FDA clears automatic insulin pump for type 2 diabetes

On Aug. 26, 2024, the FDA cleared the Insulet SmartAdjust for the management of type 2 diabetes, expanding on its existing indications.

The interoperable automated glycemic controller is sold under the brand name Omnipod 5. The device was initially cleared in January 2022 for individuals ages six and older with type 2 diabetes. Later, the FDA expanded its clearance for patients with type 1 diabetes ages two and older. However, the updated clearance adds individuals 18 and older with type 2 diabetes to the list of eligible patients.

"Today's announcement represents a significant milestone in providing easy-to-use, patient-centric technology for the treatment of type 2 diabetes," said Jim Hollingshead, Insulet president and chief executive officer, in the Insulet press release. "Insulet is paving the way for these individuals to achieve better health outcomes while living with greater confidence and freedom through the game-changing benefits of tubeless Pod therapy. Omnipod 5 is setting a new standard in diabetes management, and we are thrilled with the opportunity to make a lasting impact on the insulin-requiring type 2 diabetes community."

According to the FDA, the Insulet SmartAdjust device is an automated glycemic controller that deploys software to automatically adjust insulin delivery to a user through an alternate controller-enabled (ACE) insulin pump that responds to data from an integrated continuous glucose monitor.

Although type 2 diabetes is a major health concern across the U.S., the only insulin therapy options available to this group of patients were injections with a syringe, an insulin pen, or an insulin pump, which require patients to manually administer the medications.

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

Clearance for this device was based on the FDA's review of a 289-person clinical study that enrolled patients 18 and older with type 2 diabetes to use the Insulet SmartAdjust device for 13 weeks. The FDA press release notes that participants achieved better blood sugar control using the device without serious complications or adverse events. However, some mild to moderate adverse events were reported, including hyperglycemia, hypoglycemia, and skin irritation.

Veronica Salib has covered news related to the pharmaceutical and life sciences industry since 2022.