Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05454176 · ClinicalTrials.gov registry record · Phase 4
Diabetes in African Youth
A Phase 4 study of Type1diabetes, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 180
- Enrollment target
- 1
- Study location
NCT05454176 is a Phase 4 study of Type1diabetes that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 180 participants, below the 252-participant average among 19 other Type1diabetes trials with a reported enrollment target (29% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05454176, a Phase 4 study of Type1diabetes, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 180 participants
- Enrollment target
- 1
- Study location
Study 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). A second primary endpoint is to perform a cost analysis on flash glucose monitoring compared to 3x/day SMBG, to determine whether this technology is cost-effective in the setting of a less-resourced nation. After a 2 week assessment with blinded CGM when a potential subject's ability to wear CGM is confirmed, subjects will be enrolled for 12 months in randomized, open label study, with a primary endpoint measurement at 6 months. All subjects will receive monthly diabetes self-management education. For the first six months, months 1-6: * Half of patients (n=90) will be randomized to an unblinded FreeStyle Libre 2 CGM.They and their care providers will be able to continuously see their CGM glucose levels to assist in insulin adjustment. * Half of patients (n=90) will be given sufficient test strips for 3x daily SMBG while wearing blinded CGM (control group). Neither they nor their care providers will be able to see their CGM glucose levels (the blinded CGM is simply for outcome measurement, not an intervention). As per usual clinical practice, only the SMBG glucose levels will be available to assist in insulin adjustment. * The change between baseline to 6 months in CGM-derived glucose percent time-in- range will be compared between groups (first primary study endpoint). For the second six months, months 7-12: * The control group will switch to unblinded CGM months 7-12 (their data months 7-12 months will be compared to their data months 1-6 as part of the primary endpoint assessment). * The patients who wore the unblinded CGM months 1-6 will continue for another 6 months to assess the impact of wearing the CGM for 12 continuous months (a secondary endpoint). Once the clinical portion of the study is complete, s
Conditions Studied
Interventions
- DEVICE Libre 2
- DEVICE Device for SMBG and Libre Pro
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2022-08-15 |
| Est. Completion | 2027-08-15 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05454176
The ClinicalTrials.gov registry entry for NCT05454176 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 252-participant average among 19 other Type1diabetes trials with a reported enrollment target (29% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type1diabetes appearing as the primary indexed condition, and to 2 interventions - of which Libre 2 is the first listed.
NCT05454176 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT05454176 about?
NCT05454176 is a clinical study titled "Diabetes in African Youth". 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). A second primary endpoint is to perform a cos...
What is the current status of trial NCT05454176?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 180 participants. The study started on 2022-08-15. Estimated completion is 2027-08-15.
What conditions does trial NCT05454176 study?
This clinical trial studies the following conditions: Type1diabetes.
What interventions are being tested in trial NCT05454176?
The interventions under investigation include: Libre 2 (DEVICE), Device for SMBG and Libre Pro (DEVICE).
Who is sponsoring clinical trial NCT05454176?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05454176 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type1diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Genetics Of Autoimmunity In Type I Diabetes
RECRUITING
-
Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes
RECRUITING · NA
-
Pancreas Ultrasound Imaging in type1 Diabetes
RECRUITING
-
Health Behavior Intervention for Adults With Type 1 Diabetes
RECRUITING · NA
-
Effects of Ketosis on Brain Function in Patients With T1DM
RECRUITING · NA
-
Very Low Carbohydrate Diets and Glucagon Response in T1DM
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.