New option for people with type 2 diabetes as FDA clears automated insulin delivery system

On Monday the U.S. Food and Drug Administration (FDA) announced that it has cleared the way for the first medical device that enables automated insulin dosing for people with type 2 diabetes.

Previously, the device was only available for people with Type 1 diabetes.

“The FDA has long worked with the diabetes community to ensure access to additional options and flexibilities for diabetes management,” said Michelle Tarver, M.D., Ph.D., acting director of the FDA’s Center for Devices and Radiological Health. “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.

According to the CDC, more than 11% of Americans or 38.4 million people were diagnosed with diabetes in 2021 and their only therapy options were multiple daily injections through an insulin pen, pump or syringe.

Insulet Corporation’s Omnipod Insulin Management System, Omnipod 5 has been cleared to expand its use into type 2 diabetes treatment.

“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. “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.”

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

The Insulet SmartAdjust technology will be available to adults 18 years or older. Omnipod 5 can be prescribed through the pharmacy and is covered by many insurance plans, including Medicare Part D.

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