Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-02-23 @ 9:32 PM
Study NCT ID:
NCT01400659
Status:
COMPLETED
Last Update Posted:
2015-12-18
First Post:
2011-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pizza-Salami Study in Children and Adolescents With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-17', 'studyFirstSubmitDate': '2011-07-20', 'studyFirstSubmitQcDate': '2011-07-21', 'lastUpdatePostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CGM-Glucose Area Under the Curve', 'timeFrame': '6 hours after the test meal', 'description': 'CGM = Continuous Glucose Monitoring'}], 'secondaryOutcomes': [{'measure': 'Time of glucose nadir', 'timeFrame': '6 hours after the test meal'}, {'measure': 'hyperglycemia (6h-AUC >180 mg/dl)', 'timeFrame': '6 h after the test meal', 'description': 'AUC = Area Under the Curve'}, {'measure': 'frequency and amount of interventional hypoglycemic therapy', 'timeFrame': '6 h after the test meal', 'description': 'i.e. g of glucose required to treat hypoglycemia'}, {'measure': 'frequency of adverse events (incl. SAE)', 'timeFrame': 'during hospitalization period of the study', 'description': 'Hospital stay was from 2h before until 6h after teast meal. SAE = Severe Adverse Event'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CSII', 'prandial insulin requirements', 'bolus calculation', 'dual-wave bolus'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '20513322', 'type': 'BACKGROUND', 'citation': 'Pankowska E, Blazik M. Bolus calculator with nutrition database software, a new concept of prandial insulin programming for pump users. J Diabetes Sci Technol. 2010 May 1;4(3):571-6. doi: 10.1177/193229681000400310.'}, {'pmid': '22765260', 'type': 'DERIVED', 'citation': 'Kordonouri O, Hartmann R, Remus K, Blasig S, Sadeghian E, Danne T. Benefit of supplementary fat plus protein counting as compared with conventional carbohydrate counting for insulin bolus calculation in children with pump therapy. Pediatr Diabetes. 2012 Nov;13(7):540-4. doi: 10.1111/j.1399-5448.2012.00880.x. Epub 2012 Jul 6.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 1 diabetes\n* Age 6 - 21 years\n* Diabetes duration \\> 1 year\n* Treatment with pump therapy (CSII) \\> 3 months\n* Written informed consent by patients and parents\n* Patients must be willing to wear a glucose sensor for two days and to perform capillary blood glucose measurement twice a day\n* Patients must be willing to performed all study procedures\n\nExclusion Criteria:\n\n* Language barriers\n* Eating disorders\n* Pregnancy\n* Drug abuse\n* Patient refutes participation or study procedures'}, 'identificationModule': {'nctId': 'NCT01400659', 'briefTitle': 'Pizza-Salami Study in Children and Adolescents With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Kinderkrankenhaus auf der Bult'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PPS2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CARB Counting', 'description': '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.', 'interventionNames': ['Procedure: CFP counting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CFP counting', 'description': '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.', 'interventionNames': ['Procedure: CARB counting']}], 'interventions': [{'name': 'CFP counting', 'type': 'PROCEDURE', 'otherNames': ['CFP algorithm according to Pankowska et al.'], 'description': '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.', 'armGroupLabels': ['CARB Counting']}, {'name': 'CARB counting', 'type': 'PROCEDURE', 'otherNames': ['CARB algorithm'], 'description': '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.', 'armGroupLabels': ['CFP counting']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Olga Kordonouri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kinderkrankenhaus auf der Bult'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kinderkrankenhaus auf der Bult', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}