Insulet Corporation has received FDA clearance for its latest product, the Omnipod GO™ insulin delivery device.
The device is designed for people with type 2 diabetes who typically use daily injections of long-acting insulin and are 18 years or older.
The Omnipod GO is a wearable device that works independently and provides a constant rate of rapid-acting insulin for up to 72 hours. It has a tubeless and waterproof* Pod and offers seven pre-set daily rates, ranging from 10 to 40 units per day, and doesn't require a mobile device to function.
The device has been approved for use with U-100 insulins, including NovoLog®, Fiasp®, Humalog®, Admelog®, and Lyumjev®.
The aim of developing this product is to introduce people with type 2 diabetes to Pod therapy for insulin delivery earlier in their treatment, instead of relying solely on daily injections.
If a patient later requires both basal and bolus insulin, transitioning to another Omnipod product will be seamless.
Insulet prioritized convenience for users and physicians in developing the Omnipod GO, streamlining the prescription process, product use, and ongoing supply management. Patients can start using the device during a physician's visit and refill their supplies through their pharmacy benefit.
The Pod is rated IP28, indicating its ability to withstand submersion in water up to 3 feet deep for 30 minutes.
The company plans to launch Omnipod GO in the US market in 2024.
