FDA Gives 510(k) Clearance to App That Controls Insulin Delivery System for Type 1 Diabetes


The Omnipod 5 app from Insulet lets users sync their data in one interface and is expected to be released sometime in 2024.

An iPhone app that offers full control over the Omnipod 5 tubeless automated insulin delivery system for type 1 diabetes has received 510(k) clearance from the FDA, according to a release from medical device company Insulet.1

The clearance makes Insulet the first and only company that offers a tubeless automated insulin delivery system with a compatible app for both iPhone and Android smartphones. The app lets users sync their data in one interface, which they can then share with a healthcare provider. The iPhone app also includes a new foods feature, where users can save carbohydrate data on their favorite foods, snacks, or meals that they frequently consume.

The Omnipod 5 iPhone app will launch first with the Dexcom G6 continuous glucose monitoring system integration. A full release is expected sometime in 2024. Users of the Omnipod 5 system can download the app for free once it’s available. Insulet said it will announce availability closer to the actual release date.

“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,” Eric Benjamin, executive vice president and chief product & customer experience officer at Insulet, said in a release.1 “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.”

Omnipod 5 was first released through US retail pharmacies in August 2022, followed by releases in the United Kingdom and Germany. The tubeless automated insulin delivery system integrates with the Dexcom G6 continuous glucose monitor and helps individuals 6 years and older with type 1 diabetes protect against high and low glucose levels.2

Omnipod 5’s safety and efficacy was assessed in a 2021 study published in Diabetes Care.3 The single-arm, multicenter, prospective study included 112 children ages 6 to 14, and 129 adults ages 14 to 70. Participants received a 2-week standard therapy phase, followed by 3 months of automated insulin delivery. The study found that Omnipod 5 was safe and allowed participants to significantly improve HbA1c levels and time in target glucose range.

“Omnipod 5 has been such a life-changing technology,” Anita Swamy, assistant professor of Pediatrics at Northwestern Feinberg School of Medicine, said in a release.2 “My patients and I have seen significant improvement of their time in range with no overnight lows and much less work required. It has given parents and other caregivers more peace of mind, especially overnight, and that’s priceless.”

1. Insulet Announces FDA 510(k) Clearance of the Omnipod® 5 App for iPhone. News Release. Insulet. October 23, 2023. Accessed October 24, 2023. https://investors.insulet.com/news/news-details/2023/Insulet-Announces-FDA-510k-Clearance-of-the-Omnipod-5-App-for-iPhone/default.aspx
2. Insulet Announces Full Market Release of Omnipod® 5 Automated Insulin Delivery System. News Release. Insulet. August 1, 2022. Accessed October 24, 2023. https://investors.insulet.com/news/news-details/2022/Insulet-Announces-Full-Market-Release-of-Omnipod-5-Automated-Insulin-Delivery-System/default.aspx
3. Brown SA, Forlenza GP, Bode BW, et al. Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes. Diabetes Care. 1 July 2021; 44 (7): 1630–1640. https://doi.org/10.2337/dc21-0172
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