Insulet has announced that its Omnipod 5 Automated Insulin Delivery System has been cleared by the US Food and Drug Administration (FDA) for the indication of type 2 diabetes.
The company says that the FDA clearance makes the Omnipod 5 the first-ever automated insulin delivery (AID) system cleared for both type 1 and type 2 diabetes management. The announcement follows on from a pivotal clinical trial of the device, dubbed the SECURE-T2D trial.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The study found that patients showed glycaemic improvements with the use of Omnipod 5 compared with traditional methods of insulin injections or pump therapy, showing a significant reduction in Hemoglobin A1c (HbA1c), 0.8% overall and 2.1% in those with prior HbA1c 9.0% or higher.
Jim Hollingshead, Insulet president and chief executive Officer, said: “Today’s announcement represents a significant milestone in providing easy-to-use, patient-centric technology for the treatment of type 2 diabetes.
“Insulet is paving the way for these individuals to achieve better health outcomes while living with greater confidence and freedom through the game-changing benefits of tubeless Pod therapy. Omnipod 5 is setting a new standard in diabetes management, and we are thrilled with the opportunity to make a lasting impact on the insulin-requiring type 2 diabetes community.”
Research carried out by the US Center for Disease Control (CDC) found that 11.6% of the US population likely has some form of diabetes. Analysis by GlobalData found that by the end of 2024, the global market for insulin pumps is estimated to stand at $7bn, with that figure set to rise to $11.1bn by the end of 2030.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataAccording to Insulet, the device is the first tubeless AID system that communicates with a continuous glucose monitor (CGM), monitoring for blood sugar highs and lows continuously.
Elsewhere in diabetes management, major medical device manufacturers Medtronic and Abbott have announced a partnership to integrate Medtronic’s automated insulin delivery systems with Abbott’s CGM technology. At the same time, Know Labs has reported positive data from a proof-of-concept trial evaluating its device that non-invasively identifies the level of blood sugar in patients with diabetes.
