A team of researchers recently examined blood sugar control with the use of an artificial pancreas called the Control-IQ system on children ages 2 to 6 with Type 1 diabetes. The Control-IQ system is a diabetes management device produced by Tandem Diabetes Cars which monitors and regulates blood sugar levels. This study holds the potential to help younger children manage their blood sugar levels, as the Control-IQ system has already been sanctioned by the U.S. Food and Drug Administration for children ages 6 and up with Type 1 diabetes based on two earlier studies.
The Control-IQ artificial pancreas system. (Credit: Tandem Diabetes Care)
“After the resounding success of Control-IQ technology in people ages 6 and up, it is very rewarding to see our youngest patients, and often the most challenging patients to help, benefit as well,” said Dr. Marc D. Breton, who is a researcher at the University of Virginia School of Medicine, and is a co-author on the study. “With these results, we have now accumulated years of clinical validation of this system across all age groups and look forward to seeing this life-changing technology made available to the broadest possible population.” Dr. Breton was recently awarded the UVA’s 2022 Innovator of the Year and served as the trial’s principal investigator.
For the study, 102 children ages 2 to 6 participated in the study across three different sites in the United States: Stanford University, the University of Colorado, and the University of Virginia. The trial lasted 13 weeks, during which time 68 of the 102 participants were randomly selected to use the artificial pancreas, while the remaining 34 participants acted as the control group, meaning they didn’t use the artificial pancreas and managed their blood sugar levels normally. During the trial, all the child participants sustained their normal daily routines.
The study’s findings demonstrated a 12 percent increase in target blood sugar range for the participants using the artificial pancreas, along with an 18 percent increase during 10pm and 6am. Monitoring sugar levels during nighttime hours is vital, as unchecked hypoglycemia (very low blood sugar levels) could potentially lead to seizures, coma, and can even be fatal.
In the end, the artificial pancreas was found to be safe to use, but the researchers did not two cases of severe hypoglycemia in the artificial pancreas group, with only one in the control group. They also noted one case of diabetic ketoacidosis in the artificial pancreas group, which stemmed from the thin plastic tube in the Control-IQ system failing to connect to the insulin pump to the patient’s body.
“At the end of the day, this technology significantly improved glycemia and ensured safety of our youngest patients, but perhaps just as importantly it lessened these families’ constant anxiety about glucose levels, especially during the night,” said Dr. Breton. “It is incredibly rewarding for us to hear about these families’ experiences and how they manage to integrate these new tools in their life, offering some reprieve to the challenges they face.”
To demonstrate the ease of use for the Control-IQ system, 80 percent of the artificial pancreas training sessions and 90 percent of the overall visits during the trials were conducted virtually.
The researchers consider this study a success in using the Control-IQ system for children ages 2 to 6, and the study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases; PEDAP ClinicalTrials.gov number, NCT04796779.
Sources: New England Journal of Medicine, EurkAlert!, U.S. National Library of Medicine
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