Daily Newsletter

24 October 2023

Daily Newsletter

24 October 2023

FDA clears iPhone app for Insulet’s Omnipod 5 closed loop system

The app will be first rolled out with Dexcom’s G6 device during a 2024 full market release.

Robert Barrie October 23 2023

The US Food and Drug Administration (FDA) has cleared Insulet’s iPhone app for its Omnipod 5 hybrid closed-loop system for patients living with type 1 diabetes.

Already available on Android, Insulet claims the iPhone app clearance means the Omnipod 5 is the only tubeless automated insulin delivery (AID) system with full control from a compatible smartphone.

In addition to functional controls for the system, users will also be able to create customised food data for snacks and meals they consume frequently. The app will be free to users of the Omnipod 5 System.

Insulet stated the iPhone app will first launch with DexCom’s G6 continuous glucose monitoring system. The Omnipod 5 integrates exclusively with Dexcom’s device. A full market release of the app is slated for 2024.

The Omnipod 5 was approved by the FDA in January 2022 and received CE marking in September of the same year. It was launched in the UK in June 2023.

With nearly 70% of the world’s population being smartphone users, many medical devices that offer home monitoring come with a compatible app. A market model by GlobalData forecasts the regulatory-approved apps market will be worth $15.3bn by 2033. The diabetes app market segment is predicted to make up around $7.7bn of this.

However, there can be issues when relying on smartphones to control the device. In February 2023, Abbott issued a safety notice for its Freestyle Libre apps on Android after users reported issues of signal loss, meaning glucose alarms and glucose readings could be missed. In July this year, Abbott’s LibreLink app stopped working on iPhone devices after an update issue.

Editor’s note: This article was updated to clarify the app will launch first with the Dexcom G6 device during a full market release in 2024.

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