SWPDC FDA Real World Evidence Study for Type 1 Diabetes (H-46474)
Description
Content
Study Goal(s): The goal of the type 1 diabetes (T1D) real world evidence (RWE) demonstration project is to develop a standalone software system and application that will provide contextual and clinically relevant data dashboards synthesized from multiple devices to enable improved patient encounters and clinical management of acute glycemic events and impact long term clinical outcomes for youth with T1D.
Eligibility Criteria: None
Investigators: Daniel DeSalvo, M.D. (site principal investigator), Siripoom McKay, M.D. (co-investigator), Sruthi Menon, M.D. (co-investigator), Marisa Hilliard, Ph.D. (co-investigator)
Supported by: U.S. Food and Drug Administration
Contact
IRB: H-46474
Status:
Active
Created:
