Insulet’s Omnipod 6 and Fully Closed-Loop Systems Show Strong Clinical Results
Event summary
- Insulet presented new clinical data for Omnipod 6 and a fully closed-loop AID system for type 2 diabetes at the ADA 86th Scientific Sessions.
- STRIVE trial showed Omnipod 6 improved time in tight range by 7% for type 1 diabetes and 5% for type 2 diabetes compared to Omnipod 5.
- EVOLUTION 3 study demonstrated 64% time in range for type 2 diabetes with the fully closed-loop system, reducing daily insulin by 28 units.
- Omnipod 6 maintained safety with no instances of DKA or severe hypoglycemia.
- Insulet plans to file for FDA approval of the fully closed-loop system in 2027, with a commercial launch expected in 2028.
The big picture
Insulet’s latest clinical data underscores its leadership in tubeless insulin pump technology, with Omnipod 6 and the fully closed-loop system addressing key barriers in diabetes management. The results align with broader industry trends toward personalized and simplified diabetes care, potentially expanding access to advanced AID systems. The company’s strategic focus on reducing user effort and improving outcomes positions it well in a competitive market.
What we're watching
- Regulatory Approval
- Whether the FDA will approve the fully closed-loop system for type 2 diabetes by 2028 as planned.
- Market Adoption
- The pace at which Omnipod 6 and the fully closed-loop system will be adopted by clinics and patients.
- Competitive Positioning
- How Insulet’s advancements will position it against competitors in the automated insulin delivery market.
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