Diabetes in African Youth - Trial NCT05454176
Access comprehensive clinical trial information for NCT05454176 through Pure Global AI's free database. This Phase 4 trial is sponsored by University of Minnesota and is currently Recruiting. The study focuses on type1diabetes. Target enrollment is 180 participants.
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Study Focus
Sponsor & Location
University of Minnesota
Timeline & Enrollment
Phase 4
Aug 15, 2022
Aug 15, 2027
Primary Outcome
Glucose Time-in-Range,Cost analysis of CGM
Summary
This RCT aims to improve T1D care in East African children and young adults by testing the
 hypothesis that enabling patients to continuously monitor glucose levels with flash CGM
 technology will improve glucose time-in-range (glucose level 70-180 mg/dl).
 
 After a 2 week assessment with blinded CGM when a potential subject's ability to wear CGM is
 confirmed, subjects will be enrolled a 12 month study, with the primary endpoint at 6 months.
 All subjects will receive monthly diabetes self-management education.
 
 - Half of patients (n=90) will be given an unblinded FreeStyle Libre 2 CGM for the entire
 12 months. They will be able to see their glucose levels in real time.
 
 - Half (n=90) will be given sufficient test strips for 3x daily SMBG while wearing blinded
 CGM for 6 months (control group). They will switch to unblinded CGM months 6-12.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05454176
Device Trial