Evaluating Neurocognitive Complications of Pediatric Type 1 Diabetes (T1D) and Potential Risk and Protective Factors Clinical Centers (U01 Clinical Trial Not Allowed) | RFA DK 23 010

Opportunity Information: Apply for RFA DK 23 010

This funding opportunity (RFA-DK-23-010) is an NIH cooperative agreement (U01; clinical trial not allowed) designed to build a multi-site clinical consortium focused on how newly diagnosed type 1 diabetes affects the developing brain in pre-pubertal children. The core idea is to move beyond general observations about pediatric T1D and generate high-quality, standardized, early-in-disease data that can clarify whether, how, and under what circumstances T1D is linked to changes in neurocognitive functioning during a particularly sensitive developmental window. Rather than testing an intervention, the consortium will conduct an observational study that carefully measures neurocognitive outcomes and connects those outcomes to medical, developmental, and environmental factors that may increase risk or offer protection.

Under this NOFO, funded Clinical Centers (CCs) will be responsible for establishing and following a diverse cohort of pre-pubertal children who have been newly diagnosed with T1D. Each center will recruit participants, carry out the agreed-upon assessments, and collect harmonized data to evaluate disease-related perturbations in neurocognitive function. The opportunity emphasizes both characterization of neurocognitive impacts and discovery of associated factors, meaning the study will not only ask "what changes are seen?" but also "what clinical features (for example, glycemic metrics), developmental characteristics, and environmental exposures or supports track with better or worse neurocognitive profiles?" The expectation is that these sites will collectively generate a robust dataset large and diverse enough to identify patterns that might be missed in smaller, single-center studies.

A major structural feature is that this clinical network will operate as a cooperative research consortium alongside a separately funded Biostatistics Research Center (BRC), which is solicited under a different NOFO (RFA-DK-23-009). The BRC will lead development and coordination of a core protocol that all awarded Clinical Centers will adopt, ensuring uniformity in how participants are evaluated and how data are captured across sites. The principal investigators from the BRC and from each Clinical Center, working in partnership with NIDDK, will jointly design and implement that shared protocol across roughly 10 Clinical Centers plus the BRC. The cooperative agreement mechanism signals active programmatic involvement from NIH (in this case NIDDK) and an expectation of collaboration, common procedures, and coordinated decision-making rather than independent, site-specific studies.

The anticipated payoff is a clearer, evidence-based picture of the impact of new onset T1D on the pre-pubertal brain, along with practical insight into modifiable and non-modifiable risk and protective factors associated with neurocognitive functioning. By identifying which children may be more vulnerable and which factors may buffer against adverse outcomes, the findings are intended to inform future strategies aimed at reducing negative neurodevelopmental trajectories and long-term neurocognitive sequelae linked to pediatric T1D. In other words, the study is positioned as foundational work that can shape screening, monitoring, and ultimately the design of future preventive or supportive interventions (even though this particular funding opportunity does not support clinical trials).

Eligibility is broad and includes many U.S.-based organizational types: 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); public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (outside of higher education); for-profit organizations (other than small businesses); and small businesses. The NOFO also highlights inclusion of institutions and organizations that serve specific populations, such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, foreign institutions are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed, reinforcing that the consortium is intended to be conducted within eligible U.S.-based organizational structures.

Key administrative details from the source information include: the opportunity title is "Evaluating Neurocognitive Complications of Pediatric Type 1 Diabetes (T1D) and Potential Risk and Protective Factors Clinical Centers (U01 Clinical Trial Not Allowed)"; the funding opportunity number is RFA-DK-23-010; the agency is the National Institutes of Health; the instrument type is a cooperative agreement; the activity area is listed under food and nutrition and health; and the CFDA number is 93.847. The original application due date listed is 2023-10-26, and the award ceiling shown in the source data is 200,000.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Evaluating Neurocognitive Complications of Pediatric Type 1 Diabetes (T1D) and Potential Risk and Protective Factors Clinical Centers (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 2023-05-15.
• 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 $200,000.00 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.

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