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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Self-Management Using Smartphone Application for Type2 DM

self-management using booklet for management type 2 DM

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring T2DM, smartphone application, serum fasting glucose, HbA1c

Eligibility Criteria

21 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Haeundae Paik Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

application arm

conventional arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

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)

Full Information

NCT ID

NCT01820871

First Posted

March 26, 2013

Last Updated

November 26, 2013

Sponsor

Inje University

1. Study Identification

Unique Protocol Identification Number

NCT01820871

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Inje University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

T2DM, smartphone application, serum fasting glucose, HbA1c

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

application arm

Arm Type

Experimental

Arm Description

Arm Title

conventional arm

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Self-Management Using Smartphone Application for Type2 DM

Intervention Type

Other

Intervention Name(s)

self-management using booklet for management type 2 DM

Primary Outcome Measure Information:

Title

fasting serum glucose and HbA1c

Description

we will check the fasting serum glucose and HbA1C at the day of enrollment (day0)and those at 3months after enrollment (day 90)

Time Frame

3months after enrollemnt (day 0-day 90)

Secondary Outcome Measure Information:

Title

body weight and BMI

Description

we will check body weight and BMI at the day of enrollment (day0)and those at 3months after enrollment (day 90)

Time Frame

3months after enrollemnt (day 0-day 90)

Title

Lipid profile

Description

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)

Time Frame

3months after enrollment (day 0-90)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jongha Park, MD

Organizational Affiliation

Inje University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Haeundae Paik Hospital

City

Busan

ZIP/Postal Code

612-030

Country

Korea, Republic of

12. IPD Sharing Statement

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

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