Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-30 @ 5:51 PM
Study NCT ID:
NCT05430204
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2022-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-08-21', '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': 'Michal.F.Bartal@uth.tmc.edu', 'phone': '713-500-6421', 'title': 'Michal Fishel Bartal, MD', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Mothers were assessed from enrollment up to 6 weeks post delivery, on average 21 weeks. Infants were assessed from birth up to 6 weeks post delivery, on average 6 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'CGM screening: Infants', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL", 'otherNumAtRisk': 405, 'deathsNumAtRisk': 405, 'otherNumAffected': 0, 'seriousNumAtRisk': 405, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'one-hour Glucose tolerance test (GCT): Infants', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.', 'otherNumAtRisk': 409, 'deathsNumAtRisk': 409, 'otherNumAffected': 0, 'seriousNumAtRisk': 409, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'CGM screening: Mothers', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL", 'otherNumAtRisk': 405, 'deathsNumAtRisk': 405, 'otherNumAffected': 0, 'seriousNumAtRisk': 405, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'one-hour Glucose tolerance test (GCT): Mothers', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.', 'otherNumAtRisk': 409, 'deathsNumAtRisk': 409, 'otherNumAffected': 0, 'seriousNumAtRisk': 409, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Neonates That Show Composite Adverse Neonatal Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From birth to about 28 days of life.', 'description': 'Composite adverse neonatal outcome include one or more of the following:\n\n* Large for Gestational Age(LGA) is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al)\n* Shoulder Dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered\n* Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury\n* Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy\n* Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life\n* Fetal or neonatal death (within 28 days of birth)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Neonates That Show Adverse Neonatal Outcome of Large for Gestational Age(LGA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at time of birth', 'description': 'LGA is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Neonates That Show Adverse Neonatal Outcome of Shoulder Dystocia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at time of birth', 'description': 'Shoulder dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Neonates That Show Adverse Neonatal Outcome of Birth Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at time of birth', 'description': 'Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Neonates That Show Adverse Neonatal Outcome of Neonatal Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from birth to discharge (about 3-15 days)', 'description': 'Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Neonates That Show Adverse Neonatal Outcome of Respiratory Distress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from birth to discharge (about 3-15 days)', 'description': 'Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Fetal or Neonatal Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 28 days of birth', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Feasibility as Assessed by the Number of Participants Who Complete the CGM Diagnostic Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '405', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '388', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were only collected for participants in the GCM screening arm.'}, {'type': 'SECONDARY', 'title': 'Number of Women That Use Diabetic Medication During Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'title': 'Metformin', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Insulin', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks', 'description': 'diabetic medication is described as any glycemic control agent', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Women That Show Polyhydramnios During Pregnancy Not Related to Known Fetal Anomaly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Women That Have Preterm Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at time of birth', 'description': 'Pre term birth is described as delivery less than 37 weeks of gestation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Women That Undergo Induced Labor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at time of birth', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Women That Experience Pregnancy Induced Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Women That Experience Eclampsia: Seizures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Women Admitted Due to Poor Glucose Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment up to delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Women With Primary Cesarean Section', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at time of birth', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Women With Postpartum Hemorrhage: Defined as Greater Then 1000ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Women With Endometritis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Women With Wound Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Women With Diagnosis of Type 2 Diabetes During Postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'birth to 6 weeks postpartum', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Neonates With Apgar Score Less Than 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 minutes after birth', 'description': 'The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Neonates That Are Admitted to the Neonatal Intensive Care Unit (NICU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'birth to time of discharge from NICU (about 15 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'NICU Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '303.5'}, {'value': '123.5', 'groupId': 'OG001', 'lowerLimit': '48.0', 'upperLimit': '360.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'birth to time of discharge from NICU (about 15 days)', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Neonates With Hyperbilirubinemia Requiring Phototherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'birth to discharge (about 3-15 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Neonates With Need for Intravenous or Oral Administration Glucose Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'birth to discharge (about 3-15 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Neonates That Are Small for Gestational Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at time of birth', 'description': 'Small for gestational age, defined as a weight below 10th percentile of the expected value according to gestational age (using the nomogram published by Duryea EL et al)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Breastfed Their Babies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from birth to 6 weeks postpartum', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Formula Fed Their Babies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from birth to 6 weeks postpartum', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Bilirubin Level - Neonates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'timeFrame': 'birth to discharge (about 3 -15 days)', 'reportingStatus': 'POSTED', 'populationDescription': 'The study team decided that this outcome measure was not going to be collected therefore, the laboratory assays were not performed and no data were collected for this outcome. This outcome will not be collected in the future. The Study Protocol was not amended to reflect this collective team decision'}, {'type': 'SECONDARY', 'title': 'Cord Arterial pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '7.3'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '7.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at time of birth', 'unitOfMeasure': 'pH', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Neonates With Polycythemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'birth to discharge (about 3 -15 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Women That Experience Preeclampsia With Severe Features', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Women That Experience Super Imposed Preeclampsia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Women With Need for Blood Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Ultrasound Diagnosis of Estimated Fetal Weight >90%Ile in the Third Trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Third trimester (≥28 weeks gestation through delivery)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Women That Experience HELLP Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks', 'description': 'HELLP syndrome: a group of symptoms in pregnant women characterized by hemolysis (H), elevated liver enzymes (EL), and/or low platelet (LP) count, assessed according to ACOG guidelines.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cord Venous pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'timeFrame': 'at time of birth', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected or analyzed for Cord Venous pH. The study team determined that collection of cord venous pH was not required based on academic evidence that a different marker, arterial pH, is a reliable marker. This outcome will not be collected in the future. The Study Protocol was not amended to reflect this collective team decision. Please see outcome #30 for data on arterial pH.'}, {'type': 'SECONDARY', 'title': 'Total Health System Costs for Mothers and Infants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'OG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected or analyzed for this outcome because there was no standardized cost or charging across participants therefore there was no data to collect or analyze for any participants. This outcome will not be collected in the future. The Study Protocol was not amended to reflect this collective team decision'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CGM screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'FG001', 'title': 'one-hour Glucose tolerance test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'A total of 405 Infant-mother dyads were in the CGM screening arm. Each mother was enrolled during pregnancy, prior to the birth of her infant. Following delivery, data collection continued for both mother and infant as part of the same dyad.', 'groupId': 'FG000', 'numSubjects': '405'}, {'comment': 'A total of 409 Infant-mother dyads were in the one-hour Glucose tolerance test (GCT) arm. Each mother was enrolled during pregnancy, prior to the birth of her infant. Following delivery, data collection continued for both mother and infant as part of the same dyad.', 'groupId': 'FG001', 'numSubjects': '409'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'A total of 388 Infant-mother dyads completed the study in the CGM screening arm. Each mother was enrolled during pregnancy, prior to the birth of her infant. Following delivery, data collection continued for both mother and infant as part of the same dyad.', 'groupId': 'FG000', 'numSubjects': '388'}, {'comment': 'A total of 392 Infant-mother dyads completed the study in the one-hour Glucose tolerance test (GCT). Each mother was enrolled during pregnancy, prior to the birth of her infant. Following delivery, data collection continued for both mother and infant as part of the same dyad.', 'groupId': 'FG001', 'numSubjects': '392'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}], 'preAssignmentDetails': 'A total of 1,628 individuals (814 mother-infant dyads) were enrolled. Each mother was enrolled during pregnancy, prior to the birth of her infant. Following delivery, data collection continued for both mother and infant as part of the same dyad.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '405', 'groupId': 'BG000'}, {'value': '409', 'groupId': 'BG001'}, {'value': '814', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CGM Screening', 'description': "Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL"}, {'id': 'BG001', 'title': 'One-hour Glucose Tolerance Test (GCT)', 'description': 'Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '29', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '29', 'spread': '6.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '405', 'groupId': 'BG000'}, {'value': '409', 'groupId': 'BG001'}, {'value': '814', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Non-Hispanic White', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'Non-Hispanic Black', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '405', 'groupId': 'BG000'}, {'value': '409', 'groupId': 'BG001'}, {'value': '814', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of maternal participants on government assisted insurance', 'classes': [{'categories': [{'measurements': [{'value': '263', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '532', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of maternal participants with Nulliparous', 'classes': [{'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Nulliparous means never given birth before.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of maternal participants with body mass index (BMI) greater than 30 at first prenatal visit', 'classes': [{'categories': [{'measurements': [{'value': '215', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '460', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of maternal participants with body mass index (BMI) greater than 40', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of maternal participants with chronic hypertension', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of maternal participants with family history of diabetes mellitus', 'classes': [{'categories': [{'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '348', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of maternal participants with Gestational diabetes in previous pregnancy', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational age at randomization', 'classes': [{'categories': [{'measurements': [{'value': '26.0', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '25.8', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '25.89', 'spread': '1.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of maternal participants with Thyroid disease', 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of maternal participants with tobacco use during pregnancy', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of maternal participants with Alcohol use during pregnancy', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of maternal participants with Substance use during pregnancy', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Characteristics were not collected for infants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-05', 'size': 581841, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-31T14:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1628}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2022-06-14', 'resultsFirstSubmitDate': '2025-08-01', 'studyFirstSubmitQcDate': '2022-06-17', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-14', 'studyFirstPostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Neonates That Show Composite Adverse Neonatal Outcome', 'timeFrame': 'From birth to about 28 days of life.', 'description': 'Composite adverse neonatal outcome include one or more of the following:\n\n* Large for Gestational Age(LGA) is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al)\n* Shoulder Dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered\n* Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury\n* Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy\n* Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life\n* Fetal or neonatal death (within 28 days of birth)'}, {'measure': 'Number of Neonates That Show Adverse Neonatal Outcome of Large for Gestational Age(LGA)', 'timeFrame': 'at time of birth', 'description': 'LGA is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al)'}, {'measure': 'Number of Neonates That Show Adverse Neonatal Outcome of Shoulder Dystocia', 'timeFrame': 'at time of birth', 'description': 'Shoulder dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered'}, {'measure': 'Number of Neonates That Show Adverse Neonatal Outcome of Birth Injury', 'timeFrame': 'at time of birth', 'description': 'Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury'}, {'measure': 'Number of Neonates That Show Adverse Neonatal Outcome of Neonatal Hypoglycemia', 'timeFrame': 'from birth to discharge (about 3-15 days)', 'description': 'Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy'}, {'measure': 'Number of Neonates That Show Adverse Neonatal Outcome of Respiratory Distress', 'timeFrame': 'from birth to discharge (about 3-15 days)', 'description': 'Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life'}, {'measure': 'Number of Fetal or Neonatal Deaths', 'timeFrame': 'within 28 days of birth'}], 'secondaryOutcomes': [{'measure': 'Feasibility as Assessed by the Number of Participants Who Complete the CGM Diagnostic Testing', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks'}, {'measure': 'Number of Women That Use Diabetic Medication During Pregnancy', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks', 'description': 'diabetic medication is described as any glycemic control agent'}, {'measure': 'Number of Women That Show Polyhydramnios During Pregnancy Not Related to Known Fetal Anomaly', 'timeFrame': 'From enrollment to delivery'}, {'measure': 'Number of Women That Have Preterm Birth', 'timeFrame': 'at time of birth', 'description': 'Pre term birth is described as delivery less than 37 weeks of gestation'}, {'measure': 'Number of Women That Undergo Induced Labor', 'timeFrame': 'at time of birth'}, {'measure': 'Number of Women That Experience Pregnancy Induced Hypertension', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks'}, {'measure': 'Number of Women That Experience Eclampsia: Seizures', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks'}, {'measure': 'Number of Women Admitted Due to Poor Glucose Control', 'timeFrame': 'From enrollment up to delivery'}, {'measure': 'Number of Women With Primary Cesarean Section', 'timeFrame': 'at time of birth'}, {'measure': 'Number of Women With Postpartum Hemorrhage: Defined as Greater Then 1000ml', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks'}, {'measure': 'Number of Women With Endometritis', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks'}, {'measure': 'Number of Women With Wound Complications', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks'}, {'measure': 'Number of Women With Diagnosis of Type 2 Diabetes During Postpartum', 'timeFrame': 'birth to 6 weeks postpartum'}, {'measure': 'Number of Neonates With Apgar Score Less Than 7', 'timeFrame': '5 minutes after birth', 'description': 'The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome.'}, {'measure': 'Number of Neonates That Are Admitted to the Neonatal Intensive Care Unit (NICU)', 'timeFrame': 'birth to time of discharge from NICU (about 15 days)'}, {'measure': 'NICU Length of Stay', 'timeFrame': 'birth to time of discharge from NICU (about 15 days)'}, {'measure': 'Number of Neonates With Hyperbilirubinemia Requiring Phototherapy', 'timeFrame': 'birth to discharge (about 3-15 days)'}, {'measure': 'Number of Neonates With Need for Intravenous or Oral Administration Glucose Therapy', 'timeFrame': 'birth to discharge (about 3-15 days)'}, {'measure': 'Number of Neonates That Are Small for Gestational Age', 'timeFrame': 'at time of birth', 'description': 'Small for gestational age, defined as a weight below 10th percentile of the expected value according to gestational age (using the nomogram published by Duryea EL et al)'}, {'measure': 'Number of Participants Who Breastfed Their Babies', 'timeFrame': 'from birth to 6 weeks postpartum'}, {'measure': 'Number of Participants Who Formula Fed Their Babies', 'timeFrame': 'from birth to 6 weeks postpartum'}, {'measure': 'Maximum Bilirubin Level - Neonates', 'timeFrame': 'birth to discharge (about 3 -15 days)'}, {'measure': 'Cord Arterial pH', 'timeFrame': 'at time of birth'}, {'measure': 'Number of Neonates With Polycythemia', 'timeFrame': 'birth to discharge (about 3 -15 days)'}, {'measure': 'Number of Women That Experience Preeclampsia With Severe Features', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks'}, {'measure': 'Number of Women That Experience Super Imposed Preeclampsia', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks'}, {'measure': 'Number of Women With Need for Blood Transfusion', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks'}, {'measure': 'Number of Participants With Ultrasound Diagnosis of Estimated Fetal Weight >90%Ile in the Third Trimester', 'timeFrame': 'Third trimester (≥28 weeks gestation through delivery)'}, {'measure': 'Number of Women That Experience HELLP Syndrome', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks', 'description': 'HELLP syndrome: a group of symptoms in pregnant women characterized by hemolysis (H), elevated liver enzymes (EL), and/or low platelet (LP) count, assessed according to ACOG guidelines.'}, {'measure': 'Cord Venous pH', 'timeFrame': 'at time of birth'}, {'measure': 'Total Health System Costs for Mothers and Infants', 'timeFrame': 'From enrollment to 6 weeks post partum, on average 21 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Gestational Diabetes']}, 'referencesModule': {'references': [{'pmid': '37088275', 'type': 'DERIVED', 'citation': 'Fishel Bartal M, Ashby Cornthwaite J, Ghafir D, Ward C, Nazeer SA, Blackwell SC, Pedroza C, Chauhan SP, Sibai BM. Continuous glucose monitoring in individuals undergoing gestational diabetes screening. Am J Obstet Gynecol. 2023 Oct;229(4):441.e1-441.e14. doi: 10.1016/j.ajog.2023.04.021. Epub 2023 Apr 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether Continuous glucose monitoring (CGM) for diagnosis of gestational diabetes mellitus (GDM) improves maternal and neonatal outcomes related to GDM and to evaluate whether CGM for GDM diagnosis reduces the health system costs for mother-infant dyads compared to usual care'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 24-30 weeks gestation undergoing GDM screening\n\nExclusion Criteria:\n\n* Known diagnosis of Type I and II DM\n* History of bariatric surgery\n* Major fetal anomalies\n* Unwilling to use CGM for GDM screening\n* Incarcerated subjects\n* History of allergic reaction to any of CGM metals or adhesives in contact with the skin'}, 'identificationModule': {'nctId': 'NCT05430204', 'briefTitle': 'Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy:A Comparative Effectiveness Randomized Control Trial (PRECISE)', 'orgStudyIdInfo': {'id': 'HSC-MS-22-0153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'one-hour Glucose tolerance test (GCT)', 'interventionNames': ['Device: Group 1: one-hour GCT']}, {'type': 'EXPERIMENTAL', 'label': 'CGM screening', 'interventionNames': ['Device: Group 2: CGM placement']}], 'interventions': [{'name': 'Group 1: one-hour GCT', 'type': 'DEVICE', 'description': 'Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.', 'armGroupLabels': ['one-hour Glucose tolerance test (GCT)']}, {'name': 'Group 2: CGM placement', 'type': 'DEVICE', 'description': "CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:\n\n* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or\n* Average glucose≥130 mg/dL or\n* Any glucose value ≥200 mg/dL", 'armGroupLabels': ['CGM screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Michal Fishel Bartal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'DexCom, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Michal Fishel Bartal', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}