[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530324":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":33,"centralContacts":38,"locations":47,"responsibleParty":68,"collaborators":71,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":24,"enrollmentInfo":87,"targetDuration":24,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":50,"whyStopped":24,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Aalborg University Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Intelligent telemonitoring","EXPERIMENTAL","The subjects will be telemonitored using the intelligent telemonitoring system. All subjects will use a CGM, a Fitbit, and a smart pen during the trial period. Staff at the endocrinology clinic will monitor the data and contact the subjects continuously throughout the trial (depending on the individual needs of each subject) using the intelligent telemonitoring system with embedded decision support to facilitate treatment evaluation and adjustments. The subjects will have access to a smartphone app that is able to provide a risk for nocturnal hypoglycemia before bed.",[13],"Device: Intelligent telemonitoring",{"label":15,"type":16,"description":17,"interventionNames":18},"Telemonitoring","ACTIVE_COMPARATOR","The subjects will be telemonitored. All subjects will use a CGM, a Fitbit, and a smart pen during the entire trial period. Staff at the endocrinology clinic will monitor the data and contact the subjects continuously throughout the trial (depending on the individual needs of each subject)",[19],"Device: Telemonitoring",{"label":21,"type":22,"description":23,"interventionNames":24},"Usual care","NO_INTERVENTION","The subjects will wear a blinded CGM the first 20 days after inclusion, 20 days before the second visit to the trial site, and the final 20 days of the trial. The subjects will use a blinded smart pen throughout the trial period. Hence, the subjects cannot see their measured data during the trial and will not be monitored.",null,[26,30],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":24},"DEVICE","Telemonitoring using CGM, insulin pen data, and Fitbit data supported by data-driven decision support.",[9],{"type":27,"name":15,"description":31,"armGroupLabels":32,"otherNames":24},"Telemonitoring using CGM, insulin pen data, and Fitbit data",[15],[34],{"name":35,"affiliation":36,"role":37},"Peter Vestergaard, MD, PhD","Steno Diabetes Center North Denmark","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":24,"email":43},"Jannie Nørlev, PhD","CONTACT","004523676513","jadano@hst.aau.dk",{"name":45,"role":41,"phone":24,"phoneExt":24,"email":46},"Stine Hangaard, PhD","svh@hst.aau.dk",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Department of Endocrinology","RECRUITING","Aalborg","North Jutland","9000","Denmark","DK",{"type":57,"coordinates":58},"Point",[59,60],9.9187,57.048,{"lat":60,"lon":59},[63,67],{"name":64,"role":41,"phone":65,"phoneExt":24,"email":66},"Katrine Vogensen","004524794472","k.vogensen@rn.dk",{"name":35,"role":37,"phone":24,"phoneExt":24,"email":24},{"type":37,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Peter Vestergaard","MD, professor",[72,75],{"name":73,"class":74},"Novo Nordisk A\u002FS","INDUSTRY",{"name":76,"class":74},"DexCom, Inc.","100530324","the-intelligent-diabetes-telemonitoring-using-decision-support-to-treat-patients-on-insulin-therapy-100530324",false,"NCT06185296","The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Therapy","The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Trial: Study Protocol for a Randomized Controlled Trial","DiaTRUST","Inclusion Criteria:\n\n* Adults ≥ 18 years.\n* Diagnosis of T2D for at least 12 months prior to the day of screening.\n* Patients who are being treated with insulin or about to start insulin treatment (insulin naïve) willing to travel to trial site in North Denmark to attend in-person visits.\n* Have internet at home, have MitID, and willingness to use a smartphone and the other devices used in the trial\n* Signed informed consent.\n* Ability to understand and read Danish.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Major surgery is planned during the trial period.\n* Cancer diagnosis within five years prior to inclusion.\n* Participation in other interventional trials.\n* Limited literacy affecting the use of trial devices.\n* Patient who has worn a CGM monitor less than 6 months prior to the trial.\n* Terms that, in the opinion of the sub-investigator or investigator, render the participant unfit to conduct the trial, including lack of understanding of the trial or lack of physical or cognitive ability to participate.\n* Patients treated with mixed insulin.","ALL","18 Years",{"count":88,"type":89},51,"ESTIMATED","INTERVENTIONAL",[92],"NA","The trial is an open-label, randomized controlled trial. Patients with T2D on insulin therapy will be randomized to an intelligent telemonitoring group (intervention), a telemonitoring group (control), and a usual care group (control). Both the intelligent telemonitoring group and the telemonitoring group will use various devices at home. Hospital staff will monitor their data for three months. In the intelligent telemonitoring group, hospital staff and participants will be supported by decision-support algorithms in the management of insulin treatment.",[95],"Type 2 Diabetes Treated With Insulin",[97,98,99,100,15,101,102,103,104,105],"Diabetes","Insulin","Telemedicine","Telehealth","CGM","Wearable devices","Adherence","Decision support","Algorithms","2026-02-05",{"date":108,"type":109},"2026-02-09","ACTUAL",{"date":111,"type":109},"2025-11-15",{"date":113,"type":89},"2026-09",{"name":5,"class":6},1]