AI tool to detect thyrotoxic state using wearables in Graves’ disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective observational study evaluating Glandy HYPER, a software medical device that analyzes sleep heart-rate data from wearables and thyroid function tests to detect thyrotoxicosis in adults with Graves’ disease. Participants wear a smartwatch during sleep for 12 weeks and provide TFTs at baseline, 4, 8, and 12 weeks. The primary endpoint is the F1 score comparing the device’s output with thyrotoxicosis diagnosed by free T4 levels; secondary endpoints include sensitivity, specificity, and AUC. The study maintains standard clinical care with no treatment changes and aims to assess generalizability by comparing results to prior Korean studies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 22 years or older, regardless of sex.
* Individuals who are newly diagnosed with Graves' disease or currently undergoing treatment for it.
* Individuals who have received sufficient explanation about the investigational software and are able to use it appropriately.
* Individuals who voluntarily agree to participate in the study and have signed informed consent, either directly or via a legally authorized representative.

Exclusion Criteria:

* Individuals with cardiac conditions such as arrhythmia or heart failure.
* Individuals taking medications that significantly affect heart rate, including antiarrhythmics or antihistamines. (Intermittent short-acting beta-blockers are allowed.)
* Pregnant or breastfeeding individuals, or those planning pregnancy during the study period or not using appropriate contraception.
* Individuals with significant comorbidities that interfere with follow-up or study compliance.
* Individuals with severe psychiatric disorders, substance use disorder, or alcohol dependence.
* Individuals deemed ineligible at the discretion of the investigator for safety or ethical concerns.

Where it's running

• Umesh Masharani
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Umeshi Masharani, MD — University of California, San Francisco
• Study coordinator: Jun An
• Email: jun.an@thyroscope.com
• Phone: ‭+82 10-2849-0041‬

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.