Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-29 @ 12:12 AM
Study NCT ID:
NCT05568134
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2022-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alternate Measures of Glucose During OGTT Testing for CFRD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005951', 'term': 'Glucose Tolerance Test'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2022-10-03', 'studyFirstSubmitQcDate': '2022-10-03', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose', 'timeFrame': 'Fasting glucose before OGTT', 'description': 'Differences in fasting glucose will be measured by the difference in mg/dl between plasma glucose, CGM measured glucose, and GTT@home measured glucose.'}, {'measure': 'Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose', 'timeFrame': '1 hour mark in OGTT', 'description': 'Differences in the 1 hour glucose during the OGTT will be measured by the difference in mg/dl between plasma glucose, CGM measured glucose, and GTT@home measured glucose.'}, {'measure': 'Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose', 'timeFrame': '2 hour mark in OGTT', 'description': 'Differences in the 2 hour glucose during the OGTT will be measured by the difference in mg/dl between plasma glucose, CGM measured glucose, and GTT@home measured glucose.'}], 'secondaryOutcomes': [{'measure': 'Agreement between the categorical diagnosis of normal glucose tolerance (NGT), impaired glucose tolerance (IGT), indeterminate glycemia (INDET), and CFRD as defined by plasma glucose, CGM glucose, and GTT@home glucose.', 'timeFrame': 'Up to 2 hours', 'description': 'Categorical diagnosis of glucose tolerance as measured by plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose.'}, {'measure': 'Difference between plasma glucose and CGM measured glucose after the fasting glucose', 'timeFrame': 'Up to 20 minutes after the fasting glucose', 'description': 'Absolute differences between the glucose measurements will be measured in mg/dL'}, {'measure': 'Difference between plasma glucose and CGM measured glucose after the 1 hour mark during the OGTT.', 'timeFrame': 'Up to 20 minutes after the 1 hour mark in the OGTT', 'description': 'Absolute differences between the glucose measurements will be measured in mg/dL'}, {'measure': 'Difference between plasma glucose and CGM measured glucose after the 2 hour mark during the OGTT.', 'timeFrame': 'Up to 20 minutes after the 2 hour mark in the OGTT', 'description': 'Absolute differences between the glucose measurements will be measured in mg/dL'}, {'measure': 'The ability of untrained participants to successfully complete the GTT@home kit without any guidance from the research team', 'timeFrame': 'Up to 2 hours', 'description': 'Number of steps successfully completed as measured by the GTT@home instruction manual.'}, {'measure': "Impact of wearing a real-time CGM on participants' awareness of the importance of screening for and diagnosing CFRD.", 'timeFrame': 'Within 2 weeks after removal of the CGM', 'description': '60 minute semi-structured interviews will be conducted with participants. Transcripts will be analyzed using semantic content analysis'}, {'measure': 'Perceived benefits and burdens of CGM use', 'timeFrame': 'Within 2 weeks after removal of the CGM', 'description': "Participants will complete a CGM Benefits and Burdens survey, a 16-item measure used to assess perceptions of CGM technology in people with type 1 diabetes. Surveys may be completed on paper or online, as per the participant's preference. The survey is scored on a 5-point scale (agree/disagree scale)."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['continuous glucose monitor', 'oral glucose tolerance test'], 'conditions': ['Cystic Fibrosis', 'Cystic Fibrosis-related Diabetes']}, 'descriptionModule': {'briefSummary': 'Although early detection and treatment of cystic fibrosis-related diabetes (CFRD) can lead to significant clinical improvements and prolong life, rates of screening are poor likely due to the burdensome nature of oral glucose tolerance testing (OGTT). The investigators propose to assess the feasibility and accuracy of two screening tools, continuous glucose monitoring (CGM) and a home OGTT kit (GTT@home). If this pilot study reveals acceptable accuracy of either device, this study will allow for future studies exploring home-based OGTT screening.', 'detailedDescription': 'The investigators hypothesize that there will be strong agreement between plasma glucose and glucose as measured by either CGM or GTT@home at three different timepoints during an OGTT: fasting, 1-hour, and 2-hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 15 subjects with cystic fibrosis (CF) over 10 years of age will be approached to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cystic fibrosis\n* ≥ 10 years of age\n* Fluency in written and spoken English as the GTT@Home is currently only available in English\n\nExclusion Criteria:\n\n* Hospitalization or treatment with IV antibiotics or supraphysiologic glucocorticoids within 4 weeks\n* Major medical or psychiatric disorders other than CF\n* Use of medications known to impact the accuracy of the Dexcom G7 (hydroxyurea, \\>2g acetaminophen per day)\n* History of severe adhesive reactions that may lead to an inability to tolerate CGM wear'}, 'identificationModule': {'nctId': 'NCT05568134', 'briefTitle': 'Alternate Measures of Glucose During OGTT Testing for CFRD', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Correlations Between CGM and Serum Glucose During OGTT Testing for CFRD', 'orgStudyIdInfo': {'id': '22-020249'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OGTT Cohort', 'description': 'All enrolled participants will complete an OGTT.', 'interventionNames': ['Diagnostic Test: Oral glucose tolerance test']}], 'interventions': [{'name': 'Oral glucose tolerance test', 'type': 'DIAGNOSTIC_TEST', 'description': 'An oral glucose tolerance test will be completed. A fasting glucose will be measured.\n\nParticipants will drink 1.75 g/kg of dextrose (up to a maximum of 75 grams) within 10 minutes. Glucose values will be measured at 1 hour and 2 hours.', 'armGroupLabels': ['OGTT Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'Cystic Fibrosis Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}