NCT05454176

Diabetes in African Youth

Name: Clinical Trial NCT05454176
Creator: University of Minnesota
Keywords: type1diabetes, Libre 2, Phase 4, device, clinical trial, United States of America

Diabetes in African Youth: Improving Glucose Time-In-Range (DAYTime, Randomized Clinical Trial)

University of Minnesota·Phase 4·ClinicalTrials.gov·device·Device trialRecruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: type1diabetes
Drug/Device/Intervention: Libre 2
Study type: Interventional
Intervention type: device

Sponsor & location

Primary sponsor: University of Minnesota
Location: Minneapolis, United States of America

Timeline & enrollment

Phase: Phase 4
Start date: Aug 15, 2022
End date: Aug 15, 2027
Enrollment: 180 participants

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

Type 1 diabetes mellitusType 1 diabetes mellitus with unspecified complicationsType 1 diabetes mellitus with other specified complicationsType 1 diabetes mellitus without complicationsType 1 diabetes mellitus with multiple complications

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05454176
Type: Device Trial

About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.