MetaMedical™ Solutions Inc

Insulet gains CE mark for Omnipod 5’s combo with Abbott FreeStyle Libre sensor

Patients in Europe who use the FreeStyle Libre 2 Plus sensor can now team it with Insulet’s Omnipod 5 after the latter device received CE mark approval for compatibility with Abbott’s continuous glucose monitor (CGM). 

Insulet’s tubeless insulin pump originally received CE mark approval in September 2022 and, up to this point, was used exclusively with DexCom’s G6 CGM. With the expanded integration clearance, Insulet’s Omnipod 5 is now CE-marked for multiple CGM sensor brands.

Insulet said that the latest integration will be available in the UK and Netherlands in the first half of 2024, with additional markets to follow.

The Omnipod 5 can be used by adults and children aged two years and older with type 1 diabetes (T1D). It was originally approved by the US Food and Drug Administration (FDA) in January 2022 and underwent expanded clearances later.

The technology uses CGM data to predict glucose levels an hour ahead of time and corrects every five minutes based on individual glucose targets. The system was rolled out in the UK in June 2023.

Insulet’s international general manager Patrick Crannell said: “The addition of the Abbott FreeStyle Libre 2 Plus sensor to our CGM compatibility expands accessibility of Omnipod 5, which has been a priority for Insulet since the system launched in 2022.”

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By GlobalData

A report by GlobalData estimates that the global insulin pump device market will be worth $14.1bn by 2033. The CGM sensor market is forecast to grow to $5bn by the same year.

Currently, Medtronic and Abbott occupy the greatest market share of insulin pumps and CGMs, with a 20.5% and 19% share respectively. DexCom has a 9.2% share, according to GlobalData.

The Omnipod 5 received another companion recently. In October 2023, Insulet received FDA clearance for an iPhone app for the device. Already available on Android, the free app allows full control of the pump system via a compatible smartphone.

Insulet stated the iPhone app will first launch with DexCom’s G6 continuous glucose monitoring system. A full market release of the app is slated for 2024.

Hybrid closed-loop systems reached a milestone in the UK late last year when the National Institute of Health Care and Excellence (Nice) recommended that people living with T1D should be offered the technology, opening accessibility to hundreds of thousands of patients.

The NHS in England and Wales will offer the devices to eligible patients in a phased programme over five years.

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