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AI-Based Wearable Monitoring (Glandy HYPER) for Antithyroid Drug Dose Adjustment in Graves' Disease
Sponsor: THYROSCOPE INC.
Summary
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.
Official title: Prospective Study Evaluating Antithyroid Drug Dose Adjustment Based on AI-Powered Monitoring of Thyrotoxicosis Using Glandy HYPER in Patients With Graves' Disease
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-10-20
Completion Date
2027-07-31
Last Updated
2026-10-05
Healthy Volunteers
No
Interventions
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.
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.
Locations (2)
University Hospital Frankfurt, Centre for Internal Medicine, Medical Department 1
Frankfurt am Main, Hesse, Germany
Endokrinologikum Frankfurt am Main
Frankfurt am Main, Hesse, Germany