Insulet 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. Credit: Shutterstock / Anatoliy Cherkas

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.

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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.

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According 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.