Effectiveness of Personalized Lifestyle Intervention using CGM in Patients with Diabetes: A Randomized Clinical Trial
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0008872
- Lead Sponsor
- Jeonbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 141
(1) Adults aged 20 to 80 years.
(2) Individuals diagnosed with type 2 diabetes for at least 6 months.
(3) Individuals with HbA1C levels of 6.5% or higher.
(4) Individuals with a smartphone.
(5) Patients who have not previously used a continuous glucose monitoring (CGM) device.
(6) Individuals who have a sufficient understanding of the research purpose and procedures, and voluntarily consent to participate in the clinical study.
(1) Individuals with a history of psychiatric disorders.
(2) Individuals with serious comorbid conditions requiring treatment in addition to diabetes (e.g., diabetic nephropathy).
(3) Individuals who have undergone surgery within the past year.
(4) Individuals diagnosed with cancer within the past 5 years.
(5) Individuals who have received organ transplantation.
(6) Individuals who have received diabetes education counseling within the last 6 months.
(7) Patients whose medication has been changed within the last 3 months.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1C
- Secondary Outcome Measures
Name Time Method indices of Continuous Glucose Monitoring (CGM), lifestyles and diet variables, steps, sleep pattern, Fasting blood sugar(FBS), HbA1C, Triglyceride, Total Cholesterol, High-density lipoprotein Cholesterol (HDL-C), Low-density lipoprotein cholesterol (LDL-C), Bloold Pressure, Inbody indices, Waist Circumference, Diabetes self-management behaviors, hypoglycemic fear, System Usability Scale (SUS), DM empowerment etcl.