Integration of Novel Measures for Improved Classification of Type 2 Diabetes (U01, Clinical Trials Not Allowed) | RFA DK 23 019

Opportunity Information: Apply for RFA DK 23 019

The NIH funding opportunity "Integration of Novel Measures for Improved Classification of Type 2 Diabetes" (RFA-DK-23-019) is a cooperative agreement (U01) designed to build a coordinated research consortium focused on improving how type 2 diabetes (T2D) is classified. Instead of treating T2D as a single, uniform condition, the initiative is centered on integrating multiple kinds of data to better stratify individuals into biologically and clinically meaningful subtypes. A key emphasis is bringing together diverse investigative teams who can combine existing and emerging measures, including markers that reflect organ or tissue function, and then incorporate those measures into modern analytic approaches that can refine disease definitions.

The scientific purpose is twofold. First, the consortium is expected to develop a broadly applicable framework for identifying T2D subtypes that can be used across studies and populations, not just within one dataset or one institution's approach. Second, it aims to deepen understanding of the physiologic drivers behind those subtypes, meaning the underlying biological processes that differentiate one subtype from another. The longer-term intent is that clearer subtyping will make it easier to design and match more effective precision interventions, where prevention or treatment strategies can be tailored to the dominant mechanisms driving disease in a given person rather than relying on a one-size-fits-all model.

Because this is a U01 cooperative agreement, projects funded under this announcement are typically expected to operate in a more collaborative, NIH-involved structure than standard research grants. In practical terms, this mechanism generally supports multi-team coordination, shared standards, and joint problem-solving across the consortium to ensure that integrated data resources, analytic methods, and resulting subtype frameworks are interoperable and broadly useful. The NOFO explicitly notes that clinical trials are not allowed, which signals that the work should focus on classification, integration of measures, analysis strategies, and mechanistic understanding rather than testing clinical interventions in a trial design under this award.

The opportunity falls under the NIH and is categorized under health and nutrition-related research (CFDA 93.847). The posted award ceiling is $500,000, and the original closing date listed is October 26, 2023. While the summary does not detail the number of awards, it indicates "ExpectedAwards:" without a value, so applicants typically would need to consult the full NOFO for definitive expectations about how many projects NIH planned to support, the intended consortium structure, and any coordinating components.

Eligibility is broad and spans many organization types, including state, county, and local 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; tribal organizations (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other eligible entities. The NOFO also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

There are important limits related to foreign participation. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as applicants. However, foreign components are allowed as defined by the NIH Grants Policy Statement, meaning a U.S.-based applicant organization can include certain foreign collaborations or performance sites if they meet NIH's definition and requirements for a foreign component. This structure encourages broad scientific collaboration while keeping the applicant organization and primary award management within eligible U.S.-based institutions.

Overall, the grant is focused on building shared, integrative scientific capabilities to move T2D classification beyond traditional labels and toward data-driven, mechanism-based subtypes. By combining varied data types, especially organ- and tissue-function markers, and embedding them in advanced analytic strategies, the consortium is intended to produce a framework that is widely usable and that improves understanding of why T2D differs from person to person, setting the stage for more targeted, effective precision approaches in the future without directly conducting clinical trials under this specific award.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Integration of Novel Measures for Improved Classification of Type 2 Diabetes (U01, Clinical Trials 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 2023-05-31.
• Applicants must submit their applications by 2023-10-26. (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.
• 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 23 019

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