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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01400659
First Posted: July 22, 2011
Last Update Posted: December 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Kinderkrankenhaus auf der Bult
  Purpose
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.

Condition Intervention Phase
Type 1 Diabetes Mellitus Procedure: CFP counting Procedure: CARB counting Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Kinderkrankenhaus auf der Bult:

Primary Outcome Measures:
  • CGM-Glucose Area Under the Curve [ Time Frame: 6 hours after the test meal ]
    CGM = Continuous Glucose Monitoring


Secondary Outcome Measures:
  • Time of glucose nadir [ Time Frame: 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

  • frequency and amount of interventional hypoglycemic therapy [ Time Frame: 6 h after the test meal ]
    i.e. g of glucose required to treat hypoglycemia

  • 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


Enrollment: 42
Study Start Date: March 2009
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: CARB algorithm

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400659


Sponsors and Collaborators
Kinderkrankenhaus auf der Bult
Medtronic
Investigators
Principal Investigator: Olga Kordonouri, MD Kinderkrankenhaus auf der Bult
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kinderkrankenhaus auf der Bult
ClinicalTrials.gov Identifier: NCT01400659     History of Changes
Other Study ID Numbers: PPS2008
First Submitted: July 20, 2011
First Posted: July 22, 2011
Last Update Posted: December 18, 2015
Last Verified: December 2015

Keywords provided by Kinderkrankenhaus auf der Bult:
CSII
prandial insulin requirements
bolus calculation
dual-wave bolus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs