N/A
N=130
Development of Continuous Glucose Monitoring System Cohort for Personalized Diabetes Prevention and Management Platform
PreDiabetes · Glucose Metabolism Disorders · Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT04369833 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Number of Participants With Insulin Resistance — 69 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- continuous glucose monitoring system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pusan National University Hospital
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Insulin Resistance |
69 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Above 18 years old.
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT04369833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.