[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603237":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":10,"centralContacts":25,"locations":10,"responsibleParty":35,"collaborators":10,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":10,"eligibilityCriteria":44,"healthyVolunteers":45,"sex":46,"minAge":10,"maxAge":10,"enrollmentInfo":47,"targetDuration":10,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":10,"overallStatus":58,"whyStopped":10,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":10},{"fullName":5,"class":6},"Women and Infants Hospital of Rhode Island","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pregnant women >24 weeks gestation and their infants",null,"Pregnant women \\>24 weeks gestation; infants of pregnant women \\>24 weeks gestation, including 11 infants of women with gestational diabetes, 11 infants of women with type II diabetes, 11 infants of women with type I diabetes, 6 small-for-gestational age (SGA) infants, 6 large-for-gestational age (LGA) infants, and 12 control infants who are not considered at-risk for hypoglycemia.",[13,14],"Device: Continuous glucose monitoring","Device: Cerebral near-infrared spectroscopy",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"DEVICE","Continuous glucose monitoring","A blinded Abbott Freestyle Libre 3 Pro will be placed on the newborn",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"Cerebral near-infrared spectroscopy","Blinded cerebral near infrared spectroscopy will be assessed",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Sarbattama Sen, MD","CONTACT","401-274-1122","ssen@carene.org",{"name":32,"role":28,"phone":33,"phoneExt":10,"email":34},"Isabella Lawandy","401-274-1100","ilawandy@wihri.org",{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Sarbattama Rimi Sen","Vice Chair Pediatric Clinical Research","100603237","accuracy-of-interstitial-continuous-glucose-sensors-in-neonates-100603237",false,"NCT07133906","Accuracy of Interstitial Continuous Glucose Sensors in Neonates","Inclusion Criteria:\n\n* women aged 18 years or older\n* speaks English, Spanish, Portuguese, or Haitian Creole\n* pregnant \\>24 weeks gestation with singleton pregnancy\n\nExclusion Criteria:\n\n* known concomitant maternal or fetal condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff\n* plans to deliver at a hospital other than Women and Infants Hospital of Rhode Island",true,"ALL",{"count":48,"type":49},114,"ESTIMATED","OBSERVATIONAL","Low blood sugar in newborns is common and if prolonged or untreated may place them at increased risk for later learning and behavior challenges. Currently, we measure newborn glucose with at least four painful heel sticks, missing one in four episodes of low blood sugar. The goal of this observational study is to develop a less invasive approach to glucose monitoring, developed for newborns, that provides more frequent glucose measurements. We will also measure how a pregnant woman's health impacts newborn glucose, and how newborn glucose is linked to brain oxygen saturation and development.",[53,54,55,56,57],"Neonatal Hypoglycemia","Gestational Diabetes","Maternal Obesity Complicating Pregnancy","Small-for-gestational Age","Large-for-gestational Age","NOT_YET_RECRUITING","2025-08-13",{"date":61,"type":62},"2025-08-21","ACTUAL",{"date":64,"type":49},"2025-09",{"date":66,"type":49},"2027-06",{"name":5,"class":6}]