Comparison of continuous glucose monitoring plus self-monitoring of blood glucose versus self-monitoring of blood glucose alone on glycemic variability in children with type 1 diabetes - a randomized controlled trial

This is a randomized controlled, open label, parallel group study designed to compare the change in glycemic variability, measured by the coefficient of variation (CV percent) of glucose levels, at the end of three months between children with type 1 diabetes using intermittent scanned continuous glucose monitoring (isCGM) for fifteen days followed by self monitoring of blood glucose (SMBG), and those using SMBG alone. Secondary objectives include estimating and comparing other glycemic variability metrics such as time in range (IR 70 to 180 mg per dL), time below range (BR less than 70 mg per dL), time above range (AR greater than 180 mg per dL and greater than 250 mg per dL), and the proportion of participants achieving CV less than 36 percent between the two groups. Additional secondary objectives are to compare the change in HbA1c from baseline to three months, evaluate the correlation between glycemic variability and HbA1c, assess treatment modifications including insulin dose adjustments, dietary changes, recognition and management of glycemic excursions, and physical activity prompted by CGM use, and to evaluate any adverse effects and overall acceptability of CGM among children and caregivers.