[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589639":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":35,"centralContacts":40,"locations":49,"responsibleParty":220,"collaborators":222,"id":230,"slug":231,"hasResults":232,"nctId":233,"briefTitle":234,"officialTitle":234,"acronym":11,"eligibilityCriteria":235,"healthyVolunteers":236,"sex":237,"minAge":238,"maxAge":11,"enrollmentInfo":239,"targetDuration":11,"studyType":242,"phases":243,"briefSummary":245,"conditions":246,"keywords":248,"overallStatus":52,"whyStopped":11,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":261},{"fullName":5,"class":6},"Jaeb Center for Health Research","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Glucose Lowering Group","EXPERIMENTAL",null,[13],"Other: Diabetes Treatment",{"label":15,"type":16,"description":11,"interventionNames":17},"Usual Care Group (with periodic blinded CGM)","ACTIVE_COMPARATOR",[18],"Other: Usual Care Group",{"label":20,"type":21,"description":11,"interventionNames":11},"Observational","NO_INTERVENTION",[23,29],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Diabetes Treatment","Management will include an unblinded CGM sensor worn 24\u002F7, GDM specific nutrition information, training on using CGM in daily glucose management to achieve euglycemia (maximizing time 63-140 mg\u002FdL \\[3.5-7.8 mmol\u002FL\\]).\n\nVisits (which could be telehealth) per usual obstetrical care for glycemia management (expected to be about every 4 weeks for most participants) and weekly glycemic management with review of CGM data by site and by central CGM Resource Center for flagged cases.\n\nParticipants not receiving glucose lowering medication by 24-28 weeks will undergo OGTT per usual obstetrical management and those with positive OGTT will be treated for GDM per usual clinic routine and continue to wear an unblinded CGM.",[9],[28],"Continuous Glucose Monitoring",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Usual Care Group","The control group will receive usual obstetrical care at the clinical center. A general pregnancy nutrition information handout will be provided to each participant and a blinded CGM sensor will be placed at routine obstetrical care visits and worn for 10-14 days each time throughout the pregnancy beginning between 18-22 weeks' gestation.\n\nAt 18-22 weeks, blinded CGM data will be reviewed to assess if participant has ≥25% time \\>140 mg\u002FdL to determine if an early OGTT or glycemic management is required. Site clinicians will be unblinded to the masked CGM data for participants with CGM data ≥25% time \\>140 mg\u002FdL and those participants may be treated as those with a positive OGTT.\n\nAn OGTT will be performed at \\~24-28 weeks per the clinic's usual routine and those with positive OGTT will be treated for GDM per usual clinic routine. If real-time CGM is to be used, then unblinded study CGM sensors can be used instead of blinded sensors for the duration of the study.",[15],[34],"Blinded Continuous Glucose Monitoring",[36],{"name":37,"affiliation":38,"role":39},"Celeste Durnwald, MD","University of Pennsylvania","STUDY_CHAIR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},"Judy Sibayan, MPH, CCRP, Epidemiologist","CONTACT","813-975-8690","jsibayan@jaeb.org",{"name":47,"role":43,"phone":44,"phoneExt":11,"email":48},"Paige N Miller, BS","pmiller@jaeb.org",[50,72,89,105,122,138,156,173,189,206],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"University of Alabama at Birmingham","RECRUITING","Birmingham","Alabama","35173","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-86.80249,33.52066,{"lat":62,"lon":61},[65,69],{"name":66,"role":43,"phone":67,"phoneExt":11,"email":68},"Jennifer Bryant","832-453-8402","jlbryant@uabmc.edu",{"name":70,"role":71,"phone":11,"phoneExt":11,"email":11},"Ashley Battarbee","PRINCIPAL_INVESTIGATOR",{"facility":73,"status":52,"city":74,"state":75,"zip":76,"country":56,"countryCode":57,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"University of Miami","Miami","Florida","33016",{"type":59,"coordinates":78},[79,80],-80.19366,25.77427,{"lat":80,"lon":79},[83,87],{"name":84,"role":43,"phone":85,"phoneExt":11,"email":86},"Stephanie Cardona","305-585-5610","stephanie.cardona@miami.edu",{"name":88,"role":71,"phone":11,"phoneExt":11,"email":11},"Alfredo Rodriguez",{"facility":90,"status":52,"city":91,"state":92,"zip":93,"country":56,"countryCode":57,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Emory University","Decatur","Georgia","30033",{"type":59,"coordinates":95},[96,97],-84.29631,33.77483,{"lat":97,"lon":96},[100,103],{"name":101,"role":43,"phone":11,"phoneExt":11,"email":102},"Olivia Carter","olivia.carter2@emory.edu",{"name":104,"role":71,"phone":11,"phoneExt":11,"email":11},"Suchitra Chandrasekaran",{"facility":106,"status":52,"city":107,"state":108,"zip":109,"country":56,"countryCode":57,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"IDC at Park Nicollet","Saint Louis Park","Minnesota","55416",{"type":59,"coordinates":111},[112,113],-93.34801,44.9483,{"lat":113,"lon":112},[116,120],{"name":117,"role":43,"phone":118,"phoneExt":11,"email":119},"Shannon Krizka","(952) 993-3393","shannon.krizka@parknicollet.com",{"name":121,"role":71,"phone":11,"phoneExt":11,"email":11},"Anders Carlson",{"facility":123,"status":52,"city":124,"state":124,"zip":125,"country":56,"countryCode":57,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Icahn School of Medicine at Mount Sinai","New York","10029",{"type":59,"coordinates":127},[128,129],-74.00597,40.71427,{"lat":129,"lon":128},[132,136],{"name":133,"role":43,"phone":134,"phoneExt":11,"email":135},"Shaziah Hassan","212-241-5355","Shaziah.hassan@mssm.edu",{"name":137,"role":71,"phone":11,"phoneExt":11,"email":11},"Carol Levy",{"facility":139,"status":52,"city":140,"state":141,"zip":142,"country":56,"countryCode":57,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":59,"coordinates":144},[145,146],-81.69541,41.4995,{"lat":146,"lon":145},[149,153,154],{"name":150,"role":43,"phone":151,"phoneExt":11,"email":152},"Stacey Ehrenberg","216-618-7235","ehrenbs@ccf.org",{"name":150,"role":71,"phone":11,"phoneExt":11,"email":11},{"name":155,"role":71,"phone":11,"phoneExt":11,"email":11},"Cara Dolin",{"facility":157,"status":52,"city":158,"state":159,"zip":160,"country":56,"countryCode":57,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Oregon Health & Science University","Portland","Oregon","97239",{"type":59,"coordinates":162},[163,164],-122.67621,45.52345,{"lat":164,"lon":163},[167,171],{"name":168,"role":43,"phone":169,"phoneExt":11,"email":170},"Monica Rincon","503-494-8748","rincon@ohsu.edu",{"name":172,"role":71,"phone":11,"phoneExt":11,"email":11},"Amy Valent",{"facility":38,"status":52,"city":174,"state":175,"zip":176,"country":56,"countryCode":57,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Philadelphia","Pennsylvania","19104",{"type":59,"coordinates":178},[179,180],-75.16362,39.95238,{"lat":180,"lon":179},[183,187],{"name":184,"role":43,"phone":185,"phoneExt":11,"email":186},"Elizabeth Norton","973-600-8830","elizabeth.norton@pennmedicine.upenn.edu",{"name":188,"role":71,"phone":11,"phoneExt":11,"email":11},"Celeste Durnwald",{"facility":190,"status":191,"city":192,"state":192,"zip":11,"country":193,"countryCode":194,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Leeds Teaching Hospitals NHS Trust","NOT_YET_RECRUITING","Leeds","United Kingdom","UK",{"type":59,"coordinates":196},[197,198],-1.54785,53.79648,{"lat":198,"lon":197},[201,205],{"name":202,"role":43,"phone":203,"phoneExt":11,"email":204},"Eleanor Scott","+44 7876 031952","E.M.Scott@leeds.ac.uk",{"name":202,"role":71,"phone":11,"phoneExt":11,"email":11},{"facility":207,"status":191,"city":208,"state":208,"zip":11,"country":193,"countryCode":194,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Norfolk and Norwich University Hospitals NHS","Norwich",{"type":59,"coordinates":210},[211,212],1.29834,52.62783,{"lat":212,"lon":211},[215,219],{"name":216,"role":43,"phone":217,"phoneExt":11,"email":218},"Helen Murphy","+44 1603 286286","Helen.Murphy@uea.ac.uk",{"name":216,"role":71,"phone":11,"phoneExt":11,"email":11},{"type":221,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[223,225,228],{"name":224,"class":6},"The Leona M. and Harry B. Helmsley Charitable Trust",{"name":226,"class":227},"DexCom, Inc.","INDUSTRY",{"name":229,"class":227},"Abbott","100589639","cgm-for-the-early-detection-and-management-of-hyperglycemia-in-pregnancy-100589639",false,"NCT06957028","CGM for the Early Detection and Management of Hyperglycemia in Pregnancy","Inclusion Criteria\n\n1. Maternal age of 18 years and older\n2. Singleton pregnancy\n3. Gestational age up to 14w 6d of pregnancy, determined on ultrasound, for initiation of screening\n\n   • Although it is preferable that ultrasound results be available prior to enrollment, if ultrasound results are not available at the time of enrollment, participant can have CGM initiated but will be dropped if not eligible after results are available\n4. HbA1c \\\u003C6.5% (48 mmol\u002Fmol) since onset of pregnancy\n\n   • If HbA1c result not available at time of enrollment, participant can have blinded screening CGM initiated, but results will be needed prior to randomization to verify eligibility.\n5. No prior history of gestational diabetes mellitus (GDM)\n6. Able to read English or Spanish\n\nExclusion Criteria\n\n1. Signs of abnormal fetal or placental development (suspected fetal anomaly or placenta accreta spectrum, low PAPPA) at first routine prenatal visit\u002Fultrasound\n2. Planned termination of pregnancy or any indications of miscarriage\n3. Prior gastric bypass surgery\n4. Pregravid diabetes (type 1 or type 2)\n5. Unwillingness\u002Finability to wear CGM sensor\n6. Unwillingness to attend routine antenatal obstetric appointments\n7. Use of corticosteroids by a route that can produce hyperglycemia (e.g., oral, intravenous, intramuscular, intra-articular) during the 7 days prior to initiating CGM screening or during the CGM screening\n\n   • Topical and inhaled corticosteroids are acceptable\n8. Use of insulin during the pregnancy prior to enrollment\n9. Use of metformin within one week of the initiation of the blinded CGM sensor for screening or use of a GLP-1 or other weight-reduction medication that can affect glucose levels within 4 weeks of the initiation of the blinded CGM sensor for screening\n10. Deemed unable to participate for medical reasons identified by their physician\n\nAdditional Criteria for RCT Eligibility\n\n1. Screening CGM meeting study criteria for hyperglycemia: 5% to \\\u003C25% time \\>140 mg\u002FdL\n2. Randomization by 16 week 6 days of pregnancy\n3. No participation in a separate intervention trial.",true,"FEMALE","18 Years",{"count":240,"type":241},6000,"ESTIMATED","INTERVENTIONAL",[244],"NA","The goal of this clinical trial is to use continuous glucose monitoring (CGM) to quickly detect and manage high blood sugar in pregnant women, early in pregnancy. The main questions it aims to answer are:\n\n(1) any problems for the baby, such as being too large for their age, shoulder injuries (like broken bones), high bilirubin levels needing light treatment, low blood sugar, or needing to stay in the NICU; (2) any high blood pressure issues for the mother during pregnancy.",[247],"Gestational Diabetes Mellitus in Pregnancy",[249,250,251],"GDM","CGM","Pregnancy","2025-12-16",{"date":254,"type":255},"2025-12-23","ACTUAL",{"date":257,"type":255},"2025-05-27",{"date":259,"type":241},"2027-11-27",{"name":5,"class":6},10]