Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
Study NCT ID:
NCT05714761
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2023-01-27
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Postpartum Continuous Glucose Monitoring (CGM) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'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': 'omallg01@mssm.edu', 'phone': '212-241-7173', 'title': "Dr. Grenye O'Malley", 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Postpartum Glucose Sensor', 'description': 'Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.\n\nDexcom glucose sensor: Use of a Dexcom G6 Pro', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Second Sensor', 'description': 'Participants given a second sensor at 6 weeks after pregnancy complicated by GDM and worn at home for up to 10 days.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With at Least 72 Hours of CGM Data Downloaded.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Postpartum Glucose Sensor', 'description': 'Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.\n\nDexcom glucose sensor: Use of a Dexcom G6 Pro'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Postpartum days 10-20', 'description': 'Number of participants who returned first sensors and had at least 72 hours of CGM data downloaded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Postpartum Glucose Sensor', 'description': 'Glucose sensor worn postpartum days 1-13 and at time of glucose tolerance test.\n\nDexcom glucose sensor: Use of a Dexcom G6 Pro'}, {'id': 'OG001', 'title': 'Second Sensor', 'description': 'Participants given a second sensor at 6 weeks after pregnancy complicated by GDM and worn at home for up to 10 days at time of glucose tolerance test. Data collected for 4-12 weeks postpartum.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '83.33', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 12 weeks postpartum', 'description': 'Specificity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The specificity of a test is the number and proportion of people who test negative among all those who actually do not have that disease. A higher specificity in a test indicates it is better at correctly identifying individuals with the condition.\n\nSpecificity for Time in Range 70-180 mg/dL of \\<96% for abnormal OGTT is reported.', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'Results for usable data'}, {'type': 'SECONDARY', 'title': 'Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Postpartum Glucose Sensor', 'description': 'Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.\n\nDexcom glucose sensor: Use of a Dexcom G6 Pro'}, {'id': 'OG001', 'title': 'Second Sensor', 'description': 'Participants given a second sensor at 6 weeks after pregnancy complicated by GDM and worn at home for up to 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '66.67', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 12 weeks postpartum', 'description': 'Sensitivity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The sensitivity of a test is the number of people who test positive among all those who actually have the disease. A higher sensitivity in a test indicates it is better at correctly identifying those who have the condition and not missing cases.\n\nSensitivity for Time in Range 70-180 mg/dL of \\<96% for abnormal OGTT is reported.', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'Results for usable data'}, {'type': 'SECONDARY', 'title': 'Positive Predictive Value (PPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Postpartum Glucose Sensor', 'description': 'Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.\n\nDexcom glucose sensor: Use of a Dexcom G6 Pro'}, {'id': 'OG001', 'title': 'Second Sensor', 'description': 'Participants given a second sensor at 6 weeks after pregnancy complicated by GDM and worn at home for up to 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 12 weeks postpartum', 'description': 'PPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Positive predictive value is the probability that following a positive test result, that individual will truly have that specific disease.\n\nPositive predictive value (PPV) of Time in Range 70-180 mg/dL of \\<96% to predict abnormal OGTT is reported.', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Positive Likelihood Ratio (PLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Postpartum Glucose Sensor', 'description': 'Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.\n\nDexcom glucose sensor: Use of a Dexcom G6 Pro'}, {'id': 'OG001', 'title': 'Second Sensor', 'description': 'Participants given a second sensor at 6 weeks after pregnancy complicated by GDM and worn at home for up to 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '3.83', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 12 weeks postpartum', 'description': 'PLR for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. PLR compares the likelihood of a positive test result in people with a disease to the likelihood in people without the disease and is used to help determine how likely a disease is present if a test is positive. The higher the PRL, the stronger the evidence that a positive test result supports the presence of the condition.\n\nPLR of Time in Range 70-180 mg/dL of \\<96% to predict abnormal OGTT is reported.', 'unitOfMeasure': 'ratio', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Negative Predictive Value (NPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Postpartum Glucose Sensor', 'description': 'Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.\n\nDexcom glucose sensor: Use of a Dexcom G6 Pro'}, {'id': 'OG001', 'title': 'Second Sensor', 'description': 'Participants given a second sensor at 6 weeks after pregnancy complicated by GDM and worn at home for up to 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 12 weeks postpartum', 'description': 'NPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Negative predictive value is the probability that following a negative test result, that individual will truly not have that specific disease.\n\nNPV of Time in Range 70-180 mg/dL of \\<96% to predict abnormal OGTT is reported.', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Negative Likelihood Ratio (NLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Postpartum Glucose Sensor', 'description': 'Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.\n\nDexcom glucose sensor: Use of a Dexcom G6 Pro'}, {'id': 'OG001', 'title': 'Second Sensor', 'description': 'Participants given a second sensor at 6 weeks after pregnancy complicated by GDM and worn at home for up to 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 12 weeks postpartum', 'description': 'NLR estimates how likely a patient is to not have a disease after a negative test. The lower the NRL, the stronger the evidence that a negative test result supports the absence of the condition.\n\nNLR of Time in Range 70-180 mg/dL of \\<96% to predict abnormal OGTT is reported.', 'unitOfMeasure': 'ratio', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Postpartum Glucose Sensor', 'description': 'Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.\n\nDexcom glucose sensor: Use of a Dexcom G6 Pro'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'CGM Returned', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'Completed Routine Postpartum Oral Glucose Tolerance Test (OGTT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'Returned the Second CGM Sensor', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'unblinding of sensor data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'did not complete routine postpartum OGTT', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'did not return second CGM sensor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Recruitment was conducted from February 2023-January 2024 at a single urban medical center.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Postpartum Glucose Sensor', 'description': 'Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.\n\nDexcom glucose sensor: Use of a Dexcom G6 Pro'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'spread': '5.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Non-Hispanic White', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Non-Hispanic Black', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pre-pregnancy body mass index', 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'groupId': 'BG000', 'lowerLimit': '23.8', 'upperLimit': '30.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Insurance type', 'classes': [{'categories': [{'title': 'Commercial', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Medicaid', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education Level', 'classes': [{'categories': [{'title': 'Some high school or less', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'High school/GED', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Some college', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'College degree', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Post college', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Prefer not to answer', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Family history of type 2 diabetes', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Multigravida', 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational diabetes (GDM) in prior pregnancy', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of prenatal visits', 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'spread': '4.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'visits', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'GDM management', 'classes': [{'categories': [{'title': 'Diet/Lifestyle only', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Oral agents', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Insulin', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertensive complications', 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Delivery type', 'classes': [{'categories': [{'title': 'Vaginal', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'C-section', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-21', 'size': 489253, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-07T15:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2023-01-27', 'resultsFirstSubmitDate': '2025-02-24', 'studyFirstSubmitQcDate': '2023-01-27', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-14', 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With at Least 72 Hours of CGM Data Downloaded.', 'timeFrame': 'Postpartum days 10-20', 'description': 'Number of participants who returned first sensors and had at least 72 hours of CGM data downloaded.'}], 'secondaryOutcomes': [{'measure': 'Specificity', 'timeFrame': 'up to 12 weeks postpartum', 'description': 'Specificity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The specificity of a test is the number and proportion of people who test negative among all those who actually do not have that disease. A higher specificity in a test indicates it is better at correctly identifying individuals with the condition.\n\nSpecificity for Time in Range 70-180 mg/dL of \\<96% for abnormal OGTT is reported.'}, {'measure': 'Sensitivity', 'timeFrame': 'up to 12 weeks postpartum', 'description': 'Sensitivity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The sensitivity of a test is the number of people who test positive among all those who actually have the disease. A higher sensitivity in a test indicates it is better at correctly identifying those who have the condition and not missing cases.\n\nSensitivity for Time in Range 70-180 mg/dL of \\<96% for abnormal OGTT is reported.'}, {'measure': 'Positive Predictive Value (PPV)', 'timeFrame': 'up to 12 weeks postpartum', 'description': 'PPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Positive predictive value is the probability that following a positive test result, that individual will truly have that specific disease.\n\nPositive predictive value (PPV) of Time in Range 70-180 mg/dL of \\<96% to predict abnormal OGTT is reported.'}, {'measure': 'Positive Likelihood Ratio (PLR)', 'timeFrame': 'up to 12 weeks postpartum', 'description': 'PLR for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. PLR compares the likelihood of a positive test result in people with a disease to the likelihood in people without the disease and is used to help determine how likely a disease is present if a test is positive. The higher the PRL, the stronger the evidence that a positive test result supports the presence of the condition.\n\nPLR of Time in Range 70-180 mg/dL of \\<96% to predict abnormal OGTT is reported.'}, {'measure': 'Negative Predictive Value (NPV)', 'timeFrame': 'up to 12 weeks postpartum', 'description': 'NPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Negative predictive value is the probability that following a negative test result, that individual will truly not have that specific disease.\n\nNPV of Time in Range 70-180 mg/dL of \\<96% to predict abnormal OGTT is reported.'}, {'measure': 'Negative Likelihood Ratio (NLR)', 'timeFrame': 'up to 12 weeks postpartum', 'description': 'NLR estimates how likely a patient is to not have a disease after a negative test. The lower the NRL, the stronger the evidence that a negative test result supports the absence of the condition.\n\nNLR of Time in Range 70-180 mg/dL of \\<96% to predict abnormal OGTT is reported.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['gestational diabetes', 'oral glucose tolerance test', 'glucose sensor'], 'conditions': ['Gestational Diabetes']}, 'descriptionModule': {'briefSummary': 'This research study is being done to assess if using a glucose sensor (also known as a continuous glucose monitor) after childbirth can help identify women who are at risk of developing diabetes after having diabetes during pregnancy or gestational diabetes. Currently, screening for diabetes after childbirth is performed with an oral glucose tolerance test 6-12 weeks after delivery, but this is burdensome. This study will use a glucose sensor worn on the skin for 10 days. The data from the sensor will be compared to the standard oral glucose tolerance test. This is a single site study at the Icahn School of Medicine at Mount Sinai. The research team plans to enroll 50 participants aged 18years or older into the study. Participation in the study is expected to last up to 20 weeks and involves 4-5 visits depending on if enrollment is in the 3rd trimester of pregnancy or immediate postpartum. Study procedures include 1. Consent \\& screening. 2.Sensor placement and download after 10 days of wear. 3. a second sensor placement 2-5 days before oral glucose tolerance test (OGTT).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* include diagnosis of gestational diabetes during a current or recent pregnancy\n* age 18 or older.\n\nExclusion criteria:\n\n* include known pregestational diabetes,\n* known skin adhesive allergy which would prevent subject from wearing a CGM,\n* chronic glucocorticoid use which is planned to be ongoing after labor and delivery discharge.'}, 'identificationModule': {'nctId': 'NCT05714761', 'briefTitle': 'Postpartum Continuous Glucose Monitoring (CGM) Study', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Postpartum Dysglycemia Screening With Continuous Glucose Monitoring', 'orgStudyIdInfo': {'id': 'STUDY-20-02062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Postpartum glucose sensor', 'description': 'Will wear glucose sensor for 10 days postpartum and at time of glucose tolerance test.', 'interventionNames': ['Device: Dexcom glucose sensor']}], 'interventions': [{'name': 'Dexcom glucose sensor', 'type': 'DEVICE', 'description': 'Use of a Dexcom G6 Pro', 'armGroupLabels': ['Postpartum glucose sensor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': "Grenye O'Malley, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Aggregate data will be reported'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'DexCom, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': "Grenye O'Malley", 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}