Improving diabetes care for youth in Uganda
Diabetes in African Youth: Improving Glucose Time-In-Range (DAYTime, Randomized Clinical Trial)
This study is testing if using a continuous glucose monitor can help children and young adults with type 1 diabetes in Uganda manage their blood sugar better than regular blood testing methods.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 4 Years to 26 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05454176 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance the management of type 1 diabetes (T1D) in children and young adults in Uganda by utilizing continuous glucose monitoring (CGM) technology. Participants will be randomized to receive either a flash CGM device or standard self-monitoring blood glucose (SMBG) methods over a 12-month period, with a primary focus on improving glucose levels within the target range. The study will also evaluate the cost-effectiveness of CGM compared to traditional monitoring methods in a resource-limited setting. Monthly diabetes self-management education will be provided to all participants to support their care.
Who should consider this trial
Good fit: Ideal candidates include children and young adults aged 4-26 years in Uganda with a diagnosis of type 1 diabetes for at least 12 months who are receiving insulin therapy.
Not a fit: Patients who are pregnant, breastfeeding, or have major medical conditions that interfere with study participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve glucose control and overall diabetes management for youth in resource-poor settings.
How similar studies have performed: Other studies have shown promise in using CGM technology for diabetes management, but this specific approach in a resource-poor nation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Antoinette Moran — University of Minnesota
- Study coordinator: Beth Pappenfus
- Email: papp0086@umn.edu
- Phone: 612-624-2922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.