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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00489879
Recruitment Status : Completed
First Posted : June 21, 2007
Last Update Posted : May 20, 2008
Information provided by:
Korea University

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Hypertension Obesity Device: Mobile Health Care System (DrUB) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Efficacy of Mobile Health Care System in Patients With Type 2 Diabets and Hypertension
Study Start Date : July 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00489879

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

Responsible Party: Kyung Mook Choi, Korea University Identifier: NCT00489879     History of Changes
Other Study ID Numbers: Seoul R&BD Program
First Posted: June 21, 2007    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 2008

Keywords provided by Korea University:
Mobile Health Units
Chronic Disease

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases