Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-28 @ 4:26 AM
Study NCT ID:
NCT04803357
Status:
COMPLETED
Last Update Posted:
2025-06-25
First Post:
2020-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-30', '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': 'nehrhard@uw.edu', 'phone': '2404479566', 'title': 'Dr, Nicole Ehrhardt', 'organization': 'university of Washington Diabetes Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'high dropout rate/withdrawal immediately after randomization leading to lower number of subject analysis. Unreliable data given reporting in EMR varied for certain metrics for maternal/fetal outcomes.'}}, 'adverseEventsModule': {'timeFrame': '3 to 6.5 months(duration of pregnancy)', 'eventGroups': [{'id': 'EG000', 'title': 'Blinded CGM', 'description': 'Blinded Continuous monitoring device', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'RT- CGM', 'description': 'Real time Continuous monitoring device', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 3, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'bleeding or irritation at device site', 'notes': 'minor bleeding or irritation at device site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '103.0', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '106.2', 'spread': '9.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'mean glucose CGM', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with \\> 3 days of CGM data available at 36 weeks EGA'}, {'type': 'PRIMARY', 'title': 'TIR CGM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '92.1', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '92.4', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'Time in range, 63 - 140 mg/dL (TIR) by % continuous glucose monitoring', 'unitOfMeasure': '% of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with \\> 3 days of CGM data at 36 weeks EGA'}, {'type': 'SECONDARY', 'title': 'Fetal Birthweight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '3309.5', 'spread': '558', 'groupId': 'OG000'}, {'value': '3198.2', 'spread': '486.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'delivery', 'description': 'Birth weight \\[grams; mean (SD)\\]', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'fetal live births with data available from hospital record or 1 self reported'}, {'type': 'SECONDARY', 'title': 'TBR CGM GDM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'Time below range, 63 mg/dL threshold (TBR63) GDM', 'unitOfMeasure': '% of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'TAB CGM GDM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '8.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'Time above range, 140 mg/dL threshold (TAR140)', 'unitOfMeasure': '% of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MAGE CGM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '33.9', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '34.0', 'spread': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'Mean Amplitude of glycemic excursions (MAGE) continuous glucoe monitoring', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'SD CGM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '4.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'standard deviation Continuous glucose monitoring', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CV CGM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '18.1', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'Coefficient of variation, % (CV)The Coefficient of Variation (%CV) is calculated by dividing the glucose Standard Deviation by the mean glucose. The %CV is a standardized measure that assesses the magnitude of glucose variability. The larger the %CV, the larger the variability in CGM readings.', 'unitOfMeasure': 'percentage of variation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery', 'description': 'number(%) \\<40mg/dl of neonatal hypoglycemia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'in livebirths with glucose available in the electronic medical record'}, {'type': 'SECONDARY', 'title': 'Gestational Age at Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '39.0', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '38.5', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'delivery', 'description': 'gestational age at delivery weeks mean (sd)', 'unitOfMeasure': 'total time in weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'gestational age of participants with data available'}, {'type': 'SECONDARY', 'title': 'Mode of Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'title': 'c-section', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'vaginal', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'operative vaginal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery', 'description': 'mode of deliver reported ( vaginal, c-section, operative vaginal)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants with data available for mode of delivery'}, {'type': 'SECONDARY', 'title': 'Type of Labor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'title': 'spontaneous', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'induced', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'planned c-section', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery', 'description': 'Labor Status on Admission -(induced, spontaneous, planned c-section', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Shoulder Dystocia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery', 'description': 'number with shoulder dystocia at delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'data of participants with delivery data available'}, {'type': 'SECONDARY', 'title': 'Preeclampsia or HTN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery', 'description': 'Preeclampsia or Gestational hypertension (HTN )', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Weight Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '21.1', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '9.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'delivery', 'description': 'Maternal weight gain \\[lbs; mean (SD)\\] at delivery', 'unitOfMeasure': 'pounds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with weight gain data at delivery, some missing data'}, {'type': 'SECONDARY', 'title': 'Diabetes Medication Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 36 weeks', 'description': 'use of metformin and insulin in pregnancy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed'}, {'type': 'SECONDARY', 'title': '5 Minute Apgar', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '9', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'delivery', 'description': "5 minute apgar score A 5-minute Apgar score is a quick assessment of a newborn's overall health, particularly their ability to transition to life outside the womb. It's a score between 0 and 10, with each component (appearance, pulse, grimace, activity, and respirations) receiving a score of 0, 1, or 2. A score of 7-10 is considered reassuring, while scores below 7 may indicate the need for medical attentio", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "of patient's baby's with data available at delivery some missing data"}, {'type': 'SECONDARY', 'title': 'Live Birth or Stillbirth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'title': 'live', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'title': 'still', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'devlivery', 'description': 'live birth or still birth at delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'with EMR data available about delivery or self reported'}, {'type': 'SECONDARY', 'title': 'Birthweight Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'blinded cgm'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '1.015', 'spread': '.1332', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.1097', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'delivery', 'description': 'Birthweight ratio Birth weight ratio is defined as the ratio of observed birth weight divided by the median birth weight of the population-specific reference growth curve (based on 50% weight for gestational age). It is used to compare the birth weight of a fetus to the median for its gestational age. Higher birth weight ratios indicate larger fetuses for their gestational age, while lower ratios indicate smaller fetuse.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'of participant that had birthweights available at birth and gestational age at delivery,'}, {'type': 'SECONDARY', 'title': 'NICU Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'delivery', 'description': 'Need for neonatal intensive care admission', 'unitOfMeasure': "participants' infant", 'reportingStatus': 'POSTED', 'populationDescription': 'of data available at delivery some data missing as delivered at outside hospital without record accesss or by self-report by participant'}, {'type': 'SECONDARY', 'title': 'Neonatal Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'title': 'respiratory distress', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'birth injury', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'hypoxic encephalopathy', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'none', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery', 'description': 'neonatal respiratory distress, birth injury, hypoxic encephalopathy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'fetal data available on EMR review some data not available as delivered outside source'}, {'type': 'SECONDARY', 'title': 'Glucose Meter Fingerstick Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'blinded cgm'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'mean number of fingersticks per day by 36 weeks', 'unitOfMeasure': 'fingersticks per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants with fingerstick data available at 36 weeks EGA ; some missing data as participants did not provide glucose meter data'}, {'type': 'SECONDARY', 'title': 'Mean Days of RT-CGM Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RT_CGM Group', 'description': 'RT-CGM device use'}], 'classes': [{'categories': [{'measurements': [{'value': '64.4', 'spread': '19.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'Mean (SD) days of RT-CGM use', 'unitOfMeasure': 'days worn', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'A1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'blinded cgm'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'A1c at 36 weeks', 'unitOfMeasure': '% of A1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants with A1c at 36 weeks some missing data'}, {'type': 'SECONDARY', 'title': 'Fructosamine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '191.9', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '194.7', 'spread': '20.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'frucosamine at 36 weeks', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants with fructoasmine data at 36 weeks Some missing data'}, {'type': 'SECONDARY', 'title': 'Short Food Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group Blinded CGM', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level.'}, {'id': 'OG001', 'title': 'RT CGM Intervention Group', 'description': 'Real time continuous glucose monitor'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'starting the conversation food questionnaire Possible scores range from 0 to 16 with lower scores indicating better nutrition including more fruits and vegtables, and less or no sugared beverages.. The most healthful answer for each question is scored 0. The less healthful answer is scored 1. The least healthful answer is scored 2.\n\nTo get a total score, add up the individual item scores. The total score ranges from 0 to 16.\n\nLower scores indicate better nutrition', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'of those that answered the short food question survey'}, {'type': 'SECONDARY', 'title': 'WHO QOL Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group Blinded CGM', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level.'}, {'id': 'OG001', 'title': 'RT CGM Intervention Group', 'description': 'Real time continuous glucose monitor'}], 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'World health organization Quality of Life survey Possible scores range from 0 to 25 with higher scores indicating more happiness or contentment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'of those that answered the QOL survey'}, {'type': 'SECONDARY', 'title': 'Diabetes Distress(PAID) Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group Blinded CGM', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level.'}, {'id': 'OG001', 'title': 'RT CGM Intervention Group', 'description': 'Real time continuous glucose monitor'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '4.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': '5 items diabetes distress score Possible total score ranges from 0 to 20. Higher scores indicate more emotional distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'of those that answered the paid survey'}, {'type': 'SECONDARY', 'title': 'Walking Time Physcial Active Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group Blinded CGM', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level.'}, {'id': 'OG001', 'title': 'RT CGM Intervention Group', 'description': 'Real time continuous glucose monitor'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '36 weeks', 'description': '% of participants walking greater than 10 minutes or more per day', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'over those that answered the physical activity survey'}, {'type': 'SECONDARY', 'title': 'Metformin Only Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 36 weeks', 'description': 'use of metformin only', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed'}, {'type': 'SECONDARY', 'title': 'Insulin Use Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 36 weeks', 'description': 'use of insulin only', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed'}, {'type': 'SECONDARY', 'title': 'Insulin Use Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at delivery', 'description': 'use of insulin only', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed'}, {'type': 'SECONDARY', 'title': 'Diabetes Medication Use Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at delivery', 'description': 'use of metformin and insulin in pregnancy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed'}, {'type': 'SECONDARY', 'title': 'Metformin Use Only at Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Continuous Glucose Monitoring Devise', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.'}, {'id': 'OG001', 'title': 'RT-CGM', 'description': 'RT-CGM device wear'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at delivery', 'description': 'use of metformin only at time of delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group Blinded CGM', 'description': 'If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level.'}, {'id': 'FG001', 'title': 'RT CGM Intervention Group', 'description': 'Real time continuous glucose monitor'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Blinded CGM', 'description': 'Blinded Continuous monitoring device'}, {'id': 'BG001', 'title': 'RT- CGM', 'description': 'Real time Continuous monitoring device'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.2', 'spread': '5.1', 'groupId': 'BG000'}, {'value': '34.2', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '33.7', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-18', 'size': 507098, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-03T15:33', 'hasProtocol': True}, {'date': '2022-12-20', 'size': 302056, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-10-16T14:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'If you are in the control group, you will not be given a RT-CGM. Instead, you will be given a blinded CGM device. You will not be able to view your blood sugar results on the blinded CGM device. If you are in the control group, you will also be given a blood glucose meter to check your glucose using finger sticks according to the recommendations of your provider.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Real- time continuous glucose monitoring using the DexCom G6.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2020-11-29', 'resultsFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2021-03-16', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-06', 'studyFirstPostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Glucose', 'timeFrame': '36 weeks', 'description': 'mean glucose CGM'}, {'measure': 'TIR CGM', 'timeFrame': '36 weeks', 'description': 'Time in range, 63 - 140 mg/dL (TIR) by % continuous glucose monitoring'}], 'secondaryOutcomes': [{'measure': 'Fetal Birthweight', 'timeFrame': 'delivery', 'description': 'Birth weight \\[grams; mean (SD)\\]'}, {'measure': 'TBR CGM GDM', 'timeFrame': '36 weeks', 'description': 'Time below range, 63 mg/dL threshold (TBR63) GDM'}, {'measure': 'TAB CGM GDM', 'timeFrame': '36 weeks', 'description': 'Time above range, 140 mg/dL threshold (TAR140)'}, {'measure': 'MAGE CGM', 'timeFrame': '36 weeks', 'description': 'Mean Amplitude of glycemic excursions (MAGE) continuous glucoe monitoring'}, {'measure': 'SD CGM', 'timeFrame': '36 weeks', 'description': 'standard deviation Continuous glucose monitoring'}, {'measure': 'CV CGM', 'timeFrame': '36 weeks', 'description': 'Coefficient of variation, % (CV)The Coefficient of Variation (%CV) is calculated by dividing the glucose Standard Deviation by the mean glucose. The %CV is a standardized measure that assesses the magnitude of glucose variability. The larger the %CV, the larger the variability in CGM readings.'}, {'measure': 'Neonatal Hypoglycemia', 'timeFrame': 'delivery', 'description': 'number(%) \\<40mg/dl of neonatal hypoglycemia'}, {'measure': 'Gestational Age at Delivery', 'timeFrame': 'delivery', 'description': 'gestational age at delivery weeks mean (sd)'}, {'measure': 'Mode of Delivery', 'timeFrame': 'delivery', 'description': 'mode of deliver reported ( vaginal, c-section, operative vaginal)'}, {'measure': 'Type of Labor', 'timeFrame': 'delivery', 'description': 'Labor Status on Admission -(induced, spontaneous, planned c-section'}, {'measure': 'Shoulder Dystocia', 'timeFrame': 'delivery', 'description': 'number with shoulder dystocia at delivery'}, {'measure': 'Preeclampsia or HTN', 'timeFrame': 'delivery', 'description': 'Preeclampsia or Gestational hypertension (HTN )'}, {'measure': 'Maternal Weight Gain', 'timeFrame': 'delivery', 'description': 'Maternal weight gain \\[lbs; mean (SD)\\] at delivery'}, {'measure': 'Diabetes Medication Use', 'timeFrame': 'at 36 weeks', 'description': 'use of metformin and insulin in pregnancy'}, {'measure': '5 Minute Apgar', 'timeFrame': 'delivery', 'description': "5 minute apgar score A 5-minute Apgar score is a quick assessment of a newborn's overall health, particularly their ability to transition to life outside the womb. It's a score between 0 and 10, with each component (appearance, pulse, grimace, activity, and respirations) receiving a score of 0, 1, or 2. A score of 7-10 is considered reassuring, while scores below 7 may indicate the need for medical attentio"}, {'measure': 'Live Birth or Stillbirth', 'timeFrame': 'devlivery', 'description': 'live birth or still birth at delivery'}, {'measure': 'Birthweight Ratio', 'timeFrame': 'delivery', 'description': 'Birthweight ratio Birth weight ratio is defined as the ratio of observed birth weight divided by the median birth weight of the population-specific reference growth curve (based on 50% weight for gestational age). It is used to compare the birth weight of a fetus to the median for its gestational age. Higher birth weight ratios indicate larger fetuses for their gestational age, while lower ratios indicate smaller fetuse.'}, {'measure': 'NICU Admission', 'timeFrame': 'delivery', 'description': 'Need for neonatal intensive care admission'}, {'measure': 'Neonatal Complications', 'timeFrame': 'delivery', 'description': 'neonatal respiratory distress, birth injury, hypoxic encephalopathy'}, {'measure': 'Glucose Meter Fingerstick Per Day', 'timeFrame': '36 weeks', 'description': 'mean number of fingersticks per day by 36 weeks'}, {'measure': 'Mean Days of RT-CGM Use', 'timeFrame': '36 weeks', 'description': 'Mean (SD) days of RT-CGM use'}, {'measure': 'A1c', 'timeFrame': '36 weeks', 'description': 'A1c at 36 weeks'}, {'measure': 'Fructosamine', 'timeFrame': '36 weeks', 'description': 'frucosamine at 36 weeks'}, {'measure': 'Short Food Questionnaire', 'timeFrame': '36 weeks', 'description': 'starting the conversation food questionnaire Possible scores range from 0 to 16 with lower scores indicating better nutrition including more fruits and vegtables, and less or no sugared beverages.. The most healthful answer for each question is scored 0. The less healthful answer is scored 1. The least healthful answer is scored 2.\n\nTo get a total score, add up the individual item scores. The total score ranges from 0 to 16.\n\nLower scores indicate better nutrition'}, {'measure': 'WHO QOL Scale', 'timeFrame': '36 weeks', 'description': 'World health organization Quality of Life survey Possible scores range from 0 to 25 with higher scores indicating more happiness or contentment.'}, {'measure': 'Diabetes Distress(PAID) Survey', 'timeFrame': '36 weeks', 'description': '5 items diabetes distress score Possible total score ranges from 0 to 20. Higher scores indicate more emotional distress.'}, {'measure': 'Walking Time Physcial Active Questionnaire', 'timeFrame': '36 weeks', 'description': '% of participants walking greater than 10 minutes or more per day'}, {'measure': 'Metformin Only Use', 'timeFrame': 'at 36 weeks', 'description': 'use of metformin only'}, {'measure': 'Insulin Use Only', 'timeFrame': 'at 36 weeks', 'description': 'use of insulin only'}, {'measure': 'Insulin Use Only', 'timeFrame': 'at delivery', 'description': 'use of insulin only'}, {'measure': 'Diabetes Medication Use Delivery', 'timeFrame': 'at delivery', 'description': 'use of metformin and insulin in pregnancy'}, {'measure': 'Metformin Use Only at Delivery', 'timeFrame': 'at delivery', 'description': 'use of metformin only at time of delivery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Gestational Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether RT-CGM (real time continuous glucose monitoring) use improves glucose control, maternal outcomes, and fetal outcomes in patients diagnosed with gestational diabetes. Currently, there is very limited data on whether RT-CGM use helps patients diagnosed with gestational diabetes. By conducting this study, the investigator hopes to develop a deeper understanding of how use of a RT-CGM may affect glucose control in the gestational diabetes population.', 'detailedDescription': 'Pregnant Participants diagnosed with gestational diabetes are being invited to take part in a research study because these participants are pregnant and have gestational diabetes. Participants will be offered an opportunity to wear a medical device that monitors blood sugars (glucose). This device is called a continuous glucose monitor (CGM). The CGM measures glucose levels through a tiny plastic filament that is inserted under the skin in the abdomen by a skin prick. Typically, participants cannot feel this device once it is inserted. If participants agree to participate in this study, participants will be randomly placed into one of two groups: (1) the intervention group or (2) the control group. Participants will have a 50% (1 out of 2) chance like a coin toss of being placed into either group. If participants are in the intervention group, they will wear a real-time continuous glucose monitoring device (RT-CGM). The RT-CGM will allow participants to see glucose levels in real time. The RT-CGM will send information about glucose levels to a phone or display device so participants may see the glucose at all times. If participants are in the control group, they will not be given a RT-CGM. Instead, participants will be given a blinded CGM device. You will not be able to view your blood sugar results on the blinded CGM device. If participants are in the control group, they will also be given a blood glucose meter to check glucose using finger sticks according to the recommendations of the provider.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'A female who is pregnant', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Pregnancy and Gestation \\< 30 weeks\n2. Singleton pregnancy\n3. Confirmed gestational diabetes (by 75g or 100g oral glucose tolerance test or HbA1c)\n4. Able to read English and completed 6th grade\n5. Is able to read, understand, and sign the Informed Consent Form (ICF) and if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 \\[HIPAA\\] legislation), communicate with the investigator, and understand and comply with protocol requirements\n\nExclusion Criteria:\n\n1. Pre-gestational Type 1 or Type 2 diabetes.\n2. Newly diagnosed overt-diabetes in pregnancy \\[HbA1c ≥ 48 mmol/mol (6.5%), fasting glucose ≥ 7.0 mmol/l, random glucose ≥ 11.1 mmol/l\\].\n3. Pregnancies with established fetal anomalies (aside from echogenic intracardiac foci and/or renal pyelectasis) or possible preterm delivery secondary to maternal disease besides GDM\n4. Known endogenous/exogenous Cushing's syndrome\n5. Known chronic infections\n6. Current use of any oral form of steroid medication\n7. Already receiving continuous glucose monitoring (CGM)\n8. History of bariatric surgery\n9. Gestational Age less than 14 weeks -"}, 'identificationModule': {'nctId': 'NCT04803357', 'briefTitle': 'A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes', 'orgStudyIdInfo': {'id': 'STUDY00011755'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control : Blinded Continuous Glucose Monitoring (CGM)', 'description': 'If you are in the control group, you will wear a continuous glucose monitor but it will be blinded during pregnancy.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention: Real Time -Continuous Glucose Monitoring (RT-CGM)', 'description': 'Wearing RT- CGM during pregnancy', 'interventionNames': ['Device: Continuous glucose monitor']}], 'interventions': [{'name': 'Continuous glucose monitor', 'type': 'DEVICE', 'description': 'We are offering you an opportunity to wear a medical device that monitors your blood sugars (glucose). This device is called a continuous glucose monitor (CGM). The CGM measures glucose levels through a tiny plastic filament that is inserted under the skin in your abdomen by a skin prick. Typically, you cannot feel this device once it is inserted.', 'armGroupLabels': ['Intervention: Real Time -Continuous Glucose Monitoring (RT-CGM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Nicole M Ehrhardt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'DexCom, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, School of Medicine', 'investigatorFullName': 'Nicole Ehrhardt', 'investigatorAffiliation': 'University of Washington'}}}}