Insulet Corp.'s (NASDAQ: PODD) groundbreaking Omnipod 5 Automated Insulin Delivery ("AID") system (Omnipod 5) received the FDA's approval for use by type 2 diabetes patients (ages 18 years and above). The news comes after the company submitted 510(k) for an expanded indication of Omnipod 5 to the FDA, in June 2024, based on the favorable clinical outcomes of the SECURE-T2D pivotal trial.
With this development, Omnipod 5 is the first and only AID system indicated for both type 1 and type 2 diabetes.
Insulet's Robust Opportunity in the Type 2 Space
Diabetes is a chronic and life-threatening disease for which there is no known cure. The more common variant, type 2 diabetes, is characterized by the body's inability to either properly utilize or produce enough insulin. More than 30 million people are living with type 2 diabetes in the United States, with approximately 6 million people requiring insulin. Of these, roughly 2.5 million are using multiple daily injections ("MDI") — a form of insulin therapy that involves injecting fast-acting insulin before meals (bolus) to lower blood glucose levels to a healthy range.
Although medical therapies have advanced in the past 20 years, the percentage of adults with type 2 diabetes achieving recommended HbA1c (a common measure of blood glucose levels) targets has not seen any significant change. Only a quarter of individuals with type 2 diabetes on insulin are achieving an HbA1c of 7% or less and half of this population has an HbA1c greater than 8%. Despite guideline recommendations for insulin treatment in advanced disease, insulin therapy is often delayed or not appropriately intensified.
The SECURE-T2D Trial Boosts Approval of PODD's Omnipod 5
This is the largest study ever completed for the use of AID in type 2 diabetes, featuring highly diverse study participants who are representative ...
