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

May 2022 Council

Lead Division/Office

DEM

Point(s) of Contact

Guillermo Arreaza-Rubín, M.D.

Executive Summary

The purpose of this proposal is to build on current technology and ongoing clinical research to address barriers that limit progress toward physiological pancreatic hormone replacement open- and closed-loop systems. Specifically, the initiative would support research to: 1) test and improve the safety, reliability, and clinical efficacy of these technologies in humans; 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.