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.Apply for RFA DK 23 010
- 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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Frequently Asked Questions (FAQs)
What is the funding opportunity number for this grant?
The funding opportunity number is RFA-DK-23-010.
What is the official title of this funding opportunity?
The opportunity is titled "Evaluating Neurocognitive Complications of Pediatric Type 1 Diabetes (T1D) and Potential Risk and Protective Factors Clinical Centers (U01 Clinical Trial Not Allowed)."
Which agency is offering this opportunity?
The agency is the National Institutes of Health (NIH), with programmatic involvement from NIDDK as described in the opportunity summary.
What type of funding mechanism is this?
This is an NIH cooperative agreement using the U01 mechanism (clinical trial not allowed).
What does a "cooperative agreement (U01)" imply for awardees?
The cooperative agreement structure indicates active involvement from NIH (here, NIDDK) and an expectation that awardees will collaborate, use common procedures, and participate in coordinated decision-making rather than operating as fully independent, site-specific projects.
Are clinical trials allowed under this opportunity?
No. This U01 opportunity is designated as "clinical trial not allowed."
What is the overall purpose of this funding opportunity?
The purpose is to build a multi-site clinical consortium that studies how newly diagnosed type 1 diabetes affects the developing brain in pre-pubertal children, using high-quality, standardized, early-in-disease data collected across multiple sites.
What kind of study is the consortium expected to conduct?
The consortium is expected to conduct an observational study. It is designed to measure neurocognitive outcomes and relate them to medical, developmental, and environmental factors that may increase risk or provide protection.
Who is the primary population of interest?
The focus is on pre-pubertal children who have been newly diagnosed with type 1 diabetes (T1D).
What are the main research questions the consortium aims to address?
Based on the opportunity description, the study aims to clarify whether, how, and under what circumstances new onset pediatric T1D is linked to changes in neurocognitive functioning during a sensitive developmental period, and to identify clinical, developmental, and environmental factors associated with better or worse neurocognitive profiles.
What are "Clinical Centers (CCs)" expected to do under this NOFO?
Funded Clinical Centers are expected to establish and follow a diverse cohort of newly diagnosed pre-pubertal children with T1D, recruit participants, carry out agreed-upon assessments, and collect harmonized data to evaluate disease-related perturbations in neurocognitive function.
Why does the opportunity emphasize standardized and harmonized data?
The intent is to move beyond general observations and generate high-quality, early-in-disease data that can be compared across sites. Uniform assessments and harmonized data collection are emphasized so the consortium can create a robust dataset large and diverse enough to detect patterns that smaller single-center studies might miss.
What kinds of factors will be examined alongside neurocognitive outcomes?
The description highlights medical factors (including examples such as glycemic metrics), developmental characteristics, and environmental exposures or supports as categories of factors that may track with better or worse neurocognitive profiles.
How many sites are expected to participate in the consortium?
The shared protocol is expected to be implemented across roughly 10 Clinical Centers plus a Biostatistics Research Center (BRC).
What is the Biostatistics Research Center (BRC), and how does it relate to this opportunity?
The BRC is a separately funded component of the overall network, solicited under a different NOFO (RFA-DK-23-009). The BRC is expected to lead development and coordination of the core protocol that all awarded Clinical Centers will adopt to ensure uniform evaluations and consistent data capture across sites.
Will Clinical Centers design their own protocols independently?
No. The structure described indicates that the BRC and Clinical Center principal investigators, working in partnership with NIDDK, will jointly design and implement a shared core protocol that all Clinical Centers will adopt.
What is the anticipated outcome or payoff of the consortium work?
The anticipated payoff is a clearer evidence-based picture of how new onset T1D impacts the pre-pubertal brain, and practical insight into modifiable and non-modifiable risk and protective factors associated with neurocognitive functioning. The results are intended to inform future screening, monitoring, and the design of future preventive or supportive interventions, even though this particular opportunity does not support clinical trials.
What is the activity area associated with this opportunity?
The activity area is listed under food and nutrition and health.
What is the CFDA number listed for this opportunity?
The CFDA number provided is 93.847.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based 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); 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.
Does the opportunity specifically encourage certain institution types?
Yes. The opportunity highlights inclusion of institutions and organizations that serve specific populations, including 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.
Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply.
Are non-U.S. components of U.S. organizations eligible?
No. Non-U.S. components of U.S. organizations are not eligible.
Are foreign components allowed under NIH policy for this opportunity?
No. Foreign components (as defined by NIH policy) are not allowed.
What is the original application due date listed?
The original application due date listed is 2023-10-26.
What is the award ceiling shown in the source information?
The award ceiling shown is 200,000.
Is this opportunity focused on interventions to improve outcomes?
No. The consortium is positioned as foundational observational work to characterize neurocognitive impacts and associated risk/protective factors. While the findings are intended to inform future strategies and interventions, this specific funding opportunity does not support clinical trials and is not described as testing an intervention.
What makes this opportunity different from a single-site observational study?
It is specifically designed as a multi-site consortium with a shared protocol coordinated by a separately funded Biostatistics Research Center, aiming for standardized assessments and harmonized data collection across roughly 10 Clinical Centers to produce a large, diverse dataset.
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| Undergraduate Summer Research Education in Kidney, Urologic, and Hematologic Diseases (R25 Clinical Trial Not Allowed) Apply for RFA DK 23 013 Funding Number: RFA DK 23 013 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $130,000 |
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| Continuation of the Childhood Liver Disease Research Network (ChiLDReN) Clinical Centers (U01 Clinical Trial Required) Apply for RFA DK 23 017 Funding Number: RFA DK 23 017 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
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