Participants spent an additional 3 hours a day in the target blood sugar range – ScienceDaily

An artificial pancreas originally developed at the University of Virginia Diabetes Technology Center improves blood sugar control in children ages 2 to 6 with type 1 diabetes, according to a new study. Details of the clinical trial and its findings have just been published in New England Journal of Medicine.

Study participants using the artificial pancreas spent approximately three hours more per day on their target blood sugar compared to participants in a control group who continued to rely on the methods they were already using to control 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 has 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 the findings of two previous studies, the system was previously approved by the US Food and Drug Administration for people aged 6 years and older with type 1 diabetes.

“Following the resounding success of the Control-IQ technology in people aged 6 years and older, it is very gratifying to see our youngest patients, and often the hardest to help patients, also benefit,” said Marc D. Breton, PhD, an Investigator from the UVA School of Medicine who served as the study’s principal investigator and was recently honored as UVA’s 2022 Innovator of the Year. “With these results, we’ve accumulated years of clinical validation of this system across all age groups and look forward to seeing this transformative technology available to the widest possible population.”

Used during everyday life

The study enrolled 102 children aged 2 to 6 years at three US sites (UVA, Stanford University and 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 for the control group. All participants maintained their regular daily routines during the study.

On average, the time that participants using the artificial pancreas spent within their target blood glucose range was about 12 percentage points longer than participants in the overall control group and 18 percentage points longer during the night. 10 pm to 6 am. particularly important, as severe, uncontrolled hypoglycaemia (very low blood glucose levels) can lead to seizures, coma, or even death.

Overall, the researchers found that 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 a case of diabetic ketoacidosis in the artificial pancreas group, caused by failure of the thin plastic tube that connects the insulin pump to the patient’s body.

Of note, the majority of study-related visits—including 80% of artificial pancreas training sessions and over 90% of general visits—were conducted virtually. Obtaining the reported results under these conditions highlights the ease of use of the technology and its potential for areas without easy access to endocrinologists.

“At the end of the day, this technology significantly improved blood glucose and ensured the safety of our youngest patients, but perhaps just as importantly, it lessened these families’ constant anxiety 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, offering some relief from the challenges they face.”

published findings

The results of the study were published in the New England Journal of Medicine. 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, grant U01DK127551. Tandem Diabetes Care provided the investigative closed-loop systems used in the study, while Dexcom, Inc. provided the ongoing supplies of glucose monitors used in the study.

Participants spent an additional 3 hours a day in the target blood sugar range – ScienceDaily

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