Evaluating an AI Tool for Detecting Thyrotoxic States

This is a single-center, prospective observational study designed to validate the performance of Glandy HYPER, a software medical device that analyzes sleep heart rate data from wearable devices in conjunction with thyroid function test (TFT) results to detect thyrotoxicosis. The study targets adults aged 22 or older with newly diagnosed or currently treated Graves' disease.

Each participant will wear a smartwatch (Apple or Samsung, depending on their smartphone OS) to measure heart rate during sleep over a 12-week period. Blood samples for TFTs will be collected at four separate visits (baseline and at 4, 8, and 12 weeks). The primary endpoint is the F1 score between the investigational device's output and the diagnosis of thyrotoxicosis based on free T4 values. Secondary endpoints include sensitivity, specificity, and area under the curve (AUC) of the device's performance.

Data from the wearable device and TFTs will be used to create multiple evaluation-reference data pairs per patient, enabling within-subject validation across different time points. The study does not involve any investigational treatment or alteration to standard care and is classified as non-significant risk (NSR). The output of the software device will not influence clinical decisions during the trial.

The study also aims to assess the generalizability of the software's performance by comparing results from this U.S.-based cohort with prior studies conducted in Korea.

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.