Understanding the Pathophysiology and Clinical Course of New-Onset Diabetes Following COVID-19 (U01 Clinical Trial Not Allowed) | RFA DK 22 016

Opportunity Information: Apply for RFA DK 22 016

This NIH grant opportunity (RFA-DK-22-016) from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is seeking applications to build and run a longitudinal research cohort focused on people who develop new-onset diabetes after infection with SARS-CoV-2. The core purpose is to clarify what is driving "post-COVID" diabetes, how it unfolds over time, and what factors influence outcomes and treatment response. The award mechanism is a U01 cooperative agreement, which typically means the research team will carry out the work with substantial scientific involvement from NIH staff compared with a standard investigator-initiated grant. Clinical trials are not allowed under this announcement, so the study is intended to be observational rather than testing interventions.

A central requirement is the establishment of a well-characterized cohort that includes both children and adults, with enrollment that mirrors the geography and demographics of COVID-19 across the United States. In practical terms, applicants are expected to design recruitment and follow-up plans that do not overrepresent narrow subgroups and that can capture variation by age, sex, race and ethnicity, and other social or structural factors linked to COVID exposure, care access, and diabetes risk. Alongside the post-infection diabetes cohort, the FOA requires an appropriate comparator population that is also recruited and followed over time. That comparator group is essential for separating diabetes risk that is specifically associated with SARS-CoV-2 infection from background trends caused by the broader pandemic environment (such as disrupted medical care, changes in diet and activity, stress, and economic instability).

The scientific goals are framed around teasing apart multiple contributors to the observed excess of new-onset diabetes following SARS-CoV-2 infection. The FOA specifically calls for determining the contribution of: (1) particular pathophysiologic pathways (for example, mechanisms affecting insulin secretion, insulin resistance, inflammation, immune dysregulation, or organ-specific injury that could plausibly link infection to dysglycemia); (2) the overall health impact of the pandemic (capturing indirect effects that might increase diabetes risk even without direct viral effects); (3) COVID-19 severity (ranging from mild infection to severe disease requiring hospitalization or intensive care, which may differentially affect metabolic outcomes); and (4) COVID-19 treatments (recognizing that therapies used during acute infection could influence glucose metabolism and the likelihood of diagnosing diabetes afterward). The intent is not only to document whether diabetes occurs, but to map the clinical course over time and understand who improves, who progresses, and how patients respond to standard diabetes therapies in the post-COVID context.

NIDDK also emphasizes the importance of designing the study to address diversity and equity in a meaningful way. The announcement strongly encourages research on sex and gender differences, sexual and gender minority-related research, and robust race and ethnic diversity, referencing NIH guidance (NOT-DK-22-003). This emphasis reflects the institute's broader strategic priorities around reducing health disparities and increasing health equity, particularly among racial and ethnic minority populations and other underserved groups. Applicants are expected to build these considerations into recruitment, measurement, analysis plans, and stakeholder engagement rather than treating them as add-ons.

The opportunity aligns with the NIDDK Strategic Plan for Research, including priorities focused on multidisciplinary teams, engaging diverse stakeholders, and pursuing pathways to health for all. The FOA explicitly ties the project to Scientific Goals 1.1 and 1.2 and to cross-cutting topics that address disparities and equity. Taken together, the NIH is signaling that a competitive application will likely include strong collaboration across clinical specialties and disciplines (such as endocrinology, infectious disease, pediatrics, epidemiology, immunology, and biostatistics), rigorous longitudinal data collection, and study operations that can support broad community participation and retention.

From an eligibility standpoint, a wide range of U.S.-based organizations can apply, including state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments; tribal organizations; public housing authorities; nonprofits (with and without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and U.S. territories or possessions. Foreign institutions and non-U.S. entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible; however, foreign components (as defined by NIH policy) are allowed, which typically means limited parts of the project may be conducted internationally if well-justified and compliant with NIH rules.

Administratively, the program sits in the health and nutrition domain (CFDA 93.847) and uses a discretionary funding instrument. The listed award ceiling is $3,750,000. The original closing date for applications was December 20, 2022, and the FOA was created on July 13, 2022. Overall, the announcement is aimed at producing a high-quality, generalizable evidence base on post-COVID new-onset diabetes by following affected individuals and comparators over time, measuring mechanisms and clinical outcomes, and carefully accounting for the many pandemic-related factors that can confound or modify diabetes risk.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Understanding the Pathophysiology and Clinical Course of New-Onset Diabetes Following COVID-19 (U01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2022-07-13.
• Applicants must submit their applications by 2022-12-20. (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 $3,750,000.00 in funding.
• 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.

Apply for RFA DK 22 016

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