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OpenTrials
Completed

NCT Number: NCT04369833

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pusan national university hospital

Busan, 49241, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

OR

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

OR

  • 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

Treatment and study plan

Continuous Glucose Monitoring System

Device

wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 30, 2020
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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