Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-27 @ 5:59 AM
Study NCT ID:
NCT02276859
Status:
COMPLETED
Last Update Posted:
2018-01-31
First Post:
2014-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normal Versus Dual Wave Insulin Bolus for High-protein Food
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': 'D061267', 'term': 'Insulin Aspart'}, {'id': 'D061268', 'term': 'Insulin Lispro'}, {'id': 'C479079', 'term': 'insulin glulisine'}], '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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2014-10-07', 'studyFirstSubmitQcDate': '2014-10-24', 'lastUpdatePostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial glycemia', 'timeFrame': '60 minutes after the meal', 'description': 'Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)'}, {'measure': 'Postprandial glycemia', 'timeFrame': '120 minutes after the meal', 'description': 'Post-prandial blood glucose excursions measured by self monitoring of blood glucose'}, {'measure': 'Postprandial glycemia', 'timeFrame': '180 minutes after the meal', 'description': 'Post-prandial blood glucose excursions measured by self monitoring of blood glucose'}], 'secondaryOutcomes': [{'measure': 'Hypoglycemia episodes', 'timeFrame': '3-hour study period', 'description': 'Hypoglycemia defined as a plasma glucose concentration below 65 mg/dl with or without symptoms'}, {'measure': 'Glucose Area Under the Curve (AUC)', 'timeFrame': '3-hour study period', 'description': 'measurements based on CGMS'}, {'measure': 'Mean amplitude of glycemic excursion', 'timeFrame': '3-hour study period', 'description': 'measurements based on CGMS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dual-wave bolus', 'square bolus', 'normal bolus', 'standard bolus', 'high-protein meal', 'prandial insulin requirement'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'Patients receive a standardized high-protein test meal at breakfast time. Insulin is given as bolus (normal or dual-wave (normal plus square) and basal rate using an insulin pump. The 3h post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG) (every 1 hour) and continuous glucose monitoring system (CGMS). The intervention is taking part under in-patient clinical conditions.', 'detailedDescription': "The dual-wave bolus delivers an immediate normal pre-meal insulin bolus followed by square-wave bolus that is evenly delivered over several hours as programmed by the patient. The aim of this study is to compare post-prandial glycaemic excursions following a high-protein meal after administration of insulin by normal vs dual-wave bolus. During this prospective, cross-over, repeated measures study, pediatric patients with type 1 diabetes, treated with insulin pump therapy will be evaluated using the self-blood glucose measurements following standardized high-protein meal and two types of boluses (normal or dual-wave). The required insulin dose will be calculated based on patient's insulin-exchange ratio. A high-protein meal will be given on two subsequent breakfasts and comparisons will be made between normal and dual-wave insulin bolus delivery. Prolonged post-prandial glycaemic excursions will be identified using the CGMS."}, '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* written informed consent by patients and parents\n* patients must be willing to wear a glucose sensor for two days\n* insulin requirement more than 0,5 units/kg/day\n\nExclusion Criteria:\n\n* concomitant dietary restrictions (e.g. celiac disease or food allergy)\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': 'NCT02276859', 'briefTitle': 'Normal Versus Dual Wave Insulin Bolus for High-protein Food', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'The Optimal Type of Bolus Following a High-protein Meal in Type 1 Diabetic Children Treated With Insulin Pumps', 'orgStudyIdInfo': {'id': 'Protein Food Insulin Bolus'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal/ Dual-wave', 'description': "On the first study day, pre-breakfast insulin was given as a normal bolus 15 minutes before a standardized high-protein meal. On the second day, pre-breakfast insulin was given as a dual-wave bolus before the same high-protein meal.\n\nThe carbo-insulin and fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial.\n\nKind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine", 'interventionNames': ['Drug: insulin aspart', 'Drug: insulin lispro', 'Drug: insulin glulisine']}, {'type': 'EXPERIMENTAL', 'label': 'Dual-wave/Normal', 'description': "On the first study day, pre-breakfast insulin was given as a dual-wave bolus 15 minutes before a standardized high-protein meal. On the second day, pre-breakfast insulin was given as a normal bolus before the same high-protein meal.\n\nThe carbo-insulin and fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial.\n\nKind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine", 'interventionNames': ['Drug: insulin aspart', 'Drug: insulin lispro', 'Drug: insulin glulisine']}], 'interventions': [{'name': 'insulin aspart', 'type': 'DRUG', 'otherNames': ['NovoRapid®'], 'description': 'A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial', 'armGroupLabels': ['Dual-wave/Normal', 'Normal/ Dual-wave']}, {'name': 'insulin lispro', 'type': 'DRUG', 'otherNames': ['Humalog®'], 'description': 'A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial', 'armGroupLabels': ['Dual-wave/Normal', 'Normal/ Dual-wave']}, {'name': 'insulin glulisine', 'type': 'DRUG', 'otherNames': ['Apidra®'], 'description': 'A kind of study bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial', 'armGroupLabels': ['Dual-wave/Normal', 'Normal/ Dual-wave']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01-184', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Department of Pediatrics, Medical University of Warsaw, Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Agnieszka Szypowska', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Alberta'}, {'name': 'Katarzyna Piechowiak', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}