[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Heba Al-Alwan\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":20,"type":21},76,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Type 2 Diabetes","Chronic Kidney Disease Stage 3",[30,31],"closed-loop","type 2 diabetes","RECRUITING","2026-02-11",{"date":35,"type":36},"2026-02-12","ACTUAL",{"date":38,"type":36},"2025-06-16",{"date":40,"type":21},"2027-05",{"name":42,"class":43},"Heba Al-Alwan","OTHER",2,""]