The researchers examined 101 children between the ages of six and 13 for four months in a randomized clinical trial, and compared an experimental group with a new artificial pancreatic system with a control group using a standard continuous glucose monitoring (CGM) device and a separate insulin pump,
An artificial pancreatic system automatically monitors and regulates blood glucose levels. It is not implanted in patients, but uses a computer to coordinate the glucose monitor with the insulin pump.
Those using the artificial pancreas had a 7% improvement in blood sugar levels within the target range during the day and a 26% improvement at night compared to the control group, the study found.
“For type 1 diabetics, monitoring blood glucose levels at night is crucial because severe, uncontrolled hypoglycemia can lead to seizures, coma or even death,” the researchers wrote.
“The improvement in blood glucose control in this study was impressive, especially at night for hours, allowing parents and caregivers to sleep better at night knowing that their children are safer,” Drs. Paul Wadwa, protocol chair and a professor of pediatrics at the Barbara Davis Center for Childhood Diabetes at the University of Colorado, Aurora, said in a statement.
“Artificial pancreatic technology can mean less often that children and their families have to stop everything to take care of their diabetes. Instead, children can focus on children,” he said.
The artificial pancreas generally showed almost 11% improvement in keeping blood glucose within reach, and added an additional 3 hours a day compared to continuous glucose control and an insulin pump, the study found.
The system replaces fingerstick tests like CGM and insulin injections multiple times a day as a controlled pump, the NIDDK said.
“Less than one in five children with type 1 diabetes can successfully maintain their blood glucose in a healthy range with current treatment, which can have serious consequences on their long-term health and quality of life,” said Dr. Guillermo Arreaza- Rubín, the director of NIDDK’s Diabetes Technology Program and a project scientist with the study.
Earlier research showed that the artificial pancreatic system is safe in people aged 14 and older, Arreaza-Rubín said.
The study recorded 16 “adverse events” in the artificial pancreatic group during the study, with most related to problems with insulin pump equipment, and three “events” in the control group, the authors said. There were no cases of severe hypoglycemia, such as low blood sugar levels, such as diabetic ketoacidosis, very high blood sugar levels with a dangerous build-up of ketones.
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