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A study on the metabolic syndrome empirical model for the next-generation life health industrial ecosystem creation project

Status Approved

  • First Submitted Date

    2020/11/09

  • Registered Date

    2021/01/14

  • Last Updated Date

    2020/11/09

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005783
    Unique Protocol ID CR319089
    Public/Brief Title Development of digital health care service model for metabolic syndrome patients using IoT medical device, wellness device and app service
    Scientific Title A study on the metabolic syndrome empirical model for the next-generation life health industrial ecosystem creation project
    Acronym Smart healthcare for Metabolic Syndrome(SMS)
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number CR319089
    Approval Date 2019-12-05
    Institutional Review Board Name Yonsei University, Wonju Severance Christian Hospital Institutional Review Board
    Institutional Review Board Address 20, Ilsan-ro, Wonju-si, Gangwon-do
    Institutional Review Board Telephone 033-741-1702
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Kang Hyun Lee
    Title Professor
    Telephone +82-33-741-5400
    Affiliation Yonsei University, Wonju Severance Christian Hospital
    Address 20, Ilsan-ro, Wonju-si, Gangwon-do
    Contact Person for Public Queries
    Name Hyun Youk
    Title Professor
    Telephone +82-33-741-1616
    Affiliation Yonsei University, Wonju Severance Christian Hospital
    Address 20, Ilsan-ro, Wonju-si, Gangwon-do
    Contact Person for Updating Information
    Name Hyun Youk
    Title Professor
    Telephone +82-33-741-1616
    Affiliation Yonsei University, Wonju Severance Christian Hospital
    Address 20, Ilsan-ro, Wonju-si, Gangwon-do
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2019-12-16 Actual
    Target Number of Participant 400
    Primary Completion Date 2021-06-30 , Anticipated
    Study Completion Date 2021-06-30 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Yonsei University, Wonju Severance Christian Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2019-12-16 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Trade, Industry & Energy
    Organization Type Government
    Project ID R0006229
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University, Wonju Severance Christian Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Metabolic syndrome is a condition that is believed to be caused by insulin resistance, a condition in which two or more levels of cholesterol, blood pressure, and blood sugar levels occur. The concept of grouping various cardiovascular diseases and type 2 diabetes risk factors into one disease group. It is a useful concept that can be used to explain insulin resistance and various complicated metabolic disorders and clinical features. According to the Ministry of Health and Welfare, subjects with metabolic syndrome are at least two times more likely to develop cardiovascular disease than those without metabolic syndrome (less than three components), and are four to six times more likely to develop diabetes. It is also reported that there is an increased risk of various cancers.
    The Ministry of Health and Welfare ('07 ~ '10) analyzed the data of Korea's National Health and Nutrition Survey ('07 ~ '10) and found that 28.8% of adults over 30 years of age had a prevalence of metabolic syndrome. It was announced that 79.7% of males, 67.8% of females, and 73.7% of males and females exceeded the target.
      In addition, the Korea Institute of Health Research published a study called 'Systematic Review of the Clinical Effect of Telemedicine Services such as Hypertension and Diabetes,' conducted in 2015. In order to confirm the clinical effects of 'remote monitoring', counseling, and education, a comprehensive analysis of the results of previous studies on patients with hypertension, diabetes, and heart failure. In case of real-time feedback, negative feedback, and biological information transmission equipment is a remote device, the control group reported that the glycated hemoglobin was low in the remote monitoring group.
    Therefore, in this study, to develop a health care service model using IoT medical devices and IoT wellness devices for patients with metabolic syndrome, test groups applying IoT medical devices and IoT wellness devices, IoT medical devices and IoT wellness devices, etc. It is divided into uncontrolled control group and aims to collect blood test data between two groups (including glycated hemoglobin level and blood lipid level), IoT medical device and IoT wellness device. In addition, we would like to see whether monitoring using IoT medical devices and IoT wellness devices and active interventions based on individual values ​​are effective for blood glucose control in patients with metabolic syndrome.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-control
    Time Perspective Prospective  
    Target Number of Participant 400
    Cohort/Group Number 2
    Cohort/
    Group 1

    Cohort/Group Label

    The group using Digital Healthcare Management Service with IoT devices and Smartphone application

    Cohort/Group Description

    Among 400 people who are eligible for metabolic syndrome (or metabolic syndrome risk group), IoT medical devices and IoT wellness devices are used. 200 test groups applied
    Cohort/
    Group 2

    Cohort/Group Label

    The group using Digital Healthcare Management Service without IoT devices and Smartphone application

    Cohort/Group Description

    Among 400 people who are eligible for metabolic syndrome (or metabolic syndrome risk group), IoT medical devices and IoT wellness devices are used. 200 controls without application
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    The number of subjects in this clinical trial is 200 in the test group and 200 in the control group, a total of 400 patients. Metabolic syndrome criteria
     Only applicable subjects are recruited, and a test group and a control group are selected by random assignment** with a 50% probability. For this study, participate in the Samsung Smart Watch research project in the Wonju Severance Christian Hospital Preventive Medicine Department.
    It will be promoted to the target audience through the recruitment document.
    
    8.4 Metabolic syndrome criteria (diagnostic criteria for Korean metabolic syndrome applying NCEP-ATP Ⅲ criteria)
    1) Waist circumference: 90cm or more for men, 85cm or more for women
    2) Blood pressure: Over 130/85mmHg or those taking hypertension drugs
    3) Triglycerides: Over 150mg/dL or those who take drugs related to dyslipidemia
    4) HDL cholesterol: less than 40mg/dL in men, less than 50mg/dL in women, or those who take dyslipidemia-related drugs
    5) Fasting Blood Sugar: Those who take more than 100mg/dL of fasting plasma glucose or diabetes-related drugs
    Sampling Method
    For this study, participate in the Samsung Smart Watch research project in the Wonju Severance Christian Hospital Preventive Medicine Department.
    It will be promoted to the target audience through the recruitment document.
     Randomization**: Request a list of confirmed participation in clinical trials to the Biomedical Data Science Center in our
     Randomly assigned as a control.
    Condition(s)/Problem(s) * (E00-E90)Endocrine, nutritional and metabolic diseases 
       (E88.9)Metabolic disorder, unspecified 

    Metabolic syndrome criteria (diagnostic criteria for Korean metabolic syndrome applying NCEP-ATP Ⅲ criteria) 1) Waist circumference: 90cm or more for men, 85cm or more for women 2) Blood pressure: Over 130/85mmHg or those taking hypertension drugs 3) Triglycerides: Over 150mg/dL or those who take drugs related to dyslipidemia 4) HDL cholesterol: less than 40mg/dL for men, 50mg/dL or less for women, or those who take drugs related to dyslipidemia 5) Fasting blood sugar: Those who take more than 100mg/dL of fasting plasma glucose or diabetes-related drugs
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    40Year~80Year

    Description

    Selection criteria for test subjects
     1) Adults between 40 and 80 years of age
     2) Those subject to metabolic syndrome who do not take diabetic medications before or after diabetes diagnosis
     3) Those who meet two or more criteria for diagnosing NCEP-ATPⅢ Korean metabolic syndrome
     4) Those who consented in writing to this clinical trial
     5) Those who can understand and carry out education and instructions, and can participate in the entire clinical trial period
    Exclusion Criteria
    Exclusion criteria for test subjects
     1) Persons with physical disabilities who cannot wear IoT medical devices and IoT wellness devices
     2) Those who have been diagnosed with diabetes and are taking medication before participating in this clinical trial
     3) Those who have taken or intend to take coumadin or warfarin in the last 1 month
     4) Persons suffering from skin diseases or dysfunctions in the contact area of ​​IoT medical devices
     5) Those who have negative opinions or reluctance to wear IoT medical devices
     6) Subjects who have implanted medical devices in their bodies
     7) pregnant women
     8) Those who are participating in other clinical trials at the same time or who have participated in previous clinical trials and have not had enough time
     (Within 3 months, Exception: Samsung Smart Watch Research in Preventive Medicine Department)
     9) Subjects deemed inappropriate by the test manager and the person in charge
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    HbA1C( Glycated hemoglobin)
    Timepoint
    Within 1 month after termination
    Secondary Outcome(s) 1
    Outcome
    Compliance
    Timepoint
    Analysis with information collected during the test
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2021. 3
    Way of Sharing Available on Request
    (yhmentor@gmail.com)
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