Evaluating an AI Tool for Detecting Thyrotoxic States

Summary

This observational study aims to evaluate the performance of a software-based medical device, Glandy HYPER, in detecting the thyrotoxic state in patients with hyperthyroidism. The device utilizes heart rate data collected from commercially available wearable devices and compares it with thyroid function test results. The study will enroll patients diagnosed with Graves' disease, monitoring their heart rate during sleep and correlating these measurements with free T4 levels obtained through serial blood testing. No investigational device output will be disclosed to participants, and the study will not alter standard clinical care.

Eligibility

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.

Conditions3

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