Graves DiseaseNCT07017907
Evaluating an AI Tool for Detecting Thyrotoxic States
An observational study of Graves Disease and Hyperthyroidism/Thyrotoxicosis, run by THYROSCOPE INC. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Graves Disease, Hyperthyroidism/Thyrotoxicosis
- What is being tested?
- Heart rate-based AI software for detecting thyrotoxicosis
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2026to 31 Dec 2026
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Umesh Masharani
San Francisco, California, 94143
Umesh Masharani, MD, 415-353-2350, Umesh.Masharani@ucsf.edu
About this study
Official title: Performance Evaluation of the Software Medical Device to Detect the Thyrotoxic State in Patients With Hyperthyroidism
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.
Read the detailed 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 (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
- Graves Disease, Hyperthyroidism/Thyrotoxicosis
- Being tested
- Heart rate-based AI software for detecting thyrotoxicosis
- Keywords
- Graves disease, Hyperthyroidism, Thyrotoxicosis, Artificial intelligence, Heart rate, SaMD, wearable device
- Medical subject headings
- Graves Disease, Hyperthyroidism, Thyrotoxicosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate-based AI software for detecting thyrotoxicosisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Heart rate-based AI software for detecting thyrotoxicosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At weeks 4, 8, and 12 after baseline (Visit 2), up to 12 weeks total
Secondary outcomes (2)
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.
Measured: 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.
Measured: At weeks 4, 8, and 12 after baseline (Visit 2), up to 12 weeks total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start9 Jan 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- THYROSCOPE INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Umeshi Masharani, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017907
- Sponsor's protocol ID
- 01-01-UCSF-001
- Status last verified
- May 2026
- First submitted
- 4 Jun 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Publications
Shin K, Kim J, Park J, Oh TJ, Kong SH, Ahn CH, Moon JH, Kim MJ, Moon JH. A machine learning-assisted system to predict thyrotoxicosis using patients' heart rate monitoring data: a retrospective cohort study. Sci Rep. 2023 Nov 30;13(1):21096. doi: 10.1038/s41598-023-48199-x.
PubMed 38036639Kim KH, Lee J, Ahn CH, Yu HW, Choi JY, Lee HY, Lee WW, Moon JH. Association between Thyroid Function and Heart Rate Monitored by Wearable Devices in Patients with Hypothyroidism. Endocrinol Metab (Seoul). 2021 Oct;36(5):1121-1130. doi: 10.3803/EnM.2021.1216. Epub 2021 Oct 21.
PubMed 34674500Steinberger E, Pilz S, Trummer C, Theiler-Schwetz V, Reichhartinger M, Benninger T, Pandis M, Malle O, Keppel MH, Verheyen N, Grubler MR, Voelkl J, Meinitzer A, Marz W. Associations of Thyroid Hormones and Resting Heart Rate in Patients Referred to Coronary Angiography. Horm Metab Res. 2020 Dec;52(12):850-855. doi: 10.1055/a-1232-7292. Epub 2020 Sep 4.
PubMed 32886945Griffith ML, Bischoff LA, Baum HBA. Approach to the Patient With Thyrotoxicosis Using Telemedicine. J Clin Endocrinol Metab. 2020 Aug 1;105(8):dgaa373. doi: 10.1210/clinem/dgaa373.
PubMed 32525973Lee JE, Lee DH, Oh TJ, Kim KM, Choi SH, Lim S, Park YJ, Park DJ, Jang HC, Moon JH. Clinical Feasibility of Monitoring Resting Heart Rate Using a Wearable Activity Tracker in Patients With Thyrotoxicosis: Prospective Longitudinal Observational Study. JMIR Mhealth Uhealth. 2018 Jul 13;6(7):e159. doi: 10.2196/mhealth.9884.
PubMed 30006328
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of the Software Medical Device to Detect the Thyrotoxic State in Patients With Hyperthyroidism
- ClinicalTrials.gov ID
- NCT07017907
- Acronym / sponsor ID
- 01-01-UCSF-001
- Conditions
- Graves Disease, Hyperthyroidism/Thyrotoxicosis
- Keywords
- Graves disease, Hyperthyroidism, Thyrotoxicosis, Artificial intelligence, Heart rate, SaMD, wearable device
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- THYROSCOPE INC.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 (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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glandy HYPER Validation Cohort | – | Device: Heart rate-based AI software for detecting thyrotoxicosisarticipants 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate-based AI software for detecting thyrotoxicosisA 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. | Device | Glandy HYPER Validation Cohort |
Primary outcome
F1 Score for Detection of Thyrotoxicosis Using the Investigational Software
Time frame: At weeks 4, 8, and 12 after baseline (Visit 2), up to 12 weeks total
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.
2 secondary outcomes
Sensitivity and Specificity of the Software in Detecting Thyrotoxicosis
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
Time frame: At weeks 4, 8, and 12 after baseline (Visit 2), up to 12 weeks total
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 38036639Shin K, Kim J, Park J, Oh TJ, Kong SH, Ahn CH, Moon JH, Kim MJ, Moon JH. A machine learning-assisted system to predict thyrotoxicosis using patients' heart rate monitoring data: a retrospective cohort study. Sci Rep. 2023 Nov 30;13(1):21096. doi: 10.1038/s41598-023-48199-x.
- Background: PubMed 34674500Kim KH, Lee J, Ahn CH, Yu HW, Choi JY, Lee HY, Lee WW, Moon JH. Association between Thyroid Function and Heart Rate Monitored by Wearable Devices in Patients with Hypothyroidism. Endocrinol Metab (Seoul). 2021 Oct;36(5):1121-1130. doi: 10.3803/EnM.2021.1216. Epub 2021 Oct 21.
- Background: PubMed 32886945Steinberger E, Pilz S, Trummer C, Theiler-Schwetz V, Reichhartinger M, Benninger T, Pandis M, Malle O, Keppel MH, Verheyen N, Grubler MR, Voelkl J, Meinitzer A, Marz W. Associations of Thyroid Hormones and Resting Heart Rate in Patients Referred to Coronary Angiography. Horm Metab Res. 2020 Dec;52(12):850-855. doi: 10.1055/a-1232-7292. Epub 2020 Sep 4.
- Background: PubMed 32525973Griffith ML, Bischoff LA, Baum HBA. Approach to the Patient With Thyrotoxicosis Using Telemedicine. J Clin Endocrinol Metab. 2020 Aug 1;105(8):dgaa373. doi: 10.1210/clinem/dgaa373.
- Background: PubMed 30006328Lee JE, Lee DH, Oh TJ, Kim KM, Choi SH, Lim S, Park YJ, Park DJ, Jang HC, Moon JH. Clinical Feasibility of Monitoring Resting Heart Rate Using a Wearable Activity Tracker in Patients With Thyrotoxicosis: Prospective Longitudinal Observational Study. JMIR Mhealth Uhealth. 2018 Jul 13;6(7):e159. doi: 10.2196/mhealth.9884.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Umeshi Masharani, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves Disease and Hyperthyroidism/Thyrotoxicosis, run by THYROSCOPE INC. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun An (+82 10-2849-0041, jun.an@thyroscope.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
F1 Score for Detection of Thyrotoxicosis Using the Investigational Software (time frame: At weeks 4, 8, and 12 after baseline (Visit 2), up to 12 weeks total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07017907, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.