Washington: According to a new study, a artificial pancreas created at the University of Virginia Center for Diabetes Technologies improves glycemia treatment in children aged 2 to 6 years with type 1 diabetes. Details and conclusions of the clinical study have just been published in the New England Journal of Medicine.
Trial participants using the artificial pancreas spent approximately three more hours per day in their blood sugar target range compared to participants in a control group who continued to rely on the methods they were already using to control their blood sugar level. sugar in the blood.
The Control-IQ system, manufactured by Tandem diabetes care, is a diabetes management device that automatically controls and regulates blood glucose. The artificial pancreas has a insuline bomb which uses advanced person-based control algorithms glucose monitoring information to adjust the insulin dose as needed.
Based on the findings of two previous studies, the system has previously been approved by the US Food and Drug Administration for people 6 years and older with type 1 diabetes.
“After the resounding success of Control-IQ technology in people ages 6 and older, it is very gratifying to see our youngest patients, and often our most difficult-to-help patients, benefit as well,” said Marc D. Breton , PhD, a UVA School of Medicine Investigator 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 available to the widest possible population.”
Used during daily life
The study enrolled 102 children ages 2 to 6 at three US sites (UVA, Stanford University, and the University of Colorado) and randomly assigned 68 of them to wear the artificial pancreas system for 13 weeks, while the remaining 34 children were assigned to the control group. All participants maintained their regular daily routines during the study.
On average, the time that participants wearing the artificial pancreas spent within their target blood glucose range was about 12 percentage points higher than participants in the control group overall and 18 percentage points more during nighttime hours of sleep. 10 pm to 6 am Nighttime blood glucose monitoring is particularly important, as severe and uncontrolled hypoglycemia (very 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, caused by a 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 more than 90% of visits overall, were conducted virtually. Achieving 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 decreased these families’ constant anxiety about glucose levels, especially at night.” Breton said. “It’s incredibly gratifying for us to hear about the experiences of these families and how they manage to integrate these new tools into their lives, offering relief from the challenges they face.”
