Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Development of Continuous Glucose Monitoring System Cohort for Personalized Diabetes Prevention and Management Platform

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369833
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Pusan National University Hospital

Brief Summary:
The purpose of this study is to collect a variety of clinical data and blood glucose changes using a continuous glucose monitoring device for high-risk diabetes patients (prediabetes) in order to develop a personalized diabetes prevention and management platform based on artificial intelligence model using mathematical analysis.

Condition or disease Intervention/treatment
PreDiabetes Glucose Metabolism Disorders Diabetes Mellitus Device: continuous glucose monitoring system

Detailed Description:

After being informed about the study and potential risks, all patients giving written informed consent wear a continuous glucose monitoring device ("iPro2" professional continuous glucose monitoring, MedtronicⓇ, California, USA) and smart band ("Fitbit Inspire HR", FitbitⓇ, California, USA) for 1 week.

During this period, all patients are tested oral glucose tolerance test and take a standard diet (calorie calculated) at morning.

The patient's data from this study is compared to a predicted values by mathematical analysis model for diabetes prevention.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: Development of Continuous Glucose Monitoring System Cohort for Personalized Diabetes Prevention and Management Platform Based on Artificial Intelligence Model Using Mathematical Analysis
Actual Study Start Date : May 11, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Group/Cohort Intervention/treatment
continuous glucose monitoring group
all participants wearing a continuous glucose monitoring device
Device: continuous glucose monitoring system
wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)




Primary Outcome Measures :
  1. Glucose/insulin levels pattern [ Time Frame: 1 week ]
    Explanatory power of multiple regression model of independent variables related to blood sugar / insulin (cycle, amplitude, mean and variance of blood sugar, mean and variance of insulin)


Biospecimen Retention:   Samples Without DNA
blood sample (for HbA1c, Total cholesterol, LDL-C, HDL-C, Triglyceride, aspartate aminotransferase, alanine aminotransferase, Creatinine, free fatty acid etc), Feces (for evaluating microbiomes)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects of pre-diabetes who visited the Department of Internal Medicine and division of Endodrinology & Metabolism and the Health Examination Center, Pusan National University Hospital
Criteria

Inclusion Criteria:

  • Above 18 years old.
  • Prediabetes

    1. Fasting plasma glucose : 100~125mg/dL, fasting is defined as no caloric intake for at least 8 hours.

      OR

    2. 2-hour plasma glucose during 75g oral glucose tolerance test : 140 ~ 199mg/dL

      OR

    3. Glycated hemoglobin(HbA1c) : 5.7~6.4% (39-47mmol/mol)

Exclusion Criteria:

  • with a history of newly diagnosed and treated cancer within the last 5 years
  • with a history of hospitalization for active disease within the last 3 months
  • with a history of severe cardiovascular disease within the last 3 months
  • with a history of steroid treatment in the last 3 months
  • people who have had major surgery planned within the last 3 months or who have had surgery within 3 months
  • people who are pregnant or have been in the last 3 months after giving birth

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369833


Contacts
Layout table for location contacts
Contact: Wook Yi, Bachelor +82-51-240-7983 wg0405@gmail.com

Locations
Layout table for location information
Korea, Republic of
Pusan national university hospital Recruiting
Busan, Korea, Republic of, 49241
Contact: Wook Yi, bachelor    +82-51-240-7983    wg0405@gmail.com   
Sponsors and Collaborators
Pusan National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Sang soo Kim, Master Pusan National University Hospital
Publications of Results:

Layout table for additonal information
Responsible Party: Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT04369833    
Other Study ID Numbers: H-2003-033-088
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data are not publicly available due to privacy or ethical restrictions.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases