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Development of Continuous Glucose Monitoring System Cohort for Personalized Diabetes Prevention and Management Platform 130 Personalized Treatment Prevention

Completed
Clinical Trial NCT04369833 was an observational study for PreDiabetes, Glucose Metabolism Disorders, Diabetes Mellitus that is now completed. The study started on May 11, 2020, with plans to enroll 130 participants. Led by Pusan National University Hospital, the expected completion date was September 30, 2020. The latest data from ClinicalTrials.gov was last updated on May 9, 2022.
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 calculate...

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Official Title

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

Conditions
PreDiabetesGlucose Metabolism DisordersDiabetes Mellitus
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • H-2003-033-088
NCT ID Number
NCT04369833
Start Date (Actual)
2020-05-11
Last Update Posted
2022-05-09
Completion Date (Estimated)
2020-09-30
Enrollment (Estimated)
130
Study Type
Observational
Status
Completed
Arms / Interventions
Participant Group/ArmIntervention/Treatment
continuous glucose monitoring group
all participants wearing a continuous glucose monitoring device
continuous glucose monitoring system
wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Number of Participants With Insulin Resistance
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
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • 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)

  • 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
Pusan National University Hospital logoPusan National University Hospital
No contact data.
1 Study Locations in 1 Countries
Pusan national university hospital, Busan, 49241, South Korea