Hybrid closed-loop bests sensor-augmented therapy for young children with type 1 diabetes
Young children with type 1 diabetes had better time in range and lower mean HbA1c while using a hybrid closed-loop insulin delivery system compared with sensor-augmented insulin pump therapy, according to study data.
“With hybrid closed-loop therapy, young children spent an additional 2.1 hours with glucose levels in the recommended target range every day, without an increase in hypoglycemia, compared with sensor-augmented pump therapy,” Julia Ware, MD, clinical research associate at the Wellcome-MRC Institute of Metabolic Science-Metabolic Research Laboratories and the Medical Research Council Metabolic Disease Unit at the University of Cambridge in the U.K., told Healio. “We recommend that closed-loop therapy should be first-line treatment for very young children with type 1 diabetes.”
Ware and colleagues conducted a randomized crossover trial with 74 children aged 1 to 7 years with type 1 diabetes at least 6 months prior to enrollment who had used insulin pump therapy for at least 3 months and had an HbA1c no higher than 11% (mean age, 5.6 years; mean HbA1c, 7.3%). Children were enrolled at outpatient clinics in Austria, Germany, Luxembourg and the U.K. Participants were randomly assigned to 16 weeks with a hybrid closed-loop system with the Dana Diabecare RS insulin pump (Sooil) and Dexcom G6 continuous glucose monitor connected to a smartphone application hosting the CamAPS FX closed-loop control algorithm, or 16 weeks of sensor-augmented therapy with the same devices and closed-loop functionality disabled. At 16 weeks, participants crossed over to the opposite group following a 1- to 4-week washout period. The primary endpoint was the difference in time in range between the two groups, with percentage of time in hyperglycemia and hypoglycemia, HbA1c and mean glucose serving as secondary endpoints.
The findings were published in The New England Journal of Medicine.
The study cohort had an 8.7 percentage point higher time in range during the hybrid closed-loop phase of the trial compared with the sensor-augmented pump period (P < .001). The percentage of time spent in hyperglycemia was 8.5 percentage points lower with hybrid closed-loop therapy compared with sensor-augmented therapy. There was no difference in time spent in hypoglycemia. Mean HbA1c was 0.4 percentage points lower and mean sensor glucose 12.3 mg/dL lower during hybrid closed-loop therapy compared with sensor-augmented therapy (P < .001 for both).
“While using closed-loop, children spent around three-quarters of their day with glucose levels in the target range of 70 mg/dL to 180 mg/dL, accounting for an additional 125 minutes per day compared to standard therapy,” Ware said. “Children diagnosed with type 1 diabetes at a young age are at highest risk of neurocognitive deficits, so improving glucose control may be particularly beneficial for young children during this vulnerable stage of brain development.”
Participants used their sensor 99% of the time during the closed-loop period and 96% of the time in the sensor-augmented therapy phase. Closed-loop mode was enabled 95% of the time during the closed-loop period.
There was one serious adverse event of severe hypoglycemia in the closed-loop period and no diabetic ketoacidosis cases during the study. There were 75 other adverse events reported, with 27 each in the closed-loop and sensor-augmented pump periods and the remainder coming during a run-in period prior to the trial or the washout period.
“This study supports the adoption of hybrid closed-loop therapy in routine clinical care for very young children with type 1 diabetes,” Ware said. “Longer-term real-world studies are required to assess whether glycemic and quality of life benefits are sustained long term, which will help to inform reimbursement, facilitating wider access across the diabetes population.”
For more information:
Julia Ware, MD, can be reached at firstname.lastname@example.org.