Single Source for the Continuation of the Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Center (Collaborative U01 Clinical Trial Not Allowed)

The National Institutes of Health (NIH), specifically through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), is forecasting a single-source funding opportunity for the continuation of the Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Center. The EDIC study, a longstanding observational follow-up to the landmark Diabetes Control and Complications Trial (DCCT), is focused on understanding the long-term impact of intensive diabetes therapy in individuals with type 1 diabetes (T1D). This cooperative agreement will fund the continuation of critical research to explore the trajectory of diabetes complications over the lifespan of this well-characterized cohort. The grant seeks to advance the understanding of both microvascular and macrovascular complications associated with T1D, with additional focus on comorbidities such as cardiovascular disease, metabolic-associated steatotic liver disease (MASLD), and obstructive sleep apnea (OSA). Emerging issues like sleep disorders, frailty, and cognitive decline, which increasingly affect aging T1D patients, are central to the study’s evolving scope. The opportunity also aims to evaluate the clinical impact of novel therapeutic interventions, such as sodium-glucose co-transporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists, on renal and cardiovascular health outcomes. Technological innovation plays a major role in the proposed work. The EDIC study will incorporate modern methodologies such as continuous glucose monitoring, coronary calcification imaging, vascular tonometry, and multi-omic profiling to identify biochemical signatures linked with long-term complications. Advanced statistical techniques, including machine learning and artificial intelligence, will be utilized to define phenotypic profiles that are either vulnerable or resilient to diabetes-related conditions. Data from the EDIC cohort will be compared to other relevant datasets to maximize insight and impact, and external databases will be leveraged to assess quality-of-life outcomes and the cost-effectiveness of intensive therapy strategies over the lifespan. This is a single-source funding opportunity intended to invite application(s) from a predetermined, eligible organization or organizations with the demonstrated capacity to manage and extend the EDIC study. The competitive process will still adhere to NIH’s rigorous peer-review standards, ensuring that only scientifically meritorious proposals will receive consideration for funding. While the competition is limited in scope, the peer-review process remains integral to award decisions. Applicants must be either public or private institutions of higher education. The opportunity explicitly excludes clinical trials and is structured as a Collaborative U01 mechanism, which signifies a cooperative agreement with substantial NIH programmatic involvement anticipated throughout the performance period. While there are no cost-sharing or matching requirements associated with this grant, the program emphasizes methodological rigor and sustained cohort engagement, both of which may entail complex operational planning. The estimated application posting date is April 1, 2026, with applications due by July 1, 2026. The estimated award date is October 1, 2026, and the project is expected to start on July 1, 2027. Interested applicants may contact the Division of Diabetes, Endocrinology and Metabolic Diseases at [email protected] for further details. As a forecasted opportunity, this grant is currently in early engagement status, and additional details may be made available when the full FOA is officially released.