Clinical trial NCT04369833: Development of Continuous Glucose Monitoring System Cohort for Personalized Diabetes Prevention and Management Platform
Official title: Development of Continuous Glucose Monitoring System Cohort for Personalized Diabetes Prevention and Management Platform Based on Artificial Intelligence Model Using Mathematical Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PreDiabetes
Glucose Metabolism Disorders
Diabetes Mellitus
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects of pre-diabetes who visited the Department of Internal Medicine and division of Endodrinology \& Metabolism and the Health Examination Center, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Insulin Resistance
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan national university hospital
Study officials:
affiliation: Pusan National University Hospital
name: Sang soo Kim, Master
role: PRINCIPAL_INVESTIGATOR
References:
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