Hybrid closed-loop system poses no increased burden for children with type 1 diabetes
Children with type 1 diabetes using a hybrid closed-loop system and their parents do not report an increase in diabetes-related burden compared with those using a sensor-augmented insulin pump, according to trial data.
Erin C. Cobry, MD, an assistant professor of pediatrics at the Barbara Davis Center for Childhood Diabetes, University of Colorado Anschutz Medical Campus, and colleagues observed no significant differences in hypoglycemia fear, diabetes-related stress and other self-reported outcomes for trial participants using a t:slim X2 insulin pump with Control-IQ technology (Tandem Diabetes Care) compared with participants using their own insulin pump or a provided t:slim X2 insulin pump with predictive low-glucose suspend feature.
“Advancements in diabetes therapies offer ways to improve diabetes outcomes and reduce long-term complications; however, these advancements cannot come at the expense of the quality of life of the child and family,” Cobry told Healio. “Therefore, it is very important that ease of use and quality of life are part of evaluation of novel therapies for type 1 diabetes. The results of this study indicate that hybrid closed-loop systems can successfully be used for glycemic improvement without creating increased burden on children with type 1 diabetes or their parents.”
Researchers conducted an unblinded randomized clinical trial at four pediatric diabetes centers in the U.S. A total of 101 children aged 6 to 13 years with type 1 diabetes for at least 1 year, who weighed 25 kg to 140 kg and had a total daily insulin requirement of at least 10 U per day, were recruited along with one parent for each child. Participants were randomly assigned to a closed-loop group using the t:slim X2 insulin pump with Control-IQ (n = 78) or a sensor-augmented pump group (n = 23). Both groups used the Dexcom G6 continuous glucose monitor. The trial lasted 16 weeks, after which all participants used the t:slim X2 insulin pump with Control-IQ for an additional 12-week extension phase.
Participants filled out a series of questionnaires at baseline, at 16 weeks when the trial ended, and at 28 weeks when the extension period concluded. Both parents and children filled out the Pediatric Hypoglycemia Fear Survey, the Problem Areas in Diabetes Survey, a survey on pediatric quality of life and the Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations questionnaire. Parents also completed the Pittsburgh Sleep Quality Index.
Scores similar between groups
At 16 weeks, there was no significant difference in any of the self-reported questionnaire scores between the closed-loop and sensor-augmented pump groups. The closed-loop group reported less hypoglycemia fear, less diabetes-related distress and better quality of life at 16 weeks compared with baseline. Parents in the closed-loop cohort also reported a decrease in sleep disturbances from baseline to 16 weeks.
“We were surprised that we didn’t find significant improvements in the patient-reported outcomes after transitioning to the hybrid closed-loop system,” Cobry said. “However, this was likely due to the small sample size of the control group since this study was not powered based on the survey measures.”
During the extension phase, the sensor-augmented pump group did not have significant changes in any questionnaire scores. At 28 weeks, participants in the closed-loop group had similar scores on the questionnaires as at 16 weeks. When comparing the change in scores from baseline to 28 weeks, the closed-loop participants had significant reductions in their total score on the Pediatric Hypoglycemia Fear Survey, as well as decreases in the worry, avoidance, helplessness and social consequences subscales. There were also improvements on the pediatric quality of life questionnaire total score and in the diabetes and communication subscales for the closed-loop group.
More research needed
The researchers wrote that the families participating in the study were likely highly engaged with their child’s diabetes management and were able to use the new diabetes technology due to previous experience. They suggested future studies focus on families who face barriers as well as those who do not use technology for diabetes management.
“This study compared the closed-loop control group with a group of youth using diabetes technology and, therefore, was not compared with youth not using technology for diabetes management,” the researchers wrote. “This may have impacted the ability to find significant changes in person-reported outcomes as all study participants were using diabetes devices. Although this was the largest study of hybrid closed-loop use in children with type 1 diabetes, and the longest trial of continued use, more research is clearly needed in more general populations.”
For more information:
Erin Cobry, MD, can be reached at firstname.lastname@example.org.