Diabetes in African Youth

This study is for young people with type 1 diabetes (T1D) in Uganda, aged 4 to 26. It's testing if using the FreeStyle Libre 2, a device that continuously monitors glucose (sugar) levels, can help improve blood sugar control compared to traditional finger-prick testing. Researchers also want to see if the FreeStyle Libre 2 is cost-effective in this setting. You would need to have T1D for at least 12 months, be receiving insulin, and have access to a cell phone. The study is currently unclear on its recruitment status.

Study design
This is a randomized, open-label study with 180 participants. It compares continuous glucose monitoring with the FreeStyle Libre 2 to standard finger-prick glucose monitoring.
What's involved
You would wear a FreeStyle Libre 2 sensor for 12 months, changing it every two weeks, and attend monthly clinic visits. You would also receive monthly diabetes self-management education.
Compensation
Not stated in the trial record.
Follow-up
Your glucose time-in-range will be measured at 6 months, and a cost analysis will be performed at 1 year.

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NCT05454176

Diabetes in African Youth

Recruiting
PHASE4Ages 4–26InterventionalTreatment
University of Minnesota
~180 participants
Updated 2025-11-25 on ClinicalTrials.gov
What's tested:Libre 2Device for SMBG and Libre Pro

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Glucose Time-in-Range
Measured over 6 months
+1 more outcome measured
type1diabetes
1 sites across 1 states
Minnesota1
  • Antoinette Moran · PRINCIPAL_INVESTIGATOR · University of Minnesota

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Eligibility criteria

Inclusion

Children and youth in Uganda, age 4-26 years at the beginning of the baseline assessment
T1D (determined by clinical criteria, as autoantibody testing is not regionally available) of at least 12 months duration at the beginning of the baseline assessment
Receiving insulin therapy
Access to a cell phone (nearly ubiquitous in Uganda, even in remote areas)
At least one parent or guardian (or as per local regulations) is present in clinic and able to give consent for children under 18 years of age (those age 18-26 may give consent for themselves)

Exclusion

Unwilling or unable to be seen monthly at the pediatric diabetes clinic
Pregnant or breast-feeding; women likely to become pregnant in the next year
Major medical conditions which the investigator feels would interfere with study participation
Patient already has CGM
Inability during the baseline assessment period to wear the sensor for at least 7 days or return it
Participant deemed unlikely or unable to comply with the protocol
  • Glucose Time-in-Range6 months

    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.

  • Cost analysis of CGM1 year

    Cost analysis on flash glucose monitoring compared to 3x/day SMBG, to determine whether this technology is cost effective in the setting of a low-resource nation.