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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Self-Management Using Smartphone Application for Type2 DM; Other: self-management using booklet for management type 2 DM

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 612-030
    • Haeundae Paik Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Self-Management Using Smartphone Application for Type2 DM
Active Comparator: 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.	Other: self-management using booklet for management type 2 DM

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Inje University
• Investigators: Principal Investigator: Jongha Park, MD, Inje University

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: March 26, 2013
• First Submitted That Met QC Criteria: March 28, 2013
• First Posted (Estimate): March 29, 2013

Study Record Updates

• Last Update Posted (Estimate): November 27, 2013
• Last Update Submitted That Met QC Criteria: November 26, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: HbA1c; T2DM; smartphone application; serum fasting glucose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: SMART-DM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No