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Completed

NCT Number: NCT01820871

Self-Management Using Smartphone Application for Type2 DM 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haeundae Paik Hospital

Busan, 612-030, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-Management Using Smartphone Application for Type2 DM

Other

self-management using booklet for management type 2 DM

Other

Primary outcomes

  1. fasting serum glucose and HbA1c

    Time frame: 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 outcomes

  1. body weight and BMI

    Time frame: 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)

  2. Lipid profile

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 29, 2013
Registry last updated
Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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