Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-28 @ 7:34 PM
Study NCT ID:
NCT06372392
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-13', 'studyFirstSubmitDate': '2024-04-10', 'studyFirstSubmitQcDate': '2024-04-13', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in range (TIR)', 'timeFrame': '4 weeks', 'description': 'Comparision of TIR between groups'}], 'secondaryOutcomes': [{'measure': 'TBR', 'timeFrame': '4 weeks', 'description': 'Comparision of TBR between groups'}, {'measure': 'TAR', 'timeFrame': '4 weeks', 'description': 'Comparision of TAR between groups'}, {'measure': 'auto-corrections %', 'timeFrame': '4 weeks', 'description': 'auto-corrections % between groups'}, {'measure': 'coefficient of variability', 'timeFrame': '4 weeks', 'description': 'coefficient of variability between groups'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Type1diabetes']}, 'descriptionModule': {'briefSummary': 'Cross-over study of 20 pediatric patients (age 7-19) randomized to the group receiving universal fixed meal boluses coefficients (300/TDD for breakfast and 400/TDD other meal) or to the group with individualized coefficients for the period of 14 days with consecutive analysis of the results from Carelink Raport.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 7-19\n* type 1 diabetes diagnosed at least 1 year ago\n* insulin in the dose 0,5-1,0 units/day/kg\n* MiniMed 780G pump usage at least 1 month.\n\nExclusion Criteria:\n\n* Active coeliac disease\n* Chronic disease possible to influence diabetes treatment\n* Acute disease at the moment of recruitment'}, 'identificationModule': {'nctId': 'NCT06372392', 'briefTitle': 'Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps', 'organization': {'class': 'OTHER', 'fullName': 'Tartu University Hospital'}, 'officialTitle': 'Randomized Controlled Study of the Usage of Universal Fixed Meal Bolus Coefficients for the Control of Postprandial Hyperglycemia in the Users of Medtronic Minimed 780G Pumps', 'orgStudyIdInfo': {'id': '1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Universal coefficient', 'description': 'With fixed meal bolus coefficients (TDD/300 breakfast and TDD/400 other meals)', 'interventionNames': ['Device: Universal meal coefficient utilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Individualized coefficient', 'description': "With meal bolus coefficient individualized according to physician judgment's", 'interventionNames': ['Device: Universal meal coefficient utilization']}], 'interventions': [{'name': 'Universal meal coefficient utilization', 'type': 'DEVICE', 'description': 'Usage of universal fixed meal bolus coefficients for the control of postprandial hyperglycemia compared to individualized coefficients n the users of Medtronic Minimed 780G pumps', 'armGroupLabels': ['Individualized coefficient', 'Universal coefficient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50406', 'city': 'Tartu', 'state': 'Tartu', 'status': 'RECRUITING', 'country': 'Estonia', 'contacts': [{'name': 'Aleksandr Peet', 'role': 'CONTACT', 'email': 'aleksandr.peet@kliinikum.ee', 'phone': '5532256'}], 'facility': 'TartuUH', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}], 'centralContacts': [{'name': 'Aleksandr Peet, MD, PhD', 'role': 'CONTACT', 'email': 'aleksandr.peet@kliinikum.ee', 'phone': '5532256'}, {'name': 'Aleksandr Peet, MD, PhD', 'role': 'CONTACT', 'email': 'alekspt@hotmail.com', 'phone': '5532256'}], 'overallOfficials': [{'name': 'Aleksandr Peet', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tartu University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tartu University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Estonia Research Council', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatric endocrinologist (PI)', 'investigatorFullName': 'Aleksandr Peet', 'investigatorAffiliation': 'Tartu University Hospital'}}}}