FDA Clears Omnipod 5 AID System for Type 2 Diabetes

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has announced the expansion of indications for Insulet Corporation’s SmartAdjust technology, clearing the way for use of the Omnipod 5 Automated Insulin Delivery (AID) System in adults with type 2 diabetes.¹

Announced on August 26, 2024, the clearance makes the Omnipod 5 the first AID system to be FDA-cleared for both type 1 and type 2 diabetes management.^1,2

“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.”

In their release announcing the FDA clearance, Insulet Corporation called attention to the SECURE-T2D, which was presented at the 84th American Diabetes Association Scientific Sessions and offers evidence of the system’s efficacy in patients with type 2 diabetes.^2,3

For more on the SECURE-T2D study, check out this ADA 2024 Diabetes Technology Recap from Diabetes Dialogue, our flagship endocrinology podcast!

SECURE-T2D enrolled 305 individuals from 21 sites across the US. For inclusion, patients were required to be 18 to 75 years of age, have type 2 diabetes, have been on their current insulin regimen for 3 or more months, and have no previous AID use.³

In the trial, participants underwent a 14-day period of standard therapy to collect baseline data, which was followed by a 13-week period where all patients received the Omnipod 5 AID system with the Dexcom G6 continuous glucose monitoring system.³

At the end of the 13 weeks, the mean HbA1c among the cohort decreased from 8.2% (SD, 1.3) at baseline to 7.4% (SD, 0.9) (treatment effect= -0.8%; 95% CI, -1.0 to -0.7; P <.001). When assessing secondary glycemic metrics, results indicated use was associated with a 20% increase in time in range of 70 to 180 mg/dL (4.8 hours per day) and a 20% decrease in time above 180 mg/dL (4.8 hours per day) (P <.001). Investigators pointed out these improvements in time in range were primarily driven by a significant reduction in hyperglycemia with no increase in hypoglycemia.³

“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.¹ “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. 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.”

References:

1. Office of the Commissioner. FDA clears first device to enable automated insulin dosing for individuals with type 2 diabetes. U.S. Food and Drug Administration. August 26, 2024. Accessed August 26, 2024. https://www.fda.gov/news-events/press-announcements/fda-clears-first-device-enable-automated-insulin-dosing-individuals-type-2-diabetes.
2. Insulet Corporation. Omnipod® 5 Automated Insulin Delivery System is now FDA-cleared for People with Type 2 Diabetes. Insulet Corporation. August 26, 2024. Accessed August 26, 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. Isaacs D, Bellini N. Diabetes Dialogue: ADA 2024 diabetes technology recap. HCP Live. July 3, 2024. Accessed August 26, 2024. https://www.hcplive.com/view/diabetes-dialogue-ada-2024-diabetes-technology-recap.