[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610231":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":55,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Eastern Virginia Medical School","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Once-Daily Insulin Glargine","ACTIVE_COMPARATOR","Participants randomized to this arm will take insulin glargine once daily",[13],"Drug: Use of insulin glargine once daily",{"label":15,"type":16,"description":17,"interventionNames":18},"Twice-Daily Insulin Glargine","EXPERIMENTAL","Participants randomized to this arm will take insulin glargine twice daily",[19],"Drug: Use of insulin glargine twice daily",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Use of insulin glargine once daily","Insulin glargine will be used once daily",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Use of insulin glargine twice daily","Insulin glargine will be used twice daily",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Marwan Ma'ayeh, MD","CONTACT","7574467900","maayehmg@odu.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Sentara Norfolk General Hospital, Norfolk, Virginia 23507","RECRUITING","Norfolk","Virginia","23507","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-76.28522,36.84681,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":35,"phoneExt":26,"email":36},"Marwan Ma'ayeh",{"type":56,"investigatorFullName":54,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Assistant Professor","100610231","phase-4-once-daily-vs-twice-daily-insulin-glargine-in-pregestational-diabetes-management-100610231",false,"NCT07224893","Once-Daily vs Twice-Daily Insulin Glargine in Pregestational Diabetes Management","Once-Daily Versus Twice-Daily Insulin Glargine in the Management of Patients With Pregestational Diabetes Requiring Insulin","Inclusion Criteria:\n\n* Patients older than 18 years of age;\n* The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study;\n* Type II diabetes mellitus requiring insulin;\n* The patient is between 24 weeks 0 days and 28 weeks 0 days of gestation at the time of enrollment. Gestational age will be determined by last menstrual period, confirmed with a first trimester ultrasound, per the recommended guidelines by the American College of Obstetricians and Gynecologists.\n* Currently using or willing to use a clinically indicated continuous glucose monitor for glycemic management\n\nExclusion Criteria:\n\n* Known allergy or reaction to insulin glargine, or concurrent medical condition where the use of insulin glargine is contraindicated;\n* Contraindication to CGM use, patient declines CGM use, or CGM not covered by patient's insurance;\n* Known or suspected fetal anomaly or aneuploidy;\n* Prisoners;\n* Ongoing prenatal care outside EVMS or planned delivery outside Sentara Norfolk General Hospital.","FEMALE","18 Years",{"count":68,"type":69},200,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","The purpose of this study is to determine if taking insulin glargine twice a day instead of once a day will better manage pregestational diabetes in pregnant patients. Participants in this study will be randomly assigned to one of two groups: a group that takes insulin glargine once a day, and a group that takes it twice. Continuous glucose monitoring will be used to track blood sugar levels. The main question the study aims to answer is: Will using insulin glargine twice a day instead of once lead to a better glucose time in range?",[75,76],"Pregestational Diabetes","Pregnancy",[78],"continuous glucose monitoring","2026-05-13",{"date":81,"type":82},"2026-05-15","ACTUAL",{"date":84,"type":69},"2026-05-18",{"date":86,"type":69},"2027-12-01",{"name":5,"class":6},1]