Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-05 @ 1:33 AM
Study NCT ID:
NCT06687434
Status:
RECRUITING
Last Update Posted:
2025-05-20
First Post:
2024-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carb Counting vs. Simplified Qualitative Meal-Size Estimation
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2024-11-12', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of time in target range (70-18mg/dl)', 'timeFrame': 'Screening, after 4-6 weeks, after 3 months and after 6 months'}, {'measure': 'Hemoglobin A1C', 'timeFrame': 'Screening, after 4-6 weeks, after 3 months and after 6 months'}, {'measure': 'Percentage Continuous glucose monitoting usage', 'timeFrame': 'Screening, after 4-6 weeks, after 3 months and after 6 months'}, {'measure': 'Number of Episodes of severe hypoglycemia', 'timeFrame': 'Screening, after 4-6 weeks, after 3 months and after 6 months'}, {'measure': 'Number of episodes of Diabetic Ketoacidosis', 'timeFrame': 'Screening, after 4-6 weeks, after 3 months and after 6 months'}], 'secondaryOutcomes': [{'measure': 'Total daily insulin dose', 'timeFrame': 'at screening, after 4-6 weeks, after 3 months and after 6 months.'}, {'measure': 'basal insulin dose', 'timeFrame': 'at screening, after 4-6 weeks, after 3 months and after 6 months.'}, {'measure': 'Number of manual boluses per day', 'timeFrame': 'at screening, after 4-6 weeks, after 3 months and after 6 months.'}, {'measure': 'Number of announced meals per day', 'timeFrame': 'at screening, after 4-6 weeks, after 3 months and after 6 months.'}, {'measure': 'Daily carbohydrates input', 'timeFrame': 'at screening, after 4-6 weeks, after 3 months and after 6 months.'}, {'measure': 'Percentage of automated insulin delivery use', 'timeFrame': 'at screening, after 4-6 weeks, after 3 months and after 6 months.'}, {'measure': 'Number of automated insulin delivery exits per week', 'timeFrame': 'at screening, after 4-6 weeks, after 3 months and after 6 months.'}, {'measure': 'Percentage of automated boluses', 'timeFrame': 'at screening, after 4-6 weeks, after 3 months and after 6 months.'}, {'measure': 'Score of Diabetes distress according to questionnaire', 'timeFrame': 'At screening and after 6 months'}, {'measure': 'Score of Disordered eating behaviors according to quesiotnnaire', 'timeFrame': 'At screening and after 6 months'}, {'measure': 'Score of Dietary regimen according to questionnaire', 'timeFrame': 'At screening and after 6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Automated insulin delivery system', 'carb counting'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': "The goal of this study is to compare qualitative meal-size estimation to accurate carb counting in adolescents with Type One Diabetes using all available AID (Automated Insulin Delivery) systems. We will compare glucose control parameters and patient related outcome measures between the groups. 120 children and adolescents with type 1 Diabetes who begin using AID system will be randomly assigned to one of two groups: simplified qualitative meal size estimation or accurate carb counting. The study will last 6 months, with an additional optional follow up points at 12 and 24 months.\n\nIn the first visit all patients will receive nutrition guidance from the dietitian. In the accurate carb counting group, participants will use precise carb counting to manage their meals. In the simplified qualitative meal-size estimation group, participants will use a simplified meal announcement based on three presets for each meal, small, medium, or large, which will be personalized based on the dietitian's assessment. During the study, the dietitian will evaluate the insulin-to-carb ratio and meal estimation at least once in the first two weeks.\n\nFollow-up visits will be scheduled at 4-6 weeks, 3, and 6 months after the study's initiation. At each visit participants will upload their data from their AID systems. Evaluation of their diabetes control will be made and an assessment regarding the carbohydrates calculation method. Digital questionnaires assessing diabetes distress, disordered eating behaviors, dietary regimen, and eating patterns will be provided at the beginning of the study and after 6 months, with an additional optional follow-up points that will be held at 12 and 24 months after the study's initiation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. T1D- diagnosed\n2. Age 6-18 years\n3. Treated with insulin (multiple daily injections or pump) and intending to initiate treatment with AID systems\n\nExclusion Criteria:\n\n1. Non-T1D\n2. Unstable medical conditions (other than diabetes) that may impact weight or diabetes management (as severe psychiatric disorders, various syndromes)\n3. Use of medications that may impact weight or diabetes management (as use of steroids for an extended period of time. use of GLP-1)\n4. Inability to understand the information, material and questionnaires of the study -'}, 'identificationModule': {'nctId': 'NCT06687434', 'briefTitle': 'Carb Counting vs. Simplified Qualitative Meal-Size Estimation', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Carb Counting vs. Simplified Qualitative Meal-Size Estimation- A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'RMC-0411-24ctil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Accurate carb counting', 'description': 'Participants will use precise carb counting to manage their meals', 'interventionNames': ['Behavioral: accurate carb counting']}, {'type': 'EXPERIMENTAL', 'label': 'Simplified qualitative meal-size estimation', 'description': 'Participants will use a simplified meal announcement based on three presets for each meal, small, medium, or large, which will be personalized based on the dietitian assessment.', 'interventionNames': ['Behavioral: Simplified qualitative meal size estimation']}], 'interventions': [{'name': 'accurate carb counting', 'type': 'BEHAVIORAL', 'description': 'Participants will use precise carb counting to manage their meals', 'armGroupLabels': ['Accurate carb counting']}, {'name': 'Simplified qualitative meal size estimation', 'type': 'BEHAVIORAL', 'description': "participants will use a simplified meal announcement based on three presets for each meal, small, medium, or large, which will be personalized based on the dietitian's assessment.", 'armGroupLabels': ['Simplified qualitative meal-size estimation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4920235', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Alona Hamou, Msc', 'role': 'CONTACT', 'email': 'alonah@clalit.org.il', 'phone': '972-545-950277'}], 'facility': "Schneider Children's Medical Center", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Tal Oron, DR.', 'role': 'CONTACT', 'email': 'talo@clalit.org.il', 'phone': '972-544-290-296'}, {'name': 'Michal Gilon Keren, Phd', 'role': 'CONTACT', 'email': 'michalgk@clalit.org.il', 'phone': '972-524-311292'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}