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

December 17, 2015 updated by: Kinderkrankenhaus auf der Bult

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CARB Counting
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
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.
Other Names:
  • CFP algorithm according to Pankowska et al.
Active Comparator: CFP counting
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
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.
Other Names:
  • CARB algorithm

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kinderkrankenhaus auf der Bult

Collaborators

Medtronic

Investigators

  • Principal Investigator: Olga Kordonouri, MD, Kinderkrankenhaus auf der Bult

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

July 20, 2011

First Submitted That Met QC Criteria

July 21, 2011

First Posted (Estimate)

July 22, 2011

Study Record Updates

Last Update Posted (Estimate)

December 18, 2015

Last Update Submitted That Met QC Criteria

December 17, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPS2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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