Self-Management Using Smartphone Application for Type2 DM in Real siTuation (SMART-DM)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of smartphone application for management of type 2 diabetes mellitus (DM). Type 2 DM is an almost incurable chronic disease and continuous management is important for long-term prognosis. However, patient's compliance to conventional medical intervention is generally unsatisfactory and many patients feel difficult to access to the detail medical advice for type 2 DM. Thus, the investigators developed a smartphone application for giving programed medical intervention to patients according to patients data; blood pressure, fasting blood sugar, body weight, calorie intake,exercise amount, etc.

Official Title
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A Pilot Study of Self Management Using Application for Chronic Disease Care in Real siTuation (SMART) - DM

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Self-Management Using Smartphone Application for Type2 DM
* Other: self-management using booklet for management type 2 DM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 DM using oral hypoglycemic agent 6.5% < HbA1c < 10% systolic blood pressure > 130 mmHg or diastolic blood pressure > 80 mmHg BMI over 23.0 20 < age < 70 smartphone user (android OS based) Exclusion Criteria: Serum fasting glucose > 250 mg/L or post prandial 2 hour serum glucose > 350 mg/L systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg Diabetes mellitus patient using insulin severe chronic diabetic complications (diabetic foot ulcer, severe diabetic retinopathy, diabetic nephropathy with severe proteinuria) congestive heart failure (NYHA III-IV or left ventricular ejection fraction < 30%) Aspartate aminotransferase (AST) or alanine transaminase (ALT) over 3 times of upper normal limit Serum creatinine > 1.5 mg/dL refusal to participate in the study drug addiction or alcohol addiction major psychiatric illness steroid treatment or hormonal treatment with changing the drug or drug dosage in 1 month changing dosage of antihypertensive agent, oral hypoglycemic agent or lipid lowering agent in 1 month malignant cancer pregnancy

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 69 Years

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: application arm<br>The patients of application arm have the smartphone application (android) for management of type 2 DM. The application contains action plans and alarm system for each situation of serum fasting glucose, blood pressure, body weight, exercise amount, calori intake, medication, etc. | Other: Self-Management Using Smartphone Application for Type2 DM<br> <br> |
| Active Comparator: conventional arm<br>The patients of conventional arm have the booklet for management of type 2 DM. The application contains general medical guideline and knowledge for management of type 2 DM such as,exercise amount, calori intake, medication, etc. | Other: self-management using booklet for management type 2 DM<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting serum glucose and HbA1c | we will check the fasting serum glucose and HbA1C at the day of enrollment (day0)and those at 3months after enrollment (day 90) | 3months after enrollemnt (day 0-day 90) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight and BMI | we will check body weight and BMI at the day of enrollment (day0)and those at 3months after enrollment (day 90) | 3months after enrollemnt (day 0-day 90) | 
| Lipid profile | we will check the lipid profile (total cholesterol, Triglyceride, LDL/HDL cholesterol)at the day of enrollment (day0)and those at 3months after enrollment (day 90) | 3months after enrollment (day 0-90) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T2DM, smartphone application, serum fasting glucose, HbA1c