Actively Recruiting
Diabetes in African Youth
Led by University of Minnesota · Updated on 2025-11-25
180
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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, study investigators who are health economists from the Uganda Ministry of Health will perform a costs analysis (second primary endpoint).
CONDITIONS
Official Title
Diabetes in African Youth
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and youth in Uganda aged 4 to 26 years at baseline
- Diagnosed with type 1 diabetes for at least 12 months based on clinical criteria
- Receiving insulin therapy
- Have access to a cell phone
- Have at least one parent or guardian able to provide consent for those under 18; participants aged 18 to 26 can consent for themselves
You will not qualify if you...
- Unable or unwilling to attend monthly visits at the pediatric diabetes clinic
- Pregnant, breastfeeding, or likely to become pregnant within one year
- Presence of major medical conditions that may interfere with study participation
- Already using continuous glucose monitoring
- Unable to wear the sensor for at least 7 days or return it during baseline assessment
- Deemed unlikely or unable to comply with the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
B
Beth Pappenfus
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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