[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580994":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":59,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":26,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Cambridge","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fully automated insulin delivery","EXPERIMENTAL","Fully automated insulin delivery with CamAPS HX, Freestyle Libre 3 Sensor and Ypsopump insulin pump for 12 weeks",[13],"Device: Fully automated insulin delivery with CamAPS HX",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard therapy with a glucose sensor","ACTIVE_COMPARATOR","Standard diabetes therapy with a glucose sensor for 12 weeks",[19],"Device: Standard diabetes therapy with a glucose sensor",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Fully automated insulin delivery with CamAPS HX","Fully automated insulin delivery with CamAPS HX app, Libre 3 glucose sensor and Ypsopump insulin pump.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard diabetes therapy with a glucose sensor","Standard diabetes therapy with a Freestyle Libre 3 glucose sensor",[15],[32],{"name":33,"affiliation":5,"role":34},"Charlotte K Boughton","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+44 (0)1223 769066","cb2000@cam.ac.uk",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Addenbrooke's Hospital NHS Foundation Trust","RECRUITING","Cambridge","Cambridgeshire","CB2 0QQ","United Kingdom","UK",{"type":50,"coordinates":51},"Point",[52,53],0.11667,52.2,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":58,"phoneExt":26,"email":39},"Charlotte Boughton","+441223769066",{"type":34,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Dr Charlotte Boughton","Clinical Research Associate",[63],{"name":64,"class":6},"Cambridge University Hospitals NHS Foundation Trust","100580994","targeting-beta-cell-function-to-achieve-remission-of-type-2-diabetes-100580994",false,"NCT06844539","taRgeting bEtA-Cell Function To achIeVe Remission of Type 2 diAbeTEs","Targeting Beta-cell Function to Achieve Remission of Type 2 Diabetes (REACTIVATE). An Open-label, Single-centre, Randomised, Parallel Study to Assess the Efficacy, Safety and Utility of Fully Closed-loop Insulin Delivery in Achieving Remission of Diabetes Compared to Standard Therapy With a Glucose Sensor in Adults With Recent Onset Type 2 Diabetes","REACTIVATE","Inclusion Criteria:\n\n* Aged 18 years and older\n* Type 2 diabetes diagnosed \\>6 months and ≤5 years ago\n* Treatment with glucose lowering medication for at least 3 months\n* HbA1c \\>48 mmol\u002Fmol on 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* Pregnancy, planned pregnancy, or breast feeding\n* Severe visual or hearing impairment\n* Medically documented allergy towards the adhesive of plasters\n* Serious skin diseases located at places of the body potentially used for localisation of the glucose sensor\n* Drug or alcohol misuse\n* Group 2 driving licence holder","ALL","18 Years",{"count":76,"type":77},56,"ESTIMATED","INTERVENTIONAL",[80],"NA","The main objective of the REACTIVATE study is to investigate whether a period of intensive insulin therapy using closed-loop technology, when combined with diet and lifestyle education, can restore beta-cell function and achieve remission of recent-onset type 2 diabetes.\n\nThis is a single-centre, open-label, randomised, parallel design study comparing up to 12 weeks of fully closed-loop insulin delivery to standard care with a glucose sensor in adults with recent-onset type 2 diabetes. The primary outcome is the number of participants achieving remission of diabetes at 52 weeks, defined as HbA1c below 48mmol\u002Fmol after 12 or more weeks off all diabetes medications.\n\nOther key outcomes include area under the curve for C-peptide and glucose during mixed meal tolerance test, the proportion of time spent with glucose levels within and above the target glucose range and mean sensor glucose as recorded by glucose sensor at 52 weeks.\n\nSafety evaluation comprises severe hypoglycaemic episodes, and other adverse and serious adverse events. Utility and human factors outcomes include glucose sensor and closed-loop usage, questionnaires and semi-structured interviews.",[83],"Type 2 Diabetes",[85,86],"Remission","closed-loop","2025-03-27",{"date":89,"type":90},"2025-03-28","ACTUAL",{"date":92,"type":77},"2025-04-24",{"date":94,"type":77},"2029-04-30",{"name":5,"class":6},1]