Insulet Achieves 68% Time‑in‑Range in EVOLUTION 2 Study of Fully Closed‑Loop System for Type 2 Diabetes

PODD
March 12, 2026

Insulet reported that its fully closed‑loop Omnipod system achieved a 68% time‑in‑range rate in the EVOLUTION 2 multicenter feasibility trial, a milestone that demonstrates the platform’s ability to deliver automated insulin delivery without manual boluses in adults with type 2 diabetes.

The study, presented at the International Conference on Advanced Technologies & Treatments for Diabetes on March 11 2026, measured glucose control in 68% of the time within the target range, a 24‑percentage‑point improvement over the 44% achieved with standard injection therapy. The 68% figure represents the highest time‑in‑range reported for a fully closed‑loop system in this patient population to date.

Insulet’s leadership sees the result as a key step toward capturing the estimated 5.5 million‑patient type 2 market. The company’s Omnipod 5 system, approved for type 2 diabetes in 2024, now has a fully automated version that could broaden adoption beyond the current type 1 focus. The company plans to launch a pivotal EVOLVE study in 2026 to support a 2027 FDA submission and a commercial launch in 2028.

During its February 18 2026 earnings call, CEO Ashley McEvoy said, “Our performance shows that Insulet continues to lead with innovation, scale, and customer trust — and that our competitive position has never been stronger. As we move into 2026, we are confident in our ability to grow the global AID market, expand adoption across type 1 and type 2 diabetes, and deliver on the strategic and financial commitments we have laid out. Insulet has the talent, the technology, and the momentum to lead this category for the long term.” She added, “We entered 2026 with strong momentum and clear priorities that position us well and give us confidence in achieving our financial goals.”

Insulet’s Q4 2025 results, released on February 18 2026, showed revenue of $781.8 million, up 33.5% year‑over‑year, and a full‑year 2025 revenue of $2.7 billion, up 31.6% year‑over‑year. Adjusted earnings per share of $1.55 beat consensus estimates of $1.48, and the company guided for 20‑22% revenue growth in 2026 with an operating‑margin expansion of roughly 100 basis points. A $350 million share‑repurchase program was also authorized.

Insulet faces competition from Medtronic and Tandem Diabetes Care, both developing AID systems, and from Dexcom and Abbott Laboratories, which supply continuous glucose monitoring technology. The EVOLUTION 2 results strengthen Insulet’s competitive moat by demonstrating superior automated insulin delivery in a large, underserved patient segment, positioning the company to capture a significant share of the global type 2 diabetes market.

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