin pump.
The study showed that adolescents using the artificial pancreas system had an improvement of 7 percent in keeping blood glucose in range during the daytime, and an improvement of 26 percent in nighttime regulation over the control group. Nighttime regulation is particularly important for people with type 1 diabetes, because serious, untreated hypoglycemia may lead to seizure, coma, or even death.
"Artificial pancreatic technology will mean less times children and their families have to interrupt all to deal with their diabetes. Instead children should concentrate on being young.
During the study, seventeen adverse events, all categorized as minor, occurred in the artificial pancreatic community, most of them due to insulin pump equipment problems.
"NIDDK has funded research and technology advancement for decades to build a user-friendly automated system capable of relieving the constant burden of type 1 diabetes, from finger sticks and insulin injections to insulin dose measurements and constant tracking while enhancing diabetes control outcomes and avoiding both short- and long-term disease complications," said Arreaza-Rub.
"The artificial pancreas is a result of these years of work and it's exciting to see how this technology will help children with type 1 diabetes and their families, and potentially support anyone with diabetes in the future."
The Control-IQ device, the artificial pancreas technology used in this research, has an insulin pump equipped with advanced control algorithms based on a mathematical model, using the person's glucose monitoring information to change the insulin dose automatically.
This four-month research was part of a series of trials performed in the Closed-Loop International Diabetes (iDCL) Research.
"As we continue to pursue a cure for type 1 diabetes, having safe and efficient artificial pancreas technology, such as the technology used in this research, accessible to children with type 1 diabetes is a significant step in enhancing the quality of life and disease management in these young people," said NIDDK Director Dr. Griffin P.
The iDCL Study is one of four major research projects sponsored by NIDDK to develop and improve advanced artificial pancreatic systems through the Special Federal Funding Program for Type 1 Diabetes.
NIDDK funded this study through the grants UC4DK108483 and Tandem Diabetes Treatment, Inc.
This story first appeared on https://www.nih.gov