Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.
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."
