NCT05454176Active, not recruitingPhase 4
Diabetes in African Youth
Diabetes in African Youth: Improving Glucose Time-In-Range (DAYTime, Randomized Clinical Trial)
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 188 (actual)
- First submitted
- 6 Jul 2022
- Start date
- 15 Aug 2022
- Primary completion date
- 15 Aug 2027
- Lead sponsor
- University of Minnesota
- Diseases
- Type 1 diabetes
- NCT number
- NCT05454176
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 188
- From 15 Aug 2022 to the primary completion date, 15 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Unwilling or unable to be seen monthly at the pediatric diabetes clinic
- Major medical conditions which the investigator feels would interfere with study participation
Other
- Pregnant or breast-feeding; women likely to become pregnant in the next year
- 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
Who the study is looking for
- 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)
Age in the registry: 4 years to 26 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.