A real-world trial of younger children with Type 1 diabetes showed that a closed-loop artificial pancreas system from Tandem Diabetes Care could help increase the amount of time spent each day within a healthy blood sugar range, including overnight as they slept.
Compared to measurements taken at the beginning of the study, children ages 6 to 13 gained over two-and-a-half hours within the range after four months, for a total of about 16 hours each day on average.
In addition, between 12:00 a.m. and 6:00 a.m., 80% of children using Tandem’s automated insulin pump maintained their glucose levels compared to 54% of children in the control group.
The study, supported by the National Institutes of Health and published in The New England Journal of Medicine, saw no severe cases of low blood sugar, or hypoglycemia, and no cases of diabetic ketoacidosis—while the effects of treatment became apparent after just one month.
“Fewer than 1 in 5 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 Guillermo Arreaza-Rubín, M.D., director of the Diabetes Technology Program at the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
“Earlier research showed that the system tested in this study was safe and effective for people ages 14 and older,” said Arreaza-Rubín, who served as the study’s project scientist. “This trial now shows us this system works in a real-world setting with younger children.”
Tandem’s t:slim X2 insulin pump and its Control-IQ algorithms take sensor readings from Dexcom’s G6 continuous glucose monitor and predict the wearer’s blood sugar levels 30 minutes ahead of time before adjusting background insulin doses. The all-in-one system also delivers automatic correction boluses up to once per hour.
Originally approved for people with Type 1 diabetes ages 14 and older, the FDA expanded its usage to children as young as 6 this past June.
“For decades, NIDDK has funded research and technology development to create a user-friendly automated device that could ease the constant burden of type 1 diabetes, from the finger sticks and insulin injections, to the insulin dose calculations and constant monitoring while improving diabetes control outcomes and preventing both short- and long-term complications of the disease,” Arreaza-Rubín said.
“The artificial pancreas is a culmination of these years of effort, and it’s exciting to see how this technology may benefit children with type 1 diabetes and their families, and hopefully benefit everyone with diabetes in the future,” he said.