Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-30 @ 10:57 PM
Study NCT ID:
NCT05066893
Status:
UNKNOWN
Last Update Posted:
2021-10-04
First Post:
2021-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Boot Camp Program
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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-11-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-23', 'studyFirstSubmitDate': '2021-09-23', 'studyFirstSubmitQcDate': '2021-09-23', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes', 'Children, Only']}, 'descriptionModule': {'briefSummary': 'An intensive 13 weeks program that aims to improve glucose control in children with type 1 diabetes.', 'detailedDescription': 'Our new PeDi-BoCa Program aims to help children with type 1 diabetes achieve better diabetes control by interacting weekly with their doctor/nurse practitioner (NP) and also by using a "smart pen" that can facilitate the burden of daily calculations with the use of an app on the phone.\n\nYour child\'s doctor/NP will be able to remotely monitor your child\'s glucose every week (Dexcom) and make recommendations for changes, discuss solutions to possible obstacles and offer intensive diabetes education.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 11-18 years old\n2. HbA1c \\> 8.5%\n3. Duration of type 1 diabetes \\>1 year\n4. Child uses Dexcom and has a phone that is compatible with the InPen app and Dexcom Clarity app.\n\nExclusion Criteria:\n\nNot able to attend telehealth visits'}, 'identificationModule': {'nctId': 'NCT05066893', 'briefTitle': 'Pediatric Boot Camp Program', 'organization': {'class': 'OTHER', 'fullName': 'Georgetown University'}, 'officialTitle': 'Type 1 Diabetes Boot Camp Program: An Intensive Program to Improve Glycemic Control in Adolescents With Type 1 Diabetes', 'orgStudyIdInfo': {'id': '2604'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard of care', 'description': 'standard of care will be given as per usual care', 'interventionNames': ['Other: telehealth visits']}, {'type': 'EXPERIMENTAL', 'label': 'intensive monitoring', 'description': 'intensive monitoring every week will be given to participants', 'interventionNames': ['Other: telehealth visits']}], 'interventions': [{'name': 'telehealth visits', 'type': 'OTHER', 'description': 'intensive visits with doctor', 'armGroupLabels': ['intensive monitoring', 'standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Barbara Runner', 'role': 'CONTACT', 'email': 'diabetes@georgetown.edu', 'phone': '202-243-3560', 'phoneExt': '5'}, {'name': 'Evgenia Gourgari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medstar Pediatrics', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgetown University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}