[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498982":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":36,"centralContacts":41,"locations":48,"responsibleParty":168,"collaborators":170,"id":173,"slug":174,"hasResults":175,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":10,"eligibilityCriteria":178,"healthyVolunteers":175,"sex":179,"minAge":180,"maxAge":181,"enrollmentInfo":182,"targetDuration":10,"studyType":185,"phases":186,"briefSummary":188,"conditions":189,"keywords":10,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},{"fullName":5,"class":6},"Universitair Ziekenhuis Brussel","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Autoantibody-positive individuals",null,[12,13,14],"Diagnostic Test: Oral glucose tolerance test (OGTT)","Diagnostic Test: Hyperglycemic clamp test","Diagnostic Test: Continuous glucose monitoring",[16,23,29],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DIAGNOSTIC_TEST","Oral glucose tolerance test (OGTT)","Longitudinal study using repeated OGTT, CGM and hyperglycemic clamp tests to evaluate glycemic variability, beta cell function and insulin action in individuals at moderate, high and very high risk of clinical onset of type 1 diabetes.\n\nOGTT is performed every 6 months (every 3 months in case of dysglycemia) in all participants.",[9],[22],"OGTT",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Hyperglycemic clamp test","Longitudinal study using repeated OGTT, CGM and hyperglycemic clamp tests to evaluate glycemic variability, beta cell function and insulin action in individuals at moderate, high and very high risk of clinical onset of type 1 diabetes.\n\nClamp test is performed every 12 months in single autoantibody-positive participants and every 6 months in multiple autoantibody-positive participants. Clamp tests are not performed in participants aged between 5-11 years.",[9],[28],"clamp",{"type":17,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Continuous glucose monitoring","Longitudinal study using repeated OGTT, CGM and hyperglycemic clamp tests to evaluate glycemic variability, beta cell function and insulin action in individuals at moderate, high and very high risk of clinical onset of type 1 diabetes.\n\nA 10-day CGM recording is performed every 6 months (every 3 months in case of dysglycemia) in all participants.",[9],[34,35],"Dexcom G6","CGM",[37],{"name":38,"affiliation":39,"role":40},"Bart Keymeulen","Vrije Universiteit Brussel","PRINCIPAL_INVESTIGATOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Belgian Diabetes Registry","CONTACT","02 477 45 46","+32","contact@bdronline.be",[49,69,83,108,133,150],{"facility":50,"status":51,"city":52,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Clinique CHC MontLégia","RECRUITING","Liège","4000","Belgium","BE",{"type":57,"coordinates":58},"Point",[59,60],5.56749,50.63373,{"lat":60,"lon":59},[63,67],{"name":64,"role":44,"phone":65,"phoneExt":10,"email":66},"Alexandra Van Eyck","04 355 42 14","Alexandra.VANEYCK@chc.be",{"name":68,"role":40,"phone":10,"phoneExt":10,"email":10},"Nicole Seret, MD",{"facility":70,"status":51,"city":71,"state":72,"zip":73,"country":54,"countryCode":55,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"A.Z. Sint-Jan Brugge","Bruges","West-Vlaanderen","8000",{"type":57,"coordinates":75},[76,77],3.22424,51.20892,{"lat":77,"lon":76},[80],{"name":81,"role":44,"phone":10,"phoneExt":10,"email":82},"Fabienne Beyaert","Fabienne.Beyaert@azsintjan.be",{"facility":84,"status":51,"city":85,"state":10,"zip":86,"country":54,"countryCode":55,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Universitair Ziekenhuis Antwerpen","Antwerp","2650",{"type":57,"coordinates":88},[89,90],4.40026,51.22047,{"lat":90,"lon":89},[93,97,101,103,105],{"name":94,"role":44,"phone":95,"phoneExt":10,"email":96},"Beeldens Jente","+3 436 8409","Jente.Beeldens@uza.be",{"name":98,"role":44,"phone":99,"phoneExt":10,"email":100},"Rie Braspenning","+32 3 821 4002","Rie.Braspenning@uza.be",{"name":102,"role":40,"phone":10,"phoneExt":10,"email":10},"Christophe De Block, MD, PhD",{"name":104,"role":40,"phone":10,"phoneExt":10,"email":10},"Marieke den Brinker, MD, PhD",{"name":106,"role":107,"phone":10,"phoneExt":10,"email":10},"Niels Bochanen, MD","SUB_INVESTIGATOR",{"facility":109,"status":51,"city":110,"state":10,"zip":111,"country":54,"countryCode":55,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Universitair Ziekenhuis Gent","Ghent","9000",{"type":57,"coordinates":113},[114,115],3.71667,51.05,{"lat":115,"lon":114},[118,122,125,127,129,131],{"name":119,"role":44,"phone":120,"phoneExt":10,"email":121},"Nancy Platteau","+329 332 6394","Nancy.Platteau@uzgent.be",{"name":123,"role":44,"phone":10,"phoneExt":10,"email":124},"Els Feyen","Els.Feyen@uzgent.be",{"name":126,"role":40,"phone":10,"phoneExt":10,"email":10},"Bruno Lapauw, MD, PhD",{"name":128,"role":107,"phone":10,"phoneExt":10,"email":10},"Joke Marlier, MD",{"name":130,"role":107,"phone":10,"phoneExt":10,"email":10},"Sara Van Aken, MD",{"name":132,"role":107,"phone":10,"phoneExt":10,"email":10},"Hasan Kahya, MD, PhD",{"facility":5,"status":51,"city":134,"state":10,"zip":135,"country":54,"countryCode":55,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Jette","1090",{"type":57,"coordinates":137},[138,139],4.33419,50.87309,{"lat":139,"lon":138},[142,146,148],{"name":143,"role":44,"phone":144,"phoneExt":10,"email":145},"Karen Hanssens","+322 477 77 60","CTU-diabeteskliniek@uzbrussel.be",{"name":147,"role":40,"phone":10,"phoneExt":10,"email":10},"Aster Desouter, MD",{"name":149,"role":107,"phone":10,"phoneExt":10,"email":10},"Willem Staels, MD PhD",{"facility":151,"status":51,"city":152,"state":10,"zip":153,"country":54,"countryCode":55,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Universitair Ziekenhuis Leuven","Leuven","3000",{"type":57,"coordinates":155},[156,157],4.70093,50.87959,{"lat":157,"lon":156},[160,164,166],{"name":161,"role":44,"phone":162,"phoneExt":10,"email":163},"Natalie Van den Driessche","+3216 34 85 54","natalie.vandendriessche@uzleuven.be",{"name":165,"role":40,"phone":10,"phoneExt":10,"email":10},"Pieter Gillard, MD, PhD",{"name":167,"role":107,"phone":10,"phoneExt":10,"email":10},"Kristina Casteels, MD, PhD",{"type":169,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[171],{"name":172,"class":6},"Breakthrough T1D","100498982","continuous-monitoring-of-glycemic-variability-to-predict-dys--and-hyperglycemia-in-asymptomatic-type-1-diabetes-100498982",false,"NCT05777330","Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes","Inclusion Criteria:\n\n1. aged 5-39 years at inclusion;\n2. absence of diabetes meeting the clinical diagnostic American Diabetes Association (ADA) criteria;\n3. persistently positive for one or multiple types of autoantibodies among IAA, GADA, IA-2A and ZnT8A.\n\nExclusion Criteria:\n\n1. Pregnancy or lactation in women; \\\u003C6 months postpartum\n2. Diabetes meeting the clinical diagnostic ADA criteria;\n3. Use of illicit drugs, or overconsumption of alcohol, or history of drug or alcohol abuse;\n4. Being legally incapacitated, having significant emotional problems at the time of the study, or having a history of psychiatric disorders;\n5. Treatment with immune modulating or diabetogenic medication (e.g. corticosteroids) or medication that act to lower glycemia (oral antidiabetics) or agents that may influence insulin sensitivity or secretion;\n6. Gastric bypass or banding;\n7. History of acute or chronic pancreatitis, or (partial) pancreatectomy\n8. History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the subjects.","ALL","5 Years","39 Years",{"count":183,"type":184},75,"ESTIMATED","INTERVENTIONAL",[187],"NA","The goal of this longitudinal clinical trial is to measure variability of interstitial glucose levels with a user-friendly real-time continuous glucose monitoring (CGM) technology at regular intervals in normo- and dysglycemic multiple autoantibody-positive individuals (age 5-39 years), in comparison with single autoantibody-positive individuals in the same age range. Participants will asked to undergo repeated oral glucose tolerance tests (OGTTs) (age 5-39 years) and hyperglycemic clamp tests (age 12-39 years) in parallel for a period of at least 2-3 years. In case of confirmed dysglycemia, we propose to perform CGM and OGTT every 3 months.\n\nThe main questions the study aims to answer are:\n\n1. Do the amplitude and time trends of CGM-derived glycemic variability indices and OGTT- and clamp-derived variables differ between the intermediate, high and very high risk groups?\n2. Can (changes in) CGM-derived glycemic variability indices predict\u002Fdetect dysglycemia in initially normoglycemic (single or multiple autoantibody-positive) individuals with the same diagnostic efficiency as OGTT- or clamp-derived variables?\n3. Can (changes in) CGM-derived glycemic variability indices predict clinical onset in (stage 1 or 2) multiple autoantibody-positive individuals with the same diagnostic efficiency as OGTT- or clamp-derived variables?\n4. Can correlating (changes in) CGM-derived indices with (changes in) OGTT- and clamp-derived variables help to better understand the sequence of events leading to dysglycemia and clinical onset, as well as the relative contribution of beta cell function and insulin action to glycemic variability according to disease stage and biological and phenotypical characteristics of the individuals?",[190],"Type1 Diabetes Mellitus","2025-08-25",{"date":193,"type":194},"2025-09-02","ACTUAL",{"date":196,"type":194},"2023-08-09",{"date":198,"type":184},"2028-08",{"name":5,"class":6},6]