Evaluating Glandy HYPER Software to Detect Thyrotoxic States in Adults with Graves Disease

What this Trial Is About

Researchers are evaluating the performance of Glandy HYPER, a software medical device that uses heart rate data collected from commercially available wearable devices to detect thyrotoxicosis in patients with Graves disease. This observational study focuses on adults aged 22 and older who are either newly diagnosed with or currently treated for Graves disease. The goal is to compare the devices analysis with thyroid function test results, specifically free T4 levels, without changing standard clinical care. Participants will wear a smartwatch Apple or Samsung to monitor heart rate during sleep over a 12-week period. Blood samples for thyroid function tests will be taken at baseline and at 4, 8, and 12 weeks. The software device will analyze the heart rate data alongside test results to assess its ability to detect thyrotoxicosis. No treatment or intervention will be applied, and the devices output will not be shared with participants or used to guide their care. During the study, heart rate data from the wearable devices and thyroid function test results will be collected at multiple time points to evaluate the devices accuracy. Researchers will measure outcomes such as the F1 score, sensitivity, specificity, and area under the curve AUC of the softwares detection of thyrotoxicosis. The study is classified as low risk and participants will continue their usual medical care throughout the 12 weeks. The study also aims to compare its results with previous studies conducted in Korea to assess the softwares generalizability.

Evaluating an AI Tool for Detecting Thyrotoxic States