Study to Evaluate the Effect of the Smart Care-diabetes Management System on Subjects With Diabetes
NCT ID: NCT01505036
Last Updated: 2013-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
554 participants
INTERVENTIONAL
2010-12-31
2012-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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SMARTCARE service
U-Health service
SMARTCARE service
U-Healthcare service
Usual care
Usual care
No interventions assigned to this group
Interventions
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SMARTCARE service
U-Healthcare service
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
ALL
No
Sponsors
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SK Telecom Consortium
OTHER
Responsible Party
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Principal Investigators
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kun-ho YOON, professor
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's Hospital
sung-woo PARK, Professor
Role: PRINCIPAL_INVESTIGATOR
Kanbuk Samsung Medical Center
Jung-yeol PARK, Professor
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Medicrostar
Seoul, , South Korea
Countries
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Other Identifiers
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SMARTCARE_DM
Identifier Type: -
Identifier Source: org_study_id
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