Study to Evaluate the Effect of the Smart Care-diabetes Management System on Subjects With Diabetes

Randomized, Multi-center, Open-label, Parallel Group Study to Evaluate the Effect of the Smart Care-diabetes Management System on Subjects With Diabetes

SMARTCARE-diabetes management system' to evaluate the long-term effects on patients with diabetes.

Primary Outcome Measure: To see if there's any change in HbA1C at Visit 6 (12M) compared Visit 2 (baseline) within each group and between the two groups.

All statistical analysis will progress through the SAS (Version 9.1). statistical test's significance level is 0.05. The principle is two-sided test.

Secondary Outcome Measures :

To see if there's any change in HbA1C at each Visit (Visit 3 - Visit 6) compared Visit 2 (baseline) within each group and between the two groups.

Add a Secondary Outcome Measure:

Treatment satisfaction (DTSQ, Diabetes Treatment Satisfaction Questionnaire): To see if there's any change in treatment satisfaction scores compared Visit 2 (baseline) within each group and between the two groups.

Inclusion Criteria:

1. Type 2 diabetes
2. At least 1 year after being diagnosed with Type 2 diabetes
3. 7.0% ≤ HbA1c ≤ 10.0%
4. Agreed to participate voluntarily in the study

Exclusion Criteria:

1. Severe chronic disease
2. Diabetes mellitus complications
3. Severe renal disease; Serum creatinin > 1.5(men), > 1.4 (women)
4. Severe liver disease or AST, ALT ≥ 2.5 x ULN
5. Known not to be taking medication reliably 3 months before the screening visit
6. Insulin pump user
7. Being registered for other clinical research or are planning to participate in other clinical researches during this study
8. Pregnant woman
9. Illiterate
10. Being assessed irrelevant by the investigator