An observational study in PreDiabetes, Glucose Metabolism Disorders and Diabetes Mellitus, sponsored by Pusan National University Hospital. Completed at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-09.
Sponsored by Pusan National University Hospital · Observational
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.
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.
1,021 studies on the registry are indexed under Prediabetic State; 242 are open to participants now.
This study's enrollment of 130 is below the median of 207 across 131 observational studies indexed under Prediabetic State.
Browse Prediabetic State studies →Pusan National University Hospital is the lead sponsor of 80 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
all participants wearing a continuous glucose monitoring device
Device: continuous glucose monitoring system
wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)
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
| Milestone | Continuous Glucose Monitoring Group |
|---|---|
| Started | 130 |
| Completed | 129 |
| Not completed | 1 |
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
| Participants | Continuous Glucose Monitoring Group |
|---|---|
| Number of Participants With Insulin Resistance | 69 |
Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Continuous Glucose Monitoring Group | 0/129 (0%) | 0/129 (0%) | 1/129 (0.8%) |
| Event | Continuous Glucose Monitoring Group |
|---|---|
| bleeding on CGM insertion siteSkin and subcutaneous tissue disorders | 1/129 |
Patients who have high risk for developing diabetes with wearing CGM.
| Age, Continuous(years) | Continuous Glucose Monitoring Group |
|---|---|
| Mean | 56.6 ± 12.15 |
| Sex: Female, Male(Participants) | Continuous Glucose Monitoring Group |
|---|---|
| Female | 96 |
| Male | 33 |
| Race (NIH/OMB)(Participants) | Continuous Glucose Monitoring Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 129 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Continuous Glucose Monitoring Group |
|---|---|
| South Korea | 129 |
| Mean CGM glucose(mg/dL) | Continuous Glucose Monitoring Group |
|---|---|
| Mean | 122.6 ± 15.5 |
| the coefficient of variation of CGM glucose(percentage of coefficient of variation) | Continuous Glucose Monitoring Group |
|---|---|
| Mean | 19.6 ± 6.4 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — The data are not publicly available due to privacy or ethical restrictions.
Ran from May 2020 to primary completion in Sep 2020, 4 months.
Results were first posted in May 2022, 1 year 7 months after primary completion.
Of 45 non-industry observational studies under Prediabetic State, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 186. This study's 4 months is below that.
Counting every sponsor, half of 50 studies reached it within 50 months; a quarter within 24 and three quarters within 186.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Pusan National University Hospital