Tandem Diabetes Care (TNDM) announced an update on their ongoing clinical study.
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Tandem Diabetes Care Tests Longer-Wear Insulin Sets in Home Study
Study Overview: Tandem Diabetes Care has launched a feasibility study called “Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes.” The study will test upgrades to the company’s SteadiSet infusion set to see if people with type 1 diabetes can safely and comfortably wear these sets longer at home. For investors, this work matters because better, longer-lasting sets can improve user experience, reduce hassle, and strengthen Tandem’s core pump ecosystem.
Intervention/Treatment: The study focuses on a device called the SteadiSet Infusion Set, used with Tandem insulin pumps. Participants will try SteadiSet sets with a new, improved filling process and compare them with standard SteadiSet sets. The goal is to support extended wear, which could mean fewer set changes, more convenience, and tighter integration with Tandem’s pumps.
Study Design: This is an interventional, single-center study. Participants are placed in specific study arms rather than randomly assigned. The model is “parallel,” meaning each group uses a different pump and set option at the same time. There is no blinding; both patients and researchers know which setup is being used. The main aim is treatment-focused: to see if these extended wear options are practical and safe in real-world home use.
Study Timeline: The study status is listed as “not yet recruiting,” with the first submission date on January 6, 2026. That date marks the formal entry of the trial into the public registry. The same January 6, 2026 date is the latest update, showing this is a fresh posting with current information. Primary completion and final completion dates are not yet posted; those future milestones will show when main results and full data sets are expected, which will be key catalysts for investor reaction.
Market Implications: For Tandem Diabetes Care (TNDM), success with extended wear infusion sets could improve the appeal of both the t:slim X2 and the newer Mobi pump platforms. Longer wear times can reduce patient burden and may help keep existing users loyal while attracting new ones, especially as the market shifts toward more automated insulin delivery. This study also responds to competition from players like Medtronic and Insulet, which are pushing hardware and consumable improvements to lock in recurring revenue. While this early feasibility work is unlikely to move the stock near term, it supports Tandem’s strategy of deepening its consumables moat, which can enhance margins and visibility of recurring revenue over time. Positive data later could lift sentiment, especially if paired with strong pump adoption trends; weak or inconclusive results could raise questions about the pace of product innovation versus peers.
The study is currently listed as not yet recruiting and has been recently updated, with further details available on the ClinicalTrials portal.