Insulet’s Omnipod GO Cleared by FDA

Medical device company Insulet Corporation’s Omnipod GO insulin delivery device has been cleared by the FDA for use for people with type 2 diabetes age 18 or older who would typically take daily injections of long-acting insulin.
 
“Omnipod GO was designed to serve the more than three million people using basal insulin or transitioning to insulin therapy to treat their type 2 diabetes,” said Jim Hollingshead, President and CEO. “Our goal is to help people with type 2 diabetes successfully shift to insulin therapy with a product that fundamentally changes how they feel about diabetes management. We’re excited to bring this new solution to market and deliver on our mission to simplify life for people with diabetes.”
 
Omnipod GO is a standalone, wearable, insulin delivery system that provides a fixed rate of continuous rapid-acting insulin for 72 hours. The newest addition to the Omnipod brand features a tubeless and waterproof Pod which is offered in seven different pre-programmed daily rates, ranging from 10 to 40 units per day, and operates without the need for a handheld device to control the Pod. It has been cleared for use with the following U-100 insulins: NovoLog, Fiasp, Humalog, Admelog, and Lyumjev.
 
The product was developed to serve people with type 2 diabetes earlier in their treatment journey by starting them on Pod therapy for their insulin delivery, rather than daily injections. If a patient becomes insulin-intensive, meaning they require both basal and bolus insulin, the transition to another Omnipod product would be seamless.
 
Insulet developed Omnipod GO with convenience in mind for both the primary care physician and the user, including prescribing, getting started, training and using the product.
 
Insulet plans to commercialize Omnipod GO in the United States in 2024.