Continuous Glucose Monitoring for Glucose and Weight Management in Prediabetes and Non-severe Type 2 Diabetes: A Prospective Community-based (Workplace) Cohort Study
- Conditions
- PreDiabetesDiabetes Mellitus, Type 2
- Interventions
- Device: Freestyle Libre
- Registration Number
- NCT06542627
- Lead Sponsor
- Kangbuk Samsung Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 420
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CGM arm Freestyle Libre Glycemic control was monitored using CGM data for two weeks, followed by individualized dietary education.
- Primary Outcome Measures
Name Time Method HbA1c 8weeks after intervention HbA1c assessed by blood test after 2-week use of CGM and dietary education
- Secondary Outcome Measures
Name Time Method Fasting blood glucose 8weeks after intervention Fasting blood glucose, assessed by blood test after 2-week use of CGM and dietary education
Pre- and post-intervention questionnaire: Diabetes Treatment Satisfaction Questionnaire (DTSQ) 8weeks after intervention Pre- and post-intervention questionnaires, assessed by self-reported survey. The questionnaire is composed of three parts.
* total satisfaction (minimum 0, maximum 36, higher scores mean a better outcome.)
* perceived hyperglycaemia (minimum 0, maximum 6, higher scores mean a worse outcome.)
* perceived hypoglycaemia (minimum 0, maximum 6, higher scores mean a worse outcome.)Pre- and post-intervention questionnaire: Summary of Diabetes Self-Care Activities Questionnaire (SDSCAS). 8weeks after intervention Pre- and post-intervention questionnaires, assessed by self-reported survey. The questionnaire is composed of five parts.
* diet (values: minimum 0, maximum 28, higher scores mean a better outcome.)
* exercise (minimum 0, maximum 14, higher scores mean a better outcome.)
* blood sugar check-up (values: minimum 0, maximum 14, higher scores mean a better outcome.)
* foot care (minimum 0, maximum 14, higher scores mean a better outcome.)
* smoking (minimum 0, maximum 1, higher scores mean a worse outcome.)Body weight 8weeks after intervention Body weight assessed by blood test after 2-week use of CGM and dietary education
Lipid profiles 8weeks after intervention Lipid profiles (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride), assessed by blood test after 2-week use of CGM and dietary education
Trial Locations
- Locations (1)
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of