Insulet’s New Omnipod M Study Targets the Untapped Type 2 Diabetes Pump Market

Insulet (PODD) announced an update on their ongoing clinical study.

Study Overview: Insulet Corporation is running a new clinical study titled “An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes.” The goal is to see if its next-generation Omnipod M system is practical and helpful for adults with type 2 diabetes over a six‑week period. The study plans to enroll about 40 adults, with at least 20 starting the system and a target of 16 completing treatment. The outcome will help Insulet judge if this device can offer better day‑to‑day glucose control and support expansion of its wearable pump technology into the large type 2 diabetes market.

Intervention/Treatment: The only intervention in this study is the Omnipod M system, a medical device. It is a wearable, tubeless insulin delivery system designed to help users manage blood sugar more tightly, in part by allowing a lower glucose target. The device aims to simplify insulin use, improve glucose levels, and reduce the burden of diabetes self‑management for people with type 2 diabetes.

Study Design: This is an interventional, single‑arm feasibility study. All participants receive the same Omnipod M system, with no comparison group or placebo. There is no random assignment, and no blinding; both patients and researchers know which treatment is used. The main purpose is treatment-focused: to see if real‑world use of the device is workable and safe, and if it leads to better glucose control in this group.

Study Timeline: The trial is currently listed as “recruiting,” meaning it is still enrolling participants. The official record shows the first study submission on December 1, 2025, marking the formal start of regulatory tracking. The latest update to the listing was submitted on December 17, 2025, signaling that the protocol and status were recently reviewed and refreshed. Primary completion and full completion dates are not yet posted, so investors should assume that key results are still at least several quarters away.

Market Implications: For investors, this update underscores Insulet’s push to extend its Omnipod franchise beyond type 1 into the much larger type 2 diabetes segment. Positive feasibility data could support further, larger trials and, over time, open a new growth leg for Insulet’s revenue base. This is strategically important as rivals like Tandem Diabetes Care and Medtronic also work to adapt pump and automated insulin delivery solutions for type 2 users. Because this is an early, small study with no results yet, near‑term stock impact is likely modest, but ongoing progress can support sentiment around Insulet’s long‑term growth story and product pipeline. Investors should track follow‑on studies, regulatory signals, and any early commercial or partnership commentary once feasibility is confirmed.

The study remains ongoing and recently updated, with more details available on the ClinicalTrials.gov portal under its registered identifier.