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     129  0 Kommentare Insulet’s SECURE-T2D Pivotal Trial Results Demonstrate Omnipod 5 Improves Clinical Outcomes and Quality of Life in Type 2 Diabetes

    Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod brand of products, today shared positive results from its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) type 2 diabetes pivotal trial at the American Diabetes Association (ADA) 84th Scientific Sessions in Orlando, Florida. This landmark study evaluated the impact of AID in a diverse group of people with type 2 diabetes who require insulin.

    The SECURE-T2D pivotal trial results showed glycemic improvements with the use of Omnipod 5 compared with prior treatment of insulin injections or pump therapy in adults with type 2 diabetes. The study results showed significant reductions in HbA1c, time in hyperglycemia, and total daily insulin dose, and a large improvement in time in range (TIR), without increasing time in hypoglycemia. The study also demonstrated a clinically meaningful improvement in diabetes distress.

    “These data demonstrate that simple, easy-to-use AID technology, such as Omnipod 5, can be adopted by a broad population of people with type 2 diabetes and improve their lives,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director. “A major strength of this study is the diversity of the enrolled population in terms of varying education level, income, ethnicity, and race. These results could have a particularly striking impact among Black and Hispanic people, who experience a higher prevalence of type 2 diabetes and increased mortality rates.”

    Even though over 30 million people live with type 2 diabetes in the United States,1 there are no AID systems currently FDA-cleared for this population. Insulet recently submitted these study results to the FDA for an expansion of Omnipod 5’s indications for use for people with type 2 diabetes and, subject to FDA clearance, expects to commercially launch in the U.S. in early 2025. Omnipod 5 is currently FDA-cleared in the U.S. and C.E. marked for use in those with type 1 diabetes aged two years and older.

    “Our findings demonstrate substantial improvements in blood glucose outcomes and overall quality of life, highlighting the potential for this innovative technology to transform type 2 diabetes management with automated insulin delivery,” said Dr. Francisco Pasquel, MD, MPH of Emory University and chair of the study. “As the largest study of AID therapy in people with type 2 diabetes, we look forward to these results supporting the FDA clearance of Omnipod 5 as a safe and effective therapy for this patient population.”

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    Insulet’s SECURE-T2D Pivotal Trial Results Demonstrate Omnipod 5 Improves Clinical Outcomes and Quality of Life in Type 2 Diabetes Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod brand of products, today shared positive results from its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) …