[Breakthrough T1D](https://www.breakthrought1d.org)

October 29, 2025 (Letter of Intent) | January 13, 2026 (Full proposal)

Up to $3,000,000 total over 3 years; budget must align with project scope.

Supports clinical trials to advance therapies improving cardiovascular outcomes in people with type 1 diabetes.

LOI approval is required before submitting a full proposal.

--- ## Description This grant from Breakthrough T1D funds clinical trials aimed at developing and evaluating therapies to improve cardiovascular disease (CVD) outcomes in individuals with established type 1 diabetes (T1D). The initiative addresses the urgent need for targeted CVD therapies specifically evaluated in the T1D population, who face a disproportionately high risk of cardiovascular complications. Projects may include interventional or observational studies, mechanistic clinical trials, or post-hoc analyses of existing data, all with the goal of generating critical data to inform regulatory approvals or clinical guidelines. --- ## Due Dates - Letter of Intent (LOI) deadline: October 29, 2025 - Full proposal deadline: January 13, 2026 An approved LOI is required prior to submission of a full proposal. --- ## Funding Amount - Maximum funding: Up to $3,000,000 total for up to 3 years. - The amount requested should reflect the scope and objectives of the proposed study. - Indirect costs: Up to 10% of direct costs for non-profit institutions (Strategic Research Agreements); not permitted for for-profit (IDDP) applications. - Projects with increased scope (time or budget) may be considered with strong justification. --- ## Eligibility - Applicants must hold an M.D., D.O., D.M.D., D.V.M., Ph.D., or equivalent and have a faculty position (or equivalent) at a college, university, medical school, or research facility. - Eligible institutions include domestic and foreign non-profit organizations, public and private universities, colleges, hospitals, laboratories, units of state and local governments, and eligible federal agencies. - For-profit entities may apply under the Industry Discovery & Development Partnership (IDDP) mechanism (requires company matching funds and additional requirements). - Breakthrough T1D encourages diversity and welcomes applications from all qualified individuals and organizations. --- ## Application Process 1. **Letter of Intent (LOI):** - Submit a 2-page LOI online via the RMS360 system using the provided template. - LOIs are required and must be approved before a full proposal invitation. 2. **Full Proposal:** - Upon LOI approval, submit a full proposal using templates provided in RMS360. - Proposals should include all required scientific, budgetary, and administrative information. - Applications involving human subjects must include supplemental materials on subject safety, study design, and investigational product information. - For-profit applicants must contact Breakthrough T1D staff prior to LOI submission. 3. **Review:** - Applications are evaluated on significance, relevance, approach, innovation, environment, and the clinical translation roadmap. - Proposals must demonstrate feasibility, clear deliverables, and a plan for regulatory or commercial advancement. 4. **Award Notification:** - Award decisions are expected in May 2026, with the earliest anticipated project start in July 2026. --- ## Additional Information - The grant prioritizes clinical trials evaluating promising therapies for CVD in T1D, including repurposed, repositioned, or newly developed agents. - Innovative trial designs and collaborative approaches (e.g., academic-industry partnerships) are encouraged. - Applicants are responsible for sourcing investigational drugs and identifying study sites. - Projects must recruit diverse populations and justify the choice of trial endpoints. - Ancillary studies or inclusion of T1D participants in broader CVD trials are within scope. - Proposals for therapies already available to T1D patients should justify the need for further study. --- ## External Links - [Breakthrough T1D Funding Opportunities](https://www.breakthrought1d.org/explore-research/funding-opportunities/) - [Full RFA (PDF)](https://www.breakthrought1d.org/wp-content/uploads/2025/10/FY26_RFA_Clinical-trials-for-T1D-CVD_final_Revised.pdf) - [RMS360 Application Portal](https://breakthrought1d.smartsimple.us/) - [Breakthrough T1D Grant Handbook](https://www.breakthrought1d.org/granthandbook/) --- ## Contact Information | Topic | Name & Title | Email | |------------------|----------------------------|----------------------------------------| | Strategic fit & scientific inquiries | Courtney Ackeifi, PhD, Senior Scientist | cackeifi@BT1D.org | | Administrative inquiries | Sanjukta Mukerjee, PhD, Program Administrator | smukerjee@BT1D.org | For general inquiries, visit the [Breakthrough T1D contact page](https://www.breakthrought1d.org/contact-us/). ---

Clinical Trials To Advance Therapies For Cardiovascular Disease In Type 1 Diabetes

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