Evaluating an AI Tool for Detecting Thyrotoxic States
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorTHYROSCOPE INC.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adults aged 22 years and older with a confirmed diagnosis of Graves' disease, including both newly diagnosed and currently treated individuals. Participants will be recruited from a single center in the United States. All participants must be able to use a wearable device and provide informed consent.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Heart rate-based AI software for detecting thyrotoxicosis
DeviceA 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Glandy HYPER Validation Cohort1 intervention
Trial outcomes
Primary outcomes
1
F1 Score for Detection of Thyrotoxicosis Using the Investigational Software
The F1 score will be calculated to evaluate the performance of the AI-based investigational software in detecting thyrotoxic states. The device's output, derived from wearable heart rate data and reference data, will be compared against the diagnosis based on serum free T4 concentration at each time point. Each participant contributes multiple data pairs (evaluation-reference combinations) based on serial visits (V2-V5), and the F1 score will be calculated for each case and summarized across all cases.
Time frame
At weeks 4, 8, and 12 after baseline (Visit 2), up to 12 weeks totalSecondary outcomes
1
Sensitivity and Specificity of the Software in Detecting Thyrotoxicosis
The sensitivity and specificity of the investigational AI software will be calculated by comparing its output to the diagnosis of thyrotoxicosis based on serum free T4 levels. Results will be computed for each evaluation-reference data pair and summarized across all participants, with 95% confidence intervals.
Time frame
At weeks 4, 8, and 12 after baseline (Visit 2), up to 12 weeks total2
Area Under the Receiver Operating Characteristic Curve (AUC) for Thyrotoxicosis Detection
The AUC will be calculated to assess the diagnostic performance of the investigational software in distinguishing thyrotoxicosis from euthyroid and hypothyroid states, using free T4 levels as the reference. The AUC will be calculated per case and summarized across all evaluable cases.
Time frame
At weeks 4, 8, and 12 after baseline (Visit 2), up to 12 weeks totalSponsors and contacts
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Source ClinicalTrials.gov