Omnipod GO Receives FDA Clearance for People with Type 2 Diabetes

US Food and Drug Administration Logo
Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved clearance of the Omnipod GO, according to a release from Insulet.

Announced on April 25, 2023, clearance of the Omnipod GO, which is indicated for use an insulin delivery device for people with type 2 diabetes aged 18 or older who typically take daily injections, marks a first-of-its-kind indication for a basal-only insulin pod and Insulet plans to commercial the Omnipod GO in the US beginning in 2024.¹

“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 Chief Executive Officer.¹ “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.”

Billed as a standalone, wearable, insulin delivery system capable a fixed rate of continuous rapid-acting insulin for 72 hours, the Omnipod GO has been cleared for use with multiple U-100 insulins, including Novolog, Fiasco, Humalog, Admelog, and Lyumjev. Tubeless and waterproof, the Omnipod GO also offers 8 different programmed daily rates, ranging from 10-40 units per day and has the ability to operate without need for a handheld device to control the pod. In their release, Insulet pointed out the pod has an IP28 rating up to 25 feet for 60 minutes.¹

According to Insulet, the Omnipod GO was developed with the specific intent of serving people with type 2 diabetes earlier in their treatment journey. The company notes, if an Omnipod GO user were to become insulin-intensive, transitioning to another Omnipod product would become easier. The release also points out customers may start Omnipod GO in their physician’s office and will be able to access ongoing supplies through their pharmacy benefit.¹

The clearance of the Omnipod GO from Insulet marks the first major news for a company that dominated headlines in diabetes technology in 2022. In January 2022, the FDA announced the clearance of the Omnipod 5 for use in people with type 1 diabetes aged 6 years and older. Later, in August 2022, the FDA expanded this indication to include individuals aged 2 years and older with type 1 diabetes.²

References:

1. Insulet announces FDA clearance of Omnipod GO™, a first-of-its-kind basal-only insulin pod, further simplifying life for people with type 2 diabetes. Insulet Corporation - Insulet Announces FDA Clearance of Omnipod GO™, a First-of-its-Kind Basal-Only Insulin Pod, Further Simplifying Life for People with Type 2 Diabetes. https://investors.insulet.com/news/news-details/2023/Insulet-Announces-FDA-Clearance-of-Omnipod-GO-a-First-of-its-Kind-Basal-Only-Insulin-Pod-Further-Simplifying-Life-for-People-with-Type-2-Diabetes/default.aspx. Published April 25, 2023. Accessed April 25, 2023.
2. Campbell P. Omnipod 5 receives clearance for use in ages 2 and older with type 1 diabetes. HCP Live. https://www.hcplive.com/view/omnipod-5-receives-clearance-for-use-in-ages-2-and-older-with-type-1-diabetes. Published August 22, 2022. Accessed April 25, 2023.