AI-Based Wearable Monitoring (Glandy HYPER) for Antithyroid Drug Dose Adjustment in Graves' Disease

Hyperthyroidism, Graves Disease, Thyrotoxicosis

Glandy HYPER, Wearable device, Artificial intelligence, Methimazole, Antithyroid drug, Software as a medical device, Thyroid function

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.

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. After 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 +/- 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. Intervention 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. Control 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. Glandy 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.

No related papers found yet.

Germany