Tubeless hybrid closed-loop system boosts time in range for youths with type 1 diabetes
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Children and adolescents with type 1 diabetes had an increase in time in range and reduction in HbA1c after starting a tubeless hybrid closed-loop insulin delivery system, according to study data
As Healio previously reported, the FDA cleared the Omnipod 5 (Insulet), the first tubeless hybrid closed-loop insulin delivery system, for children and adults aged 6 years and older with type 1 diabetes in January 2022 and for children aged 2 to 5 years in August 2022. In data obtained during the months following the approval, children and adolescents aged 2 to 21 years had improvements in continuous glucose monitoring metrics that were close to what were observed in clinical trials, according to Brynn E. Marks, MD, MSHPEd, attending physician and director of technology of the Diabetes Center at Children’s Hospital of Philadelphia and assistant professor of pediatrics at Perelman School of Medicine at the University of Pennsylvania.
“Time in range improved by 11 percentage points within 9 days of Omnipod 5 initiation in a real-world cohort of youth with type 1 diabetes, and these improvements were sustained at 90 days.” Marks told Healio. “This improvement in time in range approached the 15 percentage point improvement observed in pivotal trials in youth aged 6 to 13 years and 12 percentage point improvement seen in youth aged 14 and older.”
Marks and colleagues conducted a retrospective study of 195 youths aged 2 to 21 years with type 1 diabetes who started using the Omnipod 5 from May 2022 to Nov. 1, 2022 (median age, 11.7 years; 50.3% female; 78.9% non-Hispanic white). Data were obtained from electronic medical records at the Johns Hopkins Pediatric Diabetes Center and Children’s Hospital of Philadelphia. HbA1c at baseline was any measurement up to 180 days before initiation of the hybrid closed-loop system. Follow-up HbA1c levels were collected at the visit closest to 3 months after tubeless hybrid closed-loop therapy began. CGM data were obtained at 14 days before initiation of the hybrid closed-loop system and at 90 days after initiation.
The findings were published in Diabetes Technology & Therapeutics.
Glycemic outcomes improved
Youths using the Omnipod 5 had an increase in median time in range from 49% at baseline to 61% at 90 days, and a median reduction in HbA1c from 7.5% at baseline to 6.9% at follow-up (P < .001 for both). All CGM parameters improved from baseline to 90 days. Greater improvements in glycemic outcomes were observed among those with a baseline time in range of less than 60% compared with youths with a time in range of 60% or higher at baseline.
Improvements in time in range were seen within the first 9 days of tubeless hybrid closed-loop therapy, but no changes were seen during days 10 to 18 or days 19 to 27. After improvements were observed in the first 9 days, CGM parameters remained stable through 90 days.
Users spend most of time in automated mode
The study group spent a median 98% of time in automated mode during days 1 to 9. Time in automated mode decreased to 95% through day 90 (P = .0009). The percentage of basal insulin use increased from 51% in days 1 to 9 to 53% in days 1 to 90 (P < .0001). The median number of user-initiated boluses decreased from 5.1 in the first 9 days to five through day 90 (P = .01). The percentage of bolus overrides increased from 3.3% in days 1 to 9 to 5.9% in days 1 to 90 (P < .0001).
In multivariable analysis, baseline time in range and time in automated mode predicted time in range improvement with the Omnipod 5. Each 10% increase in automated mode use increased time in range by 1.8 percentage points at 90 days (P = .0002) and each 10 percentage point decrease in baseline time in range was associated with a 4 percentage point increase in time in range at 90 days (P < .0001).
“Despite the significant improvements in time in range and HbA1c with real-world Omnipod 5 use, the 90-day time in range of 61% still fails to reach the recommended target of 70%,” Marks said. “Further advances in automated insulin delivery and studies are needed to reach recommended glycemic targets. Additional studies enrolling later adopters of Omnipod 5 that may capture a cohort that better generalizes to the overall U.S. type 1 diabetes population are also needed.”
For more information:
Brynn E. Marks, MD, MSHPEd, can be reached at marksb@chop.edu.
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