Management of Patients With Type 2 Diabetes and Hypertens... | NCT00489879

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

NCT00489879

Sponsor

Korea University

Status

Completed

Last Update Posted

May 20, 2008Estimated

Enrollment

140Estimated

Phase

Not Applicable

Conditions

Diabetes
Hypertension
Obesity

Interventions

Mobile Health Care System (DrUB)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Jun 20, 2007

First Submission Date that Met QC Criteria

Jun 20, 2007

First Posted Date

Jun 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2008

Last Update Posted Date

May 20, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Name	Type	Description	Arm Group Labels	Other Names
Mobile Health Care System (DrUB)	Device

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyung M Choi, MD	Department of Internal Medicine, Korea University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Internal Medicine, Korea University College of Medicine		Seoul	VD	152-703	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14747232	Background	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. doi: 10.2337/diacare.27.2.478.

ID	Term
D003920	Diabetes Mellitus
D006973	Hypertension
D009765	Obesity
D002908	Chronic Disease

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases