Pizza-Salami Study in Children and Adolescents With Type 1 Diabetes

This is a prospective, international multi-centre, open randomized clinical trial to assess whether the use of Paradigm REAL-Time System from the onset of Type 1 Diabetes (T1D) leads to a better glycaemic control after 12 months of T1D compared with the use of Paradigm 515/715 insulin pump combined with conventional Self-Monitoring Blood Glucose finger-sticks in paediatric patients. Total randomized treatment duration of the study for a patient will be 12 months with an optional phase of follow-up of 3 months.Patients eligible according to inclusion and exclusion criteria will be randomized to one of the two treatment groups. A total of 160 patients will be recruited. Each subject will participate in the study for 15 months, which includes 12 months of treatment and 3 months of follow-up. Each patient is asked to use either the Paradigm REAL-Time System that provides a combination of insulin pump and the Real-Time continuous glucose monitoring or Paradigm 515/715 insulin pump combined to conventional SMBG finger-sticks. Main time-points of assessments are at baseline (within one month after T1D onset) and 12 months thereafter. In total, there will be 6 study visits at the local site. During study, patients will regularly attend the outpatient clinic according to local Standard care, i.e. every 8±2 weeks.

Inclusion criteria

• Patients with type 1 diabetes
• Age 6 - 21 years
• Diabetes duration > 1 year
• Treatment with pump therapy (CSII) > 3 months
• Written informed consent by patients and parents
• Patients must be willing to wear a glucose sensor for two days and to perform capillary blood glucose measurement twice a day
• Patients must be willing to performed all study procedures

Exclusion criteria

• Language barriers
• Eating disorders
• Pregnancy
• Drug abuse
• Patient refutes participation or study procedures