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This study is a single center observational study to investigate the association between biosignals from wearables and thyroid dysfunction.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thyroid dysfunction group | 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. |
| |
| Control group | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit and Glandy | Device | Data collection from wearable devices (Fitbit Inspire 2 TM) and a mobile app (Glandy TM) Fitbit collects user's heart rate, activity, and sleep data. Glandy collects user's subjective symptom scores. |
| Measure | Description | Time Frame |
|---|---|---|
| free T4 | serum concentration of free T4 | visit 2: 1-2 weeks after enrollement (visit 1) |
| free T4 | serum concentration of free T4 | visit 3 : 4 weeks after visit 2 |
| free T4 | serum concentration of free T4 | visit 4 : 4 weeks after visit 3 |
| TSH | serum concentration of TSH | visit 2: 1-2 weeks after enrollement (visit 1) |
| TSH | serum concentration of TSH | visit 3 : 4 weeks after visit 2 |
| TSH | serum concentration of TSH | visit 4 : 4 weeks after visit 3 |
| heart rate | continuously monitored heart rate by wearable device | throughout the study period (average 3 months) |
| Activity_steps (count/min) | continuously monitored steps per minute by wearable device | throughout the study period (average 3 months) |
| Sleep_sleep start time (yyyy:mm:dd:hh:mm:ss) |
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Inclusion Criteria:
Exclusion Criteria:
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Korean adults (age 18-60) who newly diagnosed as thyroid dysfunction (thyrotoxicosis or hypothyroidism) or undergoing treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jae Hoon Moon, MD | Contact | +82-31-787-7068 | jaemoon76@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
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| ID | Term |
|---|---|
| D013971 | Thyrotoxicosis |
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D006980 | Hyperthyroidism |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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sleep start time extracted from continuously monitored sleep data by wearable device (e.q. 2021:03:15:23:00:00) |
| throughout the study period (average 3 months) |
| Sleep_sleep end time (yyyy:mm:dd:hh:mm:ss) | sleep end time extracted from continuously monitored sleep data by wearable device (e.q. 2021:03:16:06:00:00) | throughout the study period (average 3 months) |
| Hyperthyroid symptom scale | HSS gives scores from 0 to 40, where higher scores indicate more severe disease. It consists of a 10-item scale that rates nervousness, diaphoresis, heat intolerance, motor activity, tremor, weakness, hyperdynamic precordium, diarrhea, weight loss/appetite, and overall function. | visit 2: 1-2 weeks after enrollement (visit 1) |
| Zulewski's clinical score | Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe) | visit 2: 1-2 weeks after enrollement (visit 1) |
| Hyperthyroid symptom scale | HSS gives scores from 0 to 40, where higher scores indicate more severe disease. It consists of a 10-item scale that rates nervousness, diaphoresis, heat intolerance, motor activity, tremor, weakness, hyperdynamic precordium, diarrhea, weight loss/appetite, and overall function. | visit 3 : 4 weeks after visit 2 |
| Zulewski's clinical score | Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe) | visit 3 : 4 weeks after visit 2 |
| Hyperthyroid symptom scale | HSS gives scores from 0 to 40, where higher scores indicate more severe disease. It consists of a 10-item scale that rates nervousness, diaphoresis, heat intolerance, motor activity, tremor, weakness, hyperdynamic precordium, diarrhea, weight loss/appetite, and overall function. | visit 4 : 4 weeks after visit 3 |
| Zulewski's clinical score | Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe) | visit 4 : 4 weeks after visit 3 |