Understanding and Reducing Cardiovascular Disease in Type 1 Diabetes Mellitus (R01 Clinical Trial Optional) | RFA HL 21 014

Opportunity Information: Apply for RFA HL 21 014

This grant opportunity, RFA HL 21 014, is a discretionary NIH research grant (R01, clinical trial optional) from the Department of Health and Human Services focused on cardiovascular disease (CVD) in people living with Type 1 Diabetes Mellitus (T1DM). Its central purpose is to deepen what is known about why and how CVD develops in T1DM (pathophysiology), how common it is and who is most at risk (epidemiology), and what can realistically be done to lower that risk through targeted interventions. The broader long-term aim is to generate the kind of evidence that can be translated into practical, evidence-based guidelines to prevent or reduce cardiovascular complications of T1DM across the lifespan, from childhood through older adulthood.

The funding emphasizes macrovascular disease, meaning large blood vessel and major heart-related outcomes rather than primarily small-vessel complications. Projects are expected to address clinically meaningful cardiovascular endpoints such as myocardial infarction (heart attack), stroke, peripheral artery disease, heart failure, cardiomyopathy, cardiac arrhythmias, and cardiac autonomic neuropathy. Studies may also focus on relevant tissues and biological systems that underlie these outcomes, including coronary, cerebral, and large peripheral arteries, cardiac tissue, atherosclerosis, thrombosis, and lipoprotein metabolism. While research may include links between microvascular disease and later macrovascular disease (for example, diabetic kidney disease as a contributor to CVD risk), the main emphasis must remain squarely on cardiovascular disease and its prevention or reduction in people with T1DM.

The FOA supports three main types of work. First, epidemiologic studies are encouraged when they improve risk prediction and risk stratification, such as refining how CVD risk is assessed in T1DM, identifying high-risk subgroups, clarifying lifespan patterns, and strengthening the evidence base for who develops which cardiovascular outcomes and under what circumstances. Second, mechanistic studies are supported when they clarify biological pathways that drive cardiovascular risk in T1DM, including diabetes-specific mechanisms that may differ from those in Type 2 diabetes or the general population. Third, the FOA allows for small clinical trials, not necessarily to deliver definitive practice-changing answers on their own, but to generate early evidence, feasibility data, and effect-size estimates that can shape larger, later-stage trials aimed at preventing or reducing CVD complications in T1DM.

In practical terms, this is an R01 mechanism, meaning it is intended for hypothesis-driven research projects with clear aims, rigorous methods, and strong justification for their significance to T1DM-related cardiovascular health. Clinical trials are optional, so applicants can propose observational, mechanistic, translational, or interventional work depending on what best fits the scientific question. The award ceiling is listed as $500,000, and the opportunity anticipated making about 8 awards. The original posting date was January 6, 2021, with an original closing date of October 15, 2021.

Eligibility is broad and includes many organization types that commonly apply to NIH opportunities. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses; small businesses; and other entities as described in the FOA. The opportunity is associated with CFDA numbers 93.837 and 93.847, reflecting its placement within NIH funding streams relevant to heart, lung, and blood research and related areas.

Overall, the opportunity is designed to move the field toward clearer, T1DM-specific understanding of cardiovascular risk and toward actionable prevention strategies. It targets the gap between recognizing that people with T1DM face substantial cardiovascular burden and having sufficiently tailored, evidence-based approaches to predict, prevent, and reduce that burden throughout life.

• The Department of Health and Human Services, National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Understanding and Reducing Cardiovascular Disease in Type 1 Diabetes Mellitus (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.837, 93.847.
• This funding opportunity was created on Jan 06, 2021.
• Applicants must submit their applications by Oct 15, 2021. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• The number of recipients for this funding is limited to 8 candidate(s).
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).

Apply for RFA HL 21 014

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