[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; actual award depends on project scope and justification.

Supports clinical trials to develop and assess new therapies targeting cardiovascular disease in people with type 1 diabetes.

LOI approval is required before submitting a full proposal.

--- ## Description This opportunity from Breakthrough T1D funds clinical trials aimed at advancing therapies to improve cardiovascular outcomes in individuals with established type 1 diabetes (T1D). The initiative specifically targets the urgent need for effective treatments for cardiovascular disease (CVD)—the leading cause of morbidity and mortality in people with T1D. Projects may include trials of novel, repurposed, or approved therapies, with a focus on mechanistic or surrogate endpoints relevant to CVD in T1D. Collaborative approaches between academia and industry are encouraged, and proposals should address the unique pathophysiology and clinical challenges of CVD in T1D. --- ## Due Dates - **Letter of Intent (LOI) deadline:** October 29, 2025 - **Full Proposal deadline:** January 13, 2026 An approved LOI is required before submitting a full proposal. --- ## Funding Amount - **Maximum funding:** Up to $3,000,000 total for up to 3 years. - **Award size:** Varies based on project scope and justification; smaller budgets are also considered. - **Indirect costs:** For Strategic Research Agreements (SRAs), up to 10% of direct costs; indirect costs are not permitted for Industry Discovery and Development Partnerships (IDDPs). - **Industry applicants:** Must provide matching funds. --- ## Eligibility - **Institutions:** Domestic and international non-profit organizations, academic institutions, hospitals, laboratories, public/private universities, and eligible government agencies. - **Applicants:** Must hold an M.D., D.O., D.M.D., D.V.M., Ph.D., or equivalent, and a faculty or equivalent position. - **Industry:** For-profit entities may apply via the IDDP mechanism (must provide matching funds and meet additional requirements). - **Diversity:** Applications from all qualified individuals and a broad cross-section of researchers are encouraged. --- ## Application Process 1. **Letter of Intent (LOI):** - Required for all applicants. - Submit a 2-page LOI using the template via [RMS360](https://breakthrought1d.smartsimple.us/). - LOIs are assessed for programmatic fit and scientific merit. - Industry applicants must contact Breakthrough T1D scientific staff before submitting. 2. **Full Proposal:** - Only invited after LOI approval. - Use provided templates and submit via RMS360. - Proposals must include detailed project plans, budgets, biosketches, and (if applicable) human subjects documentation. 3. **Review:** - Proposals are evaluated for significance, relevance, innovation, approach, feasibility, and alignment with Breakthrough T1D’s mission. - Additional clinical review for studies involving human subjects. 4. **Award Notification:** May 2026 (anticipated). 5. **Project Start:** Earliest anticipated start is July 2026. --- ## Additional Information - **Project Types Considered:** Proof-of-concept, pilot trials, mechanistic studies, ancillary studies, inclusion of T1D cohorts in broader CVD trials, and post-hoc analyses. - **Not Supported:** Trials without T1D participants, studies not well differentiated from ongoing work, weight loss as a primary endpoint, lifestyle-only interventions, or non-clinical studies. - **Study Drug:** Applicants must secure the study drug and placebo from manufacturers before funding is finalized. - **Collaboration:** Multi-site and industry-academic collaborations are encouraged. Breakthrough T1D can help facilitate partnerships. - **Diversity in Recruitment:** Proposals should aim for participant diversity reflective of real-world populations. - **Participating Clinical Sites:** Interested sites can complete the [Participating Clinical Site Form](https://www.breakthrought1d.org/wp-content/uploads/2025/09/FY26_CVD_Participating-Clinical-Site-Form.pdf). --- ## External Links - [Funding Opportunity Details (PDF)](https://www.breakthrought1d.org/wp-content/uploads/2025/10/FY26_RFA_Clinical-trials-for-T1D-CVD_final_Revised.pdf) - [Breakthrough T1D Funding Opportunities](https://www.breakthrought1d.org/explore-research/funding-opportunities/) - [RMS360 Application Portal](https://breakthrought1d.smartsimple.us/) - [Grant Handbook](https://www.breakthrought1d.org/granthandbook/) --- ## Contact Information | Inquiry Type | Contact Person | Email Address | |----------------------|------------------------|------------------------------| | Strategic/scientific | Dr. Courtney Ackeifi | cackeifi@BT1D.org | | Administrative | Dr. Sanjukta Mukerjee | smukerjee@BT1D.org | | General/contact form | 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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