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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Time to First Normal Free T4 Level — From Visit 2 (Day 0) to Visit 5 (Week 12 +/- 1 week)
  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.

Trial sites (2)

Other trials for the same condition