FDA Expands Omnipod 5 AID System Label to Treat T2D: Daily Dose

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On August 27, 2024, we reported on the FDA expanding the indication for Insulet’s SmartAdjust technology, an interoperable automated glycemic controller that is used in Insulet's tubeless Omnipod 5 Automated Insulin Delivery (AID) System, to include management of type 2 diabetes (T2D) in individuals 18 years and older.

The decision

The Insulet SmartAdjust technology was previously indicated for the management of type 1 diabetes in persons 2 years and older. This new indication makes the Omnipod 5 the first automated insulin delivery system available for both T1D and T2D in the US.

The clearance follows the presentation of data from the SECURE-T2D trial at the American Diabetes Association Scientific Sessions in June, which included 305 adults (24% Black, 22% Hispanic/Latino) aged 18 to 75 years with T2D. As Patient Care Online previously reported, adults with T2D on a stable insulin regimen who were started on the Omnipod 5 AID system had an A1c reduction from 8.2% at baseline to 7.4% at 13 weeks (treatment effect -0.8%, 95% CI -1.0 to -0.7; P < .001). In addition, results showed a 2.1 percentage point decrease for participants with A1c of 9% or greater at baseline (10.1% at baseline vs 8.1% at 13 weeks).

FDA comment

"Automated insulin dosing technology has previously been available only for people with type 1 diabetes. Today's action helps expand access to this important diabetes management tool to millions of adults living in the U.S. with type 2 diabetes."

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