An artificial pancreas developed at the University of Virginia’s Center for Diabetes Technologies improves blood sugar management in children ages 2 to 6 with type 1 diabetes, according to a new study. The details and conclusions of the clinical study have just been published in the New England Journal of Medicine.
Study participants who used the artificial pancreas spent approximately three hours more per day within their blood sugar target range than participants in a control group, who continued to rely on the methods they were already using to control their blood sugar.
Manufactured by Tandem Diabetes Care, the Control-IQ System is a diabetes management device that automatically monitors and regulates blood sugar. The artificial pancreas has an insulin pump that uses advanced control algorithms based on the person’s glucose monitoring information to adjust the insulin dose as needed.
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Based on the results of two previous studies, the system was previously approved by the US Food and Drug Administration for people ages 6 and older with type 1 diabetes.
“Following the resounding success of Control-IQ technology in people as young as 6 years old, it is very rewarding to see that even our youngest patients, and often the most difficult patients, benefit from it,” said Marc D. Breton, PhD, a UVA School researcher of Medicine, who served as the study’s principal investigator and was recently named UVA Innovator of the Year 2022. “With these results, we have now accumulated years of clinical validation of this system in all age groups and look forward to bringing this life-changing technology to the widest possible population.”
Used in everyday life
The study enrolled 102 children between the ages of 2 and 6 years at three US sites (UVA, Stanford University, and University of Colorado), and 68 of them were randomly assigned to use the artificial pancreas system for 13 weeks, while the remaining 34 Children were assigned to the control group. All participants maintained their regular daily routine during the study.
On average, the participants who used the artificial pancreas spent about 12 percentage points longer in their target blood sugar range than participants in the control group overall and 18 percentage points longer during the night hours from 10 p.m. to 6 a.m. Nighttime blood sugar control is especially important because severe, uncontrolled hypoglycemia (very low blood sugar levels) can lead to seizures, coma, or even death.
Overall, the researchers found that the participants were able to safely use the artificial pancreas. There were two cases of severe hypoglycemia in the artificial pancreas group compared with one case in the control group. There was also one case of diabetic ketoacidosis in the artificial pancreas group, caused by a failure of the thin plastic tube connecting the insulin pump to the patient’s body.
Notably, most study-related visits—including 80% of pancreas training sessions and more than 90% of total visits—were conducted virtually. Achieving the reported results under these conditions underscores the ease of use of the technology and its potential for areas without easy access to endocrinologists.
“Ultimately, this technology significantly improved blood glucose levels and ensured the safety of our youngest patients, but perhaps just as importantly, it reduced these families’ constant anxiety about glucose levels, particularly during the night,” Breton said. “It’s incredibly rewarding for us to hear about the experiences of these families and how they manage to integrate these new tools into their lives and provide them with some respite from the challenges they face.”
This story was published from a wire agency feed with no changes to the text. Only the headline has been changed.
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