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

October 10, 2024 (Letter of Intent) | January 13, 2025 (Full proposal)

Up to $1.5 million per year, for up to 4 years (maximum $6 million total per project)

Supports clinical trials of small molecules, biologics, or combination therapies to delay, halt, or reverse type 1 diabetes progression.

--- ## Description This funding opportunity from Breakthrough T1D seeks proposals for clinical trials evaluating disease-modifying therapies (DMTs) for type 1 diabetes (T1D). The grant specifically targets interventions that delay, halt, or reverse T1D progression by supporting or expanding endogenous beta cell survival and function, disrupting autoimmune pathobiology, or combining these strategies. The goal is to generate critical clinical data on drug or biologic mechanisms, efficacy, and safety in people with T1D, ultimately expanding the clinical pipeline and increasing the likelihood of regulatory approval for new therapies. Eligible projects should be proof-of-concept or early-phase (Phase 1 or 2) clinical trials in people with stage 3 T1D, with the possibility of Phase 3 trials if pre-approved. Priority will be given to trials that test novel or repurposed agents, combination therapies, or innovative approaches to immune modulation or beta cell regeneration. --- ## Due Dates - October 10, 2024: Letter of Intent deadline - January 13, 2025: Full proposal deadline An approved LOI is required before submitting a full proposal. No extensions will be granted for these deadlines. --- ## Funding Amount - Applicants may request up to $1.5 million per year for a maximum of 4 years (total up to $6 million per project). - Budgets or timelines exceeding these guidelines must be discussed and approved by Breakthrough T1D staff prior to LOI submission. --- ## Eligibility - Open to domestic and foreign non-profit organizations, public and private institutions (universities, colleges, hospitals, laboratories, government units, and eligible federal agencies). - Principal Investigators must hold an M.D., D.M.D., D.V.M., Ph.D., or equivalent, and have a faculty position or equivalent at a research facility. - For-profit entities and industry collaborations are eligible (additional documentation required if invited for a full application). - No citizenship requirements. - Applications from underrepresented groups, women, and persons with disabilities are encouraged. --- ## Application Process - **Letter of Intent (LOI):** Submit via the [RMS360 system](https://www.breakthrought1d.org/explore-research/funding-opportunities/) using the provided template, including background, rationale, aims, endpoints, participant criteria, drug acquisition plan, and relevant IP/commercialization information. - **Full Proposal:** Only invited applicants who have submitted an approved LOI may submit a full proposal, also via RMS360 and using the full application template. - **Review Criteria:** Significance, approach, innovation, investigator experience, and research environment. - **Additional Requirements:** - Trials must include an experienced clinical trial manager. - Power calculations should be based on stimulated C-peptide AUC at endpoint (unless otherwise justified). - An extension period for follow-up and use of continuous glucose monitors (CGMs) for all participants is required. - Inclusion of patient-reported outcomes and harmonized sample collection is expected. --- ## Additional Information - Trials must focus on people with stage 3 T1D. Proposals involving other populations or phase 3 trials require pre-approval. - Applicants are responsible for securing study drugs/placebos; funding is contingent on a written commitment from the manufacturer. - Collaborative and multi-country projects are encouraged. - Proposals evaluating more than two interventions, nutraceuticals as monotherapy, or lifestyle-only interventions will not be considered. - An informational webinar will be held on August 28, 2024. --- ## External Links - [Full RFA and instructions (PDF)](https://www.breakthrought1d.org/wp-content/uploads/2024/08/FY25-RFA-Clinical-Advancement-of-DMTs-FINAL.pdf) - [Breakthrough T1D funding opportunities](https://www.breakthrought1d.org/explore-research/funding-opportunities/) - [Contact Breakthrough T1D](https://www.breakthrought1d.org/contact-us/) --- ## Contact Information | Name | Role | Email | |---------------------|----------------------------|----------------------------------------------| | Joshua Vieth, Ph.D. | Director, Research (Science contact) | [jvieth@BreakthroughT1D.org](mailto:jvieth@BreakthroughT1D.org) | | Karen Ng | Senior Program Administrator (RMS360 support) | [kng@BreakthroughT1D.org](mailto:kng@BreakthroughT1D.org) |

RFA: Accelerating clinical trials evaluating disease-modifying therapies for T1D

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