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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Self-Management Using Smartphone Application for Type2 DM; Other: self-management using booklet for management type 2 DM

• Registration Number: NCT01820871
• Lead Sponsor: Inje University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-03-26
• Study First Submitted QC: 2013-03-28
• Study First Posted: 2013-03-29
• Primary Completion: 2013-07
• Study Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
application arm	Self-Management Using Smartphone Application for Type2 DM	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.
conventional arm	self-management using booklet for management type 2 DM	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.

Primary Outcome Measures

Name	Time	Method
fasting serum glucose and HbA1c	3months after enrollemnt (day 0-day 90)	we will check the fasting serum glucose and HbA1C at the day of enrollment (day0)and those at 3months after enrollment (day 90)

Secondary Outcome Measures

Name	Time	Method
Lipid profile	3months after enrollment (day 0-90)	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)
body weight and BMI	3months after enrollemnt (day 0-day 90)	we will check body weight and BMI at the day of enrollment (day0)and those at 3months after enrollment (day 90)

Trial Locations

Locations (1)

Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of