An artificial pancreas created at the University of Virginia Center for Diabetes Technology improves blood sugar management in 2- to 6-year-old children with type 1 diabetes, according to a new study. Details and findings of the clinical study were recently published in the New England Journal of Medicine.
Trial participants using the artificial pancreas spent about three hours per day in their blood sugar target range compared to control group participants who relied on the methods they were already using to manage their blood sugar.
The Control-IQ System, manufactured by Tandem Diabetes Care, is a diabetes management device that automatically monitors and regulates blood glucose. The artificial pancreas contains an insulin pump that uses advanced control algorithms to adjust insulin doses as needed based on the individual’s glucose-monitoring information.
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Based on the findings of two earlier studies, the system has been approved by the US Food and Drug Administration for people 6 years of age and older with type 1 diabetes.
“After the tremendous success of Control-IQ technology in people 6 years and older, it is very rewarding to see our youngest patients, and often to help even the most challenging patients, benefit,” said Mark D. Breton, Ph.D., said one. 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. “With these results, we have now accumulated years of clinical validation of this system in all age groups and look forward to seeing this life-changing technology made available to the widest possible population.”
Used in daily life
The study enrolled 102 children between the ages of 2 and 6 at three US sites (UVA, Stanford University and the University of Colorado) and assigned 68 of them to use the artificial pancreas system for 13 weeks, while the remaining 34 children were assigned for 13 weeks. control group. All participants maintained their regular daily schedule during the study.
On average, participants using the artificial pancreas spent about 12 percentage points more time within their target blood glucose range than participants in the overall control group, and 18 percentage points more time controlling nighttime blood glucose from 10 p.m. to 6 a.m. Particularly significant, severe, undiagnosed hypoglycemia (extremely low blood glucose levels) can lead to seizures, coma, or even death.
Overall, the researchers found, the participants were able to use the artificial pancreas safely. There were two cases of severe hypoglycemia in the artificial pancreas group compared to one in the control group. There was also one case of diabetic ketoacidosis in the artificial pancreas group due to failure of the thin plastic tubing connecting the insulin pump to the patient’s body.
Of note, the majority of study-related visits—80% of training sessions on the artificial pancreas and more than 90% of overall visits—were conducted virtually. Obtaining results reported under these conditions highlights the ease of use of the technology and its potential in areas not readily accessible to endocrinologists.
“At the end of the day, this technology significantly improved glycemia and ensured the safety of our youngest patients, but perhaps more importantly it reduced these families’ concerns about glucose levels, especially at night.” Breton said. “It’s incredibly rewarding for us to hear about these families’ experiences and how they manage to integrate these new tools into their lives, providing some relief for the challenges they face.”
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