Grant Title: Clinical, Behavioral, and Physiological Studies of Open-and Closed-loop Platforms: Toward Personalized, Fully Automated, Accessible Systems
Grant Description: This funding opportunity aims to support clinical research utilizing current and emerging technologies to address barriers hindering the progress towards physiological pancreatic hormone replacement open- and closed-loop systems. The grant will focus on several key areas including:
1. Testing and improving the safety, reliability, and clinical efficacy of these technologies.
2. Addressing behavioral/psychosocial factors influencing the usability and acceptance of these systems, and validating measures that can be used as outcomes for efficacy and benefit demonstration.
3. Testing these technologies in subpopulations of patients not typically included in clinical trials but who can potentially benefit the most.
4. Testing these technologies in underserved individuals, those from low-income backgrounds, racial and ethnic minorities, and understanding disparities in the use and adoption of these systems.
5. Utilizing these technologies as tools to advance understanding of glucose regulation, its pathophysiology, and related factors in patients with type 1 diabetes (T1D).
Required Information for Application:
1. Research Proposal: A detailed plan outlining how the applicant intends to address the research goals mentioned in the grant description.
2. Project Timeline: A timeline for the proposed research activities, including key milestones and deliverables.
3. Budget: A comprehensive budget detailing the requested funds and explaining how they will be allocated across different aspects of the research.
4. Investigator Information: Background and qualifications of the principal investigator(s) and any co-investigators involved in the proposed study.
5. Research Team: Details of the research team and their roles in the project.
6. Institutional Support: Information about the applicant's institution, including facilities, resources, and support available for the proposed research.
7. Ethical Considerations: A plan for addressing ethical considerations related to conducting human studies, including informed consent, confidentiality, and protection of participants' rights.
8. Data Management Plan: An outline of how data will be collected, stored, and analyzed, ensuring data privacy and integrity.
9. Collaboration and Partnerships: If applicable, details of any collaborations or partnerships with other institutions or organizations involved in the research.
10. Letters of Support: Letters of support from relevant stakeholders, such as patient advocacy groups, healthcare providers, or community organizations endorsing the proposed research.
11. Dissemination Plan: A plan for sharing the research findings with the scientific community, healthcare practitioners, and
