[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560611":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":187,"collaborators":190,"id":197,"slug":198,"hasResults":199,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":199,"sex":205,"minAge":206,"maxAge":26,"enrollmentInfo":207,"targetDuration":26,"studyType":210,"phases":211,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":112,"whyStopped":26,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":228},{"fullName":5,"class":6},"University of Cambridge","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fully closed-loop insulin delivery (CamAPS HX)","EXPERIMENTAL","The automated closed loop system (CamAPS FX) will consist of:\n\n* YpsoPump insulin pump (Ypsomed, Burgdorf, Switzerland)\n* FreeStyle Libre 3 glucose sensor (Abbott Diabetes Care, CA, USA)\n* Smartphone hosting CamAPS HX app with the Cambridge model predictive control algorithm\n* Cloud upload system to review CGM\u002Finsulin data.\n\nParticipants will use the fully closed-loop system for 26 weeks at home",[13],"Device: CamAPS HX",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard insulin therapy with glucose sensor","ACTIVE_COMPARATOR","Usual insulin therapy and FreeStyle Libre 3 glucose sensor (Abbott Diabetes Care, CA, USA) for 26 weeks at home.",[19],"Other: Standard insulin therapy with glucose sensor",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","CamAPS HX","The automated closed loop system (CamAPS HX) will consist of:\n\nYpsoPump insulin pump Freestyle Libre 3 glucose sensor Smartphone hosting CamAPS HX app with the Cambridge model predictive control algorithm",[9],null,{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Participants usual insulin therapy with Freestyle Libre 3 glucose sensor",[15],[31],{"name":32,"affiliation":5,"role":33},"Roman Hovorka","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Charlotte K Boughton, PhD","CONTACT","+44 (0)1223 769066","cb2000@medschl.cam.ac.uk",{"name":41,"role":37,"phone":26,"phoneExt":26,"email":42},"Angel Tseung","ftt20@cam.ac.uk",[44,59,72,84,97,110,124,135,146,157,165,176],{"facility":45,"status":46,"city":47,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"University of Melbourne","NOT_YET_RECRUITING","Melbourne","Australia","AU",{"type":51,"coordinates":52},"Point",[53,54],144.96332,-37.814,{"lat":54,"lon":53},[57],{"name":58,"role":37,"phone":26,"phoneExt":26,"email":26},"David O'Neal",{"facility":60,"status":46,"city":61,"state":26,"zip":26,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Medical University of Graz","Graz","Austria","AT",{"type":51,"coordinates":65},[66,67],15.44197,47.06733,{"lat":67,"lon":66},[70],{"name":71,"role":37,"phone":26,"phoneExt":26,"email":26},"Julia Mader",{"facility":73,"status":46,"city":74,"state":26,"zip":26,"country":75,"countryCode":26,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Diabetes Centre, Institute of Clinical and Experimental Medicine","Prague","Czechia",{"type":51,"coordinates":77},[78,79],14.42076,50.08804,{"lat":79,"lon":78},[82],{"name":83,"role":37,"phone":26,"phoneExt":26,"email":26},"Martin Haluzík",{"facility":85,"status":46,"city":86,"state":26,"zip":26,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"CHU de Toulouse","Toulouse","France","FR",{"type":51,"coordinates":90},[91,92],1.44367,43.60426,{"lat":92,"lon":91},[95],{"name":96,"role":37,"phone":26,"phoneExt":26,"email":26},"Hélène Hanaire",{"facility":98,"status":46,"city":99,"state":26,"zip":26,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Bern University Hospital","Bern","Switzerland","CH",{"type":51,"coordinates":103},[104,105],7.44744,46.94809,{"lat":105,"lon":104},[108],{"name":109,"role":37,"phone":26,"phoneExt":26,"email":26},"Lia Bally",{"facility":111,"status":112,"city":113,"state":26,"zip":26,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust","RECRUITING","Cambridge","United Kingdom","UK",{"type":51,"coordinates":117},[118,119],0.11667,52.2,{"lat":119,"lon":118},[122],{"name":123,"role":37,"phone":26,"phoneExt":26,"email":26},"Charlotte Boughton",{"facility":125,"status":46,"city":126,"state":26,"zip":26,"country":114,"countryCode":115,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Royal Derby Hospital","Derby",{"type":51,"coordinates":128},[129,130],-1.47663,52.92277,{"lat":130,"lon":129},[133],{"name":134,"role":37,"phone":26,"phoneExt":26,"email":26},"Emma Wilmot",{"facility":136,"status":112,"city":137,"state":26,"zip":26,"country":114,"countryCode":115,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Leicester Diabetes Centre","Leicester",{"type":51,"coordinates":139},[140,141],-1.13169,52.6386,{"lat":141,"lon":140},[144],{"name":145,"role":37,"phone":26,"phoneExt":26,"email":26},"Pratik Choudhary",{"facility":147,"status":112,"city":148,"state":26,"zip":26,"country":114,"countryCode":115,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Guy's and St Thomas' NHS Foundation Trust","London",{"type":51,"coordinates":150},[151,152],-0.12574,51.50853,{"lat":152,"lon":151},[155],{"name":156,"role":37,"phone":26,"phoneExt":26,"email":26},"Sufyan Hussain",{"facility":158,"status":112,"city":148,"state":26,"zip":26,"country":114,"countryCode":115,"cosmosGeoPoint":159,"geoPoint":161,"contacts":162},"King's College Hospital, King's College NHS Foundation Trust",{"type":51,"coordinates":160},[151,152],{"lat":152,"lon":151},[163],{"name":164,"role":37,"phone":26,"phoneExt":26,"email":26},"Yee Cheah",{"facility":166,"status":46,"city":167,"state":26,"zip":26,"country":114,"countryCode":115,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust","Manchester",{"type":51,"coordinates":169},[170,171],-2.23743,53.48095,{"lat":171,"lon":170},[174],{"name":175,"role":37,"phone":26,"phoneExt":26,"email":26},"Hood Thabit",{"facility":177,"status":112,"city":178,"state":26,"zip":26,"country":114,"countryCode":115,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Norfolk and Norwich University Hospital","Norwich",{"type":51,"coordinates":180},[181,182],1.29834,52.62783,{"lat":182,"lon":181},[185],{"name":186,"role":37,"phone":26,"phoneExt":26,"email":26},"Sankalpa Neupane",{"type":33,"investigatorFullName":188,"investigatorTitle":189,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Dr Roman Hovorka","Professor of Metabolic Technology",[191,193,195],{"name":192,"class":6},"University of Edinburgh",{"name":194,"class":6},"Jaeb Center for Health Research",{"name":196,"class":6},"Swansea University","100560611","closed-loop-in-adults-with-type-2-diabetes-100560611",false,"NCT06579404","Closed-loop in Adults With Type 2 Diabetes","An Open-label, Multinational, Multicentre, Randomised, Single-period Parallel Study to Assess the Efficacy, Safety and Utility of Fully Closed-loop Insulin Delivery Compared to Standard Insulin Therapy With CGM in Adults With Type 2 Diabetes","COYOTE","Inclusion Criteria:\n\n* Aged 18 years and older\n* Type 2 diabetes diagnosed for at least 12 months\n* Established on an SGLT2 inhibitor and\u002For GLP-1 receptor agonist for at least 3 months, or have been offered these therapies previously.\n* Treatment with insulin therapy for at least 6 months\n* HbA1c ≤ 15% (140 mmol\u002Fmol) analysis from local laboratory or equivalent\n* Willing to wear study devices and follow study instructions\n* Capacity to consent to participate in the study\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Current use of insulin pump\n* Current use of any closed-loop system\n* Any physical\u002Fpsychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by study clinician\n* Known or suspected allergy against insulin\n* Medically documented allergy towards the adhesive\n* Pregnancy, planned pregnancy, or breast feeding\n* Severe visual impairment\n* Severe hearing impairment\n* Medically documented allergy towards the adhesive (glue) of plasters\n* Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor\n* Illicit drugs abuse\n* Prescription drugs abuse\n* Alcohol abuse","ALL","18 Years",{"count":208,"type":209},224,"ESTIMATED","INTERVENTIONAL",[212],"NA","The main objective of this study is to determine the efficacy, safety and utility of fully closed-loop glucose control in the home setting in adults with type 2 diabetes (T2D). This study builds on previous and on-going studies of closed-loop systems that have been performed in Cambridge in adults with type 2 diabetes in the inpatient and in the home setting and in children and adults with type 1 diabetes.\n\nThis is an open-label, multi-national, multi-centre, randomised, single-period parallel study, involving a run-in period followed by a 26-week intervention period during which glucose levels will be controlled either by a fully closed-loop system or by participants usual insulin therapy with continuous glucose monitoring. A total of up to 224 adults with type 2 diabetes using insulin will be recruited through outpatient diabetes clinics, primary care centres, social media advertising and other established methods at participating centres. Participants will receive appropriate training in the safe use of the study devices.\n\nThe primary outcome is the between group difference in HbA1c at 26 weeks. Other key outcomes include the time spent with glucose levels within, above and below the target glucose range (3.9-10.0mmol\u002FL) and mean sensor glucose as recorded by CGM over the 26 weeks. Insulin requirements, body weight, renal and liver function will also be compared. Safety evaluation comprises severe hypoglycaemic episodes, and other adverse and serious adverse events. Human factors outcomes include CGM \\& closed-loop usage, questionnaires and semi-structured interviews.",[215],"Type 2 Diabetes Treated With Insulin",[217,218],"Closed-loop insulin delivery","Type 2 diabetes","2026-03-10",{"date":221,"type":222},"2026-03-13","ACTUAL",{"date":224,"type":222},"2024-12-06",{"date":226,"type":209},"2027-07",{"name":5,"class":6},12]