Status:
COMPLETED
Study to Evaluate the Effect of the Smart Care-diabetes Management System on Subjects With Diabetes
Lead Sponsor:
SK Telecom Consortium
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
Phase:
NA
Brief Summary
SMARTCARE-diabetes management system' to evaluate the long-term effects on patients with diabetes.
Detailed Description
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 throug...
Eligibility Criteria
Inclusion
- Type 2 diabetes
- At least 1 year after being diagnosed with Type 2 diabetes
- 7.0% ≤ HbA1c ≤ 10.0%
- Agreed to participate voluntarily in the study
Exclusion
- Severe chronic disease
- Diabetes mellitus complications
- Severe renal disease; Serum creatinin \> 1.5(men), \> 1.4 (women)
- Severe liver disease or AST, ALT ≥ 2.5 x ULN
- Known not to be taking medication reliably 3 months before the screening visit
- Insulin pump user
- Being registered for other clinical research or are planning to participate in other clinical researches during this study
- Pregnant woman
- Illiterate
- Being assessed irrelevant by the investigator
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
554 Patients enrolled
Trial Details
Trial ID
NCT01505036
Start Date
December 1 2010
End Date
September 1 2012
Last Update
February 6 2013
Active Locations (1)
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1
Medicrostar
Seoul, South Korea, 137-701