Insulet’s Updated Omnipod 5 Algorithm Approved by FDA

On December 4, 2026, Insulet, maker of the tubeless Omnipod insulin pump, announced they had received Food and Drug Administration (FDA) approval of their improved algorithm in the Omnipod 5 automated insulin delivery (AID) system.

New features include a lower target glucose level option of 100 mg/dL, down from between 110-150 mg/dL, and a smoother automated experience for users. These were the two most requested improvements from users of the past three years. 

“This reflects our relentless commitment to delivering meaningful innovation for those living with diabetes and the healthcare providers who support them. Every improvement we make is designed to strengthen clinical outcomes while making the Pod experience simpler, more personalized, and so seamless it disappears into everyday life,” said Eric Benjamin, Insulet EVP and Chief Operating Officer.

These are the biggest improvements to the system since its launch in early 2022.

What does this mean for people with diabetes?

The new 100 mg/dL target glucose level expands users’ target level options. A user can opt for a blood sugar target anywhere between 100 and 150 mg/dL in 10 mg/dL increments. This flexibility helps people who want tighter control of their blood sugar levels meet their goals. It may also help them gain higher time in range. 

The change will also apply to the system’s insulin delivery, improving how it reacts to blood sugar changes. Studies have shown that lowering the blood sugar target is associated with an increase in time in range, with no increase in low blood sugar levels. 

The upgrade also helps users stay in Automated Mode with fewer interruptions

Improvements reflect real-world feedback from users 

Both of these changes reflect Insulet’s responsiveness to real user feedback. These changes will help blend the system into a person’s real life, working behind the scenes to help control blood sugar levels with less user input. 

“These enhancements to the Omnipod 5 algorithm are a meaningful step forward. As a clinician, it’s exciting to offer patients a system that not only supports strong clinical outcomes but also builds their confidence in managing diabetes daily. More targeted glucose options and fewer interruptions mean a better experience for people with diabetes and their families,” said Dr. Anita Swamy, MD, pediatric endocrinologist and medical director of the Chicago Children’s Diabetes Center.

These updates are expected to launch in the U.S. in the first half of 2026. 

To learn more, the press release is available here. 

The Omnipod 5 system is approved for people aged 2 and older with type 1 diabetes (T1D) and 18 and older with type 2 diabetes (T2D).