Evaluating an AI Tool for Detecting Thyrotoxic States

Launched by THYROSCOPE INC. · Jun 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new software tool called Glandy HYPER, which aims to help doctors identify a condition known as thyrotoxicosis in patients with hyperthyroidism, particularly those diagnosed with Graves' disease. The tool uses heart rate data collected from popular wearable devices, like fitness trackers, and compares this information with blood test results that measure thyroid hormone levels. The goal is to see if the heart rate data can reliably indicate how well the thyroid is functioning, which could help in managing the condition.

To participate in this study, individuals must be at least 22 years old and either newly diagnosed with Graves' disease or currently undergoing treatment for it. Participants will wear a device that tracks their heart rate while they sleep, and their thyroid hormone levels will be monitored through regular blood tests. It’s important to note that the results from the software will not be shared with participants, and the study will not change their usual medical care. Some individuals, such as those with certain heart conditions or those who are pregnant, may not be eligible to join. Overall, this trial aims to explore a new way to support the care of patients with hyperthyroidism.

Gender

ALL

Eligibility criteria

• 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.