[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592112":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":10,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":10,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"HJN Sverige AB\u002FNeko Health","INDUSTRY",[8,12,15,18,21],{"label":9,"type":10,"description":11,"interventionNames":10},"diabetes_severe_cohort",null,"Patients with severe type 1 diabetes (microangiopathy \u002F diabetic feet), with complications. Severe angiopathy defined as proliferative retinopathy, macroalbuminuria, and kidney failure with at least CKD-class 3B and severe neuropathy with or without foot ulcers.",{"label":13,"type":10,"description":14,"interventionNames":10},"diabetes_moderate_cohort","Patients with type 1 diabetes and moderate microangiopathy. moderate non-proliferative retinopathy or proliferative retinopathy, macroalbuminuria or kidney failure (defined as estimated glomerular filtration rate \\\u003C60 mL\u002Fmin\u002F1.73 m2 body surface) up to CKD-class 3A, and manifest neuropathy, (group c).",{"label":16,"type":10,"description":17,"interventionNames":10},"diabetes_mild_cohort","Patient with mild microangiopathy, mild-moderate non-proliferative retinopathy and\u002For microalbuminuria and\u002For early signs of neuropathy (group b).",{"label":19,"type":10,"description":20,"interventionNames":10},"diabetes_none_cohort","Patient with no microangiopathy, except for simplex or background retinopathy, which is in an early and reversible state (group a).",{"label":22,"type":10,"description":23,"interventionNames":10},"healthy_cohort","Age- and sex- matched healthy controls, with no known increased risk of cardiovascular disease.",[25],{"name":26,"affiliation":27,"role":28},"Sarah Tehrani, MD, PhD","Danderyd Hospital, Department of Internal Medicine, Stockholm, Sweden","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Mattias Windå","CONTACT","+46703169040","mattias@nekohealth.com",[36],{"facility":37,"status":38,"city":39,"state":10,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"VO Medicinska Specialiteter, Danderyd Hospital","RECRUITING","Stockholm","182 88","Sweden","SE",{"type":44,"coordinates":45},"Point",[46,47],18.06871,59.32938,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":52,"phoneExt":10,"email":53},"Sara Tehrani, MD, PhD","+46 73 679 70 74","sara.tehrani@regionstockholm.se",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100592112","the-mind-study---microangiopathy-in-diabetes-100592112",false,"NCT06989190","The MIND Study - Microangiopathy IN Diabetes","Phase 1: Severe Diabetic Complications (50 patients)\n\nInclusion Criteria:\n\n* Severe type 1 diabetes (microangiopathy \u002F diabetic feet), severe angiopathy defined as proliferative retinopathy, macroalbuminuria, and kidney failure with at least CKD-class 3B and severe neuropathy with or without foot ulcers.\n* Age range: primarily 18-45 years, if not sufficient number of subjects can be found, then 18-60 years span is considered\n\nPhase 2: Scale of severity. In phase 2, patients are included with a broad range of severity levels. Patients with diabetes type 1 will be included.\n\nInclusion criteria:\n\n* Age range: 18-45 years (younger patients are targeted for focus on microvascular complications, rather than age-related cardiovascular disease)\n* Patient with no microangiopathy, except for simplex or background retinopathy, which is in an early and reversible state (group a), 100 patients.\n* Patient with mild microangiopathy, mild-moderate non-proliferative retinopathy and\u002For microalbuminuria and\u002For early signs of neuropathy (group b), 100 patients.\n* Patient with moderate microangiopathy. moderate non-proliferative retinopathy or proliferative retinopathy, macroalbuminuria or kidney failure (defined as estimated glomerular filtration rate \\\u003C60 mL\u002Fmin\u002F1.73 m2 body surface) up to CKD-class 3A, and manifest neuropathy, (group c), 50 patients.\n\nHealthy controls:\n\n\\- Healthy control matched to the type 1 diabetes patients in age and gender, with no known risk of increased cardiovascular disease.\n\nExclusion Criteria:\n\n* Patients unable to understand patient information due to cognitive impairment\n* Patients unable to understand patient information due to language barriers\n* Ongoing acute infection or inflammatory condition\n* Pregnant or breastfeeding women\n* Patients with damaged and\u002For scarred tissue in the areas of interest for the investigational or comparator devices",true,"ALL","18 Years","60 Years",{"count":67,"type":68},400,"ESTIMATED","OBSERVATIONAL","This clinical investigation will evaluate two contactless optical devices based on spatial frequency domain and laser speckle technology for quantification of the skin micro-circulation in patients with diabetes mellitus type 1.",[72],"Diabetes Type 1","2025-05-16",{"date":75,"type":76},"2025-05-25","ACTUAL",{"date":78,"type":76},"2023-12-19",{"date":80,"type":68},"2026-12",{"name":5,"class":6},1]