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Insulet Announces FDA 510(k) Clearance of Omnipod® 5 Algorithm Enhancements that Redefine Insulin Delivery and Simplify the Pod Experience
New 100 mg/dL Target Glucose setting offers more customization and tighter glucose management. Enhanced algorithm helps users remain in Automated Mode to
About this update from Insulet Corporation
[{"type":"text","content":"\n\nNew 100 mg/dL Target Glucose setting offers more customization and tighter glucose management.\n\n\nEnhanced algorithm helps users remain in Automated Mode to improve the user experience.\n\n\nMost requested new features enable healthcare providers to more effectively modify diabetes therapy to meet needs of people with diabetes.\n\n\n ACTON, Mass.--(BUSINESS WIRE)--\nInsulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced it has received FDA 510(k) clearance for significant enhancements to the Omnipod 5 Automated Insulin Delivery System. These updates to the Omnipod 5 algorithm set a new benchmark in tubeless diabetes technology by offering a lower 100 mg/dL Target Glucose option and a more seamless automated experience.\n\n“This is the most significant algorithm advancement to our Omnipod 5 System since its launch in 2022,” said Eric Benjamin, Insulet Executive Vice President 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.”\n\nMore Flexibility with a Lower Target Glucose Setting\n\nThe new 100 mg/dL Target Glucose expands Omnipod 5’s customization range to six settings between 100-150 mg/dL in 10 mg/dL increments. This flexibility allows healthcare providers to tailor insulin delivery more precisely, supporting individuals seeking tighter glucose management or those striving to meet specific glucose goals. It also directly impacts automated insulin delivery and improves the algorithm’s responsiveness. Real world evidence has shown that lowering the glucose target is associated with increased time in range, with no clinically meaningful change in Time Below Range1 (TBR).\n\nDesigned with Patients and HCPs in Mind\n\nIn addition, the upgraded Omnipod 5 algorithm helps users stay in Automated Mode with fewer interruptions, even during prolonged high glucose events. These advancements are designed to deliver strong clinical results with increased ...