Insulet Secures FDA Clearance for Major Omnipod 5 Algorithm Update

Acton, Massachusetts-based Insulet has received FDA 510(k) clearance for a significant update to its Omnipod 5 Automated Insulin Delivery System, marking the most substantial algorithm upgrade since the system launched in 2022. The enhancements introduce a 100 mg/dL Target Glucose option and improve the stability of Automated Mode, expanding customization and aiming to simplify daily diabetes management.

The new target setting broadens the system’s configurable range to six levels between 100 and 150 mg/dL. This allows clinicians to fine-tune insulin delivery for users seeking tighter glucose control or working toward individualized treatment goals. According to the company, real-world evidence shows that lower glucose targets can increase time in range without a clinically meaningful rise in time below range.

The algorithm has also been refined to keep users in Automated Mode for longer, reducing interruptions even during extended periods of high glucose. Insulet says these changes are intended to deliver stronger clinical consistency while making the system easier to use in day-to-day life. “These new features address the two most requested enhancements and reflect our relentless commitment to delivering meaningful innovation for those living with diabetes,” said Eric Benjamin, Insulet’s Executive Vice President and Chief Operating Officer.

Clinicians expressed similar optimism. “More target glucose options and fewer interruptions mean a better experience for people with diabetes and their families,” said Dr. Anita Swamy, Pediatric Endocrinologist and Medical Director of the Chicago Children’s Diabetes Center.

Insulet expects the updated algorithm to roll out in the United States in the first half of 2026. Omnipod 5 is currently cleared for individuals aged two and older with type 1 diabetes and adults aged 18 and older with type 2 diabetes.