ACTON, Mass. — Insulet Corporation (NASDAQ: PODD), the global leader in tubeless insulin pump technology, announced it has received FDA 510(k) clearance for a series of significant enhancements to the Omnipod 5 Automated Insulin Delivery System. The updates introduce a new 100 mg/dL Target Glucose option and a more seamless automated experience, marking one of the most substantial advancements to the system since its 2022 launch.
Eric Benjamin, Insulet Executive Vice President and Chief Operating Officer, said, “This is the most significant algorithm advancement to our Omnipod 5 System since its launch in 2022. 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.”
The new 100 mg/dL Target Glucose setting expands the customization range to six options between 100 and 150 mg/dL in 10 mg/dL increments. This increased flexibility allows healthcare providers to tailor therapy more precisely for individuals seeking tighter glucose management or working toward specific goals. The enhanced target range also improves automated insulin delivery responsiveness. Real-world evidence indicates that lowering the glucose target increases time in range without causing a clinically meaningful change in Time Below Range.
The upgraded Omnipod 5 algorithm is also designed to help users remain in Automated Mode with fewer interruptions, even during extended periods of high glucose. The improvements are intended to support strong clinical results while reducing disruptions to daily life and easing the burden of diabetes management for both users and healthcare professionals.
“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,” said Dr. Anita Swamy, M.D., Pediatric Endocrinologist and Medical Director of the Chicago Children’s Diabetes Center.
The enhanced Omnipod 5 algorithm is expected to roll out in the United States in the first half of 2026. Omnipod 5 is currently cleared for people aged 2 and older with type 1 diabetes and adults aged 18 and older with type 2 diabetes.
