[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463660":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":41,"responsibleParty":59,"collaborators":25,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":25,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":25,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University of Massachusetts, Worcester","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuous Glucose Monitoring (CGM)","EXPERIMENTAL","Patients will be randomized to application of a continuous glucose monitor (CGM). They will apply the device in the clinical setting and be instructed how to download their information onto their smartphones or using the CGM device reader. They will use the CGM for the duration of the pregnancy until delivery.",[13],"Device: Continuous Glucose Monitor",{"label":15,"type":16,"description":17,"interventionNames":18},"Fingerstick Glucose Monitoring","ACTIVE_COMPARATOR","Patients will be randomized to checking their blood glucose with fingerstick monitors at time of fasting in the AM, and 2 hours after each meal. This is the standard of care for patients in the pregnancy diabetes clinic.",[19],"Device: Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)",[21,26],{"type":22,"name":23,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Continuous Glucose Monitor",[9],null,{"type":22,"name":27,"description":27,"armGroupLabels":28,"otherNames":25},"Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)",[15],[30],{"name":31,"affiliation":5,"role":32},"Gianna L Wilkie, MD","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","7743642523","Gianna.Wilkie@umassmemorial.org",{"name":39,"role":35,"phone":25,"phoneExt":25,"email":40},"Heidi Leftwich, DO","Heidi.Leftwich@umassmemorial.org",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"University of Massachusetts Memorial Medical Center","RECRUITING","Worcester","Massachusetts","01605","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-71.80229,42.26259,{"lat":54,"lon":53},[57],{"name":31,"role":35,"phone":58,"phoneExt":25,"email":37},"508-334-4067",{"type":32,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Gianna Wilkie","Clinical Fellow in Maternal Fetal Medicine","100463660","continuous-glucose-monitor-use-in-pregnancy-100463660",false,"NCT05317585","Continuous Glucose Monitor Use in Pregnancy","Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial","Inclusion Criteria: Women will be deemed eligible for the study by the following inclusion criteria:\n\n* 1\\) age greater than or equal to 18 years old\n* 2\\) singleton gestation less than or equal to 14 weeks at initial obstetric visit\n* 3\\) established diagnosis of T2DM by laboratory criteria including hemoglobin A1c ≥6.5%, oral glucose tolerance test ≥200 mg\u002FdL, or fasting plasma glucose ≥126 mg\u002FdL\n* 4\\) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC\n* 5\\) able and willing to provide informed consent\n\nExclusion Criteria: Women will be deemed ineligible for the study based on the following exclusion criteria:\n\n* 1\\) known diagnosis of type 1 diabetes or gestational diabetes\n* 2\\) plan to receive prenatal care or delivery outside of UMMHC\n* 3\\) inability to provide informed consent\n* 4\\) multifetal gestation","FEMALE","18 Years",{"count":72,"type":73},180,"ESTIMATED","INTERVENTIONAL",[76],"NA","The purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.",[79,80],"Type 2 Diabetes Treated With Insulin","Pregnancy, High Risk",[82,83],"Type 2 diabetes","Pregnancy","2025-09-29",{"date":86,"type":87},"2025-10-01","ACTUAL",{"date":89,"type":87},"2024-05-23",{"date":91,"type":73},"2027-07-01",{"name":5,"class":6},1]