Biosignals by Wearables in Thyroid Dysfunction

Seoul National University

Status: Enrolling

Conditions: Thyrotoxicosis; Hypothyroidism

Treatments: Device: Fitbit and Glandy

Study type: Observational

Funder types: Other

Identifiers

NCT04806269

B-2012-654-303

Details and patient eligibility

About

This study is a single center observational study to investigate the association between biosignals from wearables and thyroid dysfunction.

Full description

An algorithm to predict thyroid dysfunction using heart rate and activity data from wearables was generated based on our previous clinical studies. This study was conducted to collect more data to advance the algorithm.

Patients with thyroid dysfunction including hypothyroidism and thyrotoxicosis were eligible for this study. During the study period, each subject wears a smart band (Fitbit Inspire 2 TM) and gets 3 times of thyroid function tests with 1-month interval. Study participants will use a mobile app (Glandy TM) to collect the symptom scores.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who were newly diagnosed as thyroid dysfunction (thyrotoxicosis or hypothyroidism) or undergoing treatment
• Subjects who are able to use wearable devices, smart phones, and mobile apps

Exclusion criteria

• Subjects with restrictions on normal activities due to diseases other than thyroid dysfunction
• Subjects who are taking medications affecting heart rate
• Subjects with diseases affecting heart rate (i.e. arrhythmia)

Trial design

120 participants in 2 patient groups

Thyroid dysfunction group

Description:

Subjects with thyroid dysfunction including thyrotoxicosis and hypothyroidism Subjects who were newly diagnosed or undergoing treatment for thyroid dysfunction can be included in the study. Subjects should use a wearable device (Fitbit Inspire 2 TM) and a mobile app (Glandy TM) during the study period.

Treatment:

Device: Fitbit and Glandy

Control group

Description:

Subjects without thyroid dysfunction including thyrotoxicosis and hypothyroidism. Subjects should use a wearable device (Fitbit Inspire 2 TM) and a mobile app (Glandy TM) during the study period.

Treatment:

Device: Fitbit and Glandy