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FDA Approval of Omnipod 5 Looks More Promising with Impressive Trial Results

Updated: 10/4/21 3:00 pmPublished: 10/4/21
By Andrew Briskin

The recent release of clinical trial results shows that Omnipod 5, an automated insulin delivery (AID) system, can significantly increase Time in Range and reduce stress around managing diabetes.

At the European Association for the Study of Diabetes (EASD) 2021 conference, experts discussed the positive impacts of using Omnipod 5, highlighted by encouraging results from the latest clinical trial data published in Diabetes Care.

Omnipod 5 is a new automated insulin delivery (AID) system that integrates the Omnipod patch pump with the Dexcom G6 continuous glucose monitor. Using the smart algorithm built in to the patch pump, these devices are linked and can be controlled directly from the smartphone app, unlike the previous version,, which required an external Personal Diabetes Manager (PDM) – a small smartphone-like device that gives you control over the insulin pump pod.

This new device can predict changes in glucose levels and then automatically adjust the users’ insulin doses. The app will only be available for Android users initially, but Insulet is working on an iPhone version – though no timelines has been announced for when this version will be available.

Improvements in A1C, Time in Range, and hypoglycemia reduction were all observed over a 12-month period while using Omnipod 5,” said Dr. Trang Ly, one of the researchers on this study and the senior vice president and medical director at Insulet, which makes the Omnipod.


Children (6-14)

Adults (14-70)

Percent achieving A1C less than 7.0% at start of trial



Percent achieving A1C less than 7.0% at one year



Time in Range increase at one year

3.5 hours/day

2.3 hours/day

New data also demonstrates that use of the Omnipod 5 can improve quality of life for people with diabetes.

“We see a significant reduction in diabetes distress [in Omnipod 5 users] in terms of stress over eating, hypoglycemia, general diabetes management, and interacting with a physician,” said Dr. William Polonsky, founder of the Behavioral Diabetes Institute, a nonprofit organization in San Diego, focused on the social, emotional, and psychological barriers in diabetes. “What was particularly impressive was that these people were already starting at a low level of diabetes distress, so the impact that [Omnipod 5] can have on those with higher distress levels can be even more significant.”

Both adults and caregivers of children and teens using Omnipod 5 also reported greater satisfaction. “When asked if they were satisfied with their previous treatment or if they preferred their new treatment on Omnipod 5, people were significantly more satisfied with the new treatment,” said Dr. Polonsky.

The study found that 85% of adult users and 96% of caregivers reported that they would be more likely to recommend Omnipod 5 over their prior treatment method. Additionally, 81% of adults and 96% of caregivers said they would prefer to continue using Omnipod 5 rather than returning to their treatment prior to the study.

“The Omnipod 5 can be a very impactful tool for people with type 1 diabetes,” said Dr. Polonsky. “People with diabetes will gain the most from systems that allow them to think less about their diabetes each day while still showing improvements in glucose control. AID and technology like the Omnipod 5 go a long way in this direction.”

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About the authors

Drew Briskin joined the diaTribe Foundation in 2021 after graduating from the University of Pennsylvania where he majored in Health and Societies with a minor in Chemistry. As an undergraduate,... Read the full bio »