Participants of the study spent three more hours per day within their target blood sugar range. Details of the clinical study and its findings were published in the New England Journal of Medicine.
Tandem Diabetes Care manufactured the Control-IQ system, which automatically monitors and regulates blood glucose. The artificial pancreas’s insulin pump uses advanced control algorithms based on each person’s glucose-monitoring information to adjust the insulin does as needed for that person.
The findings of two earlier UVA studies have made it possible for the U.S. Food and Drug Administration to approve the system for ages 6 and older who have Type 1 diabetes.
“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,” Dr. Marc D. Breton, a UVA School of Medicine researcher who served as the trial’s principal investigator and was recently honored as UVA’s 2022 Innovator of the Year, said. “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.”
At three sites at UVA, Stanford University and the University of Colorado, 102 children were enrolled between ages 2 and 6 in the study. Sixty-eight of them were randomly assigned use of the artificial pancreas system for 13 weeks. The remaining 34 children were a control group. All participants maintained their daily routines during the study.
Participants used the artificial pancreas on average approximately 12 percentage points higher than participants in the control group, and 18 percentage points higher during the overnight hours of 10 p.m. to 6 a.m. Nighttime blood glucose control is especially important, because unchecked low blood glucose levels can lead to seizures, coma or even death.
Two cases of hypoglycemia occurred in the artificial pancreas group compared to one in the control group. One case of diabetic ketoacidosis in the artificial pancreas group was caused by a failure of the thin plastic tube that connects the insulin pump to the patient’s body.
Most of the study-related visits were conducted virtually, including 80 percent of training sessions on the artificial pancreas system.
“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.”
Funding for the study was provided by the National Institutes of Health’s National Institute of Diabetes and Digestive and Kidney Diseases, grant U01DK127551.
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Rebecca Barnabi
