A new study shows that an artificial pancreas originally developed at the University of Virginia Tech Diabetes Center improves blood sugar control in children ages 2 to 6 with type 1 diabetes. Clinical study details and results have just been published in New England Journal of Medicine.
Trial participants who used the artificial pancreas spent nearly three more hours per day in their target blood sugar range than control participants who continued to rely 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 based on the person’s glucose monitoring information to adjust the insulin dose as needed.
Based on findings from two previous studies, the regimen was previously approved by the FDA for people 6 years of age and older with type 1 diabetes.
Mark D. said: a UVA School of Medicine researcher who served as principal investigator on the trial and was recently honored as the 2022 UVA Innovator of the Year. “With these findings, we now have years of clinical validation of this system across all age groups and we look forward to seeing this transformative technology Life is available to the largest possible number of the population.”
used during everyday life
The study enrolled 102 children between the ages of 2 and 6 years at three US sites (UVA, Stanford University, and the University of Colorado) and randomly assigned 68 of them to use the artificial pancreas system for 13 weeks, while the remaining 34 children were assigned to a control group. All participants maintained their regular daily routines during the study.
On average, participants who used the artificial pancreas spent time within their target blood glucose range about 12 percentage points higher than control group participants overall and 18 percentage points higher during the nighttime hours of 10 p.m. to 6 a.m. Especially important, as severe and uncontrolled hypoglycemia (blood glucose levels that are too low) 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 in the control group. There was also one case of diabetic ketoacidosis in the artificial pancreas group, due to failure of the thin plastic tube that connects the insulin pump to the patient’s body.
It should be noted that most of the visits related to the study – including 80% of training sessions on the artificial pancreas and more than 90% of all visits – were conducted approx. The achievement of the reported results under these conditions highlights the ease of use of the technology and its potential in areas not easily accessible to endocrinologists.
“At the end of the day, this technology significantly improved blood sugar and ensured safety for younger patients, but perhaps just as importantly it reduced these families’ constant anxiety about glucose levels, especially during the night.” Britton said. “It is so exciting to hear about the experiences of these families and how they have been able to incorporate these new tools into their lives, and to offer some relief to the challenges they face.”
published results
The results of the study have been published in New England Journal of Medicine. The study authors are R. Paul Wadwa, Zachariah W.Reed, Bruce A. Buckingham, Mark D. DeBoer, Laya Ekhlaspour, Gregory P. Forlenza, Melissa Schoelwer, John Lum, Craig Kollman, Roy W. Beck, and Breton.
This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, with grant U01DK127551. Tandem Diabetes Care provided the closed-loop probe systems used in the trial, while Dexcom, Inc. Supplies for continuous glucose monitoring used in the experiment.
