Biosignals by Wearable Devices in Hypothyroidism (Hypo_AT)

Clinical Application of Continuous Monitoring Data for Biosignals by Commercially Available Wearable Devices in the Patients With Hypothyroidism

This is a prospective observational cohort study. Monitoring continuous biosignals using wearable devices in thyroid cancer patients who are planned to withdraw their levothyroxine for radioactive iodine therapy. Through this, bio signals can be collected in the subjects in hypothyroid status. Physical activity, heart rate, and sleep data will be collected during the study period.

Study Overview

• Status: Completed
• Conditions: Hypothyroidism
• Intervention / Treatment: Other: levothyroxine withdrawal

Detailed Description

A prospective observational cohort study including two groups.

Hypothyroid group:

Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to withdraw their levothyroxine for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices

Control group:

Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to get rhTSH (not to withdraw their levothyroxine) for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices Thyroid hormone levels and continuously collected bio signals including activity, heart rate, and sleep data will be obtained during study period.

Association between thyroid status and bio signals will be investigated.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to get radioactive iodine therapy

Description

Inclusion Criteria:

• Patients with differentiated thyroid carcinoma underwent total thyroidectomy
• Patients who are planned to get radioactive iodine therapy
• Patients who are able to use wearable device and smartphones

Exclusion Criteria:

• Patients who are not able to use wearable device and smartphones
• Patients who are maintaining drugs affecting heart rate
• Patients who have any other disease which can affect biosignals

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypothyroid group; Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to withdraw their levothyroxine for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices	Other: levothyroxine withdrawal; All participants of this study are decided to get radioactive iodine therapy using levothyroxine withdrawal or human recombinant TSH injection prior to the study enrollment. That decision is independent with this study protocol. This study just collect continuous bio signals using wearable devices in the patients undergoing two different preparation methods for radioactive iodine therapy. That is why this study is an observational cohort study.
Control group; Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to get rhTSH (not to withdraw their levothyroxine) for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
physical activity (steps)	steps data measured by wearable device, collected and recorded in 1 min increment	throughout the study period average 4 months
heart rate (beats)	heart rate data measured by wearable device, collected and recorded in 1 min increment	throughout the study period average 4 months
free T4 level (ng/dL)	thyroid hormone level	baseline (visit 1)
free T4 level (ng/dL)	thyroid hormone level	after 2 to 3 months (visit 2)
free T4 level (ng/dL)	thyroid hormone level	after 3 to 4 months (visit 3)
Zulewski hypothyroidism score ( point)	Scoring system to evaluate hypothyroid symptoms and signs	baseline (visit 1)
Zulewski hypothyroidism score ( point)	Scoring system to evaluate hypothyroid symptoms and signs	after 2 to 3 months (visit 2),
Zulewski hypothyroidism score ( point)	Scoring system to evaluate hypothyroid symptoms and signs	after 3 to 4 months (visit 3)
TSH level (mIU/L)	thyroid stimulating hormone level	baseline (visit 1)
TSH level (mIU/L)	thyroid stimulating hormone level	after 2 to 3 months (visit 2)
TSH level (mIU/L)	thyroid stimulating hormone level	after 3 to 4 months (visit 3)

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 14, 2019
• Primary Completion (ACTUAL): October 15, 2020
• Study Completion (ACTUAL): October 15, 2020

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (ACTUAL): April 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 3, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: B-1906/547-304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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