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FDA Approves Omnipod 5 iPhone App, Expected in 2024

Omnipod 5 users will soon be able to control their AID system through a free iPhone app available in the new year. Like the Android app, iPhone users will be able to bolus insulin, change pods, and more from their smartphone. 

Since Insulet launched the Omnipod 5 in August 2022, Android users have been able to control the automated insulin delivery (AID) system from their smartphones. 

Meanwhile, iPhone owners have long needed to carry around a separate device – a smartphone-like item called a PDM (personal diabetes manager) – to control their AID system. 

In October 2023, the FDA approved the Omnipod 5 iPhone app, which will simplify and improve diabetes management for iPhone users. The highly anticipated iPhone app is expected to be available in 2024. 

Read on to explore key features of the Omnipod 5, including how to access and configure the AID system to better manage your diabetes. 

What is the Omnipod 5?

The Omnipod 5 AID system includes three components:

  • A tubeless, wearable insulin pump that is worn for up to three days and holds 200 units of insulin. The pump comes embedded with the AID algorithm.

  • A Dexcom G6 continuous glucose monitor (CGM) (the Omnipod 5 system is only compatible with this CGM currently, not the Dexcom G7).

  • The Omnipod 5 mobile app, which is free for compatible Androids and iPhones. It can also be pre-downloaded on a controller provided by Insulet. The app allows users full control over basal and bolus insulin rates directly from the app.

Insulet is continuing to develop Omnipod 5 integration with the Dexcom G7 and compatibility with Abbott Freestyle Libre CGMs

iPhone app to launch with new custom foods feature

The Omnipod 5 iPhone appLike the Android app, the Omnipod 5 iPhone app allows users to bolus insulin, change pods, configure settings, and more. A new custom foods feature will allow users to save carbohydrate counts for favorite foods, snacks, or meals, greatly simplifying mealtime dosing. 

Insulet has not shared specific details on when the app will be available but expects full market release sometime in 2024. 

How to set up Omnipod 5

Learning to use the technological features of a new system can be a challenge, especially for those transitioning to AID from another form of insulin delivery.

To set up your Omnipod 5 system, Insulet provides a series of short training modules for the initial setup, pod activation, connecting your CGM, programming alarms, and more.

How much does Omnipod 5 cost?

The AID system is available through retail and mail-order pharmacies for anyone with insurance coverage and a prescription from their healthcare provider. Co-pay costs vary based on the type of insurance

To check your insurance coverage, talk to your healthcare provider and ask them to send prescriptions for the Omnipod 5 G6 intro kit and the Omnipod 5 G6 pods to ASPN Pharmacies. ASPN will check your coverage, identify your co-pay, and direct your prescription to the pharmacy of your choice. The mobile app can be downloaded at no additional cost from the Google Play Store, or is available pre-programmed on the controller provided by Insulet.

The new system can also be purchased out of pocket through retail pharmacies, or through Costco for members. For existing users of the Omnipod DASH system, Insulet’s OmnipodPromise program allows users to upgrade to the new system for free.

How effective is Omnipod 5? 

Clinical trial results published in 2021 demonstrated that for people ages 14-70, using the Omnipod 5 system helped increase Time in Range by an average of 2.3 hours per day.

For children ages 6-13, the improvement was even more significant with an increased time in range of 3.5 hours per day. The data also suggested that the Omnipod 5 system can improve the overall quality of life for people with type 1 diabetes. 

In 2022, the FDA cleared the Omnipod system for younger children ages 2-5. In a recent study of the Omnipod 5 system in this age group, the system helped increase time in range by an average of 2.6 hours per day. Also, throughout the entire 13-week trial, there was not a single instance of severe hypoglycemia or diabetic ketoacidosis (DKA) in children using the Omnipod 5 system.

Read more about the benefits of automated insulin delivery here: