Hybrid closed-loop system boosts time in range for young children with type 1 diabetes
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Key takeaways:
- Children aged 2 to 5 years had 3 more hours per day of time in range using a hybrid closed-loop insulin delivery system vs. standard care.
- Severe adverse events were rare with use of a hybrid closed-loop system.
Young children using a hybrid closed-loop insulin delivery system had a greater time in range at 13 weeks compared with those receiving standard care, according to a study published in The New England Journal of Medicine.
In the multicenter Pediatric Artificial Pancreas randomized controlled trial, children aged 2 to 5 years with type 1 diabetes were randomly assigned, 2:1, to the t:slim X2 insulin pump with Control-IQ (Tandem Diabetes Care) plus a continuous glucose monitor (Dexcom G6, Dexcom) or standard care with use of a personal insulin pump or multiple daily insulin injections plus CGM. At 13 weeks, time in range increased in the hybrid closed-loop group from 56.7% at baseline to 69.3% at 13 weeks, whereas the standard care group had a minimal increase from 54.9% at baseline to 55.9% at 13 weeks.
“After the resounding success of Control-IQ technology in people aged 6 years and up, we now show that this technology is safe and efficacious for children aged 2 to 5 years with type 1 diabetes,” Marc D. Breton, PhD, associate director for research in the Center for Diabetes Technology at the University of Virginia, told Healio. “Compared to standard of care, Control-IQ users spent approximately 3 hours longer per day in the desired glucose range of 70 mg/dL to 180 mg/dL, with no additional risk of hypoglycemia.”
Breton and colleagues enrolled 102 young children aged 2 to 5 years with type 1 diabetes who were prescribed insulin for at least 6 months prior to the trial, weighed at least 20 lb and received at least 5 U of insulin daily. Of the cohort, 68 were randomly assigned to the hybrid closed-loop insulin delivery system with CGM, and 34 were randomly assigned to standard care with a CGM for 13 weeks. Virtual or in-person visits took place at 2, 6 and 13 weeks, and telephone contacts were made at 1 and 10 weeks. HbA1c was measured at randomization and 13 weeks. The primary outcome was the percentage of time spent in range with a glucose level of 70 mg/dL to 180 mg/dL. Time above range of 250 mg/dL or higher, time below range of 70 mg/dL or lower, and time below range of 54 mg/dL or lower were secondary outcomes. Safety outcomes included episodes of severe hypoglycemia and diabetic ketoacidosis.
Time in range higher with hybrid closed-loop system
The hybrid closed-loop group had a greater increase in time in range during the trial compared with standard care (mean difference; 12.4 percentage points; 95% CI, 9.5-15.3; P < .001). The treatment effect in the hybrid closed-loop group was observed in the first week and persisted during the entire trial. Time in range was higher in the closed-loop group compared with standard care during daytime (67% vs. 56%) and nighttime (74% vs. 56%).
The closed-loop group had a lower time above range (mean difference; –5.4 percentage points; 95% CI, –7.3 to –3.6; P < .001), lower mean glucose (mean difference; –17.7 mg/dL; 95% CI, –23.2 to –12.2; P < .001) and lower HbA1c (mean difference; –0.42 percentage points; 95% CI, –0.62 to –0.22; P < .001) than the standard care group. Time below range did not differ between the two groups.
Adverse events were reported by a higher proportion of children using hybrid closed-loop compared with standard care (60% vs. 32%; P = .001). There were two cases of severe hypoglycemia in the closed-loop group and one in the standard care group. One episode of DKA occurred in the closed-loop group that was related to an infusion set failure.
“Our findings confirm that this technology is safe and reduces hyperglycemia for a broad population, including children using multiple daily injections and children with degraded glycemic control,” Breton said. “The system was most beneficial for children who struggled to maintain target glycemia on standard care. The very low occurrence of severe adverse events, the additional protection against hyperglycemia with very limited exposure to hypoglycemia and the satisfaction of the families with the system all speak to a clear clinical benefit for young children and their caregivers.”
In a related editorial, Daniela Bruttomesso, MD, PhD, of the department of medicine at University of Padua in Italy, wrote that the findings may introduce more telemedicine in diabetes care for younger children, and a mix of in-person and virtual visits may become routine in the future.
Bruttomesso wrote that the trial had a few limitations, such as the short duration, the closed-loop group having more unscheduled provider contacts than the standard care group, and the lack of comparison between in-person initiation of a closed-loop system with remote initiation.
“Aside from such limitations, the trial conducted by Wadwa et al confirms that in very young children with type 1 diabetes and suboptimal glycemic control, a closed-loop system may be recommended to improve the glucose profile and short-term and long-term outcomes,” Bruttomesso wrote. “Furthermore, it appeared that closed-loop therapy may be started remotely.”
Reference:
- Bruttomesso D. N Engl J Med. 2023;doi:10.1056/NEJMe2301252.
For more information:
Marc D. Breton, PhD, can be reached at mb6nt@virginia.edu.
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