Recruiting

Observational Study

Sponsor:

THYROSCOPE INC.

Code:

NCT07017907

Conditions

Graves Disease

Hyperthyroidism/Thyrotoxicosis

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Heart rate-based AI software for detecting thyrotoxicosis

Study Details

Brief 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.

Conditions

Graves Disease

Hyperthyroidism/Thyrotoxicosis

Study ID

NCT07017907

Start date

Jan 9, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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 ]

Central Contacts and Locations

Central contacts

Jun An

‭+82 10-2849-0041‬jun.an@thyroscope.com

Jae Hoon Moon, MD, PhD

+82-10-5105-9815jaehoon.moon@thyroscope.com

Locations

Umesh Masharani

Recruiting

San Francisco, California, United States, 94143

Contacts

Umesh Masharani, MD

415-353-2350Umesh.Masharani@ucsf.edu

More Information

Sponsor

THYROSCOPE INC.

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • Graves disease
  • Hyperthyroidism
  • Thyrotoxicosis
  • Artificial intelligence
  • Heart rate
  • SaMD
  • wearable device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by THYROSCOPE INC. on 2026-06-01.