Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-03-04 @ 12:02 PM
Study NCT ID:
NCT03039933
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2016-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-08', 'studyFirstSubmitDate': '2016-12-19', 'studyFirstSubmitQcDate': '2017-01-31', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in scores on the Hypoglycemia Fear Survey', 'timeFrame': 'Baseline, 3 and 6 months', 'description': 'To address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by evaluating the efficacy of Blood Glucose Awareness Training as compared to treatment as usual.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type1diabetes', 'Fear of Hypoglycemia']}, 'descriptionModule': {'briefSummary': 'The overall objective and Primary Aim of this Limited Competition: Small Grant Program (R03) is to address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by conducting a pilot randomized clinical trial to evaluate the efficacy of Blood Glucose Awareness Training, which has been adapted for, but never evaluated in adolescents with Type 1 Diabetes (T1D) and their parents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adolescents aged 10-17 years and their parent(s) or legal guardian;\n* T1D duration \\>1 year;\n* insulin pump use \\>6 months;\n* agreement of both parent and adolescent to participate in intervention sessions;\n* elevated scores on the Parent Hypoglycemia Fear Survey - Behavior Subscale.\n\nExclusion Criteria:\n\n* developmental disability or reading disorder that prevents understanding of the intervention materials; and\n* non-English speaking adolescents and parents.'}, 'identificationModule': {'nctId': 'NCT03039933', 'briefTitle': 'Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes', 'orgStudyIdInfo': {'id': '16-0645'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fear of Hypoglycemia Intervention', 'description': 'Cognitive behavioral therapy based psychological intervention occurring every other week for 12 weeks.', 'interventionNames': ['Behavioral: Fear of Hypoglycemia']}, {'type': 'OTHER', 'label': 'Treatment As Usual', 'description': 'Control group completes questionnaires but does not receive any study intervention. Receives medical care as usual.', 'interventionNames': ['Other: Treatment As Usual']}], 'interventions': [{'name': 'Fear of Hypoglycemia', 'type': 'BEHAVIORAL', 'description': 'Participants will receive exposure and response prevention and/or hypoglycemia awareness training.', 'armGroupLabels': ['Fear of Hypoglycemia Intervention']}, {'name': 'Treatment As Usual', 'type': 'OTHER', 'otherNames': ['Standard of Care'], 'description': 'Treatment As Usual', 'armGroupLabels': ['Treatment As Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado, Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Kimberly Driscoll, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Virginia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}