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 Type 1 Diabetes, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 180
- Enrollment target
- 1
- Study location
NCT05454176: Recruiting Phase 4 study of Type 1 Diabetes, sponsored by University of Minnesota.
NCT05454176 is a Phase 4 study of Type 1 Diabetes that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 180 participants, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05454176, a Phase 4 study of Type 1 Diabetes, 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
Primary Outcome
The change in glucose Time-in-Range (percent time glucose levels are 70-180 mg/dl) from baseline to six months will be compared between patients wearing the unblinded CGM to those performing standard 3x/day SMBG.
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 |
What NCT05454176 shows while recruiting
NCT05454176 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Libre 2 is the first listed.
NCT05454176 reports a single indexed study location in 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: Type 1 Diabetes.
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 Type 1 Diabetes
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.
Where NCT05454176's enrollment target sits among peer trials
180 32nd of 198 higher than 166 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Extended Bolus for Meals in a Closed-loop System
RECRUITING · Phase 4
-
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
RECRUITING · Phase 4
-
Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose
COMPLETED · Phase 4
-
Lunch Time Insulin Injection by School Nurse for Poorly Controlled Diabetes
COMPLETED · Phase 4
-
Effect of Urinary Alkalinization on Urine Uric Acid Precipitation and Crystallization in Adults With Type 1 Diabetes
COMPLETED · Phase 4
-
Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01558804 · 180 participants
GRoup A StrePtococcus
- NCT02932176 · 180 participants
Machine Learning for Handheld Vascular Studies
- NCT03384563 · 180 participants · Phase 4
Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane
- NCT03423628 · 180 participants · Phase 1
A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI