[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 per award; smaller budgets also considered.

Supports clinical trials to advance therapies that improve cardiovascular outcomes for people with type 1 diabetes.

--- ## Description This opportunity from Breakthrough T1D funds clinical trials aimed at developing and testing therapies to improve cardiovascular disease (CVD) outcomes in individuals with established type 1 diabetes (T1D). The program addresses the significant unmet need for targeted CVD treatments in the T1D population, encouraging proposals for trials of new, repurposed, or existing therapies, including mechanistic and proof-of-concept studies. Projects may focus on innovative trial designs, mechanistic endpoints, or real-world studies and should ultimately generate data to inform future therapy development and clinical guidelines for cardiovascular care in T1D. --- ## Due Dates - **Letter of Intent (LOI) deadline:** October 29, 2025 - **Full proposal deadline:** January 13, 2026 Applicants must first submit a LOI to be considered for invitation to submit a full proposal. --- ## Funding Amount - **Maximum award:** Up to $3,000,000 total for up to 3 years per project - **Scope:** Funding level should match project scope; smaller budgets are welcome and will be considered. - **Indirect costs:** For Strategic Research Agreements (SRAs, non-profit/academic): up to 10% of the total request. For Industry Discovery & Development Partnerships (IDDPs, for-profit): indirect costs are not permitted. --- ## Eligibility - **Institutions:** Domestic and foreign non-profit organizations (universities, hospitals, research institutes, public/private entities), units of state and local government, and eligible federal agencies. - **Principal Investigator:** Must hold an M.D., D.O., D.M.D., D.V.M., Ph.D., or equivalent and have a faculty or equivalent research position. - **For-profit entities:** Eligible to apply under the IDDP mechanism; additional requirements and company matching funds apply. - **Diversity:** Applications encouraged from all qualified individuals and a broad cross-section of researchers. --- ## Application Process 1. **Letter of Intent (LOI):** - Submit online via [RMS360](https://breakthrought1d.smartsimple.us/). - Use the provided LOI template; maximum 2 pages. - LOI is required to be considered for a full proposal invitation. 2. **Full Proposal:** - Only by invitation after LOI approval. - Complete application using RMS360 templates. - Include all required documentation (e.g., human subjects research plans if applicable). 3. **Review Criteria:** - Significance, relevance, approach, innovation, environment, resource sharing plan, and clinical translation roadmap. --- ## Additional Information - **Project Types:** Trials may be at any stage (Phase 1–3), including mechanistic, proof-of-concept, pilot, or ancillary studies. - **Therapies:** Projects may evaluate new, repurposed, or existing therapies for CVD in T1D. - **Collaborations:** Academic-industry collaborations are encouraged; Breakthrough T1D can help connect potential partners. - **Special Requirements:** Applicants must secure study drug/placebo provision and identify study sites; diversity in recruitment is strongly encouraged. - **Human Subjects:** All studies involving human subjects must comply with U.S. DHHS regulations (45 CFR 46) and NIH guidelines. --- ## External Links - [Funder homepage](https://www.breakthrought1d.org) - [Funding opportunities overview](https://www.breakthrought1d.org/explore-research/funding-opportunities/#project-concepts) - [Full RFA and program details (PDF)](https://www.breakthrought1d.org/wp-content/uploads/2025/10/FY26_RFA_Clinical-trials-for-T1D-CVD_final_Revised.pdf) - [Apply via RMS360](https://breakthrought1d.smartsimple.us/) --- ## Contact Information | Area | Contact | Email | |--------------------------|----------------------------------------|--------------------------------------------| | Strategic Fit & Science | Courtney Ackeifi, PhD, Senior Scientist| cackeifi@BT1D.org | | Administrative | Sanjukta Mukerjee, PhD, Program Admin | smukerjee@breakthrought1d.org | For system or application questions, contact the administrative contact above. ---

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

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