[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580994":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":63,"studyPopulation":56,"armGroups":64,"interventions":77,"overallOfficials":87,"centralContacts":91,"locations":96,"responsibleParty":115,"collaborators":118,"id":121,"slug":56,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":56,"enrollmentInfo":130,"targetDuration":56,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":99,"whyStopped":56,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"University of Cambridge","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":56},[9],{"measure":10,"description":11,"timeFrame":12},"The number of participants achieving remission of diabetes at 52 weeks","The between group difference in the number of participants achieving remission of diabetes at 52 weeks, defined as HbA1c \\\u003C48mmol\u002Fmol after ≥12 weeks off all diabetes medications.","52 weeks",[14,17,18,20,21,24,25,28,30,33,34,37,38,41,42,45,46,49,50,53,54],{"measure":15,"description":15,"timeFrame":16},"Mixed meal tolerance test (MMTT) area under the curve for C-peptide","12 weeks",{"measure":15,"description":15,"timeFrame":12},{"measure":19,"description":19,"timeFrame":16},"Mixed meal tolerance test (MMTT) area under the curve for glucose",{"measure":19,"description":19,"timeFrame":12},{"measure":22,"description":23,"timeFrame":16},"Proportion of time spent in tight target glucose range (3.9 to 7.8mmol\u002Fl)","Proportion of time spent with sensor glucose in tight target glucose range (3.9 to 7.8mmol\u002Fl)",{"measure":22,"description":23,"timeFrame":12},{"measure":26,"description":27,"timeFrame":16},"Proportion of time spent in target glucose range (3.9 to 10.0mmol\u002Fl)","Proportion of time spent with sensor glucose in target glucose range (3.9 to 10.0mmol\u002Fl)",{"measure":29,"description":27,"timeFrame":12},"Proportion of time spent intarget glucose range (3.9 to 10.0mmol\u002Fl)",{"measure":31,"description":32,"timeFrame":16},"Proportion of time spent below target glucose range (\u003C3.9mmol\u002Fl)","Proportion of time spent below target glucose range (\\\u003C3.9mmol\u002Fl)",{"measure":31,"description":32,"timeFrame":12},{"measure":35,"description":36,"timeFrame":16},"Proportion of time spent above target glucose range (>10.0mmol\u002Fl)","Proportion of time spent above target glucose range (\\>10.0mmol\u002Fl)",{"measure":35,"description":36,"timeFrame":12},{"measure":39,"description":40,"timeFrame":16},"Mean sensor glucose","Mean sensor glucose (mmol\u002Fl)",{"measure":39,"description":40,"timeFrame":12},{"measure":43,"description":44,"timeFrame":16},"Glycated haemoglobin","HbA1c (mmol\u002Fmol)",{"measure":43,"description":44,"timeFrame":12},{"measure":47,"description":48,"timeFrame":16},"Blood pressure","Blood pressure (mmHg)",{"measure":47,"description":48,"timeFrame":12},{"measure":51,"description":52,"timeFrame":16},"Body weight","Body weight (kg)",{"measure":51,"description":52,"timeFrame":12},{"measure":55,"description":55,"timeFrame":12},"Number of diabetes medications",null,{"allocation":58,"interventionModel":59,"interventionModelDescription":56,"primaryPurpose":60,"observationalModel":56,"timePerspective":56,"maskingInfo":61},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":62,"maskingDescription":56,"whoMasked":56},"NONE","This 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.\n\nRecruitment will target up to 56 participants to allow for drop-outs. Participants will be recruited from outpatient clinics at Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, local GP surgeries, social media advertising or other established practices at the centre. Written informed consent will be obtained from all participants before any study related activities.\n\nAfter obtaining informed consent, the baseline visit (including mixed meal tolerance test) and a 2-3 week run-in period, participants will be randomised to either 12 weeks use of fully closed-loop insulin delivery or 12 weeks during which they will apply their standard diabetes therapy with a glucose sensor. Participants in both groups will receive diet and lifestyle advice with specific focus on the impact of diet and lifestyle choices on glucose sensor readings and trends.\n\nFollowing the 12 weeks intervention period (and repeat mixed meal tolerance test) all participants will continue with standard diabetes therapy for nine months of follow-up (and final mixed meal tolerance test). Diabetes therapies will be adjusted every 3 months based on HbA1c.\n\nThe study includes up to 5 visits and 6 telephone\u002Femail contacts. Visits 2 and 3 may be combined. All participants will continue to be seen by their clinical team at frequencies as appropriate in line with usual clinical practice. All study visits will be scheduled in addition to routine clinical visits and will be performed by the research team. Maximum time in the study is 56 weeks.",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"Fully automated insulin delivery","EXPERIMENTAL","Fully automated insulin delivery with CamAPS HX, Freestyle Libre 3 Sensor and Ypsopump insulin pump for 12 weeks",[70],"Device: Fully automated insulin delivery with CamAPS HX",{"label":72,"type":73,"description":74,"interventionNames":75},"Standard therapy with a glucose sensor","ACTIVE_COMPARATOR","Standard diabetes therapy with a glucose sensor for 12 weeks",[76],"Device: Standard diabetes therapy with a glucose sensor",[78,83],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":56},"DEVICE","Fully automated insulin delivery with CamAPS HX","Fully automated insulin delivery with CamAPS HX app, Libre 3 glucose sensor and Ypsopump insulin pump.",[66],{"type":79,"name":84,"description":85,"armGroupLabels":86,"otherNames":56},"Standard diabetes therapy with a glucose sensor","Standard diabetes therapy with a Freestyle Libre 3 glucose sensor",[72],[88],{"name":89,"affiliation":5,"role":90},"Charlotte K Boughton","PRINCIPAL_INVESTIGATOR",[92],{"name":89,"role":93,"phone":94,"phoneExt":56,"email":95},"CONTACT","+44 (0)1223 769066","cb2000@cam.ac.uk",[97],{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"Addenbrooke's Hospital NHS Foundation Trust","RECRUITING","Cambridge","Cambridgeshire","CB2 0QQ","United Kingdom","UK",{"type":106,"coordinates":107},"Point",[108,109],0.11667,52.2,{"lat":109,"lon":108},[112],{"name":113,"role":93,"phone":114,"phoneExt":56,"email":95},"Charlotte Boughton","+441223769066",{"type":90,"investigatorFullName":116,"investigatorTitle":117,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"Dr Charlotte Boughton","Clinical Research Associate",[119],{"name":120,"class":6},"Cambridge University Hospitals NHS Foundation Trust","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":131,"type":132},56,"ESTIMATED","INTERVENTIONAL",[135],"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.",[138],"Type 2 Diabetes",[140,141],"Remission","closed-loop","2025-03-27",{"date":144,"type":145},"2025-03-28","ACTUAL",{"date":147,"type":132},"2025-04-24",{"date":149,"type":132},"2029-04-30",{"name":5,"class":6},1]