Omnipod 5 Expanded Clearance for Type 2 Diabetes

FDA has cleared an Insulet 510(k) for the Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for use by those with Type 2 diabetes (ages 18 years and older). Previously, the insulin pump was FDA-cleared for Type 1 diabetes management.

The clearance is based on recent data showing that Omnipod 5 significantly improves health outcomes for people with Type 2 diabetes. “The SECURE-T2D clinical study demonstrated that compared to prior insulin therapy methods in adults with Type 2 diabetes, Omnipod 5 use resulted in considerable reductions in HbA1c [glucose level]: 0.8% overall and 2.1% in those with prior HbA1c 9.0% or higher,” the company says. “Time in hyperglycemia and total daily insulin dose were also reduced, and there was a 20% improvement in time in range, increasing by 4.8 hours per day, without increasing time in hypoglycemia. The study also demonstrated a clinically meaningful improvement in diabetes distress.”