The Omnipod 5 automated insulin delivery system has been highly anticipated since its FDA clearance in January 2022. This tubeless insulin pump system with smartphone control offers advanced features like automated basal delivery, customizable glucose targets, and activity tracking modes.

In August 2022, the Omnipod 5 officially launched in the United States, initially controlled through a separate dedicated device or compatible Android smartphone. Now, Omnipod has announced FDA 510(k) clearance for the Omnipod 5 app on iPhone, with an expected full release in 2024.

Key Details on the Upcoming iOS App

  • The Omnipod 5 iOS app will provide the same functionality as the Android app, allowing users to view data, deliver bolus doses, and control pod functions all through their iPhone.
  • Exclusive to iPhone, the app will feature a “Custom Foods” tool to save carb details for frequently eaten meals and snacks. This can simplify mealtime bolusing.
  • The app will first launch integrated with the Dexcom G6 CGM. Omnipod is also working on compatibility for the next-generation Dexcom G7, though a timeline has not been shared.
  • Per Omnipod, the app has been designed specifically for iPhones with Apple’s user experience in mind. It will include iOS-optimized features like dark mode.
  • The Omnipod 5 app for iPhone is expected to have a full market release later in 2024, according to the company’s announcement.

What This Means for Current and Future Users

This FDA clearance is exciting news for both existing Omnipod 5 users and those considering the system.

For those already on Omnipod 5, the smartphone app will provide more choice and flexibility. Users won’t need to carry around an extra controller device and can access all key functions right from their iPhones.

Importantly, current Omnipod 5 customers won’t need a new prescription to transition to the iPhone app once available. They’ll simply be able to download the free app and pair it with their existing pumps.

As for people considering automated insulin delivery, the upcoming iOS app makes Omnipod 5 an option for iPhone users preferring smartphone control. With tubes and separate receivers eliminated, the system offers uncompromising convenience and automation.

Diabetes advocates also highlight Omnipod 5’s pay-as-you-go pharmacy distribution model as a plus. Without long-term contracts, people can try the latest technology at their convenience.

What to Expect Leading Up to the iOS Launch

While the full rollout isn’t expected right now, here’s a look at what potential developments to keep an eye out for:

More Compatibility Details

Omnipod is currently testing the app with a variety of iPhone models. As launch nears, the company will likely share more specifics on compatible devices and iOS versions.

Users eager to transition to the app will want to check this compatibility list when released. Upgrading your iPhone to maintain app functionality may be recommended.

Potential Beta Testing

Some medical devices conduct beta testing programs prior to full launch, where select users get early access.

Omnipod may decide to beta test the iOS app with a smaller group of users ahead of the wide 2024 release.

If they open registration, signing up could allow interested iPhone users to be amongst the very first with app access.

Gradual Initial Rollout

While a 2024 target has been set, Omnipod may gradually roll out the app across regions.

Following FDA clearance in the United States, launching first domestically before expanding internationally is generally the norm.

So, the app could become available to some US-based users earlier, with additional countries added over time leading into 2024.

The iOS Future for Omnipod

Pending the successful launch of the Omnipod 5 app, iOS integration may expand further down the road.

Omnipod’s parent company Insulet is developing a suite of apps designed specifically for caregivers and healthcare providers.

The Omnipod View and Omnipod Display apps for iOS are intended to allow remote monitoring of users by parents or doctors.

These companion apps would provide high-level glucose data and notifications without giving full pump control. While timelines haven’t been shared yet, they underscore Insulet’s commitment to iOS offerings.

For users, the simplicity and convenience of managing diabetes through a single iPhone will only continue improving over time.

Conclusion

The upcoming release of the Omnipod 5 app on iPhone will be a major milestone for Insulet. With smartphone control and advanced hybrid closed loop features, this unique tubeless pump system continues pushing the industry forward.

Diabetes management is highly personal, so enabling choice in both hardware and software is key. By expanding Omnipod 5 to iOS, more people will be empowered to enjoy the benefits of automated insulin delivery their way.