Impact of the continuous glucose control on metabolic control and quality of life in patients with pediatric diabetes following multi-injection therapy

Introduction. The management of diabetes in children and adolescents is a major issue both from a clinical point of view and for the impact on the quality of life of patients and their parents’. The complexity of management in these age groups is supported by the difficulty of achieving adequate therapeutic targets and the increased risk of hypoglycemia. The Continuous Glucose Monitoring (CGM) system is a key tool in the field of diabetes care, but there is little evidence on the impact of CGM on quality of life and satisfaction for the treatment of children and adolescents with type 1 diabetes treated with insulin multi-injection therapy and their parents.

Aims. The study has been designed to evaluate the efficacy of CGM over standard self monitoring blood glucose in reducing glycated hemoglobin levels after 24 weeks in children and adolescents with type 1 diabetes and inadequate metabolic control. Glycemic variability, quality of life of children and adolescents with type 1 diabetes and their parents and safety will also be assessed.

Type of study. Randomized, controlled parallel group (1: 1), open-label, multicenter clinical trial

Population. 212 children and adolescents with type 1 diabetes with not adequate metabolic control, treated with multi-injection insulin regimens

Centers. 10 Italian pediatric diabetes clinics

Promoter. Valentino Cherubini – Department of Health of Women and Children, University Hospital, Ospedali Riuniti Ancona, Salesi Hospital, Ancona

Funding. Dexcom USA (no conditional support)

Status. Study being activated