FDA clears Insulet's Omnipod 5 closed-loop, tubeless insulin pump for adults and children

Insulet has secured an FDA clearance for its latest tubeless insulin pump, the Omnipod 5, a patch-like device capable of adjusting daily doses to changes in the wearer’s blood sugar levels.

Designed for adults and children over the age of six with Type 1 diabetes, the long-awaited Omnipod 5—formerly known as the Omnipod Horizon—is controlled by a smartphone and pairs with Dexcom’s G6 continuous glucose monitor to provide automated background insulin delivery.

Insulet said it will begin selling the prescription Omnipod 5 device through U.S. pharmacies, starting with an initially limited release before expanding its commercial reach, according to a statement. The company is also offering users of its current Omnipod DASH system—a more manual tubeless pump—an upgrade to the Omnipod 5 at no additional cost once insurance coverage becomes available.

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Using the Dexcom G6, the hybrid closed-loop system takes a blood sugar reading every five minutes, and then works to predict trends up to one hour in the future. By increasing, decreasing or pausing insulin, the device aims to keep glucose levels from going too high or dropping too low. The smartphone app, meanwhile, includes a program for calculating bolus doses during meals.

Insulet President and CEO Shacey Petrovic described the waterproof pump, worn on the skin of the upper arm, as an “elegant system” that allows people with diabetes to avoid manual daily injections, managing insulin tubes and taking repeated fingersticks. The device carries enough insulin for up to 72 hours of continuous dosing.

The Omnipod 5 and Dexcom G6 CGM (Business Wire)

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In addition, the company has outlined plans to apply for an expanded indication at the FDA soon to enable the Omnipod 5’s use in preschool children with Type 1 diabetes as young as two years old before the end of this year.

Insulet has also said it would pursue discussions with the FDA in 2022 about the requirements for pivotal clinical trials to examine Omnipod 5’s use among people with Type 2 diabetes. The company expects to present early data from a feasibility study in that patient population at a future medical conference.

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The agency's green light for the Omnipod 5 was initially expected in early 2021 but was then pushed to that December and then early 2022 following hold-ups as the FDA requested additional data on the device and separate delays due to the regulatory workload brought on by the COVID-19 pandemic.