Self-Management Using Smartphone Application for Type2 DM in Real siTuation (SMART-DM)
NCT ID: NCT01820871
Last Updated: 2013-11-27
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
60 participants
INTERVENTIONAL
2012-11-30
2013-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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application arm
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.
Self-Management Using Smartphone Application for Type2 DM
conventional arm
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.
self-management using booklet for management type 2 DM
Interventions
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Self-Management Using Smartphone Application for Type2 DM
self-management using booklet for management type 2 DM
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
69 Years
ALL
No
Sponsors
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Inje University
OTHER
Responsible Party
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Jongha Park
Study principal investigator
Principal Investigators
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Jongha Park, MD
Role: PRINCIPAL_INVESTIGATOR
Inje University
Locations
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Haeundae Paik Hospital
Busan, , South Korea
Countries
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Other Identifiers
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SMART-DM
Identifier Type: -
Identifier Source: org_study_id