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

Pusan National University

Status

Completed

Conditions

Diabetes Mellitus

Glucose Metabolism Disorders

PreDiabetes

Treatments

Device: continuous glucose monitoring system

Study type

Observational

Funder types

Other

Identifiers

NCT04369833

H-2003-033-088

Details and patient eligibility

About

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.

Full 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.

Enrollment

130 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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