Biosignals by Wearables in Thyroid Dysfunction

Clinical Application of Continuous Monitoring Data for the Pulse Rate, Exercise, and Symptom Survey by Wearable Device in the Patients With Thyroid Dysfunction

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

Study Overview

• Status: Recruiting
• Conditions: Hypothyroidism; Thyrotoxicosis
• Intervention / Treatment: Device: Fitbit and Glandy

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Korean adults (age 18-60) who newly diagnosed as thyroid dysfunction (thyrotoxicosis or hypothyroidism) or undergoing treatment

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Fitbit and Glandy; 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.
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.	Device: Fitbit and Glandy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Hypothyroidism; Mobile app; Wearable device; Biosignals; Thyrotoxicosis
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hyperthyroidism; Hypothyroidism; Thyrotoxicosis
• Other Study ID Numbers: B-2012-654-303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No