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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This contract seeks to continue funding for the EDIC Research Center to support long-term follow-up studies of the EDIC cohort, focusing on the development and progression of complications related to type 1 diabetes. The research will explore a range of serious health issues including microvascular disease, cardiovascular and liver conditions, sleep disorders, mortality, and other associated comorbidities. Key objectives include investigating the trajectory of age-related morbidities such as cognitive decline, physical function, and frailty, as well as understanding how these are influenced by risk factors impacting quality of life, self-management practices, and caregiver burden. A significant part of the work involves evaluating the effects of emerging therapies like SGLT2 inhibitors and GLP-1 receptor agonists on kidney and heart health. The initiative also encourages the use of advanced statistical tools including machine learning and artificial intelligence to identify patient phenotypes that are either vulnerable or resistant to diabetes complications. Cutting-edge technologies, such as continuous glucose monitoring, coronary calcification imaging, and vascular tonometry, will be leveraged and compared with data from existing cohorts. Additionally, the program will address obesity-related outcomes and comorbidities such as metabolic-associated steatotic liver disease and obstructive sleep apnea, reflecting the growing rates of obesity within the type 1 diabetes population. Multi-omic analyses will be employed to uncover biochemical markers linked to complications, while external databases will be utilized to assess the cost-effectiveness and quality-of-life impacts of intensive diabetes therapy over a patient’s lifespan. This single source forecast invites eligible organizations to apply through a peer-reviewed process administered by the National Institutes of Health.
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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.
