Clinical, Behavioral, and Physiological Studies of Open- and Closed-loop Platforms: Toward Personalized, Fully Automated, Accessible Systems (R01 Cl…

The purpose of this fundng opportunity announcemnt (FOA) is to promote clinical research using current and emerging technologies to address barriers that limit progress toward physiological pancreatic hormone replacement open- and closed-loop systems. It will support research to: 1) test and improve the safety, reliability, and clinical efficacy of these technologies; 2) address behavioral/psychosocial factors that play a role in the usability and acceptance of these systems and validation of measures that may be used as outcomes for the demonstration of efficacy and benefit; 3) test these technologies in subpopulations of patients not usually included in clinical trials who may benefit the most from their use; 4) test these technologies in individuals who are underserved or in low income and/or racial and ethnic minority groups, and better understand disparities in the use and adoption of these systems; and 5) use the technologies as tools to advance understanding of glucose regulation and its pathophysiology in patients with type 1 diabetes (T1D) including counter-regulation and impaired awareness of hypoglycemia. Research goals include improved metabolic control with decreased glycemic excursions, prevention of acute and chronic complications, and improved quality of life in patients with diabetes and their caregivers. Only human studies will be considered responsive to this FOA, applications involving animal or in vitro studies are not responsive to this FOA.

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.