NCT06542627RecruitingNot Applicable
Continuous Glucose Monitoring for Glucose and Weight Management in Prediabetes and Non-severe Type 2 Diabetes
Kangbuk Samsung Hospital2 sites in 2 countries420 target enrollmentStarted: May 22, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 420
- Locations
- 2
- Primary Endpoint
- HbA1c
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Cheol-Young Park
Professor, MD. PhD
Kangbuk Samsung Hospital
Study Sites (2)
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