PreDiabetes, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DEVICEFreestyle Libre
Glycemic control was monitored using CGM data for two weeks, followed by individualized dietary education.
Sponsors
Samsung Electronics
Kangbuk Samsung Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 8weeks after intervention | HbA1c assessed by blood test after 2-week use of CGM and dietary education |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting blood glucose | 8weeks after intervention | Fasting blood glucose, 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 |
| Body weight | 8weeks after intervention | Body weight 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.) |
Countries
South Korea
Contacts
Primary ContactPark
Backup ContactKo
Outcome results
None listed