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

Completed

• Conditions: PreDiabetes; Glucose Metabolism Disorders; Diabetes Mellitus
• Interventions: Device: continuous glucose monitoring system

• Registration Number: NCT04369833
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-30
• Study Start: 2020-05-11
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Results First Submitted: 2021-03-13
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-26
• Last Update Submitted: 2022-02-26
• Results First Posted: 2022-05-09
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
continuous glucose monitoring group	continuous glucose monitoring system	all participants wearing a continuous glucose monitoring device

Primary Outcome Measures

Name	Time	Method
Number of Participants With Insulin Resistance	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

Trial Locations

Locations (1)

Pusan national university hospital; 🇰🇷 Busan, Korea, Republic of