The US Food and Drug Administration (FDA) has cleared medical device company Insulet’s Omnipod GO basal-only insulin pod for people with Type 2 diabetes aged 18 and above.
The Omnipod GO pod is indicated for use by individuals who rely on daily injections of long-acting insulin.
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A standalone and wearable insulin delivery system, the pod delivers a fixed rate of non-stop rapid-acting insulin over the course of three days.
The company introduced a tubeless and waterproof pod as the latest feature of the Omnipod brand.
The pod is available in seven different pre-programmed daily rates, ranging between ten and 40 units a day. It can be operated without a handheld device.
The Omnipod is approved to be filled with a range of U-100 insulins including Fiasp, Humalog, NovoLog, Lyumjev and Admelog.
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By GlobalDataInsulet president and CEO Jim Hollingshead said: “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.
“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.”
The product was developed for use by people with Type 2 diabetes in the early part of the treatment. It is designed to encourage patients to switch to pod therapy for their insulin delivery instead of taking daily injections.
It also supports a seamless transition to another Omnipod product in case of patients requiring both basal and bolus insulin. Omnipod GO is designed to provide convenience for primary care physicians and patients.
The FDA clearance will boost Insulet’s plans to commercialise the product in the US next year.
