The Omnipod 5 Automated Insulin Delivery System, developed by Insulet Corporation, has been a game-changer for individuals with type 1 diabetes since its FDA approval in January 2022. This tubeless insulin pump system integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) system to automatically adjust insulin delivery and protect against glycemic events.

While the system has been available with a dedicated controller and Android smartphone app, many users have eagerly awaited the release of an iOS app for iPhone compatibility.

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FDA Clearance for Omnipod 5 App for iPhone

On October 23, 2023, Insulet Corporation announced that it had received FDA 510(k) clearance for the Omnipod 5 App for iPhone. This milestone makes Insulet the first and only company to offer a tubeless automated insulin delivery system with full control from a compatible iPhone or Android smartphone.

Eric Benjamin, Executive Vice President and Chief Product & Customer Experience Officer at Insulet, celebrated this achievement, stating, “Today, we celebrate this significant milestone in our ongoing effort to provide people with diabetes solutions that improve their lives and help them think less about diabetes. We are thrilled to add the iOS platform to our mobile app offerings and elevate Omnipod 5’s market-leading position in phone-controlled AID systems.”

Features and Benefits of the Omnipod 5 App for iPhone

The Omnipod 5 App for iPhone will offer the same functionality as the Omnipod 5 App for Android, along with additional capabilities and an intuitive design. Users will have access to a new custom foods feature, allowing them to save carbohydrate data for favorite foods, snacks, or meals that are consumed frequently. This feature will simplify mealtime math and bolusing by enabling users to add their favorite meals directly to the SmartBolus calculator.

The app will provide users with the freedom and flexibility of controlling their Omnipod 5 System from a single device, eliminating the need to carry a separate controller. With the app, users can bolus, change a Pod, adjust settings, and more, all from their compatible iPhone.

Launch Timeline and Compatibility

The Omnipod 5 App for iPhone will launch first with the Dexcom G6 CGM integration, with a full market release anticipated in Q4 2024. Users of the Omnipod 5 System will be able to download the iPhone app free of charge once it becomes available.

Insulet has stated that the transition to the iPhone app will be simple for those with compatible devices. The company will inform the diabetes community of the release timing closer to the launch date. To stay informed about Insulet’s progress with future innovations, interested individuals can visit the Omnipod website.

Real-World Insights and Global Expansion

As of August 2023, Insulet had over 100,000 active Omnipod 5 users in the United States. Real-world data from a dataset of 55,150 individuals with type 1 diabetes using the Omnipod 5 system showed impressive results, with users achieving good Time in Range (TIR) and remarkably low incidence of hypoglycemia. The median Omnipod 5 user had a 94% “time in automode,” underscoring the system’s usability and practicality.

Omnipod 5 has also expanded globally, with a successful launch in the UK and Germany in 2023. Insulet aims to make Omnipod 5 accessible to “most” of its European customers in the near future.

Integration with FreeStyle Libre 2 and Future Advancements

In addition to the iPhone app release, Insulet has successfully incorporated the FreeStyle Libre 2 sensor into the Omnipod 5 app, enabling seamless communication between the Omnipod 5 Pod and the FreeStyle Libre 2 sensor. A randomized controlled study featuring this new integration is set to begin shortly in the UK, France, and Belgium.

Insulet remains committed to innovation for both type 1 and type 2 diabetes patients. The company is working on a groundbreaking next-generation Omnipod 5 algorithm, which promises to further enhance the system’s performance and user experience.

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The FDA clearance of the Omnipod 5 App for iPhone marks a significant milestone for Insulet Corporation and the diabetes community. With the upcoming release of the iOS app in 2024, Omnipod 5 users will have even more flexibility and convenience in managing their diabetes through automated insulin delivery. As Insulet continues to innovate and expand globally, the future looks promising for individuals seeking advanced diabetes management solutions.