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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489879
• Other study ID #: Seoul R&BD Program
• Status: Completed
• Phase: N/A
• First received: June 20, 2007
• Last updated: May 19, 2008
• Start date: July 2007
• Est. completion date: October 2007

Study information

• Verified date: May 2008
• Source: Korea University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Obesity

Intervention

Device:
• Mobile Health Care System (DrUB)

Locations

Country	Name	City	State
Korea, Republic of	Department of Internal Medicine, Korea University College of Medicine	Seoul	VD

Sponsors (1)

Lead Sponsor	Collaborator
Korea University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Kwon HS, Cho JH, Kim HS, Song BR, Ko SH, Lee JM, Kim SR, Chang SA, Kim HS, Cha BY, Lee KW, Son HY, Lee JH, Lee WC, Yoon KH. Establishment of blood glucose monitoring system using the internet. Diabetes Care. 2004 Feb;27(2):478-83. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c, fasting blood glucose level, Weight change, Blood pressure level in the morning, lipid profiles		baseline, 3months later
Secondary	exercise time during one week, self reported change in dietary habit, fat consumption ratio		baseline, 3months later