Insulet Corporation, a Massachusetts-based leader in diabetes technology, has received U.S. Food and Drug Administration (FDA) clearance for its Omnipod 5 Automated Insulin Delivery System to be used in managing Type 2 Diabetes (T2D). Previously approved for Type 1 Diabetes (T1D), this marks the Omnipod 5 as the first automated insulin pump authorized by the FDA for both T1D and T2D patients.
Jim Hollingshead, President and CEO of Insulet, hailed the approval as a milestone for patient-centered diabetes care. “This advancement signifies a major leap in providing accessible, effective technology for T2D management,” Hollingshead stated. “With the introduction of tubeless Pod therapy, Omnipod 5 is not only setting new standards in diabetes management but also enhancing the quality of life for individuals with T2D.”
The FDA’s decision was influenced by results from the SECURE-T2D study, presented at the American Diabetes Association’s 84th Scientific Sessions. This clinical trial compared the Omnipod 5 with conventional insulin injection and pump therapies. Findings revealed that the Omnipod 5 significantly lowered HbA1c levels, reduced time spent in hyperglycemia, and decreased total daily insulin doses while maintaining stable blood glucose levels without increasing hypoglycemia risk.
Dr. Anne L. Peters, Director of the University of Southern California Westside Center for Diabetes, emphasized the potential of Omnipod 5 to transform diabetes management. “The Omnipod 5 simplifies insulin delivery for T2D patients and has shown substantial improvements in clinical outcomes and quality of life,” Peters said. “This innovative technology has the potential to revolutionize how insulin-dependent T2D patients manage their condition.”
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