FDA Clears Omnipod GO Insulin Delivery Device for Persons with Type 2 Diabetes

The US Food and Drug Administration (FDA) today cleared the Omnipod GO insulin delivery device for use by people with type 2 diabetes (T2D) aged ≥18 years who require daily injections of long-acting insulin to control hyperglycemia, according to manufacturer Insulet.

Omnipod GO is a wearable tubeless insulin delivery system automated to deliver a fixed rate of continuous long-acting insulin for 72 hours, eliminating the need for daily injections for 3 days, Insulet states. The device, described by Insulet as a “first of its kind basal-only insulin Pod,” is waterproof* and fully disposable.

“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, Insulet president and chief executive officer, in the press statement. “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.” Current plans, noted in the statement, are to commercialize the device in the US in 2024.

Omnipod GO is available with 7 different preprogrammed daily insulin delivery rates, ranging from 10 to 40 units per day. The device has been FDA-cleared for use with 5 U-100 insulin brands: NovoLog, Fiasp, Humalog, Admelog, and Lyumjev, Insulet says.

The manufacturer explains that the product was developed with the new T2D insulin user in mind, noting that initiation to daily insulin using the Pod vs daily injections could be a less uncomfortable experience. If the patient should one day require a basal-bolus insulin regimen, according to the press statement, “the transition to another Omnipod product would be seamless.”

Patients can begin treatment with Ominpod Go in a physician’s office and will be able to receive needed supplies through a pharmacy benefit. 

Today’s FDA clearance of Ominpod GO was preceded by clearance in January 2022 of the Omnipod 5 for use in people with type 1 diabetes aged ≥6 years and in August 2022 by an expanded indication for persons aged ≥2 years with type 1 diabetes.

*In 25 feet of water for up to 60 minutes.