NCT01400659

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

The PIZZA-Salami Trial: Monocentric Randomised Cross-over Study of Carb Counting vs. Carb Plus Fat/Protein Counting Based Insulin Bolus Used for Sensor-augmented Continuous Subcutaneous Insulin Infusion (CSII) in Pediatric Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Kinderkrankenhaus auf der Bult · Academic / Other
• Sex: All
• Age: 6 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The Pizza-Salami-Study aims to investigate the efficacy of carbohydrate plus fat/protein (CFP) counting compared with carbohydrate (CARB) counting using normal and dual-wave bolus in sensor-augmented pump therapy in children and adolescents with type 1 diabetes. For fat/protein counting the model used by Pankowska et al. will be applied.

Detailed description

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
PROCEDURE	CFP counting	Patients receive a standardized test meal at lunch time. The required insulin dose is calculated by CFP counting. Insulin is given as bolus and basal rate using an insulin pump. Continuous glucose monitoring is performed by sensor-augmented pump system for 6 hours after the meal. The intervention is taking part under in-patient clinical conditions.
PROCEDURE	CARB counting	Patients receive a standardized test meal at lunch time. The required insulin dose is calculated by CARB counting. Insulin is given as bolus and basal rate using an insulin pump. Continuous glucose monitoring is performed by sensor-augmented pump system for 6 hours after the meal. The intervention is taking part under in-patient clinical conditions.

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-07-01
• Completion: 2009-11-01
• First posted: 2011-07-22
• Last updated: 2015-12-18