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

Children's Hospital Auf der Bult

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes Mellitus

Treatments: Procedure: CARB counting; Procedure: CFP counting

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01400659

PPS2008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 6 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

42 participants in 2 patient groups

CARB Counting

Active Comparator group

Description:

For CARB counting, insulin dose will be calculated according to the carbohydrate content of the test meal (1 carb unit = 10 g carbohydrate). The insulin-to-carbohydrate ratio will be applied according to the current individual therapy of the patient.

Treatment:

Procedure: CFP counting

CFP counting

Active Comparator group

Description:

For CFP counting, insulin dose will be calculated according the carbohydrate content (1 carb unit = 10 g carbohydrate) as well as fat/protein content (1 FPU = 100 kcal from fat and protein) of the meal. The insulin-to-carbohydrate ratio will be applied according to the current individual therapy of the patient. The insulin-to-FPU ratio is the same as the insulin to carb ratio.

Treatment:

Procedure: CARB counting