Evaluating an AI Tool for Detecting Thyrotoxic States
Key facts
- Who runs it
- THYROSCOPE INC.
- Where
- San Francisco, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 15 people, planned
- Started
- 9 Jan 2026
- Expected to end
- 31 Dec 2026
- Type of study
- Observational
- Treatments tested
- Heart rate-based AI software for detecting thyrotoxicosis
- Record updated
- 1 June 2026
Who can take part
- Age
- 22 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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 take part
- 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.)
- Individuals with severe psychiatric disorders, substance use disorder, or alcohol dependence
- 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 deemed ineligible at the discretion of the investigator for safety or ethical concerns
Where in United States
- Umesh MasharaniSan Francisco, United StatesContact: Umesh Masharani, MDTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- 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.
Treatment: Heart rate-based AI software for detecting thyrotoxicosis
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Performance Evaluation of the Software Medical Device to Detect the Thyrotoxic State in Patients With Hyperthyroidism
- Record updated
- 1 June 2026