An observational study in Graves Disease and Hyperthyroidism/Thyrotoxicosis, sponsored by THYROSCOPE INC.. Recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by THYROSCOPE INC. · Observational
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.
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.
162 studies on the registry are indexed under Graves Disease; 53 are open to participants now.
This study's planned enrollment of 15 is below the median of 120 across 56 observational studies indexed under Graves Disease.
Browse Graves Disease studies →THYROSCOPE INC. is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Adults aged 22 years and older with a confirmed diagnosis of Graves' disease, including both newly diagnosed and currently treated individuals. Participants will be recruited from a single center in the United States. All participants must be able to use a wearable device and provide informed consent.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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.
F1 Score for Detection of Thyrotoxicosis Using the Investigational Software
The F1 score will be calculated to evaluate the performance of the AI-based investigational software in detecting thyrotoxic states. The device's output, derived from wearable heart rate data and reference data, will be compared against the diagnosis based on serum free T4 concentration at each time point. Each participant contributes multiple data pairs (evaluation-reference combinations) based on serial visits (V2-V5), and the F1 score will be calculated for each case and summarized across all cases.
Time frame: At weeks 4, 8, and 12 after baseline (Visit 2), up to 12 weeks total
Sensitivity and Specificity of the Software in Detecting Thyrotoxicosis
The sensitivity and specificity of the investigational AI software will be calculated by comparing its output to the diagnosis of thyrotoxicosis based on serum free T4 levels. Results will be computed for each evaluation-reference data pair and summarized across all participants, with 95% confidence intervals.
Time frame: At weeks 4, 8, and 12 after baseline (Visit 2), up to 12 weeks total
Area Under the Receiver Operating Characteristic Curve (AUC) for Thyrotoxicosis Detection
The AUC will be calculated to assess the diagnostic performance of the investigational software in distinguishing thyrotoxicosis from euthyroid and hypothyroid states, using free T4 levels as the reference. The AUC will be calculated per case and summarized across all evaluable cases.
Time frame: At weeks 4, 8, and 12 after baseline (Visit 2), up to 12 weeks total
Plan to share: No — The individual participant data (IPD) collected in this study will not be shared with other researchers due to privacy concerns and the sensitive nature of the biometric and clinical data involved. Data are collected solely for regulatory and scientific validation purposes and will be handled in accordance with applicable privacy regulations.
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