FDA Clears Tubeless Automated Insulin-Delivery System for Adults with Type 2 Diabetes

The FDA has cleared an automated insulin delivery system for adults 18 years and older with type 2 diabetes (T2D), according to an agency press release.¹

In an August 26, 2024, announcement, the FDA stated it expanded the indications for the Insulet SmartAdjust technology, previously indicated for the management of type 1 diabetes (T1D) in persons 2 years and older, to also include management of T2D in persons 18 years and older. The Insulet SmartAdjust technology, used in the company’s tubeless Omnipod 5 Automated Insulin Delivery (AID) System, automatically adjusts insulin delivery by connecting to an alternate controller-enabled insulin pump and integrated continuous glucose monitor.¹

This new indication makes the Omnipod 5 the first automated insulin delivery system available for both T1D and T2D in the US, according to a press release from Insulet.²

"The FDA has long worked with the diabetes community to ensure access to additional options and flexibilities for diabetes management," Michelle Tarver, MD, PhD, acting director of the FDA's Center for Devices and Radiological Health, said in the statement. "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."¹

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).

“I’ve seen first-hand how difficult it is for patients to reach their targets with injections,” Anne L. Peters, MD, Director of the University of Southern California Westside Center for Diabetes, said in the Insulet press release. “Omnipod 5 makes it easier for people with type 2 diabetes to take their insulin and stay in range, leading to remarkable improvements in clinical outcomes and overall quality of life. I believe this innovative technology has the potential to transform the lives of insulin-requiring people with type 2 diabetes.”²

References:

1. FDA clears first device to enable automated insulin dosing for individuals with type 2 diabetes. FDA. News release. August 26, 2024. Accessed August 27, 2024. https://www.fda.gov/news-events/press-announcements/fda-clears-first-device-enable-automated-insulin-dosing-individuals-type-2-diabetes
2. Omnipod® 5 automated insulin delivery system is now FDA-cleared for people with type 2 diabetes. Insulet. News release. August 26, 2024. Accessed August 27, 2024. https://investors.insulet.com/news/news-details/2024/Omnipod-5-Automated-Insulin-Delivery-System-is-now-FDA-cleared-for-People-with-Type-2-Diabetes/default.aspx