[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ketoacidosis-diabetic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ketoacidosis-diabetic":29},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100650187","the-bright-study-device-name-halo-system-100650187",false,"NCT07745998","The BRIGHT Study (Device Name: HALO System)","The BRIGHT Study, an Open Label, Single-arm, Interventional, Multicenter, Prospective Study of the Diagnostic Feasibility of the HALO System, Designed to Evaluate the Safety and Performance of the HALO SYSTEM in Subjects With Diabetes Mellitus","Inclusion Criteria:\n\n* Willing to sign an informed consent form\n* Age ≥ 18 years\n* Willing to comply to study protocol requirements (study visits with frequent venous blood sampling and deliberate insulin, glucose, ketone and lactate challenges)\n* Willing to charge the SENSOR on daily basis\n* Willing not to insert their standard CGM and\u002For insulin pump in and around the SENSOR implant site (± radius 5 cm)\\[TS\\| XR1.1\\] Diagnosed with type 1 diabetes mellitus according to the World Health Organization criteria, for at least 12 months prior to screening, on CSII therapy\n\nExclusion Criteria:\n\n* Known allergy to polydimethylsiloxane (PDMS)\n* A contraindication to undergo challenging tests (i.e., ischemic heart disease, epilepsy, panhypopituitarism, hypoadrenalism, untreated hypothyroidism)\n* History of hepatitis C or HIV or other disease transmissible by blood\n* A condition requiring or likely to require magnetic resonance imaging during the study duration\n* Female participants who are pregnant, planning on becoming pregnant or nursing\n* Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication (oral anticoagulants; antiplatelets (such as aspirin, ticagrelor are allowed).\n* Anemia identified by a haemoglobin \\\u003C14 g\u002FdL for men or \\\u003C12 g\u002FdL for women\n* The presence of any other active implanted device\n* The presence of any other CGM sensor\u002Fpump located in the lower abdomen (other location is acceptable)\n* Waist circumference of \\>120 cm\n* Any disorder, which in the investigator's opinion might jeopardise participants' safety or compliance with the protocol.","ALL","18 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of the BRIGHT study is to evaluate safety and performance of the HALO SYSTEM in subjects with diabetes mellitus. The primary objectives of this clinical investigation are 1) the evaluation of sensor's performance by demonstrating sensor's accuracy and stability and 2) to confirm safe implantation of the Sensor and safety of the device during implantation.",[26,27,28,29,30,31],"Diabetes Mellitus - Type 1","Diabetes Mellitus - Type 2","Diabetes Mellitus","Ketoacidosis, Diabetic","Hyperglycaemia (Diabetic)","Hypoglycemia (Diabetic)",[33,34,35,36,37,38,39,40],"CMM","CGM","Diabetes mellitus - type 1","Diabetes mellitus - type 2","ketoacidosis, diabetic","continuous multi-metabolite monitoring","hyperglycaemia (diabetic)","hypoglycaemia (diabetic)","NOT_YET_RECRUITING","2026-08-03",{"date":44,"type":45},"2026-08-04","ACTUAL",{"date":47,"type":20},"2026-12",{"date":49,"type":20},"2027-06",{"name":51,"class":52},"Indigo Diabetes NV","INDUSTRY"]