Evaluating Neurocognitive Complications of Pediatric Type 1 Diabetes (T1D) and Potential Risk and Protective Factors Biostatistics Research Center (U01 Clinical Trial Not Allowed) | RFA DK 23 009

Opportunity Information: Apply for RFA DK 23 009

This funding opportunity (RFA-DK-23-009) is a National Institutes of Health (NIH) cooperative agreement (U01) to support a Biostatistics Research Center (BRC) that will serve as the centralized statistical, data coordination, and analytic hub for a multi-site clinical research consortium studying the neurocognitive effects of newly diagnosed type 1 diabetes (T1D) in pre-pubertal children. The overall goal is to generate strong, standardized, longitudinal evidence on how early T1D-related metabolic changes may influence brain development and cognitive functioning, and to identify factors that increase risk or provide protection. The award mechanism is explicitly "Clinical Trial Not Allowed," meaning the work is observational in nature rather than an interventional trial.

The BRC funded under this NOFO will partner with approximately 10 Clinical Centers (CCs) that are funded separately under a companion solicitation (RFA-DK-23-010). Those CCs will recruit and follow a diverse cohort of pre-pubertal children newly diagnosed with T1D and will conduct longitudinal assessments aimed at detecting disease-related perturbations in neurocognitive function. In practice, the BRC and the CC principal investigators, working closely with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), will function as a cooperative consortium. Because this is a U01 cooperative agreement, the expectation is active collaboration and shared governance: the study protocol, data standards, and analytic plans are designed and implemented jointly across sites rather than independently by each awardee.

From the BRC perspective, the work centers on ensuring the consortium can run a uniform protocol across all sites and produce high-quality, comparable data over time. That typically implies responsibility for statistical leadership, harmonized data collection and management approaches, centralized quality control, and the development and execution of rigorous analysis plans that can address longitudinal neurocognitive outcomes and associated clinical, developmental, and environmental exposures. The scientific deliverable is not just descriptive trends, but a clearer understanding of which factors (for example, disease metrics, developmental stage, and environmental context) are associated with better or worse neurocognitive trajectories after T1D onset. The longer-term public health aim is to use those findings to inform strategies that could reduce adverse neurodevelopmental outcomes and long-term neurocognitive complications in children with T1D, even if the current study itself is not testing an intervention.

Eligibility is broad and includes many U.S.-based organization types, such as 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 and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); and small businesses. The announcement also highlights additional eligible applicant categories including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. At the same time, it clearly restricts foreign involvement: non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed.

Key administrative details from the listing include: the funding instrument is a cooperative agreement (U01), the agency is NIH (specifically NIDDK involvement is emphasized), the assistance listing (CFDA) number is 93.847, the opportunity category is discretionary, the activity category is health/food and nutrition-related, and the original application due date shown is 2023-10-26. The listed award ceiling is $1,200,000. Overall, the NOFO is positioning the BRC as the backbone for a coordinated, multi-center, longitudinal observational study intended to clarify how early-life T1D affects the developing brain and which modifiable or contextual factors may worsen or buffer neurocognitive outcomes.

• 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 Biostatistics Research Center (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 $1,200,000.00 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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