A Study Protocol for a Randomized, Controlled Trial: Improving Glucose Time-in-Range in Diabetes in African Youth...

Area of Science:

• Endocrinology
• Public Health
• Medical Technology

Background:

• Type 1 diabetes (T1D) management in East Africa faces challenges with poor metabolic control.
• Current routine care relies on self-monitoring of blood glucose (SMBG) via fingersticks, which is insufficient for optimal glucose management.
• There is a need for evidence-based, cost-effective solutions for T1D management in low-resource settings.

Purpose of the Study:

• To evaluate the effectiveness of continuous glucose monitoring (CGM) compared to SMBG in improving glucose time-in-range (TIR) among Ugandan youth with T1D.
• To assess the cost-effectiveness of implementing CGM in a low-resource setting for T1D management.
• To inform T1D management guidelines in resource-limited environments.

Main Methods:

• A randomized controlled trial involving 180 Ugandan youth (ages 4-26) with T1D over four 12-month cohorts.
• Intervention group received unblinded CGM for 12 months; control group initially received SMBG supplies with blinded CGM, then switched to unblinded CGM.
• Primary endpoints included change in glucose TIR and a cost analysis; data analyzed using linear mixed effects models.

Main Results:

• CGM is hypothesized to significantly improve glucose TIR compared to SMBG.
• The cost analysis will consider direct and indirect costs, including hospitalizations and diabetes complications.
• Monthly diabetes education was provided to all participants.

Conclusions:

• CGM shows promise as an effective and potentially cost-effective tool for improving T1D management in youth in East Africa.
• Findings will support the development of evidence-based guidelines for T1D care in low-resource settings.
• This study contributes to optimizing metabolic control and reducing long-term complications in a vulnerable population.