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

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

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Other: SMARTCARE service


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMARTCARE service<br>U-Health service | Other: SMARTCARE service<br>* U-Healthcare service<br>* Other names: U-Healthcare;|
| No Intervention: Usual care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, smart-care, U-health care