[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527191":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":29,"responsibleParty":52,"collaborators":10,"id":54,"slug":10,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":10,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":10,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Insulet Corporation","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Omnipod User",null,"All new users for the Omnipod 5 System will be required to register with Insulet's Podder Central. Users already in Podder Central will be required to log into their account before logging into the Omnipod 5 Controller if transitioning to the Omnipod 5 System. As part of the onboarding process, users will be invited to participate in this registry.",[13],"Device: Omnipod 5",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Omnipod 5","The Omnipod 5 System consists of a tubeless insulin Pod and the Omnipod® 5 App, installed on a designated Controller or compatible Android smartphone. The Omnipod 5 System works with the Dexcom G6® Continuous Glucose Monitoring System to continuously adapt and automatically deliver insulin according to personal needs.\n\nEvery two weeks while on the Omnipod 5 system, participants will receive a push notification to complete assessments including any severe hypoglycemia or diabetic ketoacidosis events experienced since the prior assessment.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Trang Ly, MBBS, PhD","CONTACT","978-600-7000","APClinical@insulet.com",{"name":27,"role":23,"phone":24,"phoneExt":10,"email":28},"Julie Perkins","jperkins@insulet.com",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Circuit Clinical","RECRUITING","Buffalo","New York","14203","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-78.87837,42.88645,{"lat":42,"lon":41},[45,49],{"name":46,"role":23,"phone":47,"phoneExt":10,"email":48},"Carmina VanHAll","603-309-7690","cvanhall@circuitclinical.com",{"name":50,"role":51,"phone":10,"phoneExt":10,"email":10},"Ashok Subramanian, MD","PRINCIPAL_INVESTIGATOR",{"type":53,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100527191",false,"NCT06144554","Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes","Post Market Registry to Collect Real-World Safety and Effectiveness Data for the Omnipod 5 System in Children and Adults With Type 1 Diabetes","Inclusion Criteria:\n\n1. Self-reported type 1 diabetes\n2. Prescribed, obtained, and have been using the Omnipod 5 System for no more than two weeks or plan to start using the system within the next two weeks\n3. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog\n4. Able to read and speak English or Spanish (when available) fluently and reside full time in the United States\n5. Willing to collect A1C samples using a provided home kit and send the samples to the registry specific core laboratory at baseline and 3, 6, 9 and 12 months\n6. Willing and able to complete registry assessments every two weeks\n7. Willing and able to complete registry outcome questionnaires at baseline, 6 months and end of study (or at withdrawal)\n8. Is not currently pregnant or planning to become pregnant in the next 12 months and is using a reliable form of birth control\n9. Access to internet via phone, tablet and\u002For computer to use the registry online platform\n10. Willing to provide CGM and insulin delivery data collected prior to using the Omnipod 5 System, if available (participants will not be excluded if data is not provided)\n11. Willing and able to provide informed consent (or assent) and\u002For has a parent\u002Fguardian willing and able to provide informed consent as applicable\n\nExclusion Criteria:\n\n1. Diagnosed with sickle cell anemia and\u002For hemoglobinopathy\n2. Planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on Omnipod 5\n3. Adults that are unable to provide informed consent","ALL","2 Years",{"count":63,"type":64},2200,"ESTIMATED","OBSERVATIONAL","This is a decentralized observational clinical registry to collect real-world evidence related to the safety and effectiveness of the Omnipod 5 system in children and adults with Type 1 Diabetes.",[68],"Type 1 Diabetes",[68,70,71,72],"Omnipod","Automated Insulin Delivery","Registry","2026-06-29",{"date":75,"type":76},"2026-07-01","ACTUAL",{"date":78,"type":76},"2023-09-25",{"date":80,"type":64},"2028-09",{"name":5,"class":6},1]