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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Kinderkrankenhaus auf der Bult
ClinicalTrials.gov Identifier:
NCT01400659
First received: July 20, 2011
Last updated: July 21, 2011
Last verified: July 2011
  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 algorithm
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time of glucose nadir [ Time Frame: 6 hours after the test meal ] [ Designated as safety issue: No ]
  • hyperglycemia (6h-AUC >180 mg/dl) [ Time Frame: 6 h after the test meal ] [ Designated as safety issue: No ]
  • frequency and amount of interventional hypoglycemic therapy [ Time Frame: 6 h after the test meal ] [ Designated as safety issue: Yes ]
    i.e. g of glucose required to treat hypoglycemia

  • frequency of adverse events (incl. SAE) [ Time Frame: during hospitalization period of the study ] [ Designated as safety issue: Yes ]
    Hospital stay was from 2h before until 6h after teast meal.


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 algorithm
Patients receive a standardized test meal at lunch time. The required insulin dose is calculated either by CARB or 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: CFP algorithm
Patients receive a standardized test meal at lunch time. The required insulin dose is calculated either by CARB or 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.

  Eligibility

Ages Eligible for Study:   6 Years to 21 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400659

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Olga Kordonouri, MD, Kinderkrankenhaus auf der Bult
ClinicalTrials.gov Identifier: NCT01400659     History of Changes
Other Study ID Numbers: PPS2008
Study First Received: July 20, 2011
Last Updated: July 21, 2011
Health Authority: Germany: Ethics Commission

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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014