[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576167":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":52,"collaborators":24,"id":56,"slug":24,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":24,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":24,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":24,"overallStatus":36,"whyStopped":24,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"University of Virginia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin + Insulin","ACTIVE_COMPARATOR","Pregnant women with gestational diabetes who have uncontrolled blood sugar on metformin alone will be started on insulin and will stay on metformin.",[13],"Drug: Metformin + Insulin",{"label":15,"type":10,"description":16,"interventionNames":17},"Insulin","Pregnant women with gestational diabetes who have uncontrolled blood sugar on metformin along will be started on insulin and metformin will be discontinued.",[18],"Drug: Insulin",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Pregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stay on metformin and add insulin.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Pregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stop on metformin and add insulin.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Amanda R Urban, MS","CONTACT","4344093100","ajr5y@uvahealth.org",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Charlottesville","Virginia","22903","United States",{"type":42,"coordinates":43},"Point",[44,45],-78.47668,38.02931,{"lat":45,"lon":44},[48,50],{"name":49,"role":31,"phone":32,"phoneExt":24,"email":33},"Amanda Urban",{"name":51,"role":31,"phone":24,"phoneExt":24,"email":24},"Christopher Ennen, MD",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Christopher S. Ennen","Associate Professor, Division of Maternal Fetal Medicine","100576167",false,"NCT06781775","GDM: Insulin with or Without Metformin?","Gestational Diabetes Treatment: Should We Continue Metformin When Starting Insulin? a Randomized Control Trial","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Pregnant female meeting diagnosis for gestational diabetes requiring medical treatment\n4. Ability to take oral medication and be willing to adhere to the metformin regimen\n5. Willing to take insulin if needed\n6. Willing to take blood sugars 4 times per day\n\n   \\-\n\n   Exclusion Criteria:\n   * 1\\) Metformin allergy or known intolerance, known hypersensitivity to insulin 2) Severe hepatic dysfunction 3) Chronic kidney disease 4) Pregnancy with major fetal anomalies 5) Non-viable pregnancy","FEMALE","18 Years","50 Years",{"count":66,"type":67},130,"ESTIMATED","INTERVENTIONAL",[70],"PHASE4","This will be a randomized trial of patients with gestational diabetes who start hypoglycemic therapy with metformin but eventually require insulin. It will examine whether continuing metformin when adding insulin versus discontinuing metformin when insulin is added is beneficial. The investigators hypothesize that continuing metformin will reduce the needed insulin dosage and improve maternal and neonatal outcomes in these patients.",[73],"Gestational Diabetes","2025-01-13",{"date":76,"type":77},"2025-01-17","ACTUAL",{"date":79,"type":77},"2024-12-12",{"date":81,"type":67},"2027-05-01",{"name":5,"class":6},1]