[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658981":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":38,"studyPopulation":35,"armGroups":39,"interventions":52,"overallOfficials":63,"centralContacts":68,"locations":74,"responsibleParty":99,"collaborators":35,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":35,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":109,"maxAge":35,"enrollmentInfo":110,"targetDuration":35,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":121,"overallStatus":128,"whyStopped":35,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"THYROSCOPE INC.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Time to First Normal Free T4 Level","Time (days) from initiation of antithyroid medication (methimazole) at Visit 2 to the first laboratory confirmation of a serum free T4 (fT4) level within the site-specific normal range (Site 1: 0.82-1.77 ng\u002FdL; Site 2: 0.93-1.67 ng\u002FdL), assessed at scheduled and unscheduled clinic visits and compared between the intervention and control arms.","From Visit 2 (Day 0) to Visit 5 (Week 12 +\u002F- 1 week)",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"Number of Occurrences of Free T4 Below the Lower Limit of Normal","Number of clinic visits (scheduled or unscheduled) per participant at which serum free T4 is below the site-specific lower limit of normal (Site 1: \\\u003C0.82 ng\u002FdL; Site 2: \\\u003C0.93 ng\u002FdL), as an indicator of overtreatment (iatrogenic hypothyroidism).",{"measure":18,"description":19,"timeFrame":20},"Change From Baseline in Thyroid-Related Quality of Life (ThyPRO-39)","Thyroid-related quality of life is assessed with the self-administered ThyPRO-39 questionnaire (Thyroid-Related Patient-Reported Outcome, 39-item short version) at each clinic visit. Scale scores, including the composite quality-of-life impact score, range from 0 to 100, with higher scores indicating worse quality of life. Scores at each visit and change from baseline (Visit 2) are reported.","Baseline (Visit 2, Day 0), Week 4 (Visit 3), Week 8 (Visit 4) and Week 12 (Visit 5); visits +\u002F- 1 week",{"measure":22,"description":23,"timeFrame":24},"Number of Participants With Procedure-Related Serious Incidents","Serious incidents (as defined in Regulation (EU) 2017\u002F745) assessed by the investigator as related to the study device or study procedures, coded using IMDRF terminology.","From informed consent (Visit 1) to Visit 5 (Week 12 +\u002F- 1 week)",[26],{"measure":27,"description":28,"timeFrame":29},"Diagnostic Performance of Glandy HYPER for Detecting Thyrotoxicosis","Agreement between the Glandy HYPER output (thyrotoxic vs. non-thyrotoxic) and the thyroid status determined by laboratory free T4 (site-specific reference ranges) at each clinic visit with a blood test, expressed as sensitivity, specificity, positive predictive value and negative predictive value with 95% confidence intervals, pooled across both arms. Evaluated after completion of the study schedule.","At each clinic visit with a blood test from Visit 3 (Week 4) to Visit 5 (Week 12 +\u002F- 1 week)",{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":35,"timePerspective":35,"maskingInfo":36},"RANDOMIZED","PARALLEL","Participants are randomized 2:1 to Glandy HYPER-supported methimazole dose adjustment (intervention arm) or standard care (control arm).","TREATMENT",null,{"masking":37,"maskingDescription":35,"whoMasked":35},"NONE","This is an exploratory, post-market, prospective, randomized, open-label, two-arm clinical study conducted at two sites in Frankfurt, Germany (protocol 01-01-DE-001). It evaluates the clinical utility, performance and safety of Glandy HYPER, a CE-marked (MDR Class IIa) AI-based software medical device, in supporting methimazole (MMI) dose adjustment in adults with newly diagnosed or persistent thyrotoxic Graves' disease.\n\nAfter written informed consent at Visit 1 (screening, Day -14 to 0), participants are randomized 2:1 (intervention:control) using a computer-generated procedure in the secuTrial EDC system. All participants receive a smartwatch with a CE-certified ECG function (Apple Watch for iOS users, Samsung Galaxy Watch for Android users) and are trained in its use; they wear it during sleep (at least 3 hours) and record an ECG before bedtime. Patients already taking MMI must be able to stop it between Visit 1 and Visit 2. At Visit 2 (baseline, Day 0), participants with confirmed thyrotoxicosis (free T4) and available sleep heart rate data are registered and MMI is started. Follow-up visits take place at Weeks 4, 8 and 12 (Visits 3-5, each +\u002F- 1 week) with routine blood tests (free T4, TSH, liver parameters, blood count); the ThyPRO-39 quality-of-life questionnaire is completed at Visits 2-5. Participation lasts approximately 14 weeks.\n\nIntervention arm (n=20): The MMI starting dose is determined by a predefined algorithm based on the Visit 1 free T4 level relative to the upper limit of normal. Glandy HYPER provides a once-daily thyrotoxicosis status result. If a \"non-hyperthyroid\" result occurs on three or more occasions between scheduled visits, the treating physician decides on MMI dose adjustment based on the clinical and laboratory situation, taking the Glandy HYPER data into account, and may schedule an unscheduled visit for laboratory confirmation; an unscheduled visit replaces the next scheduled visit. At each visit, if free T4 is above the normal range, the dose follows the predefined dose criteria; if free T4 is within the normal range, the dose is determined by the physician.\n\nControl arm (n=10): MMI is started and adjusted by the physician according to routine care. Wearable data are collected, but Glandy HYPER results are not disclosed to participants or physicians and are not used for clinical decisions.\n\nGlandy HYPER provides decision support only, and all dose decisions are made by the treating physician. After completion of the study schedule, the performance of Glandy HYPER in detecting thyrotoxicosis is evaluated against the laboratory free T4-based thyroid status.",[40,47],{"label":41,"type":42,"description":43,"interventionNames":44},"Intervention arm (Glandy HYPER-supported)","EXPERIMENTAL","Participants wear a smartwatch and use the Glandy HYPER app, which provides a once-daily thyrotoxicosis status result based on sleep heart rate data. Methimazole (MMI) is started at Visit 2 at a dose determined by a predefined algorithm based on the Visit 1 free T4 level. If a \"non-hyperthyroid\" result occurs on three or more occasions between scheduled visits, the treating physician decides on MMI dose adjustment based on the clinical and laboratory situation, taking the Glandy HYPER data into account, and may schedule an unscheduled visit for laboratory confirmation. All dose decisions are made by the treating physician.",[45,46],"Device: Glandy HYPER (AI-based monitoring software)","Drug: Methimazole",{"label":48,"type":49,"description":50,"interventionNames":51},"Control arm (Standard care)","ACTIVE_COMPARATOR","Participants wear the same smartwatch; wearable data are collected, but Glandy HYPER results are not disclosed to participants or physicians and are not used for clinical decisions. Methimazole (MMI) is started at Visit 2 and adjusted by the physician according to routine clinical care based on blood tests at scheduled visits (every 4 weeks +\u002F- 1 week); the visit interval may be shortened at the physician's discretion.",[46],[53,58],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":35},"DEVICE","Glandy HYPER (AI-based monitoring software)","CE-marked (MDR Class IIa) software as a medical device (mobile app) that analyzes sleep heart rate data collected by a smartwatch, together with thyroid function test results (free T4, TSH), to provide information on thyrotoxicosis status. In the intervention arm, the once-daily results are available to the treating physician to support methimazole dose adjustment.",[41],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":35},"DRUG","Methimazole","Oral antithyroid drug for the treatment of hyperthyroidism. Intervention arm: starting dose per a predefined free T4-based algorithm; subsequent adjustments are decided by the treating physician taking Glandy HYPER results into account. Control arm: starting dose and adjustments per the physician's routine clinical judgment.",[48,41],[64],{"name":65,"affiliation":66,"role":67},"Jörg Bojunga, Prof. Dr. med.","Universitätsmedizin Frankfurt (University Hospital Frankfurt)","PRINCIPAL_INVESTIGATOR",[69],{"name":70,"role":71,"phone":72,"phoneExt":35,"email":73},"Clinical Research Team, THYROSCOPE INC.","CONTACT","+82 52 264 4154","research@thyroscope.com",[75,90],{"facility":76,"status":35,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"University Hospital Frankfurt, Centre for Internal Medicine, Medical Department 1","Frankfurt am Main","Hesse","60590","Germany","DE",{"type":83,"coordinates":84},"Point",[85,86],8.68417,50.11552,{"lat":86,"lon":85},[89],{"name":65,"role":67,"phone":35,"phoneExt":35,"email":35},{"facility":91,"status":35,"city":77,"state":78,"zip":92,"country":80,"countryCode":81,"cosmosGeoPoint":93,"geoPoint":95,"contacts":96},"Endokrinologikum Frankfurt am Main","60596",{"type":83,"coordinates":94},[85,86],{"lat":86,"lon":85},[97],{"name":98,"role":67,"phone":35,"phoneExt":35,"email":35},"Alexander Mann, Prof. Dr. med.",{"type":100,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100658981","ai-based-wearable-monitoring-glandy-hyper-for-antithyroid-drug-dose-adjustment-in-graves-disease-100658981",false,"NCT07857421","AI-Based Wearable Monitoring (Glandy HYPER) for Antithyroid Drug Dose Adjustment in Graves' Disease","Prospective Study Evaluating Antithyroid Drug Dose Adjustment Based on AI-Powered Monitoring of Thyrotoxicosis Using Glandy HYPER in Patients With Graves' Disease","Inclusion Criteria:\n\n* Adults (\\>= 22 years) newly diagnosed with Graves' disease or currently in a thyrotoxic state despite ongoing treatment\n* Diagnosis of Graves' disease based on: primary hyperthyroidism confirmed by thyroid function test (TFT); positive TSH-receptor antibody (TRAb); and clinical presentation consistent with Graves' disease\n* At screening (Visit 1), individuals who have received an explanation of and are able to use Glandy HYPER\n* Individuals who voluntarily decide to participate in the clinical study and have signed the informed consent form\n\nExclusion Criteria:\n\n* Patients who are taking or require propylthiouracil (PTU) due to intolerance to methimazole (MMI), pregnancy, or other reasons\n* Patients currently on MMI therapy if MMI cannot be discontinued from Visit 1 (screening) until Visit 2\n* Individuals with cardiac disorders such as arrhythmia, heart failure, etc.\n* Individuals currently taking medications that affect heart rate, including all types of antiarrhythmic drugs, antihistamines, etc. (intermittent use of short-acting beta-blockers to relieve hyperthyroid symptoms is permitted)\n* Pregnant or breastfeeding women\n* Patients who plan to become pregnant or do not agree to use appropriate contraceptive methods (pregnancy testing is required for women of childbearing potential)","ALL","22 Years",{"count":111,"type":112},30,"ESTIMATED","INTERVENTIONAL",[115],"NA","Graves' disease is the most common cause of hyperthyroidism and is usually treated with antithyroid drugs such as methimazole (MMI). The MMI dose is adjusted according to periodic blood tests, but individual responses vary, so some patients remain hyperthyroid longer than necessary while others become hypothyroid from overtreatment. Glandy HYPER is a CE-marked, AI-based software medical device that analyzes sleep heart rate data collected by a smartwatch, together with thyroid function test results, to provide daily information on thyrotoxicosis status. This exploratory, post-market, two-center, randomized, open-label study in Germany evaluates whether MMI dose adjustment supported by Glandy HYPER shortens the time to normalization of free T4 compared with standard care, and also assesses overtreatment, thyroid-related quality of life, and safety.",[118,119,120],"Hyperthyroidism","Graves Disease","Thyrotoxicosis",[122,123,124,60,125,126,127],"Glandy HYPER","Wearable device","Artificial intelligence","Antithyroid drug","Software as a medical device","Thyroid function","NOT_YET_RECRUITING","2026-10-02",{"date":131,"type":132},"2026-10-05","ACTUAL",{"date":134,"type":112},"2026-10-20",{"date":136,"type":112},"2027-07-31",{"name":5,"class":6},2]