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

May 19, 2008 updated by: Korea University

Efficacy of Mobile Health Care System in Patients With Type 2 Diabets and Hypertension

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

Study Overview

Status

Completed

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

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • VD
      • Seoul, VD, Korea, Republic of, 152-703
        • Department of Internal Medicine, Korea University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c, fasting blood glucose level, Weight change, Blood pressure level in the morning, lipid profiles
Time Frame: baseline, 3months later
baseline, 3months later

Secondary Outcome Measures

Outcome Measure
Time Frame
exercise time during one week, self reported change in dietary habit, fat consumption ratio
Time Frame: baseline, 3months later
baseline, 3months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kyung M Choi, MD, Department of Internal Medicine, Korea University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria

June 20, 2007

First Posted (Estimate)

June 21, 2007

Study Record Updates

Last Update Posted (Estimate)

May 20, 2008

Last Update Submitted That Met QC Criteria

May 19, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Seoul R&BD Program

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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