Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT04124302
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2019-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479079', 'term': 'insulin glulisine'}, {'id': 'D061267', 'term': 'Insulin Aspart'}, {'id': 'D061268', 'term': 'Insulin Lispro'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2019-08-23', 'studyFirstSubmitQcDate': '2019-10-10', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial glycemia', 'timeFrame': '30 minutes after meal', 'description': 'Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).'}, {'measure': 'Postprandial glycemia', 'timeFrame': '60 minutes after meal', 'description': 'Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).'}, {'measure': 'Postprandial glycemia', 'timeFrame': '90 minutes after meal', 'description': 'Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).'}, {'measure': 'Postprandial glycemia', 'timeFrame': '120 minutes after meal', 'description': 'Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).'}, {'measure': 'Postprandial glycemia', 'timeFrame': '150 minutes after meal', 'description': 'Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).'}, {'measure': 'Postprandial glycemia', 'timeFrame': '180 minutes after meal', 'description': 'Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).'}, {'measure': 'Postprandial glycemia', 'timeFrame': '210 minutes after meal', 'description': 'Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).'}, {'measure': 'Postprandial glycemia', 'timeFrame': '240 minutes after meal', 'description': 'Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).'}, {'measure': 'Postprandial glycemia', 'timeFrame': '270 minutes after meal', 'description': 'Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).'}, {'measure': 'Postprandial glycemia', 'timeFrame': '300 minutes after meal', 'description': 'Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).'}], 'secondaryOutcomes': [{'measure': 'Glucose Area Under the Curve (AUC)', 'timeFrame': '5 hours study period', 'description': 'Measurements based on Continuous Glucose Monitoring System (CGMS)'}, {'measure': 'The Difference Between The Maximum and Baseline Glucose Level - mean amplitude of glycaemic excursion (MAGE)', 'timeFrame': '5 hours study period', 'description': 'Measurements based on SMBG'}, {'measure': 'Hypoglycemia Episodes', 'timeFrame': '5 hours study period', 'description': 'Hypoglycemia defined as a plasma glucose concentration below 70mg/dl with or without symptoms'}, {'measure': 'Time in target postprandial glycemia', 'timeFrame': '5 hours study period', 'description': 'Time spent in the target range between 70 and 180 mg/dL based on CGMS'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes type 1', 'insulin bolus', 'prandial insulin requirement', 'postprandial glycemia', 'insulin pump therapy', 'mixed meal'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the impact of two different insulin dose calculation on postprandial glycemia after mixed meal in children with type 1 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* duration of type 1 diabetes longer than 12 months\n* insulin pump therapy longer than 3 months\n* treated by the same type of insulin longer than 3 months\n* written informed consent by patients and parents\n\nExclusion Criteria:\n\n* celiac disease\n* diabetes related complications (e.g. nephropathy)\n* any disease judged by the investigator to affect the trial\n* withdrawal of consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT04124302', 'briefTitle': 'The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal in Children With Type 1 Diabetes Mellitus- Randomized Study.', 'orgStudyIdInfo': {'id': 'Mixed Meal Bolus'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IPF', 'description': 'Total meal bolus will consist of insulin for carbohydrates (IC) and insulin for proteins and fats (IPF) based on individual insulin-to-carbohydrate ratio (ICR). Dual bolus will be given 15 minutes before the mixed meal (toast with cheese).', 'interventionNames': ['Drug: Insulin Glulisine', 'Drug: Insulin Aspart', 'Drug: Insulin Lispro']}, {'type': 'EXPERIMENTAL', 'label': '30%IC', 'description': 'Total meal bolus will consist of insulin for carbohydrates (IC) calculated based on individual insulin-to-carbohydrate ratio (ICR) and insulin for proteins and fats (IPF) estimated as 30% of IC. Dual bolus will be given 15 minutes before the mixed meal (toast with cheese).', 'interventionNames': ['Drug: Insulin Glulisine', 'Drug: Insulin Aspart', 'Drug: Insulin Lispro']}], 'interventions': [{'name': 'Insulin Glulisine', 'type': 'DRUG', 'otherNames': ['Apidra'], 'description': 'A kind of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.', 'armGroupLabels': ['30%IC', 'IPF']}, {'name': 'Insulin Aspart', 'type': 'DRUG', 'otherNames': ['NovoRapid'], 'description': 'A kind of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.', 'armGroupLabels': ['30%IC', 'IPF']}, {'name': 'Insulin Lispro', 'type': 'DRUG', 'otherNames': ['Humalog, Liprolog'], 'description': 'A kind of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.', 'armGroupLabels': ['30%IC', 'IPF']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Warsaw', 'country': 'Poland', 'facility': 'Warsaw Medical University', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}