Artificial pancreas improves blood sugar control in young children with type 1 diabetes
An artificial pancreas improves blood sugar control in children ages 2 to 6 with type 1 diabetes, researchers reported on March 16, 2023 the NEJM/New England Journal of Medicine.
“After the resounding success of Control-IQ technology in people ages 6 and up, it is very rewarding to see our youngest patients, and often the most challenging patients to help, benefit as well,” said lead investigator Marc D. Breton, PhD, associate professor at the University of Virginia School of Medicine in Charlottesville, “With these results, we have now accumulated years of clinical validation of this system across all age groups and look forward to seeing this life-changing technology made available to the broadest possible population.”
The Control-IQ system, manufactured by Tandem Diabetes Care, automatically monitors and regulates blood glucose. To adjust the insulin dose as needed, this artificial pancreas contains an insulin pump using advanced control algorithms based on the individual’s glucose-monitoring information.
This system has already been approved by the U.S. Food and Drug Administration (FDA) for patients with type 1 diabetes ages 6 and older.
In this 13-week, multicenter trial, the investigators randomized children at least 2 years-old and less than 6 years-old who had been diagnosed with type 1 diabetes to be treated with the closed-loop Control -IQ system of insulin delivery or with standard care. Standard care included either an insulin pump or multiple daily injections of insulin plus a continuous glucose monitor.
The primary endpoint of the study was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring.
The investigators enrolled 102 children. They randomized 68 of the subjects to use the artificial pancreas system for 13 weeks. They assigned the remaining 34 subjects to the standard care/control group.
They reported that the mean percentage of time that, in the artificial pancreas group, the glucose level was within the target range increased from 56.7% at baseline to 69.3% during the 13-week follow-up period, and from 54.9% to 55.9% in the standard-care group. This is a statistically significant mean adjusted difference of 12.4 percentage points, which is equivalent to approximately 3 hours per day.
Notably, subjects using the artificial pancreas spent 18% more overnight time (10 p.m. to 6 a.m.) within their target blood glucose range than the control group. Nocturnal blood glucose control is particularly important since unchecked hypoglycemia can lead to seizures, coma or even death.
“At the end of the day, this technology significantly improved glycemia and ensured safety of our youngest patients, but perhaps just as importantly it lessened these families’ constant anxiety about glucose levels, especially during the night.” Breton said. “It is incredibly rewarding for us to hear about these families’ experiences and how they manage to integrate these new tools in their life, offering some reprieve to the challenges they face.”