Limited Competition for the Continuation of Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Center (Collaborative U01 Clinical Trial Not Allowed) | RFA DK 21 503

Opportunity Information: Apply for RFA DK 21 503

This NIH funding opportunity (RFA-DK-21-503) supports the continued operation of the Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Center through a cooperative agreement mechanism (U01) and is explicitly not for a clinical trial. EDIC is the long-running observational follow-up to the landmark Diabetes Control and Complications Trial (DCCT), which established that intensive diabetes management significantly lowers the risk of major diabetes complications compared with conventional therapy. When DCCT ended, all participants were instructed in intensive therapy, and EDIC was launched in 1994 to track what happens over the long term in this well-characterized group of people with type 1 diabetes.

The central goal of the announcement is to maintain and extend long-term follow-up of the EDIC cohort so researchers can continue to evaluate how earlier intensive glycemic control influences later health outcomes, sometimes decades after the original intervention. EDIC has already shown that the benefits of intensive therapy persist over time, and it has generated extensive knowledge about how diabetes complications develop and progress. This FOA focuses on sustaining those efforts by keeping the cohort engaged, collecting high-quality longitudinal data, and enabling continued use of EDIC data plus stored biologic, genetic, and other samples to answer important questions about type 1 diabetes outcomes across adulthood and aging.

The EDIC Research Center funded under this FOA serves as the coordinating hub for the study. It is responsible for managing and supporting the network of EDIC Clinical Centers that carry out the core study activities defined in the protocol and Manual of Operations. Those clinical centers handle participant visits, standardized assessments, and other required activities under both local and central IRB oversight. In practice, this means the Research Center role is heavily oriented toward study coordination, oversight, harmonization of procedures, and ensuring consistent implementation of EDIC core operations across sites, rather than launching new interventional testing.

From a scientific scope standpoint, the continued follow-up is intended to deepen understanding of the longer-term course of type 1 diabetes and the emergence of complications in a cohort that has been tracked with unusual rigor. The FOA highlights outcomes and complication areas that include, but are not limited to, severe microvascular disease (such as blindness, kidney failure, and amputation), cardiovascular disease, liver disease, sleep disorders, and mortality. The value of EDIC is that it links these later-life outcomes to decades of prior clinical information, glycemia history, and other risk-factor data, creating a uniquely powerful resource for understanding trajectories of disease and identifying predictors and mechanisms of complications.

Eligibility is limited and primarily geared toward U.S.-based entities, including public and state-controlled institutions of higher education. Non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations are not eligible to apply, although foreign components (as defined by NIH policy) are allowed under certain circumstances, consistent with NIH Grants Policy Statement rules. In other words, the award is intended to be led and administered domestically, while still permitting certain defined international components when justified and allowable.

Administratively, this opportunity is categorized as discretionary funding and uses a cooperative agreement structure, which typically implies substantial NIH program involvement during performance, with shared responsibilities and ongoing collaboration between the awardee and NIH. The CFDA listing is 93.847, the agency is the National Institutes of Health, and the original closing date was 2021-11-30. The listed award ceiling is $6,300,000. Overall, the announcement is aimed at preserving and advancing one of the most influential longitudinal resources in diabetes research by ensuring the EDIC cohort continues to be followed in a standardized, coordinated way that supports both ongoing core surveillance and high-value collaborative research using EDIC data and samples.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition for the Continuation of Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Center (Collaborative 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 2021-08-17.
• Applicants must submit their applications by 2021-11-30. (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 $6,300,000.00 in funding.
• Eligible applicants include: Public and State controlled institutions of higher education.

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