Evaluating an AI Tool for Detecting Thyrotoxic States

🩺 Protocol 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.

Primary Research Facility: Umesh Masharani (San Francisco, California)

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

Diagnosed with, undergoing evaluation for, or seeking treatment related to Graves Disease?

🔍 Study Population / Focus Area (Source: Protocol Primary Condition)

Aged 22 Years or older?

🔍 Protocol Specified Minimum Age: 22 Years

Able to attend required clinic visits at Umesh Masharani (San Francisco, California)?

🔍 Logistical Requirement: Site at Umesh Masharani

📍 Primary Site Map

Site: Umesh Masharani — San Francisco, California

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.