Diabetes Mellitus, Glucose Metabolism Disorders, PreDiabetes
Conditions
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.
Interventions
DEVICEcontinuous glucose monitoring system
wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)
Sponsors
Pusan National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 129 |
| Total | 129 |
Baseline characteristics
| Characteristic | Continuous Glucose Monitoring Group |
|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 12.15 |
| Mean CGM glucose | 122.6 mg/dL STANDARD_DEVIATION 15.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 129 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment South Korea | 129 participants |
| Sex: Female, Male Female | 96 Participants |
| Sex: Female, Male Male | 33 Participants |
| the coefficient of variation of CGM glucose | 19.6 percentage of coefficient of variation STANDARD_DEVIATION 6.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 129 |
| other Total, other adverse events | 1 / 129 |
| serious Total, serious adverse events | 0 / 129 |
Outcome results
Primary
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
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitoring Group | Number of Participants With Insulin Resistance | 69 Participants |