Insulet's New System Signals a Paradigm Shift for Type 2 Diabetes Care

BARCELONA, Spain – March 10, 2026 – Insulet Corporation is set to unveil compelling new clinical data this week for a first-of-its-kind automated insulin delivery system designed specifically for adults with Type 2 diabetes (T2D). The results from the EVOLUTION 2 study, presented at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD), signal a major step toward bringing fully automated, or “closed-loop,” technology to the largest segment of the diabetes community.

This development represents a potential turning point in diabetes management, promising to lift the significant daily burden of dosing calculations and blood sugar monitoring from the shoulders of millions. As the global leader in tubeless insulin pump technology, Insulet’s move into the T2D automated-care space could reshape treatment standards and expand the market for advanced diabetes technology.

“At Insulet, our mission is to transform the lives of people with diabetes, and our recent work in developing a fully closed-loop system for people with type 2 diabetes is a major step forward,” said Dr. Trang Ly, Senior Vice President and Chief Medical Officer at Insulet, in a statement ahead of the conference.

A Leap Forward in Automated Insulin Delivery

The centerpiece of Insulet's presentation is the EVOLUTION 2 study, a multicenter trial in New Zealand that evaluated the safety and efficacy of the company’s new fully closed-loop (FCL) system. The results, to be presented by Dr. Martin de Bock of the University of Otago, are highly encouraging.

According to the research, participants using the final algorithm version of the FCL system achieved an average of 68% Time in Range (TIR), a key metric for glycemic control. This marks a 24% improvement over their previous standard injection therapy, translating to nearly six additional hours per day spent within the target blood glucose range. Critically, this improvement was achieved while maintaining exceptional safety. Time Below Range (TBR), or hypoglycemia, was minimal, with a median of just 0.14%, far below the clinically recommended threshold of 4%. The study reported no instances of severe hypoglycemia or diabetic ketoacidosis (DKA).

The positive user experience was a standout finding, with over 90% of participants choosing to continue with the system in an ongoing extension study—a powerful testament to the technology's perceived benefit and ease of use. These benefits were observed consistently across a diverse group of participants, regardless of their baseline HbA1c, body mass index, or ethnicity.

This new FCL system is distinct from Insulet's existing Omnipod 5, which recently gained FDA clearance for T2D. The EVOLUTION studies are focused on developing a fully closed-loop system that further simplifies management by eliminating the need for user-initiated meal boluses, a significant step beyond current hybrid closed-loop technologies.

Redefining Management for a Growing Population

For the vast majority of people with Type 2 diabetes, management is a relentless, 24/7 job fraught with challenges. Many patients report a lack of sufficient support, struggle with the motivation required for daily self-management, and face significant mental health burdens. The decision to start insulin therapy is often delayed due to fears surrounding injections and the complexities of dosing.

A fully automated system like the one Insulet is developing directly confronts these unmet needs. By automating insulin delivery based on real-time glucose data, the system offloads the cognitive burden of the disease. This not only simplifies treatment but can also lead to a profound improvement in quality of life, reducing stress, worry, and the constant fear of dangerous blood sugar fluctuations.

This technological advance comes on the heels of Insulet’s successful SECURE-T2D pivotal trial for its Omnipod 5 system. That trial, the largest and most diverse of its kind, demonstrated that the hybrid closed-loop system increased Time in Range by an average of 4.8 hours per day and lowered HbA1c by 0.8% for T2D users. The success of Omnipod 5 laid the groundwork for this next evolution in care, proving the viability and benefit of automated systems for the T2D population.

A Strategic Push into a Multi-Billion Dollar Market

Insulet’s focus on the T2D market is a calculated and strategic move into a massive and underserved sector. The global market for Type 2 diabetes treatments was valued at over $32 billion in 2022, and while insulin pumps have been available for years, their adoption among this group remains low—currently around 5%. However, projections show this figure could triple to 15% by 2027, representing a substantial growth opportunity.

Insulet is not alone in recognizing this potential. Competitors like Medtronic and Tandem Diabetes Care have also recently secured FDA clearance for their own automated insulin delivery systems for the T2D population. This intensifying competition is accelerating innovation across the industry, with companies vying to create the simplest, most effective, and most accessible solutions.

In this competitive landscape, Insulet’s core technology—the tubeless, wearable Omnipod—remains a key differentiator. Its discreet, patch-like design eliminates the tubing associated with traditional insulin pumps, a feature that may prove particularly appealing to T2D patients who are new to pump therapy and value simplicity and comfort. The company's pharmacy channel distribution model also lowers barriers to entry by eliminating high upfront costs and long-term commitments, further enhancing accessibility.

The Road Ahead: From Clinical Trials to Commercial Reality

While the EVOLUTION 2 results are a major milestone, the new FCL system is still on the development pathway. Insulet plans to initiate a larger pivotal trial, named EVOLVE, in 2026. The data from this study will be used to support a 510(k) submission to the FDA in 2027, with a projected commercial launch in 2028.

In the meantime, the company is preparing for the U.S. launch of its FDA-cleared Omnipod 5 system for Type 2 diabetes in early 2025. This dual-pronged strategy allows Insulet to establish a strong foothold in the T2D market with an existing, proven product while simultaneously developing the next generation of fully automated care.

Investors are watching closely, as reflected in the company's strong financial performance. Insulet recently raised its annual revenue guidance, citing sustained demand and confidence in its expansion strategy. The announcements at ATTD are expected to further bolster this confidence, showcasing a clear and ambitious roadmap for future growth.

The activity at the ATTD conference—from the main symposium to seven additional presentations and poster sessions on Insulet’s product pipeline—underscores the company's deep commitment to pushing the boundaries of diabetes technology. As these innovations move from clinical trials to commercial reality, they hold the promise of not just improving glycemic metrics, but fundamentally transforming the experience of living with diabetes for millions around the world.