Design and rationale of the IN CONTROL trial: the effects of real-time continuous glucose monitoring on glycemia and quality of life in patients with type 1 diabetes mellitus and impaired awareness of hypoglycemia

摘要: Hypoglycemia is the main side effect of intensified insulin therapy in type 1 diabetes and recognized as a limitation achieving glycemic targets. Patients with impaired awareness hypoglycemia have threefold to sixfold increased risk severe hypoglycemia. Real-time continuous glucose monitoring may help patients achieve better control less hypoglycemic episodes. Accordingly, one hypothesize that particularly mellitus will profit most from this technology improvements their quality life. However, has not yet been established. This trial aims study real-time on glycemia life specifically established two-center, randomized, cross-over 12-week wash-out period between intervention periods. A total 52 according Gold et al. criteria be randomized receive or blinded for 16 weeks. After period, cross over other intervention. The primary outcome measure time spent euglycemia. Secondary outcomes include (diabetes-specific) markers variables. It remains unclear whether benefit real-life. provide insight into potential benefits patient population. Clinicaltrials.gov: NCT01787903 .