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Management of Patients With Type 2 Diabetes and Hypertension Using Mobile Health Care System

This study has been completed.
Sponsor:
Information provided by:
Korea University
ClinicalTrials.gov Identifier:
NCT00489879
First received: June 20, 2007
Last updated: May 19, 2008
Last verified: May 2008
History of Changes
  Purpose

The purpose of this study is to determine whether cellular phone based health care system is effective in the treatment of diabetes and hypertension.


Condition Intervention
Diabetes
Hypertension
Obesity
 Device: Mobile Health Care System (DrUB)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Efficacy of Mobile Health Care System in Patients With Type 2 Diabets and Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Korea University:

Primary Outcome Measures:
  • HbA1c, fasting blood glucose level, Weight change, Blood pressure level in the morning, lipid profiles [ Time Frame: baseline, 3months later ]

Secondary Outcome Measures:
  • exercise time during one week, self reported change in dietary habit, fat consumption ratio [ Time Frame: baseline, 3months later ]

Estimated Enrollment: 140
Study Start Date: July 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Diabetes care is facilitated by a patient's being engaged in a self-management program with the advice and counsel of physicians, but many diabetic patients can not receive the continous monitoing and advice from his physician in their every day life. It is very difficult to keep up life style modification in their real life.

Few studies have examined the effects of cellular phone based intervention that provide an interactive component daily. Our goal is to test the hypothesis that diabetes and hypertension management using cellular phone based health care system would result in significant improvement of blood glucose and blood pressure level.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type II diabetes using only oral hypoglycemic agents
  • 7% < HbA1c < 10%
  • systolic blood pressure > 130 or diastolic blood pressure > 80
  • BMI > 23
  • 20 < age < 75

Exclusion Criteria:

  • type I diabetes or type II diabtes using insulin treatment
  • liver, renal or heart disease
  • recent change (within 1 month) in the type or dosage of anti-diabetic agent, anti-hypertensive medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489879

Locations
Korea, Republic of
Department of Internal Medicine, Korea University College of Medicine
Seoul, VD, Korea, Republic of, 152-703
Sponsors and Collaborators
Korea University
Investigators
Principal Investigator: Kyung M Choi, MD Department of Internal Medicine, Korea University College of Medicine
  More Information

Publications:

Responsible Party: Kyung Mook Choi, Korea University
ClinicalTrials.gov Identifier: NCT00489879     History of Changes
Other Study ID Numbers: Seoul R&BD Program
Study First Received: June 20, 2007
Last Updated: May 19, 2008
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea University:
Mobile Health Units
Chronic Disease

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
 Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013