[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566402":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":55,"collaborators":10,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":10,"enrollmentInfo":67,"targetDuration":70,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":10,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Commercial AID system",null,"Pregnant individuals with type 1 diabetes (T1D) using commercially available automated insulin delivery (AID) systems for glycemic management in pregnancy",[13],"Other: Commercial AID system",{"label":15,"type":10,"description":16,"interventionNames":17},"Open source AID system","Pregnant individuals with type 1 diabetes T1D) using open source automated insulin delivery (AID) systems (also known as do-it-yourself AID systems or hacked AID systems) for glycemic management in pregnancy",[18],"Other: Open source AID system",[20,23],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":10},"AID system that is commercially available and FDA approved for use",[9],{"type":6,"name":15,"description":24,"armGroupLabels":25,"otherNames":10},"AID system that uses unregulated open-source software to customize an insulin delivery algorithm to connect an insulin pump to a continuous glucose monitor",[15],[27],{"name":28,"affiliation":5,"role":29},"Nasim Sobhani, MD","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"Primary Investigator","CONTACT","(415) 307-9319","cosclipstudy@ucsf.edu",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","San Francisco","California","94158","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-122.41942,37.77493,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":53,"phoneExt":10,"email":54},"Nasim Sobhani","415-307-9319","COSCLIPStudy@UCSF.edu",{"type":56,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100566402","commercial-or-open-source-closed-loop-impact-on-pregnancy-study-100566402",false,"NCT06654713","Commercial or Open Source Closed Loop Impact on Pregnancy Study","Commercial or Open Source Closed Loop Impact on Pregnancy (COSCLIP) Study","COSCLIP","Inclusion criteria:\n\n* Pregnant\n* Diagnosis of type 1 diabetes (T1D) prior to pregnancy\n* Active use of automated insulin delivery (AID) system\n\nExclusion criteria:\n\n* Diagnosis of other forms of diabetes (gestational diabetes, type 2 diabetes, monogenic diabetes)","FEMALE","18 Years",{"count":68,"type":69},1000,"ESTIMATED","1 Year","OBSERVATIONAL","The goal of this observational study is to better understand what happens when pregnant people with type 1 diabetes (T1D) use automated insulin delivery (AID) systems. The main questions this study aims to answer are:\n\n* What are the maternal and neonatal outcomes with AID system use in pregnancy?\n* What are the glycemic outcomes with AID system use in pregnancy?\n* What are the behavioral and emotional outcomes with AID system use in pregnancy?\n\nResearchers will compare pregnant people who use commercial AID systems and pregnant people who use open source AID systems to see if outcomes are different with these different types of systems.\n\nParticipants will be asked to remotely share their AID system data with the research team; complete online surveys regarding behavioral and emotional health; and sign an authorization to release health information to allow the research team to access medical records.",[74,75,76,77],"Type 1 Diabetes","Pregnancy, High Risk","Insulin Dependent Diabetes","Pregnancy Related","2025-05-06",{"date":80,"type":81},"2025-05-07","ACTUAL",{"date":83,"type":81},"2025-03-13",{"date":85,"type":69},"2029-12-31",{"name":5,"class":6},1]