Insulet Insult Corporation (PODD), a medical devices company, on Saturday released results for the STRIVE trial for Omnipod 6, an automated insulin delivery system, and the EVOLUTION 3 feasibility study for the fully-closed loop system in treating type-2 diabetes. The data was presented at the 2026 scientific sessions of the American Diabetes Association (ADA).
The company manufactures the Omnipod tubeless insulin pumps as an alternative to traditional insulin delivery methods. The Omnipod 6 is a new advancement in these automated insulin delivery (AID) systems and is being assessed alongside a fully closed-loop (FCL) for treating type 2 diabetes.
The STRIVE pivotal trial evaluated Omnipod 6 across 132 participants, including 98 type 1 diabetes patients, and 34 type 2 diabetes patients. Patients were randomized to use Omnipod 6 or Omnipod 5 for 4 weeks, followed by crossing over to the alternate system for the next 4 weeks.
Data suggested that type 1 diabetes patients showed a 77% improved time in the range of 70-180 mg/dL on Omnipod 6, compared to 73% for the same range on Omnipod 5. Type 2 diabetes patients showed a similar 76% improved time on Omnipod 6, while those on Omnipod 5 recorded a 73% improvement in time.
Additionally, patients switching to a bolus optional phase after treatment yielded significant results, with type 1 diabetes patients showing a 76% time in range with 2.2 fewer boluses per day. Type 2 diabetes patients showed a 74% time in range with 2.5 boluses per day. These results indicate that Omnipod 6 may be helpful in diabetes patients who do not always bolus.
The EVOLUTION 3 pre-pivotal study evaluated the fully closed-loop (FCL) system in 36 adults with type 2 diabetes using insulin. Results indicated that the FCL delivered 64% time in range, a 12% improvement with low hypoglycemia, and a reduction in daily insulin use from 86U to 58U with no weight gain.
Based on the strength of these results, the company has initiated enrollment in a randomized controlled pivotal EVOLVE trial, with a 510(k) filing to the FDA planned for 2027. A commercial launch is also anticipated for 2028.
PODD closed Friday at $153.22, up 4.65%. In the pre-market, shares are trading at $153.88, up 0.43%.
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