Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-04-14 @ 12:11 PM
Study NCT ID:
NCT02880267
Status:
COMPLETED
Last Update Posted:
2018-12-31
First Post:
2016-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-27', 'studyFirstSubmitDate': '2016-08-23', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a proportion of blood glucose values, compared between CGM and a lab glucose analyzer matched to an accuracy measurement of %20/20 mg/dL', 'timeFrame': '10 Days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring (CGM) System', 'detailedDescription': 'The objective of the study is to establish performance of the System compared to a laboratory reference measurement. The effectiveness of the System will be evaluated by comparison of CGM values to a laboratory reference, Yellow Spring Instrument (YSI), using arterialized venous sample measurements. Performance will be evaluated in terms of point and rate accuracy of the System in reference to YSI.\n\nThe safety profile of the System will be characterized by the incidence of device-related Adverse Events (AEs) experienced by study subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 2 or older\n* Diagnosis of Type 1 diabetes or Type 2 diabetes, on intensive insulin therapy\n* Willing to participate in a clinic session involving venous sampling for evaluation of study end point\n\nExclusion Criteria:\n\n* Use of acetaminophen\n* Known allergy to medical-grade adhesives\n* Pregnancy\n* Hematocrit outside specification of the study-assigned blood glucose meter'}, 'identificationModule': {'nctId': 'NCT02880267', 'briefTitle': 'Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System', 'organization': {'class': 'INDUSTRY', 'fullName': 'DexCom, Inc.'}, 'officialTitle': 'Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System', 'orgStudyIdInfo': {'id': 'PTL-902220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CGM Users', 'description': 'Glucose challenge during a clinic sessions to assess performance of CGM compared to reference measurement', 'interventionNames': ['Device: CGM']}], 'interventions': [{'name': 'CGM', 'type': 'DEVICE', 'description': 'Glucose challenge during a clinic session to assess CGM performance compared to a laboratory reference measurement.', 'armGroupLabels': ['CGM Users']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'AMCR Institute', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Sansum', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Diabetes', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Joslin Diabetes Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Rainier', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'David PRice, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'DexCom, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DexCom, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}