FRIDAY, Aug. 28, 2020 (HealthDay News) -- An artificial pancreas system is safe and effective at managing blood sugar levels in kids as young as age 6 with type 1 diabetes, according to a new study.
The system uses a continuous glucose monitor (CGM) to track blood sugar levels and automatically delivers insulin when needed using an insulin pump. It replaces reliance on fingerstick or CGM with delivery of insulin by injection or a patient- or caregiver-controlled pump.
A clinical trial at four pediatric diabetes centers in the United States enrolled 101 kids with type 1 diabetes, aged 6 to 13 years. One group used the artificial pancreas Control-IQ system, while a "control group" used a standard CGM and separate insulin pump. Kids were followed for four months.
Compared to the control group, those who used the artificial pancreas saw a 7% improvement in their daytime in-range blood glucose control and a 26% improvement in nighttime control.
Nighttime control is especially important for people with type 1 diabetes because severe, unchecked hypoglycemia (low blood sugar) can result in seizure, coma or even death.
The overall time-in-range for patients using the artificial pancreas was nearly 11% higher than in the control group. That translated to 2.6 hours more time-in-range per day, according to the study published Aug. 26 in the New England Journal of Medicine.
The study was funded by the U.S. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
"Fewer than one in five 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," said project scientist Dr. Guillermo Arreaza-Rubín, director of NIDDK's Diabetes Technology Program.
"Earlier research showed that the system tested in this study was safe and effective for people ages 14 and older," he added in an institute news release. "This trial now shows us this system works in a real-world setting with younger children."
Protocol chair Dr. R. Paul Wadwa, pediatric medical director at the University of Colorado's Barbara Davis Center for Childhood Diabetes in Aurora, hailed the improvements in overnight blood glucose control.
"Parents and caregivers [can] sleep better at night knowing their kids are safer," he said. "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."
Based on clinical trial data, the U.S. Food and Drug Administration has approved the use of the Control-IQ system in children 6 and older.
The U.S. Centers for Disease Control and Prevention has more on type 1 diabetes.
SOURCE: U.S. National Institute of Diabetes and Digestive and Kidney Diseases, news release, Aug. 26, 2020