An artificial pancreas system that can automatically monitor and regulate blood glucose levels in Type 1 diabetic children as young as 6 was found to be safe and effective, according to a study published in the New England Journal of Medicine.
The artificial pancreas, which the researchers also refer to as “closed-loop control,” is described as an “all-in-one” management system for diabetes, according to a press release provided to Fox News. The system relies on a continuous glucose monitor (CGM) to track blood glucose levels and provides insulin as needed through a pump automatically, the news release said.
This means the diabetic child does not have to rely on fingerstick tests, injections or a patient- or caregiver-controlled pump, the release stated.
The clinical trial involved four pediatric facilities, including one at Barbara Davis Center for Childhood Diabetes at the University of Colorado Anschutz Medical Center. The research teams studied 101 children between 6 and 13 years old every other week over a course of four months. The participants were assigned to a group that used the artificial pancreas system or a control group that used the standard CGM with a separate insulin pump. All participants were told to go about their daily routines throughout the study duration, the release stated.
The researchers found the children in the artificial pancreas group had a 7% improvement in maintaining blood sugar levels during the day and 26% improvement at night compared to those who did not use the system. The control of blood glucose levels at night is significant, the release indicated, as unchecked hypoglycemic levels, when severe, can lead to seizures, coma and possibly death.
Additionally, the study showed that the artificial pancreas group spent 2.6 more hours per day in their recommended blood glucose range.
“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 Anschutz Medical Campus, said in the news 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,” he added.
The trial was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) along with Tandem Diabetes Care Inc.
“As we continue to search for a cure for type 1 diabetes, making artificial pancreas technology that is safe and effective, such as the technology used in this study, available to children with Type1 diabetes is a major step in improving the quality of life and disease management in these youth,” NIDDK Director Dr. Griffin P. Rodgers said in the release.
Sixteen adverse events were noted in the artificial pancreas group, according to the report. However, the events were classified as minor and attributed to the pump. The researchers stated no diabetic ketoacidosis or severe hypoglycemic events occurred.
“We’ve entered an exciting time when the long-expected era of an ‘artificial pancreas’ is becoming a reality. This study shows that in fairly young children, ages 6 to 13, a ‘closed-loop’ insulin sensor and pump were able to keep blood glucose levels in a healthy range significantly better than one of the best insulin pump/sensor systems available today,” a spokesperson for the American Diabetes Association told Fox News in an email. “This is great news for both kids and adults who want to focus on their daily lives and safely spend less time focusing on their diabetes management.”
Tandem Diabetes Care has received clearance from the U.S. Food and Drug Administration (FDA) for use of the Control-IQ system in children as young as 6.