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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMARTCARE service | Experimental | U-Health service |
|
| Usual care | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMARTCARE service | Other | U-Healthcare service |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients who attain,Hemoglobin A1C ≤ 7.0% and Blood pressure ≤ 130/80 and LDL-Cholesterol ≤ 100 or LDL-Cholesterol ≤ 70, all at 12 months. | Rate of patients who attain, Hemoglobin A1C ≤ 7.0% and Blood pressure ≤ 130/80 and and LDL-Cholesterol ≤ 100 or LDL-Cholesterol ≤ 70, all at 12 months. | 0 to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1C at visit 3,4,6 from baseline | Change in Hemoglobin A1C at Visit3,4,6 from baseline. Reduce Hemoglobin A1c after study | 0 to 12 months |
| change in QOL(Quality of life) | Change in QOL(Quality of life) at Visit 6 from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| kun-ho YOON, professor | Seoul St. Mary's Hospital | Principal Investigator |
| sung-woo PARK, Professor | Kanbuk Samsung Medical Center | Principal Investigator |
| Jung-yeol PARK, Professor | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicrostar | Seoul | 137-701 | South Korea |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 0 to 12 months |
| Treatment satisfaction(DTSQ, Diabetes Treatment Satisfaction Questionnaire) | change in Treatment satisfaction(DTSQ, Diabetes Treatment Satisfaction Questionnaire) at Visit 6 from baseline. | 0 to 12 months |
| Changes in lipid profile at Visit 4 and 6 from baseline. | Changes in lipid profile at visit 4 and 6 from baseline. Reduction of lipid profile | 0 to 12 months |
| Changes in body weight | Changes in body weight at each visit(visit 3,4,5,6) from baseline during 12 months. Reduction of body weight | 0 to 12 months |
| Changes in Waist Circumference(WC) | Changes in Waist Circumference(WC) at each visit(visit 3,4,5,6) from baseline during 12 months. Reduction of Waist Circumference(WC) | 0 to 12 months |
| Changes in Blood Pressure | Changes in Blood Pressure at each visit(visit 3,4,5,6) from baseline during 12 months. Changes in mean Blood Pressure | 0 to 12 months |