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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Procedure: CFP counting
* Procedure: CARB counting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CARB Counting<br>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. | Procedure: CFP counting<br>* 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.<br>* Other names: CFP algorithm according to Pankowska et al.;|
| Active Comparator: CFP counting<br>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. | Procedure: CARB counting<br>* 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.<br>* Other names: CARB algorithm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGM-Glucose Area Under the Curve | CGM = Continuous Glucose Monitoring | 6 hours after the test meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of glucose nadir |  | 6 hours after the test meal | 
| hyperglycemia (6h-AUC >180 mg/dl) | AUC = Area Under the Curve | 6 h after the test meal | 
| frequency and amount of interventional hypoglycemic therapy | i.e. g of glucose required to treat hypoglycemia | 6 h after the test meal | 
| frequency of adverse events (incl. SAE) | Hospital stay was from 2h before until 6h after teast meal. SAE = Severe Adverse Event | during hospitalization period of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CSII, prandial insulin requirements, bolus calculation, dual-wave bolus