The study, led by U.S. researchers, showed that the novel system was safe and effective for managing blood glucose in children as young as 6 years old.
Type 1 diabetes is a highly prevalent chronic illness diagnosed in childhood, occurring in approximately 1 in 400 to 600 children in the United States. While appropriate treatment is essential for ensuring optimal glucose control and reduced risks of future complications, nearly 80% of children with type 1 diabetes do not meet glycemic control goals as set forth by the American Diabetes Association.
A new artificial pancreas system may be the answer for some of these patients, according to a recent study published in the New England Journal of Medicine. The study, led by U.S. researchers, showed that the novel system was safe and effective for managing blood glucose in children as young as 6 years old.
“Fewer than 1 in 5 children with type 1 diabetes are able to successfully keep their blood glucose in a healthy range with current treatment, which may have serious consequences on their long-term health and quality of life,” according to a statement made by Guillermo Arreaza-Rubín, M.D., director of NIDDK’s Diabetes Technology Program and key scientist involved in the study. “Earlier research showed that the system tested in this study was safe and effective for people ages 14 and older. This trial now shows us this system works in a real-world setting with younger children.”
The artificial pancreas used in this study – the Control-IQ system – is referred to as a “closed-loop control.” Tandem Diabetes Care, the developer of the system, considers it an all-in-one diabetes management platform. The system monitors blood glucose levels with a continuous glucose monitor (CGM) and delivers insulin automatically, when needed, using an insulin pump. The pump is programed with advanced control algorithms which are based on mathematical modeling of the patient’s glucose monitoring information.
The 16-week, multicenter study was part of several trials performed in the International Diabetes Closed-Loop (iDCL) Study. This study involves researchers from Stanford University School of Medicine, Yale University School of Medicine, University of Virginia Center for Diabetes Technology and the University of Colorado.
The study cohort included 101 children between 6 and 13 years of age, all of whom were randomized 3:1 to either the artificial pancreas system (n=78) or a control intervention comprising standard CGM and a separate insulin pump (n=23). Participants continued living their normal lives so the researchers could investigate how the artificial pancreas system works in a real-world setting.
At baseline, the glycated hemoglobin levels were between 5.7% to 10.1%. From baseline to 16 weeks of treatment, the mean percentage of time glucose levels were in the target range (70-180 mg/decilter) increased from 53±17% to 67±10%, respectively, in the closed loop group. This was a significantly greater increase than that observed in the control group of 51±16% to 55±13% (mean adjusted difference, 11 percentage points; 95% CI, 7-14; P<0.001). The overall time-in-range goal for patients assigned to the artificial pancreas translated to approximately 2.6 more hours per day compared with the control group.
The median percentage of time glucose levels were <70 mg/deciliter was 1.6% in the artificial pancreas group and 1.8% in the control group. The artificial pancreas system was in the closed-loop mode for (median) 93% of the time. Neither group experienced episodes of diabetic ketoacidosis or severe hypoglycemia.
Overall, children who used the closed-loop system experienced a 7% improvement in maintaining glucose within a normal range during the day, and another 26% experienced improvement in nighttime control of their glucose. These findings are of significant clinical importance, as unmanaged hypoglycemia at night in patients with type 1 diabetes could lead to coma, seizure or death.
“The improvement in blood glucose control in this study was impressive, especially during the overnight hours, letting parents and caregivers sleep better at night knowing their kids are safer,” according to a statement made by corresponding study author R. Paul Wadwa, M.D., professor of pediatrics at the Barbara Davis Center for Childhood Diabetes at the University of Colorado, Aurora. “Artificial pancreas technology can mean fewer times children and their families have to stop everything to take care of their diabetes. Instead, kids can focus on being kids.”
A limitation of this study was the strict inclusion of children between the ages of 6 and 13.
“We still need to learn more about how this system will work for children under 6 years of age, and beyond the study, we want to see the real world impact of this system in larger numbers of patients over longer periods of time,” Wadwa told BioSpace. “It will also be important for clinicians to learn how to best help patients with type 1 diabetes optimize their use of this system and do the best they can managing their diabetes.”
In spite of the limitations, the investigators believe the findings from this trial will support promising endeavors for the future of pediatric type 1 diabetes care.
“The findings from this study will support safe and effective use of this system for children in this age group,” Wadwa said. “This could have a tremendous clinical impact due to improved diabetes control for children in this age range using this hybrid closed loop system.” In a previous statement, Dr. Arreaza-Rubín added that he hopes this new “technology may benefit children with type 1 diabetes and their families, and hopefully benefit everyone with diabetes in the future.”
Based on the data from this trial as well as the other iDCL studies, the Control-IQ system received clearance from the U.S. FDA for use in children as young as 6 years of age.
