Insulet Corp.’s groundbreaking Omnipod 5 Automated Insulin Delivery (AID) system has received FDA approval for use by type 2 diabetes patients aged 18 years and above. This approval marks a significant milestone in the treatment of type 2 diabetes, making Omnipod 5 the first and only AID system indicated for both type 1 and type 2 diabetes. The FDA’s decision follows Insulet’s submission of a 510(k) application in June 2024, seeking expanded indication for Omnipod 5 based on the positive clinical outcomes of the SECURE-T2D pivotal trial.
Diabetes, a chronic and life-threatening disease, affects over 30 million individuals in the United States, with type 2 diabetes being the more common variant. Characterized by the body’s inability to properly utilize or produce enough insulin, type 2 diabetes requires careful management to prevent complications. Over 6 million people in the US require insulin for diabetes management, and approximately 2.5 million of them rely on multiple daily injections (MDI) to regulate their blood glucose levels. While advancements in medical therapies have been made, achieving recommended HbA1c (a measure of blood glucose control) targets remains a challenge for many individuals with type 2 diabetes. Only a quarter of those on insulin therapy achieve an HbA1c of 7% or less, and a concerning half have an HbA1c exceeding 8%. This highlights the need for effective and convenient treatment options like Omnipod 5.
The SECURE-T2D trial, the largest study ever conducted on the use of AID in type 2 diabetes, showcased the effectiveness of Omnipod 5 in improving health outcomes. The trial involved a diverse participant pool, representative of the general US population. The results indicated that Omnipod 5 significantly reduced HbA1c levels compared to prior insulin therapy methods, with an overall reduction of 0.8% and a reduction of 2.1% in individuals with prior HbA1c levels of 9% or higher. The study also observed a reduction in time spent in hyperglycemia, a decrease in total daily insulin dose, and a 20% improvement in time spent in the target blood glucose range (increasing by 4.8 hours per day), all without increasing the risk of hypoglycemia. Additionally, the study demonstrated a clinically meaningful improvement in diabetes distress, highlighting the positive impact of Omnipod 5 on patients’ overall well-being.
Omnipod 5’s tubeless pod therapy provides a patient-centric approach to diabetes management, offering convenience and greater freedom for individuals with type 2 diabetes. The system’s advanced SmartAdjust technology automatically adjusts insulin delivery every 5 minutes, eliminating the need for multiple daily injections and simplifying the management process. Omnipod 5 is also waterproof, discreet, and wearable, making it a practical and comfortable option for daily use. As the top-rated and most prescribed pump in the United States, Omnipod 5 is a convenient and accessible option for patients, available through pharmacies and covered by various insurance plans, including Medicare Part D.
Insulet’s commitment to addressing the needs of the type 2 diabetes community is further underscored by its recent investment in a new state-of-the-art manufacturing facility in Malaysia. This strategic move will enable Insulet to meet the growing demand for Omnipod 5 and strengthen its global operational capabilities. The company’s efforts to expand its manufacturing capacity and enhance its supply chain resilience position it for continued success in the growing type 2 diabetes market.
The global market for type 2 diabetes is expected to reach $32 billion in 2022, with a projected compound annual growth rate (CAGR) of 8.2% through 2032. This growth is driven by the rising prevalence of type 2 diabetes, particularly fueled by the global obesity epidemic. Insulet’s Omnipod 5, with its proven effectiveness and user-friendly design, is well-positioned to capitalize on this growing market and provide individuals with type 2 diabetes with a powerful tool for managing their condition.
