[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587194":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":64,"collaborators":68,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":26,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":56,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Centre Hospitalier Universitaire Vaudois","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fully closed-loop insulin delivery (CamAPS HX)","EXPERIMENTAL","The CamAPS HX closed-loop system will consist of :\n\n* mylife Ypsopump insulin pump (Ypsomed, Switzerland)\n* FreeStyle Libre 3 CGM (Abbott, USA)\n* Cambridge model predictive control algorithm on a smartphone (CamAPS, UK)\n* Cloud upload system to review CGM\u002Finsulin data",[13],"Device: CamAPS HX",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard insulin therapy with CGM","ACTIVE_COMPARATOR","Participants in the control arm will continue their standard insulin therapy. They will also receive a Freestyle Libre 3 glucose sensor (Abbott, USA).",[19],"Device: Standard insulin therapy with CGM",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","CamAPS HX","The CamAPS HX fully closed-loop system consists of an insulin pump, a continuous glucose monitoring (CGM) sensor, as well as the CamAPS HX app, which resides on a smartphone and communicates wirelessly with the insulin pump.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Participants will continue their standard insulin therapy with a Freestyle Libre 3 CGM",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Heba Al-Alwan, MD, PhD","CONTACT","+4179 556 27 98","heba.al-alwan@chuv.ch",[37,54],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"NOT_YET_RECRUITING","Lausanne","Canton of Vaud","1011","Switzerland","CH",{"type":45,"coordinates":46},"Point",[47,48],6.63282,46.516,{"lat":48,"lon":47},[51,52],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},{"name":32,"role":53,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":55,"status":56,"city":39,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},"CHUV","RECRUITING",{"type":45,"coordinates":58},[47,48],{"lat":48,"lon":47},[61],{"name":62,"role":33,"phone":63,"phoneExt":26,"email":35},"Heba Alwan","41795562798",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Heba Al-Alwan","Medical doctor",[69,71],{"name":70,"class":6},"Swiss National Science Foundation",{"name":72,"class":73},"Institute of Primary Health Care (BIHAM), Switzerland","UNKNOWN","100587194","closed-loop-impact-on-chronic-kidney-disease-in-type-2-diabetes-100587194",false,"NCT06925217","Closed-Loop Impact on Chronic Kidney Disease in Type 2 Diabetes","The Effect of Fully Closed-loop Insulin Delivery on Renal Oxygenation in People With Type 2 Diabetes and Chronic Kidney Disease: an Open-label, Single-center, Randomized Two-arm Parallel Trial","CLICK","Inclusion Criteria:\n\n* Informed consent signed by the subject\n* Age 18 years and older\n* Type 2 diabetes diagnosed for at least 12 months\n* Treatment with insulin therapy for at least 6 months\n* CKD defined either as an eGFR 30-59 ml\u002Fmin\u002F1.73m² or presence of albuminuria \\> 3 mg\u002Fmmol (stage A2 or A3 according to KDIGO) with an eGFR \\> 30 ml\u002Fmin\u002F1.73m². CKD must be present for at least 6 months.\n* HbA1c \\\u003C 12% based on a venous blood sample from the screening visit\n* Receiving treatment with an SGLT2 inhibitor and\u002For GLP-1 receptor agonist for at least 3 months, have been offered these therapies previously, or contraindication\u002Fintolerance to receiving these therapies\n* Willing to wear study devices and follow study instructions\n* Capable of giving an informed consent\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Current use of insulin pump\n* Current use of any closed-loop system\n* Alternative cause of CKD according to medical records such as polycystic kidney disease, glomerulonephritis, congenital urogenital tract diseases, etc.\n* Known or suspected allergy against insulin\n* Pregnancy, planned pregnancy, or breast feeding\n* Severe visual impairment\n* Severe hearing impairment\n* Two or more episodes of severe hypoglycemia in the last 6 months\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* 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* Recent (less than three months) history of myocardial infarction, percutaneous coronary intervention, stroke, or hospitalization for heart failure with reduced ejection fraction\n* History of renal transplantation requiring ongoing immunosuppressive therapy\n* Known or suspected non-compliance, drug or alcohol abuse\n* Inability to follow the procedures of the investigation, e.g. due to language problems\n* Incapacity to give informed consent\n* Contra-indication to undergo MR-imaging according to a standard checklist such as the presence of a pacemaker or other implanted metallic device or severe claustrophobia.\n* Subject refuses to be informed of incidental findings related to their health discovered during imaging or other study-related exams\n* Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation\n* Previous enrolment into the current investigation\n* Enrolment of the PI, his\u002Fher family members, employees and other dependent persons","ALL","18 Years",{"count":85,"type":86},76,"ESTIMATED","INTERVENTIONAL",[89],"NA","The main objective of this study is to evaluate the effect of fully automated closed-loop glucose control on renal tissue oxygenation among people with type 2 diabetes and chronic kidney disease.\n\nThis is a single-center, open-label parallel design study that will compare 26 weeks of fully-automated closed-loop glucose control with standard insulin therapy and continuous glucose monitoring, following a run-in period. A total of up to 76 adults with type 2 diabetes and chronic kidney disease will be recruited through outpatient diabetes and nephrology clinics.\n\nThe primary outcome is renal tissue oxygenation measured using blood oxygenation level-dependent magnetic resonance imaging at 26 weeks. Other key outcomes include glycated hemoglobin at 26 weeks and time spent with glucose levels within and above the target glucose range (3.9-10.0mmol\u002FL). Other glycemic and renal outcomes (including renal function) will also be assessed, as well as patient-reported outcome measures using validated questionnaires. Safety evaluations include severe hypoglycemic episodes and other adverse and serious adverse events.",[92,93],"Type 2 Diabetes","Chronic Kidney Disease Stage 3",[95,96],"closed-loop","type 2 diabetes","2026-02-11",{"date":99,"type":100},"2026-02-12","ACTUAL",{"date":102,"type":100},"2025-06-16",{"date":104,"type":86},"2027-05",{"name":66,"class":6},2]