Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-31 @ 9:29 PM
Study NCT ID:
NCT04905628
Status:
UNKNOWN
Last Update Posted:
2022-02-21
First Post:
2021-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-17', 'studyFirstSubmitDate': '2021-05-24', 'studyFirstSubmitQcDate': '2021-05-24', 'lastUpdatePostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dexcom Continuous Glucose Monitoring (CGM) System Performance', 'timeFrame': '10 Days', 'description': 'The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to Yellow Springs Instrument (YSI) comparator venous plasma measurements'}], 'secondaryOutcomes': [{'measure': 'System Related Adverse Device Effects', 'timeFrame': '10 Days', 'description': 'The Dexcom Continuous Glucose Monitoring (CGM) System will be characterized by Adverse Device Effects experienced by study participants'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '38315503', 'type': 'DERIVED', 'citation': "Polsky S, Valent AM, Isganaitis E, Castorino K, O'Malley G, Beck SE, Gao P, Laffel LM, Brown FM, Levy CJ. Performance of the Dexcom G7 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Diabetes Technol Ther. 2024 May;26(5):307-312. doi: 10.1089/dia.2023.0516. Epub 2024 Mar 1."}]}, 'descriptionModule': {'briefSummary': 'Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Age ≥ 18 years\n2. Confirmed pregnancy\n3. Diagnosis of Gestational Diabetes (GDM), Type 1 Diabetes Mellitus (T1DM), or Type 2 Diabetes Mellitus (T2DM)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed pregnancy\n* Diagnosis of Gestational Diabetes (GDM), Type 1 Diabetes Mellitus (T1DM), or Type 2 Diabetes Mellitus (T2DM)\n* Willing to wear up to the required number of Systems for the total duration of study wear\n* Able to follow study procedures;\n* Able to speak, read, and write in English or Spanish.\n\nExclusion Criteria:\n\n* Extensive skin changes/diseases that preclude wearing the required number of Systems at the proposed wear sites\n* Known allergy to medical-grade adhesives\n* Hematocrit outside specification\n* Prescribed drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications during current pregnancy\n* Currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period\n* Currently using Hydroxyurea for treatment\n* Require a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the sensor wear period'}, 'identificationModule': {'nctId': 'NCT04905628', 'briefTitle': 'Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'DexCom, Inc.'}, 'officialTitle': 'Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'PTL-904284'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dexcom CGM System', 'description': 'Dexcom CGM System', 'interventionNames': ['Device: Dexcom CGM System']}], 'interventions': [{'name': 'Dexcom CGM System', 'type': 'DEVICE', 'description': 'Dexcom CGM System', 'armGroupLabels': ['Dexcom CGM System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nina Shelton', 'role': 'CONTACT', 'email': 'nshelton@sansum.org'}, {'name': 'Kristin Castorino, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sansum Diabetes Research Institute', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christie Beatson, RD, CDE', 'role': 'CONTACT', 'email': 'CHRISTIE.BEATSON@CUANSCHUTZ.EDU'}, {'name': 'Sarit Polsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Barbara Davis Center for Childhood Diabetes', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "Julianne O'Connell", 'role': 'CONTACT', 'email': 'julianne.oconnell@joslin.harvard.edu'}, {'name': 'Florence Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Joslin Diabetes Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Selassie Ogyaadu', 'role': 'CONTACT', 'email': 'selassie.ogyaadu@mssm.edu'}, {'name': 'Carol Levy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Monica Rincon', 'role': 'CONTACT', 'email': 'mfmresearch@ohsu.edu'}, {'name': 'Amy Valent, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'Stayce Beck, PhD, MPH', 'role': 'CONTACT', 'email': 'PTL904284@dexcom.com', 'phone': '858-203-6454'}, {'name': 'Nelly Njeru', 'role': 'CONTACT', 'email': 'PTL904284@dexcom.com', 'phone': '858-203-6379'}], 'overallOfficials': [{'name': 'Carol Levy, MD, CDCES', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}, {'name': 'Sarit Polsky,, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barbara Davis Center'}, {'name': 'Florence Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Joslin Diabetes Center'}, {'name': 'Kristin Castorino, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sansum Diabetes Research Institute'}, {'name': 'Amy Valent, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DexCom, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}