Single Source for the Continuation of the Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Center (Collaborative U01 Clinical Trial Not Allowed)
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The National Institutes of Health is issuing a forecast for a single source competition to support the EDIC Research Center in the long-term follow-up of the EDIC cohort. This initiative focuses on studying the development and progression of complications in type 1 diabetes, specifically targeting severe microvascular, cardiovascular, and liver diseases, as well as sleep disorders and mortality. The research aims to analyze the trajectory of age-related morbidities like cognition and frailty, while evaluating the impact of emerging therapies such as SGLT2 inhibitors and GLP-1 receptor agonists on renal and cardiovascular outcomes. The program emphasizes the use of advanced statistical methods, including machine learning and artificial intelligence, to identify phenotypes susceptible or resilient to complications. It incorporates modern technologies like continuous glucose monitoring and vascular tonometry, alongside multi-omic approaches to identify biochemical signatures. Additionally, the research will address obesity-related comorbidities such as metabolic-associated steatotic liver disease and obstructive sleep apnea, while utilizing external databases to assess the cost-effectiveness and quality-of-life impacts of intensive therapy. Applications will undergo a standard peer-review process to determine funding eligibility.
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The primary purpose of this FOA is to support the EDIC Research Center in continuing long-term follow-up of the EDIC cohort to study the development and progression of complications in type 1 diabetes (T1D). The research will address severe microvascular disease, cardiovascular and liver disease, sleep disorders, mortality, and other comorbidities. The goals are to investigate the trajectory of age-related morbidities such as cognition, physical function, and frailty, and to identify their associations with risk factors that affect quality of life, self-management, and caregiver burden. Particular emphasis will be placed on evaluating the impact of emerging therapies, including SGLT2 inhibitors and GLP-1 receptor agonists, on renal and cardiovascular outcomes.
The initiative also encourages the application of advanced statistical methods, including machine learning and artificial intelligence, to identify phenotypes that are either susceptible or resilient to diabetes-related complications. Modern technologies, such as continuous glucose monitoring, coronary calcification imaging, and vascular tonometry, will be used and compared with data from existing cohorts. In addition, the program will support assessments of obesity-related outcomes and comorbidities—including metabolic-associated steatotic liver disease (MASLD) and obstructive sleep apnea (OSA)—within the increasingly overweight/obese T1D population. Multi-omic approaches to identify biochemical signatures associated with complications are also expected. Finally, the leveraging of external databases to examine the cost-effectiveness and quality-of-life impact of intensive therapy across the lifespan will be encouraged.
This is a Forecast for a single source competition that will invite application(s) from eligible organization(s) to apply. Please see Eligibility Section for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.
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