FDA clears tubeless hybrid closed-loop insulin delivery system for young children
Click Here to Manage Email Alerts
The FDA has cleared the first tubeless hybrid closed-loop insulin delivery system for use by children aged 2 to 5 years with type 1 diabetes, according to an industry press release.
The Omnipod 5 (Insulet) tubeless automated insulin delivery system was approved for use in all people with type 1 diabetes aged 2 years and older. As Healio previously reported, the FDA cleared the Omnipod 5 for people with type 1 diabetes aged 6 years and older in January 2022.
“We received tremendous first-hand reports of how Omnipod 5 made diabetes management easier for our pivotal trial participants, and the clinical data demonstrated impressive glycemic improvements as well,” Trang Ly, MBBS, FRACP, PhD, senior vice president and medical director for Insulet, said in a press release. “This expanded indication for younger children gives us great pride, knowing we can further ease the burden of glucose management for these children and their caregivers with our simple to use, elegant, automated insulin delivery system.”
In a single-arm study published in Diabetes Care, 80 young children aged 2 to 5 years used the Omnipod 5 for 13 weeks after 14 days of baseline data collection. At 13 weeks, participants had a 0.55% mean decline in HbA1c and a 10.9% mean increase in time in target glucose range between 70 mg/dL and 180 mg/dL of. Time below range declined by a mean of 0.27% at 13 weeks and time above range decreased by a mean of 9.9%. No severe hypoglycemia or diabetic ketoacidosis episodes were reported during the study.
The Omnipod 5 integrates the Dexcom G6 continuous glucose monitor and a smartphone with the Omnipod 5 mobile application to automatically adjust insulin and protect against hyperglycemia and hypoglycemia. Health care professionals can prescribe the Omnipod 5 to patients with insurance coverage.
Reference:
- Sherr JL, et al. Diabetes Care. 2022;doi:10.2337/dc21-2359.
Collapse
Read more about
Click Here to Manage Email Alerts