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
CRIS Registration Number |
KCT0005783 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Ministry of Trade, Industry & Energy |
Organization Type | Government |
Project ID | R0006229 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Yonsei University, Wonju Severance Christian Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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
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 |
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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)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | HbA1C( Glycated hemoglobin) |
|
Timepoint | Within 1 month after termination |
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Secondary Outcome(s) 1 | ||
Outcome | Compliance |
|
Timepoint | Analysis with information collected during the test |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2021. 3 |
Way of Sharing | Available on Request
(yhmentor@gmail.com) |
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