FDA clears tubeless, automated insulin system for children age 2 and older


The Food and Drug Administration has approved use of the Omnipod 5 automated insulin delivery system (Insulet Corp) for children aged 2 years and older with type 1 diabetes, the company announced on Aug. 22.

Omnipod 5 was originally cleared for use in individuals age 6 and older in Jan. 2022, as previously reported by this news organization. It is the third semi-automated closed-loop system approved in the United States but the first that is tubing-free. It integrates with the Dexcom G6 continuous glucose monitor system and a compatible smartphone to automatically adjust insulin and protect against high and low glucose levels.

“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, PhD, senior vice president and medical director at Insulet, said in a news 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 recent clinical trial in very young children (age 2-5.9 years) with type 1 diabetes, Jennifer L. Sherr, MD, PhD, and colleagues found that the Omnipod 5 lowered A1c by 0.55 percentage points and reduced time in hypoglycemia (< 70 mg/dL) by 0.27%. According to their findings, published in Diabetes Care, time spent in target glucose range (70-180 mg/dL) increased by 11%, or by 2.6 hours more per day, in children in the study.

According to the release, the Omnipod 5 can now be prescribed to patients with insurance coverage. Patients can access their prescription through the pharmacy.

A version of this article first appeared on Medscape.com.

Next Article: