Continuous Glucose Monitoring for Glucose and Weight Management in Prediabetes and Non-severe Type 2 Diabetes

Kangbuk Samsung Hospital1 site in 1 country420 target enrollmentMay 22, 2023

ConditionsPreDiabetes Diabetes Mellitus, Type 2

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: PreDiabetes
Sponsor: Kangbuk Samsung Hospital
Enrollment: 420
Locations: 1
Primary Endpoint: HbA1c
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aimed to evaluate the effectiveness of use of Continuous Glucose Monitoring (CGM), combined with personalized dietary education and use of smartphone applications in improving glucose control and weight management.

Registry

clinicaltrials.gov

Start Date

May 22, 2023

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Kangbuk Samsung Hospital

Responsible Party

Principal Investigator

Cheol-Young Park

Professor, MD. PhD

Kangbuk Samsung Hospital

Eligibility Criteria

Inclusion Criteria

•Subjects over the age of 19
•Patients with type 2 diabetes
•Fasting blood glucose ≥ 126 mg/dL or
•HbA1c ≥ 6.5% or
•Type 2 diabetes by clinical history and treated with antidiabetic medications or lifestyle Modifications
•Patients with prediabetes
•Fasting blood glucose 100-125 mg/dL
•HbA1c 5.7-6.4%
•Willing to participate in the study

Exclusion Criteria

•Subjects less than 19 years old
•Patients with type 1 diabetes
•Pregnant at the time of screening or planning to become pregnant during the study
•Severe chronic diseases such as cancer, stroke, proliferative retinopathy, myocardial infarction, chronic renal disease, or amputation of a diabetic foot
•Diagnosed with or treated for myocardial infarction, stroke, end-stage renal disease, liver failure, or chronic lung disease within the past year
•Severe liver disease (e.g., cancer, liver cirrhosis, hepatitis B, hepatitis C)
•Diseases of the biliary tract, thyroid disorders, autoimmune disorders, or acute infections
•Planning to be admitted to a hospital within 2 months
•Unable to participate in the mobile intervention study as determined by the investigator

Outcomes

Primary Outcomes

HbA1c

Time Frame: 8weeks after intervention

HbA1c assessed by blood test after 2-week use of CGM and dietary education

Secondary Outcomes

Fasting blood glucose(8weeks after intervention)
Pre- and post-intervention questionnaire: Diabetes Treatment Satisfaction Questionnaire (DTSQ)(8weeks after intervention)
Pre- and post-intervention questionnaire: Summary of Diabetes Self-Care Activities Questionnaire (SDSCAS).(8weeks after intervention)
Body weight(8weeks after intervention)
Lipid profiles(8weeks after intervention)