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

Metabolic control is poor in East Africa for youth with type1 diabetes (T1D). Self-monitoring of blood glucose (SMBG) by fingerstick 2-3 times daily is routine care. This randomized controlled trial (RCT) will test the hypothesis that providing continuous glucose monitoring (CGM) to Ugandan youth with T1D will improve glucose time-in-range (TIR glucose 3.9-10.0 mmol/L) and be cost effective in this setting. Ugandan youth with T1D (<i>n</i> = 180, age 4-26 years) will be divided into four 12-month cohorts (August 2022-August 2027). Half will receive unblinded Freestyle Libre 2 Flash CGM for 12 months. For six months, control subjects received sufficient test strips for SMBG three times daily while wearing blinded Freestyle Libre Pro CGM (for endpoint assessment), and then they switch to unblinded CGM for six months. Everyone receives monthly diabetes education. The primary endpoints are as follows: (1) the six-month change from baseline in glucose TIR, unblinded CGM versus SMBG; (2) a cost analysis of CGM versus SMBG. The TIR hypothesis will be tested by linear mixed effects models. Cost analysis assumptions include direct material and indirect costs like hospitalizations, missed school/work, and diabetes complications. The study will inform T1D management guidelines in a low resource setting using evidence-based recommendations.