Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-01 @ 6:27 PM
Study NCT ID:
NCT02087995
Status:
COMPLETED
Last Update Posted:
2017-08-24
First Post:
2014-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness and Safety Study of the Dexcom G4 Platinum With Modified Algorithm
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}], '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': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abalo@dexcom.com', 'phone': '8582000203', 'title': 'Andrew Balo/ EVP', 'organization': 'Dexcom, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '7 days of continuous glucose monitoring system use.', 'description': 'AEs assessed for all participants enrolled into the study', 'eventGroups': [{'id': 'EG000', 'title': 'Real Time Continuous Glucose Monitoring System', 'description': 'Real Time Continuous Glucose Monitoring System Wear over a 7 day period', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 1, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Blister, skin', 'notes': 'Skin blister from study procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Time Continuous Glucose Monitoring System', 'description': 'Real Time Continuous Glucose Monitoring System Wear over a 7 day period'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7-day wear period', 'description': 'The percentage of CGM system values that are within 20% of the reference value for YSI glucose levels \\> 80 mg/dL or within 20 mg/dL at the reference glucose levels \\< 80 mg/dL.', 'unitOfMeasure': 'Units analyzed% matched pairs w/i %20/20', 'reportingStatus': 'POSTED', 'populationDescription': 'For the demographic and other baseline characteristic information, data from all 51 enrolled subjects was summarized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Real Time Continuous Glucose Monitoring System', 'description': 'Real Time Continuous Glucose Monitoring System Wear over a 7 day period'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Real Time Continuous Glucose Monitoring System', 'description': 'Real Time Continuous Glucose Monitoring System Wear over a 7 day period'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.7', 'spread': '15.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years old', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Type 1 and Type 2 diabetes patients'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2014-02-03', 'resultsFirstSubmitDate': '2015-08-04', 'studyFirstSubmitQcDate': '2014-03-12', 'lastUpdatePostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-25', 'studyFirstPostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement.', 'timeFrame': '7-day wear period', 'description': 'The percentage of CGM system values that are within 20% of the reference value for YSI glucose levels \\> 80 mg/dL or within 20 mg/dL at the reference glucose levels \\< 80 mg/dL.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '25961446', 'type': 'DERIVED', 'citation': 'Peyser TA, Nakamura K, Price D, Bohnett LC, Hirsch IB, Balo A. Hypoglycemic Accuracy and Improved Low Glucose Alerts of the Latest Dexcom G4 Platinum Continuous Glucose Monitoring System. Diabetes Technol Ther. 2015 Aug;17(8):548-54. doi: 10.1089/dia.2014.0415. Epub 2015 May 11.'}]}, 'descriptionModule': {'briefSummary': 'To establish the performance of the Dexcom G4 Platinum with a Modified Algorithm continuous monitoring system when compared to a laboratory reference measurement.', 'detailedDescription': 'A study to evaluate the performance of a modification to the G4 Platinum CGM system in adults with diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18 years or older\n* Diagnosis of Type 1 diabetes or Type 2 diabetes on Intensive Insulin Therapy (ITT)\n* Willing to participate in a clinic session\n\nExclusion Criteria:\n\n* Use of Acetaminophen during study period\n* Pregnancy\n* Hematocrit (HCT) \\<35% (females) and 38% (males)\n* Dialysis, history of cardiovascular disease, epilepsy, severe migraines in the past 6 months, adrenal disease, syncope, significant hypoglycemia unawareness, or a history of severe hypoglycemia within the last 6 months.\n* Any condition that, in the opinion of the Investigator, would interfere with their participation in the study or pose and excessive risk to study staff.'}, 'identificationModule': {'nctId': 'NCT02087995', 'briefTitle': 'Effectiveness and Safety Study of the Dexcom G4 Platinum With Modified Algorithm', 'organization': {'class': 'INDUSTRY', 'fullName': 'DexCom, Inc.'}, 'officialTitle': 'Effectiveness and Safety Study of the Dexcom G4 Platinum With Modified Algorithm', 'orgStudyIdInfo': {'id': 'PTL901100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous Glucose Monitoring System', 'description': 'Single-Arm, CGM Device Glucose challenge performed during a clinic session to obtain accuracy data for the CGM system compared to a venous reference measurement', 'interventionNames': ['Device: Continuous Glucose Monitoring']}], 'interventions': [{'name': 'Continuous Glucose Monitoring', 'type': 'DEVICE', 'otherNames': ['CGM System', 'G4 Platinum CGM System', 'Dexcom G4 CGM System'], 'description': 'A prescribed clinic session day for participating subjects.', 'armGroupLabels': ['Continuous Glucose Monitoring System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'John Muir Physician Network Clinical Research', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '92026', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'AMCR Institute', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research, Inc.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}], 'overallOfficials': [{'name': 'Andy Balo', 'role': 'STUDY_CHAIR', 'affiliation': 'DexCom, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DexCom, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}