Performance Evaluation of the Software Medical Device to Detect the Thyrotoxic State in Patients With Hyperthyroidism
THYROSCOPE INC.
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.
Description
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 (base…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
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 signi…
Interventions
- DeviceHeart rate-based AI software for detecting thyrotoxicosis
A software-based investigational medical device that uses artificial intelligence to detect the thyrotoxic state in patients with hyperthyroidism. The device analyzes resting heart rate data collected from wearable devices along with thyroid function test results (free T4 and TSH). The device is not FDA-approved and will be used solely for observational performance evaluation without influencing clinical care.
Location
- Umesh MasharaniSan Francisco, California