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

February 26, 2022 updated by: Pusan National University Hospital

Development of Continuous Glucose Monitoring System Cohort for Personalized Diabetes Prevention and Management Platform Based on Artificial Intelligence Model Using Mathematical Analysis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Insulin Resistance
Time Frame: 1 week
the prevalence of insulin resistance in participants was measured. Insulin resistance was calculated by HOMA-IR(homeostatic model assessment of insulin resistance), QUICKI (quantitative insulin sensitivity check index) and Matsuda index
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Investigators

  • Principal Investigator: Sang soo Kim, Master, Pusan National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 11, 2020

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

September 30, 2020

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (ACTUAL)

April 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2022

Last Update Submitted That Met QC Criteria

February 26, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2003-033-088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data are not publicly available due to privacy or ethical restrictions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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