Evaluating an AI Tool for Detecting Thyrotoxic States

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Graves Disease Hyperthyroidism/Thyrotoxicosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Glandy HYPER Validation Cohort

articipants diagnosed with Graves' disease who are either newly diagnosed or currently under treatment. All participants will wear a commercially available smartwatch (Apple or Samsung) to measure sleep heart rate, and undergo thyroid function testing (free T4 and TSH) at baseline and follow-up visits over 12 weeks. No therapeutic intervention will be applied, and data from wearable devices will be used solely for observational performance evaluation of the investigational software.

Heart rate-based AI software for detecting thyrotoxicosis

Intervention Type DEVICE

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.

Interventions

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Heart 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No