Artificial pancreas safe and provides good blood glucose control in young children

The use of an artificial pancreas in young children aged 5 to 8 years with type 1 diabetes improved mean blood glucose levels with no increases in the incidence of hypoglycemia, and may be safe and improve overall diabetes control in these patients, according to results from a recently completed pilot study published in the journal Diabetes Technology & Therapeutics.

The artificial pancreas, developed at the University of Virginia Center for Diabetes Technology, was designed to automatically monitor and regulate blood glucose levels in patients with type 1 diabetes, and thus eliminate the need for finger sticks. The platform is comprised of a re-configured Smartphone that runs advanced algorithms wirelessly and is linked to a blood glucose monitor; and an insulin pump is worn by the patient and to a remote-monitoring site.

“In addition to automatically regulating the amount of insulin to be delivered, another important benefit of the artificial pancreas is to prevent hypoglycemic events that can have catastrophic consequences and is one of the most threatening situations for children with type 1 diabetes and their parents,” said Daniel R. Chernavvsky, MD, a UVA Center for Diabetes Technology researcher, and Chief Medical Officer, TypeZero Technologies, Inc., a digital health and personalized medicine company, in Charlottesville, VA, that has licensed the artificial pancreas system. 

In a randomized, crossover trial, researchers enrolled 12 children aged 5 to 8 years old (median age: 7 years; 6 males), and assessed how well an artificial pancreas that had been adapted for use with young children with parental lockout controls was able to control diabetes compared with the usual insulin pump and continuous glucose monitor.

They followed the children using the artificial pancreas for 68 hours in a controlled environment (resort), and then for another 68 hours while they were at home, using their regular home-treatment regimen.

When using the artificial pancreas, children had lower mean blood glucose levels 152 mg/dL vs 190 mg/dL; P < 0.001), and spent more time within target blood-sugar ranges (70-180 mg/dL) compared with home care (73% vs 47%, respectively; P < 0.001 after adjusting for activity), with no increases in hypoglycemia (less than 70 mg/dL; 1.1% vs 1.6%). No adverse events occurred during either regimen.

“The data show that the artificial pancreas, which delivers insulin in an automated way to individuals with type 1 diabetes, appears to be safe and effective for use in young children age 5 to 8 years,” said UVA School of Medicine researcher and lead author Mark DeBoer, MD.

Dr. DeBoer says the next step is to follow the children for longer periods to determine how effective the artificial pancreas is during the children’s regular lives, in school and at home. In addition, they are enrolling subjects for further clinical trials to assess the artificial pancreas in those aged 14 years and older with type 1 diabetes.