FDA Expands Omnipod 5 AID System Label to Treat Type 2 Diabetes

The FDA has approved the first automated insulin dosing device for adults with type 2 diabetes.¹

The agency announced Monday that it expanded 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 in individuals 18 years and older. The Insulet SmartAdjust technology was previously approved for the management of type 1 diabetes in individuals 2 years and older.

The FDA approved the first automated insulin dosing device for adults with type 2 diabetes | Image credit: Andrey Popov – stock.adobe.com

This label expansion makes the Omnipod 5 AID System the first to be FDA approved for type 1 and type 2 diabetes management.

The SmartAdjust technology is connected to an alternate controller-enabled insulin pump and an integrated continuous glucose monitor (iCGM), and automatically adjusts insulin delivery to the user every 5 minutes, eliminating the need for multiple daily injections.

“I’ve seen first-hand how difficult it is for patients to reach their targets with injections,” said Anne L. Peters, MD, director of the University of Southern California Westside Center for Diabetes.² “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.”

Earlier this year, the FDA approved the Dexcom Stelo Glucose Biosensor System as the first over-the-counter CGM, which became commercially available the same day as the Omnipod 5 approval.^3,4 The iCGM is accessible directly to consumers and designed for adults managing diabetes with oral medications or those without diabetes; it is not suitable for individuals with severe hypoglycemia.

Together, the approvals of both an over-the-counter iCGM and an AID system for individuals with type 2 diabetes in the same year mark a significant step in expanding access to glucose monitoring tools without a prescription.

“The FDA has long worked with the diabetes community to ensure access to additional options and flexibilities for diabetes management,” said Michelle Tarver, MD, PhD, acting director of the FDA’s Center for Devices and Radiological Health, noting that this approval makes AID technology accessible to millions of adults with type 2 diabetes after being limited to those with type 1 diabetes.¹ “The FDA is committed to advancing new device innovation that can improve the health and quality of life for people living with chronic diseases that require day-to-day maintenance like diabetes.”

Insulet recently shared data from the SECURE-T2D clinical study showing that the Omnipod 5 system significantly enhances health outcomes and simplifies diabetes management for individuals with type 2 diabetes.⁵ Compared with previous insulin therapy methods, Omnipod 5 use led to a notable reduction in hemoglobin A_1C (HbA_1C): 0.8% overall and 2.1% in those with an initial HbA_1C of 9.0% or higher. The study also reported decreased time in hyperglycemia, reduced daily insulin dosage, a 20% improvement in time in range—increasing by 4.8 hours daily—and a meaningful reduction in diabetes-related distress, all without an increase in hypoglycemia.

References

1. FDA clears first device to enable automated insulin dosing for individuals with type 2 diabetes. News release. FDA. 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. News release. Insulet. 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

3. Klein HE. FDA approves first over-the-counter continuous glucose monitor. The American Journal of Managed Care^®. March 6, 2024. Accessed August 27, 2024. https://www.ajmc.com/view/fda-approves-first-over-the-counter-continuous-glucose-monitor

4. Stelo by Dexcom, the first over-the-counter glucose biosensor in the U.S., is now available. News release. Dexcom. August 26, 2024. Accessed August 27, 2024. https://investors.dexcom.com/news/news-details/2024/Stelo-by-Dexcom-the-First-Over-the-Counter-Glucose-Biosensor-in-the-U.S.-Is-Now-Available/

5. Insulet’s SECURE-T2D pivotal trial results demonstrate Omnipod 5 improves clinical outcomes and quality of life in type 2 diabetes. News release. Insulet. June 21, 2024. Accessed August 27, 2024. https://investors.insulet.com/news/news-details/2024/Insulets-SECURE-T2D-Pivotal-Trial-Results-Demonstrate-Omnipod-5-Improves-Clinical-Outcomes-and-Quality-of-Life-in-Type-2-Diabetes/default.aspx