AI medical trial: detecting thyrotoxicosis from consumer-wearable heart rate with AI (Thyroscope, Glandy HYPER)

1Hyperthyroidism meets wearables

Thyroscope's observational study (NCT07017907) evaluates an AI software medical device, "Glandy HYPER," that uses heart rate from a commercial wearable to detect an overactive thyroid (thyrotoxicosis).

2Evaluated as software as a medical device

Per the registry summary, this observational study aims to evaluate the performance of the software-based medical device "Glandy HYPER" in detecting the thyrotoxic state in patients with hyperthyroidism. The device uses heart-rate data from commercially available wearables and compares it with thyroid function test results.

The study enrolls patients diagnosed with Graves' disease, monitoring their heart rate during sleep and correlating it with serial free-T4 levels obtained by blood testing. Importantly, no investigational device output is disclosed to participants, and the study does not alter standard clinical care. Target enrollment 15; 2026; recruiting.

3The digital biomarker idea

In hyperthyroidism (e.g., Graves' disease), metabolism is elevated, causing palpitations, rapid heart rate, and weight loss; worsening thyrotoxicosis strains the heart. Because heart rate can be measured continuously and easily with consumer smartwatches, combining it with AI to flag signs of a thyrotoxic state could help with deciding when to seek care or with monitoring. Note this is an early, small (15-participant) observational study.

4Matching everyday recordings against laboratory values

The idea of a digital biomarker is to catch signs of a disease state from signals available in daily life. Here, how that matching is done is written into the design.

1. 1Measure with a consumer wearableHeart rate is monitored continuously during sleep
2. 2AI analyses itSigns of a thyrotoxic state are detected
3. 3Match against blood testsCorrelated with free T4 values from serial blood sampling
4. 4Do not disclose the resultThe device output is withheld from participants and standard care is unchanged

In hyperthyroidism metabolism accelerates, producing palpitations, tachycardia and weight loss. Heart rate can be measured continuously and easily on a consumer smartwatch, so combining that with AI to catch signs of a thyrotoxic state could help with when to seek care and with follow-up. This is an early observational study targeting 15 cases.