Extended 6-Month Follow-Up of A Randomized Clinical Trial to Assess the Efficacy and Safety of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes in Young Children Aged 4 to <10 Years

Abstract

In a 6-month randomized trial of continuous glucose monitoring (CGM) in children 4–9 years of age with type 1 diabetes (1), the DirecNet Study Group reported no difference in change in A1C between the CGM and usual care groups, although parents expressed high satisfaction with use of CGM. In a 6-month posttrial phase, the CGM group continued to use CGM and the control group was started on CGM. This observation provides a summary of the findings for both groups during this posttrial phase. Sixty-four of the 69 children in the CGM group who completed the trial participated in the extension phase; all 64 completed the 12-month visit. Baseline A1C was 7.9 ± 0.8 and 7.8 ± 0.8% at the beginning of the extension phase and 7.9 ± 0.8% at 12 months. During the extension phase, A1C decreased ≥0.5% in 14% and increased ≥0.5% in 25%. Sensor use dropped from a median of 92 h/week at 6 months to …