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Clinical Trials/NCT04369833
NCT04369833
Completed
Not Applicable

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

Pusan National University Hospital1 site in 1 country130 target enrollmentMay 11, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PreDiabetes
Sponsor
Pusan National University Hospital
Enrollment
130
Locations
1
Primary Endpoint
Number of Participants With Insulin Resistance
Status
Completed
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 11, 2020
End Date
September 30, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Above 18 years old.
  • Prediabetes
  • Fasting plasma glucose : 100\~125mg/dL, fasting is defined as no caloric intake for at least 8 hours.
  • 2-hour plasma glucose during 75g oral glucose tolerance test : 140 \~ 199mg/dL
  • 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

Outcomes

Primary Outcomes

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

Study Sites (1)

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