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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01400659 |
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Date of registration:
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20/07/2011 |
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Primary sponsor: |
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Public title:
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Pizza-Salami Study in Children and Adolescents With Type 1 Diabetes
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Scientific 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 |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01400659 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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Olga Kordonouri, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kinderkrankenhaus auf der Bult |
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Key inclusion & exclusion 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
Age minimum:
6 Years
Age maximum:
21 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 1 Diabetes Mellitus
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Intervention(s)
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Procedure: CFP algorithm
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Primary Outcome(s)
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CGM-Glucose Area Under the Curve
[Time Frame: 6 hours after the test meal]
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Secondary Outcome(s)
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frequency and amount of interventional hypoglycemic therapy
[Time Frame: 6 h after the test meal]
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frequency of adverse events (incl. SAE)
[Time Frame: during hospitalization period of the study]
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hyperglycemia (6h-AUC >180 mg/dl)
[Time Frame: 6 h after the test meal]
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Time of glucose nadir
[Time Frame: 6 hours after the test meal]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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