AI-Based Wearable Monitoring (Glandy HYPER) for Antithyroid Drug Dose Adjustment in Graves' Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorTHYROSCOPE INC.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (>= 22 years) newly diagnosed with Graves' disease or currently in a thyrotoxic state despite ongoing treatment
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
At screening (Visit 1), individuals who have received an explanation of and are able to use Glandy HYPER
Individuals who voluntarily decide to participate in the clinical study and have signed the informed consent form
Disqualifiers
Patients who are taking or require propylthiouracil (PTU) due to intolerance to methimazole (MMI), pregnancy, or other reasons
Patients currently on MMI therapy if MMI cannot be discontinued from Visit 1 (screening) until Visit 2
Individuals with cardiac disorders such as arrhythmia, heart failure, etc.
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Glandy HYPER (AI-based monitoring software)
DeviceCE-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.
Methimazole
DrugOral 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Intervention arm (Glandy HYPER-supported)Experimental treatment 2 interventions
Group B: Control arm (Standard care)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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/dL; Site 2: 0.93-1.67 ng/dL), assessed at scheduled and unscheduled clinic visits and compared between the intervention and control arms.
Time frame
From Visit 2 (Day 0) to Visit 5 (Week 12 +/- 1 week)Secondary outcomes
1
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: \<0.82 ng/dL; Site 2: \<0.93 ng/dL), as an indicator of overtreatment (iatrogenic hypothyroidism).
Time frame
From Visit 2 (Day 0) to Visit 5 (Week 12 +/- 1 week)2
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.
Time frame
Baseline (Visit 2, Day 0), Week 4 (Visit 3), Week 8 (Visit 4) and Week 12 (Visit 5); visits +/- 1 week3
Number of Participants With Procedure-Related Serious Incidents
Serious incidents (as defined in Regulation (EU) 2017/745) assessed by the investigator as related to the study device or study procedures, coded using IMDRF terminology.
Time frame
From informed consent (Visit 1) to Visit 5 (Week 12 +/- 1 week)Other outcomes
1
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.
Time frame
At each clinic visit with a blood test from Visit 3 (Week 4) to Visit 5 (Week 12 +/- 1 week)Sponsors and contacts
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Source ClinicalTrials.gov
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