Effects of Health Care Provider-mediated, Remote Coaching System Through the PDA-type Glucometer and the Internet on Diabetes Management

December 30, 2009 updated by: The Catholic University of Korea

The purpose of this study is to investigate the effectiveness of the new diabetes care delivery system applied to preexisting public health care resources through advanced information technologies such as PDA-type glucometer and the Internet on the glycemic control of type 2 diabetes patients lived in isolated rural area.

The investigators conducted a prospective, randomized, controlled trial in patients with type 2 diabetes for 12 weeks. The intervention group was treated with the new health care delivery system, where diabetes center provided specialized management, mediated by nurse of primary health care posts using the Internet and the PDA-type glucometer, while the control group with conventional health care. HbA1c, fasting plasma glucose and lipids levels were measured at baseline and follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

115

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

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

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes patients
  • Aged ≥ 40 years
  • Baseline HbA1c of 7.0 to 11.0 % who had been already followed up for more than 6 months in the health care post

Exclusion Criteria:

  • Participants with diagnosed or suspected disease of the liver, pancreas, endocrine organs, or kidney
  • Ischemic heart disease or cerebrovascular disease or a history of such disease
  • A creatinine level > 0.133 mmol/L
  • Treatment with an intensified insulin regimens and those unable .

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: Supportive Care

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle counseling
Behavioral: lifestyle counseling
supporting diabetes patients using Internet communication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c

Secondary Outcome Measures

Outcome Measure
PP2hr Lipid profile

Collaborators and Investigators

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

Sponsor

The Catholic University of Korea

Collaborators

Ministry for Health Welfare and Family Affairs

Investigators

  • Principal Investigator: Kun-Ho Yoon, Ph.D., Catholic Medical College

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 Registration Dates

First Submitted

December 30, 2009

First Submitted That Met QC Criteria

December 30, 2009

First Posted (Estimate)

December 31, 2009

Study Record Updates

Last Update Posted (Estimate)

December 31, 2009

Last Update Submitted That Met QC Criteria

December 30, 2009

Last Verified

June 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Seoul R&D Project

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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