AI-Based Wearable Monitoring (Glandy HYPER) for Antithyroid Drug Dose Adjustment in Graves' Disease
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- Who runs it
- THYROSCOPE INC.
- Trial code
- NCT07857421
- Record updated
- 5 October 2026
- Original description
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.Read full original descriptionShow less
Prospective Study Evaluating Antithyroid Drug Dose Adjustment Based on AI-Powered Monitoring of Thyrotoxicosis Using Glandy HYPER in Patients With Graves' Disease
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.
Inclusion: 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.
Exclusion: Patients currently on MMI therapy if MMI cannot be discontinued from Visit 1 (screening) until Visit 2; 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); Individuals with cardiac disorders such as arrhythmia, heart failure, etc; Patients who are taking or require propylthiouracil (PTU) due to intolerance to methimazole (MMI), pregnancy, or other reasons; Pregnant or breastfeeding women; Patients who plan to become pregnant or do not agree to use appropriate contraceptive methods (pregnancy testing is required for women of childbearing potential).