Establishing a Cohort to Clarify Risk and Protective Factors for Neurocognitive Complications of Pediatric Type 1 Diabetes (T1D) - Planning Cooperative Agreements (U34 Clinical Trial Not Allowed) | RFA DK 18 007

Opportunity Information: Apply for RFA DK 18 007

The National Institutes of Health (NIH), through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), released this funding opportunity (RFA-DK-18-007) to support a planning-phase cooperative agreement (U34) for a future national, multi-site observational cohort study focused on pediatric type 1 diabetes (T1D). The scientific aim is to prospectively clarify which factors increase risk for, or protect against, neurocognitive complications in children who develop T1D in roughly the 5 to 10 year age range, alongside an appropriate comparison group without T1D (or otherwise suitable comparators as justified by the study). Because this is a planning award, it is not intended to fund the full cohort itself; it funds the groundwork needed to launch a large, coordinated cohort that can reliably answer these questions over time. The FOA is explicitly labeled "Clinical Trial Not Allowed," meaning applicants are expected to propose observational research planning and infrastructure rather than interventional clinical trials.

This U34 mechanism is structured around three core purposes. First, it allows early peer review of the rationale for the proposed cohort study, so reviewers can weigh in on whether the central questions are compelling and whether the approach is likely to produce interpretable, high-impact findings. Second, it supports rigorous assessment of the proposed study design, including key design choices that can make or break an observational cohort, such as eligibility criteria, recruitment sources, timing and frequency of follow-up, choice of neurocognitive outcomes, exposure and covariate measurement strategies (for example, glycemic metrics, hypoglycemia and hyperglycemia exposure, psychosocial factors, sleep, comorbidities, socioeconomic context), and the structure of the comparison sample. Third, it provides resources to develop the essential operational elements needed for a large multi-site effort, including the study protocol and manual of procedures, standardization across sites, data management and quality control systems, and the analysis and governance plans required to manage and interpret complex longitudinal data.

A major emphasis of the opportunity is readiness-building for a national, collaborative cohort. In practical terms, the planning period is meant to produce the concrete deliverables that would allow a subsequent full-scale cohort application or launch to proceed efficiently and consistently across many clinical and community settings. This includes building consensus on core neurocognitive and behavioral assessments, aligning biospecimen or clinical data collection plans if relevant, designing participant retention strategies suitable for children and families over years of follow-up, and putting in place clear policies for data sharing, publication, privacy protections, and cross-site coordination. The cooperative agreement format also signals substantial NIH programmatic involvement, so awardees should expect an active partnership with NIDDK staff as the plans are refined.

The FOA strongly encourages applicants to consult with NIDDK scientific staff before submitting an application. That is a practical signal that NIDDK expects prospective applicants to discuss feasibility, scope, alignment with institute priorities, and how the proposed planning activities will translate into a viable national cohort effort. Early contact can also help applicants understand expectations around study organization, multi-site leadership, and how to handle common cohort challenges such as harmonization of measures, minimizing bias, and ensuring the cohort reflects the diversity of children affected by T1D.

Eligibility is broad and includes many government, academic, nonprofit, and private-sector entities. Eligible applicants listed include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; federally recognized Native American tribal governments and other tribal organizations; and public housing authorities/Indian housing authorities. The FOA also highlights additional eligible groups 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), eligible federal agencies, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and non-U.S. (foreign) entities. This breadth reflects the reality that successful pediatric cohort studies often require partnerships spanning pediatric diabetes clinics, schools, community organizations, and institutions with strong ties to diverse populations.

From an administrative standpoint, this is a discretionary grant opportunity using the cooperative agreement funding instrument, categorized under Food and Nutrition/Health with CFDA number 93.847. The posting indicates an award ceiling of $225,000. The original closing date was 2019-04-11, and the FOA was created on 2019-01-23. While the notice does not specify the number of expected awards in the provided text, the intent is clearly to seed the planning work needed for a later, larger-scale national observational cohort.

In summary, this opportunity is best understood as a structured planning grant to design a high-quality, multi-site, longitudinal observational cohort study examining how pediatric-onset T1D relates to neurocognitive outcomes, with careful attention to both risk factors and protective factors. The U34 supports the up-front scientific and operational work required to launch a coordinated national effort, emphasizing standardized methods, robust data infrastructure, and early engagement with NIDDK to ensure the proposed cohort is feasible, rigorous, and positioned to generate actionable evidence about neurocognitive complications in children with T1D.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Establishing a Cohort to Clarify Risk and Protective Factors for Neurocognitive Complications of Pediatric Type 1 Diabetes (T1D) - Planning Cooperative Agreements (U34 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 2019-01-23.
• Applicants must submit their applications by 2019-04-11. (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 $225,000.00 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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