Insulet has received U.S. Food and Drug Administration (FDA) 510(k) clearance for enhancements to its Omnipod 5 automated insulin delivery (AID) system.

The updates are to the Omnipod 5 algorithm. They set a new benchmark in tubeless diabetes technology by providing a lower 100 mg/dL Target Glucose option and a more seamless automated experience, the company said.

The new Target Glucose expands Omnipod 5’s customization range to six settings between 100-150 mg/dL in 10 mg/dL increments. The flexibility lets healthcare providers tailor insulin delivery more precisely to support people seeking tighter glucose management, or those aiming to meet specific glucose goals.

Insulet said it also impacts automated insulin delivery and improves the algorithm’s responsiveness. Real-world evidence has demonstrated that lowering the glucose target is related to increased time in range, with no clinically meaningful change in Time Below Range (TBR).

The upgraded algorithm also helps users remain in Automated Mode with fewer interruptions, even during prolonged high glucose events. The advancements were engineered to provide strong clinical results with more flexibility and greater ease of use, with less interruptions to daily life.

The Omnipod 5 algorithm updates are expected to launch in the U.S. in the first half of 2026, where Omnipod 5 is cleared for people aged 2 and older with type 1 and aged 18 and older with type 2 diabetes.

“This is the most significant algorithm advancement to our Omnipod 5 System since its launch in 2022,” said Eric Benjamin, Insulet executive VP and chief operating officer. “These new features address the two most requested enhancements and reflect 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.”

“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 target glucose options and fewer interruptions mean a better experience for people with diabetes and their families,” added Dr. Anita Swamy, MD, pediatric endocrinologist and medical director of the Chicago Children’s Diabetes Center.