FDA clears wearable insulin pod for adults with type 2 diabetes using basal insulin
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Key takeaways:
- The FDA has cleared the Omnipod Go for use by adults with type 2 diabetes who require daily basal insulin.
- The pod is tubeless, waterproof and can provide insulin in seven preprogrammed delivery rates.
The FDA granted clearance for a stand-alone, wearable insulin delivery pod for adults aged 18 years and older with type 2 diabetes who use basal insulin daily, according to a press release.
The Omnipod Go (Insulet) is an insulin delivery system that provides a fixed rate of continuous rapid-acting insulin for 72 hours. The device is a tubeless and waterproof pod that offers a range of seven preprogrammed daily delivery rates of insulin from 10 U to 40 U per day. The pod operates without the need for a handheld device.
The Omnipod Go is designed for use with basal insulin only. The FDA clearance allows the device to be used with insulin aspart (NovoLog and Fiasp, Novo Nordisk), insulin lispro (Humalog, Eli Lilly; Admelog, Sanofi) and insulin lispro-aabc (Lyumjev, Eli Lilly). If users become insulin-intensive and require both basal and bolus insulin while using the Omnipod Go, they can transition to another Omnipod device, according to the release.
“Omnipod Go was designed to serve the more than 3 million people using basal insulin or transitioning to insulin therapy to treat their type 2 diabetes,” Jim Hollingshead, PhD, president and CEO of Insulet, said in a press release. “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.”
Adults with diabetes will be able to start using Omnipod Go in their physician’s office and will be able to access ongoing supplies through their pharmacy benefit. Insulet plans to make the Omnipod Go commercially available in the U.S. in 2024, according to the release.
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