Abstract
INTRODUCTION: To assess the impact of real-time continuous glucose monitoring (RT-CGM) instead of first-generation flash glucose monitoring (FGM) on hypoglycaemia in children and adolescents with type 1 diabetes. METHODS: In this randomized controlled interventional study, young individuals with type 1 diabetes used RT-CGM or FGM for 8 weeks. We evaluated changes in time below range (TBR), severe hypoglycaemia (SH), HbA1c, glycaemic variability, and impaired awareness of hypoglycaemia with RT-CGM (intervention group) in comparison with FGM. RESULTS: We randomly assigned 37 participants to either the intervention group (n = 19) or the control group (n = 18). At 8 weeks, we did not find a decrease in TBR in either group, but there was a significant reduction in SH in the intervention group. For participants with TBR ≥ 5% at baseline, we observed significant reductions in 24-h TBR, wake TBR, sleep TBR, and glucose variability at 8 weeks in the intervention group. CONCLUSIONS: The use of RT-CGM versus FGM decreased SH in young individuals with type 1 diabetes, and TBR and glucose variability in patients with a higher TBR at baseline. The patient's history should be taken into account when advising on the method of blood glucose monitoring, as RT-CGM could be more effective in younger patients at high risk for SH. TRIAL REGISTRATION: ClinicalTrials.gov NCT04249102.