Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT04721158
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2021-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
CGM Use in Children With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rwolf@jhu.edu', 'phone': '410-955-6463', 'title': 'Dr. Risa Wolf', 'organization': 'Johns Hopkins Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The limitations of this study include the small study size with a limited number of participants completing both 10-day trial period and 3/6-month follow up visits. There were a large number of patients who had device connectivity and adhesive issues. Many participants were lost to follow up.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'CGM Arm', 'description': 'Children with type 2 diabetes will wear a continuous glucose monitor for 10 days.\n\nContinuous glucose monitor: Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'DKA admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Time in Range Glucose Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM Sample Given', 'description': 'Youth with T2D \\> 3 months, on insulin, with no prior CGM use were enrolled'}], 'classes': [{'title': '5 days', 'categories': [{'measurements': [{'value': '49.2', 'spread': '38', 'groupId': 'OG000'}]}]}, {'title': '10 days', 'categories': [{'measurements': [{'value': '50.7', 'spread': '39', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days, 10 days', 'description': 'The percentage of total time that the patient uses the continuous glucose monitor (CGM) where the blood glucose falls between 70 and 180 mg/dL', 'unitOfMeasure': 'percentage of time in target range', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with CGM use at both 5-days and 10-days'}, {'type': 'PRIMARY', 'title': 'Hemoglobin A1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM Sample Given', 'description': 'Youth with T2D \\> 3 months, on insulin, with no prior CGM use were enrolled'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.2', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': '3-6 months', 'categories': [{'measurements': [{'value': '10.3', 'spread': '3.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 - 6 months', 'description': 'HbA1c at baseline and 3-6 month follow-up.', 'unitOfMeasure': 'percentage of glycosylated hemoglobin A1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with A1c available at baseline and 3-6 months'}, {'type': 'PRIMARY', 'title': 'More Frequent Insulin Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM Arm', 'description': 'Children with type 2 diabetes will wear a continuous glucose monitor for 10 days.\n\nContinuous glucose monitor: Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Sometimes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 days from CGM placement', 'description': 'Response to "Did you take your insulin more often than before?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with 10 day follow up surveys'}, {'type': 'PRIMARY', 'title': 'More Frequent Glycemic Control Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM Arm', 'description': 'Children with type 2 diabetes will wear a continuous glucose monitor for 10 days.\n\nContinuous glucose monitor: Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sometimes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 days', 'description': 'Response to "Do you look at or check your blood sugar more often than before?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who responded to the survey conducted at 10 day follow up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CGM Sample Given', 'description': 'Youth with T2D \\> 3 months, on insulin, with no prior CGM use were enrolled'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Device did not connect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CGM Arm', 'description': 'Children with type 2 diabetes will wear a continuous glucose monitor for 10 days.\n\nContinuous glucose monitor: Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'groupId': 'BG000', 'lowerLimit': '15', 'upperLimit': '17.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'groupId': 'BG000', 'lowerLimit': '7.3', 'upperLimit': '12.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Percentage of glycosylated hemoglobin', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-12', 'size': 371598, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-12T23:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-22', 'studyFirstSubmitDate': '2021-01-19', 'resultsFirstSubmitDate': '2023-07-13', 'studyFirstSubmitQcDate': '2021-01-19', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-13', 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Time in Range Glucose Control', 'timeFrame': '5 days, 10 days', 'description': 'The percentage of total time that the patient uses the continuous glucose monitor (CGM) where the blood glucose falls between 70 and 180 mg/dL'}, {'measure': 'Hemoglobin A1c', 'timeFrame': 'Baseline, 3 - 6 months', 'description': 'HbA1c at baseline and 3-6 month follow-up.'}, {'measure': 'More Frequent Insulin Administration', 'timeFrame': '10 days from CGM placement', 'description': 'Response to "Did you take your insulin more often than before?"'}, {'measure': 'More Frequent Glycemic Control Monitoring', 'timeFrame': '10 days', 'description': 'Response to "Do you look at or check your blood sugar more often than before?"'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['continuous glucose monitoring (CGM)', 'Hemoglobin A1c'], 'conditions': ['Type 2 Diabetes', 'Hyperglycemia Due to Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '40303266', 'type': 'DERIVED', 'citation': 'Phu A, Lin T, Manfredo JA, Brown EA, Wolf RM. Similar Perceptions on Continuous Glucose Monitor Use amongst Youth with Type 1 and Type 2 Diabetes. Pediatr Diabetes. 2023 Jun 19;2023:1979635. doi: 10.1155/2023/1979635. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for a 10 day wear period in pediatric Type 2 diabetes patients improves short term time in range glucose control and 3-6 month glycemic control.', 'detailedDescription': 'The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for 10 days has an impact on short and long term glycemic control and behavior in youth onset Type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes, diabetes duration \\>3 months\n\nExclusion Criteria:\n\n* Prior use of CGM'}, 'identificationModule': {'nctId': 'NCT04721158', 'acronym': 'IMPaCT2', 'briefTitle': 'CGM Use in Children With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'IMPlementation of Continuous Glucose Monitoring in Children With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'IRB00255470-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CGM Arm', 'description': 'Children with type 2 diabetes will wear a continuous glucose monitor for 10 days.', 'interventionNames': ['Device: Continuous glucose monitor']}], 'interventions': [{'name': 'Continuous glucose monitor', 'type': 'DEVICE', 'otherNames': ['Dexcom G6 CGM'], 'description': 'Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.', 'armGroupLabels': ['CGM Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Pediatric Diabetes Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Risa M Wolf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}