[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552169":3},{"organization":4,"outcomesModule":7,"designInfo":126,"detailedDescription":78,"studyPopulation":78,"armGroups":133,"interventions":148,"overallOfficials":156,"centralContacts":163,"locations":174,"responsibleParty":214,"collaborators":216,"id":218,"slug":78,"hasResults":219,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":219,"sex":225,"minAge":226,"maxAge":78,"enrollmentInfo":227,"targetDuration":78,"studyType":230,"phases":231,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":176,"whyStopped":78,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":256},{"fullName":5,"class":6},"Steno Diabetes Center Copenhagen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":75},[9],{"measure":10,"description":11,"timeFrame":12},"Difference in change from baseline to study end in sleep efficiency between the two groups.","Measured by HomeSleepTest for 3 consecutive days. Expressed in percentage.","Baseline and week 18",[14,17,19,21,24,27,30,33,35,37,39,42,44,46,48,51,54,57,60,63,66,69,72],{"measure":15,"description":16,"timeFrame":12},"Total sleep duration","As measured by HomeSleepTest for 3 consequtive days. Expressed in minutes.",{"measure":18,"description":16,"timeFrame":12},"Time in sleep stages",{"measure":18,"description":20,"timeFrame":12},"As measured by HomeSleepTest for 3 consequtive days. Expressed in percentages.",{"measure":22,"description":23,"timeFrame":12},"Sleep latency","As measured by HomeSleepTest and ActiGraph for 3 consequtive days.Expressed in minutes",{"measure":25,"description":26,"timeFrame":12},"Waking after sleep onset","As measured by HomeSleepTest and Actigraph for 3 consequtive days. Expressed in minutes",{"measure":28,"description":29,"timeFrame":12},"24-hour blood pressure","Measured using SpaceLabs Ontrak. Expressed in mmHg, SBP, DBP and MAP means and differences at day\u002Fnighttime. Presence of nighttime dipping (defined as MAP reduction of 10% or more). Difference in dat day- and nighttime defined as time asleep measured by HST.",{"measure":31,"description":32,"timeFrame":12},"Heart rate variability","Measured using Bittium Faros 180 holter monitors for 24 hours. Measured as standard deviation of NN intervals in milliseconds.",{"measure":31,"description":34,"timeFrame":12},"Measured using Bittium Faros 180 holter monitors for 24 hours. Measured as root mean square of successive RR interval differences (rMSSD) in milliseconds.",{"measure":31,"description":36,"timeFrame":12},"Measured using Bittium Faros 180 holter monitors for 24 hours. Measured as frequency-domain distribution absolute power in milliseconds squared.",{"measure":31,"description":38,"timeFrame":12},"Measured using Bittium Faros 180 holter monitors for 24 hours. Measured as frequency-domain distribution relative power in percentage.",{"measure":40,"description":41,"timeFrame":12},"Cognitive function","Measured using Cambridge Neuropsychological Test Automated Battery (CANTAB) with the Rapid Visual Information Processing test for both the adult and pediatric population.",{"measure":40,"description":43,"timeFrame":12},"Measured using Cambridge Neuropsychological Test Automated Battery (CANTAB) with the Delayed Matching to Sample test for both the adult and pediatric population.",{"measure":40,"description":45,"timeFrame":12},"Measured using Cambridge Neuropsychological Test Automated Battery (CANTAB) with the Spatial Working Memory test for the adult population only.",{"measure":40,"description":47,"timeFrame":12},"Measured using Cambridge Neuropsychological Test Automated Battery (CANTAB) with the Stop Signal Task test for the adult population only.",{"measure":49,"description":50,"timeFrame":12},"Inflammatory markers","Defined in fold changes to expression of IL-1β, IL-6, IL-8, TNF-α, MCP-1, VEGF-α, CRP, ICAM-1, V-CAM-1, CRP. Assessed using multiplex ELISA analyses with MesoScale V-Plex and S-Plex plates.",{"measure":52,"description":53,"timeFrame":12},"Hypoglycaemia Fear Survey scores","Possible scores between 0-44, higher scores mean more fear of hypoglycemia.",{"measure":55,"description":56,"timeFrame":12},"Diabetes Distress Scale scores","Possible scores between 7-42, higher scores mean more diabetes distress.",{"measure":58,"description":59,"timeFrame":12},"Pittsburgh Sleep Quality Index scores","Measured for adults only. Possible scores between 0-21, higher scores means more severe sleep issues.",{"measure":61,"description":62,"timeFrame":12},"EuroQol 5-Domain scores","For adults the 5 Likert scale (5Q-5D-5L) will be used. For children the Young scale (5Q-5D-Y) scale will be used.",{"measure":64,"description":65,"timeFrame":12},"5-item World Health Organization Well-Being Index (WHO-5) scores","Possible scores between 0-100. Lower scores means worse well-being.",{"measure":67,"description":68,"timeFrame":12},"Sleep Screening Questionnaire Children and Adolescents (SSQ-CA) scores","Measured for children",{"measure":70,"description":71,"timeFrame":12},"Sleep efficiency","Measured in percentages, assessed using 7 days of ActiGraph data, supported by daily electronic sleep diaries.",{"measure":73,"description":74,"timeFrame":12},"Wake time after sleep onset","Measured in minutes, assessed using 7 days of ActiGraph data, supported by daily electronic sleep diaries.",[76,79,82,84,86,88,90,93,96,98,101,104,107,110,113,115,117,120,123],{"measure":77,"description":78,"timeFrame":12},"HbA1c",null,{"measure":80,"description":81,"timeFrame":12},"Time with glucose values in range of 3.9 -10.0 mmol\u002FL","Measured in percentage.",{"measure":83,"description":81,"timeFrame":12},"Time with glucose values \u003C 3.9 mmol\u002Fl",{"measure":85,"description":81,"timeFrame":12},"Time with glucose values \u003C 3.0 mmol\u002Fl",{"measure":87,"description":81,"timeFrame":12},"Time with glucose values > 10.0 mmol\u002Fl",{"measure":89,"description":81,"timeFrame":12},"Time with glucose values > 13.9 mmol\u002Fl",{"measure":91,"description":92,"timeFrame":12},"Sensor glucose","Measured as mmol\u002Fl with mean values and standard deviations",{"measure":94,"description":95,"timeFrame":12},"Glucose coefficient of variation","Measured in percentage",{"measure":97,"description":81,"timeFrame":12},"Time with rapid glucose change (> 1,5 mmol\u002Fl\u002F15 min)",{"measure":99,"description":100,"timeFrame":12},"Bodyweight","Measured in kilograms.",{"measure":102,"description":103,"timeFrame":12},"BMI standard deviation scores","Measured in the pediatric population.",{"measure":105,"description":106,"timeFrame":12},"Total daily insulin dose","Measured in IE and assessed by 2-week insulin pump data downloads",{"measure":108,"description":109,"timeFrame":12},"Total daily carbohydrate intake","Measured in grams and assessed by 2-week insulin pump data downloads",{"measure":111,"description":112,"timeFrame":12},"Hypoglycaemia awareness status","Assessed by the Gold questionaire. Possible scores between 1-7 with 7 being worst hypoglycemia awareness.",{"measure":111,"description":114,"timeFrame":12},"Assessed by the Clarke questionaire. Possible scores between 0-7 with 7 being worst hypoglycemia awareness.",{"measure":111,"description":116,"timeFrame":12},"Assessed by the Pedersen-Bjergaard questionaire. Possible outcomes are \"Aware\", \"Impaired\" and \"Unaware\".",{"measure":118,"description":119,"timeFrame":12},"Energy expenditure","Measured in kcal and assessed with 7 days of ActiGraph data.",{"measure":121,"description":122,"timeFrame":12},"Physical activity level","Categorized as sedentary, light and moderate-to-vigorous levels, assessed with 7 days of ActiGraph data.",{"measure":124,"description":125,"timeFrame":12},"Number of severe hypoglycaemia events","Expressed in diffence in number of events from baseline to end. Defined as cognitive impairment requiring external assistance for recovery.",{"allocation":127,"interventionModel":128,"interventionModelDescription":129,"primaryPurpose":130,"observationalModel":78,"timePerspective":78,"maskingInfo":131},"RANDOMIZED","PARALLEL","Randomized, open-label study comparing type-1 diabetes patients receiving usual treatment, with patients transitioning to AID systems","TREATMENT",{"masking":132,"maskingDescription":78,"whoMasked":78},"NONE",[134,139,142,146],{"label":135,"type":136,"description":78,"interventionNames":137},"Adults with type 1 diabetes (intervention)","EXPERIMENTAL",[138],"Device: Automated insuling delivery system",{"label":140,"type":141,"description":78,"interventionNames":78},"Adults with type 1 diabetes (control)","NO_INTERVENTION",{"label":143,"type":136,"description":144,"interventionNames":145},"Children with type 1 diabetes (intervention)","Pediatric population of 7-17 years, stratified 1:1 to two groups of 7-11 and ≥12 years accordingly",[138],{"label":147,"type":141,"description":144,"interventionNames":78},"Children with type 1 diabetes (control)",[149],{"type":150,"name":151,"description":152,"armGroupLabels":153,"otherNames":154},"DEVICE","Automated insuling delivery system","Closed-loop insulin pumps including MiniMed 780G, Tandom T2-slim x2 and YpsoCamAPS",[135,143],[155],"Closed-loop insulin pumps",[157,160],{"name":158,"affiliation":5,"role":159},"Kirsten Nørgaard, MD, Prof.","PRINCIPAL_INVESTIGATOR",{"name":161,"affiliation":162,"role":159},"Kurt Kristensen, MD, PhD","Aarhus University Hospital",[164,170],{"name":165,"role":166,"phone":167,"phoneExt":168,"email":169},"Michael Z Sørensen, MD","CONTACT","26836584","+45","michael.zaucha.soerensen.02@regionh.dk",{"name":171,"role":166,"phone":172,"phoneExt":168,"email":173},"Natalie V Olesen, MD","31627437","nataol@rm.dk",[175,191,203],{"facility":5,"status":176,"city":177,"state":178,"zip":179,"country":180,"countryCode":181,"cosmosGeoPoint":182,"geoPoint":187,"contacts":188},"RECRUITING","Herlev","Greater Copenhagen","2730","Denmark","DK",{"type":183,"coordinates":184},"Point",[185,186],12.43998,55.72366,{"lat":186,"lon":185},[189],{"name":190,"role":166,"phone":78,"phoneExt":78,"email":78},"Kirsten Nørgaard",{"facility":192,"status":176,"city":193,"state":78,"zip":194,"country":180,"countryCode":181,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Steno Diabetes Center Aarhus","Aarhus","8200",{"type":183,"coordinates":196},[197,198],10.21076,56.15674,{"lat":198,"lon":197},[201],{"name":202,"role":166,"phone":78,"phoneExt":78,"email":78},"Kurt Kristensen",{"facility":204,"status":176,"city":205,"state":78,"zip":194,"country":180,"countryCode":181,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Diagnostisk Center, Regionshospitalet Silkeborg","Silkeborg",{"type":183,"coordinates":207},[208,209],9.54508,56.1697,{"lat":209,"lon":208},[212],{"name":213,"role":166,"phone":78,"phoneExt":78,"email":78},"Klavs W Hansen",{"type":159,"investigatorFullName":190,"investigatorTitle":215,"investigatorAffiliation":5,"oldNameTitle":78,"oldOrganization":78},"Professor",[217],{"name":162,"class":6},"100552169",false,"NCT06469593","Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics","AID-BEYOND: Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics","AID-BEYOND","Inclusion Criteria (Adults):\n\n* Age ≥18 years\n* Type 1 diabetes ≥3 years\n* CGM or intermittently scanned CGM (isCGM) use ≥6 months\n* Approval from the responsible health care provider (HCP) to start AID\n* Specific AID system chosen ahead of screening after participant has been thoroughly informed\n\nInclusion Criteria (Children):\n\n* Age 7-17 years\n* Type 1 diabetes ≥6 months\n* CGM or isCGM use ≥6 months\n* Approval from the responsible HCP to start AID\n* Specific AID system chosen ahead of screening after participant has been thoroughly informed\n\nExclusion Criteria:\n\n* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start\n* Use of commercial or open-source AID systems prior to study participation\n* Daily use of paracetamol (acetaminophen)\n* Breast-feeding, pregnancy or planning to become pregnant within 4 months\n* Alcohol or drug abuse\n* Severe cardiac disease\n* Retinopathy contraindicating HbA1c \\\u003C53 mmol\u002Fmol\n* Other concomitant medical or psychological condition that, according to the investigator's assessment, makes the person unsuitable for study participation\n* Lack of compliance with key study procedures at the discretion of the investigator","ALL","7 Years",{"count":228,"type":229},200,"ESTIMATED","INTERVENTIONAL",[232],"NA","The goal of this clinical trial is to determine if transitioning to automated insulin delivery (AID) systems, can improve objectively measured sleep quality and quantity and alleviate cardiovascular risk factors in both children and adults diagnosed with type 1 diabetes. The main questions it aims to answer are:\n\n* Does the intervention improve sleep efficiency as measured by the HomeSleepTest, EEG based device, 4 months after initiation?\n* Can the use of AID treatment alleviate cardiovascular risk measured by heart rate variability (HRV), blood pressure and inflammatory markers?\n* Researchers will compare AID systems to usual treatment, including both multiple daily injections and sensor augmented pumps to see if the above benefits can be achieved with AID in comparison. Participants will be randomized 1:1 to either start AID treatment or to continue their usual care. The study will be open label.\n\nParticipants will, at baseline and after 4 months:\n\n* Have taken blood and urine samples to measure metabolic and inflammatory parameters\n* Perform digital cognitive testing using the CANTAB software\n* Fill out questionnaires related to quality of life, fear of hypoglycemia, hypoglycemia awareness, eating habits and sleep quality\n* Wear a blinded CGM for 10 days\n* Monitor sleep at home using the HomeSleepTest for 3 consecutive nights\n* Wear a Holter monitor for 24 hours to determine HRV parameters\n* Measure blood pressure for 24 hours at 30 min intervals\n* Wear an ActiGraph for 7 days to assess sleep and activity, supported by daily electronic sleep diaries\n\nParticipants randomized to AID treatment will receive education in the use of the systems.\n\nVirtual follow-up visits are scheduled at week 1, 5 and 9 for both control and intervention groups during the study, following baseline examinations.",[235],"Diabetes Mellitus, Type 1",[237,238,239,240,241,242,243,244,245,246],"Closed-loop insulin pump","Automated insulin delivery","AID systems","Artificial pancreas","Type 1 Diabetes","T1D","Sleep","Cognition","Cardiovascular risk","Inflammation","2024-06-17",{"date":249,"type":250},"2024-06-21","ACTUAL",{"date":252,"type":250},"2024-06-15",{"date":254,"type":229},"2027-12-31",{"name":5,"class":6},3]