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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
- Sponsor
- THYROSCOPE INC. (Industry)
- Enrollment
- 30 planned
- Conditions
- Hyperthyroidism; Graves Disease; Thyrotoxicosis
- Interventions
- Glandy HYPER (AI-based monitoring software); Methimazole
- Ages
- adults, older adults
- Registry
- NCT07857421
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Time to First Normal Free T4 Level
History
Study completion expected
Primary completion expected
Started
Registered