Multicenter, Open-label, Randomized Trial to Compare the Effectiveness of Structured Education and Safety of FreeStyle Libre or Self-Monitoring of Blood Glucose (SMBG) in patients with type 2 Diabetes Mellitus using Multiple Daily Injections or Insulin Pumps
All subjects must participate in Blind Continuous Glucose Monitoring(CGM) for two weeks prior to Visit 2 visit (random assignment). Subjects who meet the selection/exclusion criteria in Visit 2 visits are randomly assigned to the test group (personal in-depth education and FreeStyle Libre) or control 1 (standard education and FreeStyle Libre) or control 2 (standard education and SMBG) at a 1:1:1 ratio. In the test group, personal in-depth education is conducted at baseline (Visit 2), 4 weeks (Visit 3), 8 weeks (Visit 4), 12 weeks (Visit 5), and 18 weeks (Visit 6), and the time required for education and preparation time required for patient education are checked. Control groups 1 and 2 conduct routine insulin basic injection training as standard education at baseline (Visit 2) and 12 weeks (Visit 5). After randomization, FreeStyle Libre is applied to the test group and control group 1 for 24 weeks, and SMBG is performed for 22 weeks and Blind CGM is applied for 2 weeks at 22 weeks (Visit 7). Blood glucose measurements collected from FreeStyle Libre are collected through the reader program, and are checked in real time by researchers and used for education, research, and analysis. Prior to the implementation of FreeStyle Libre for the collection of real-time blood sugar collected through FreeStyle Libre, the subject is given consent to disclose blood sugar information. All subjects visit baseline (Visit 2), 12 weeks (Visit 5), and 24 weeks (Visit 8) to conduct surveys on physical examinations, blood tests and urine tests (Central Lab), and treatment satisfaction questionnaire (DTSQ).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
159
FreeStyle Libre flash sensor-based glucose monitoring system (FSGM; Abbott Diabetes Care, Witney, Oxon, UK)
Self-Monitoring of Blood Glucose and Continuous Glucose Monitoring
Samsung Medical Center
Seoul, South Korea
HbA1c (%) changes
HbA1c (%) changes at 24 weeks compared to baseline
Time frame: 24 weeks
HbA1c (%) changes
HbA1c (%) changes at 12 weeks compared to baseline
Time frame: 12 weeks
Percentage of time in level 2 hypoglycemia (<54 mg/dL)
Percentage of time in level 2 hypoglycemia (\<54 mg/dL) at 24 weeks compared to baseline
Time frame: 24 weeks
Percentage of time in level 1 hypoglycemia (<70- 54 mg/dL)
Percentage of time in level 1 hypoglycemia (\<70- 54 mg/dL) at 24 weeks compared to baseline
Time frame: 24 weeks
Percentage of time in level 1 hypoglycemia (> 180 mg/dL)
Percentage of time in level 1 hypoglycemia (\> 180 mg/dL) at 24 weeks compared to baseline
Time frame: 24 weeks
Percentage of time in level 2 hypoglycemia (> 250 mg/dL)
Percentage of time in level 2 hypoglycemia (\> 250 mg/dL) at 24 weeks compared to baseline
Time frame: 24 weeks
Percentage of time in range (70 - 180mg/dL)
Percentage of time in range (70 - 180mg/dL) at 24 weeks compared to baseline
Time frame: 24 weeks
Mean glucose changes
Mean glucose changes at 24 weeks compared to baseline
Time frame: 24 weeks
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Coefficient of variation(CV) changes
Coefficient of variation(CV) changes at 24 weeks compared to baseline
Time frame: 24 weeks
Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes
Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes at 12 weeks compared to baseline
Time frame: 12 weeks
Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes
Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes at 24 weeks compared to baseline
Time frame: 24 weeks