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

This study has been completed.
Sponsor:
Collaborator:
Ministry for Health Welfare and Family Affairs
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01041144
First received: December 30, 2009
Last updated: NA
Last verified: June 2005
History: No changes posted
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Lifestyle Intervention
Glucose Control
Internet Communication
 Behavioral: lifestyle counseling

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • HbA1c

Secondary Outcome Measures:
  • PP2hr Lipid profile

Estimated Enrollment: 115
Arms Assigned Interventions
Experimental: Lifestyle counseling Behavioral: lifestyle counseling
supporting diabetes patients using Internet communication

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Criteria

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 .
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041144

Locations
Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-041
Sponsors and Collaborators
The Catholic University of Korea
Ministry for Health Welfare and Family Affairs
Investigators
Principal Investigator: Kun-Ho Yoon, Ph.D. Catholic Medical College
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01041144     History of Changes
Other Study ID Numbers: Seoul R&D Project
Study First Received: December 30, 2009
Last Updated: December 30, 2009
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs
Korea: Food and Drug Administration

Keywords provided by The Catholic University of Korea:
Diabetes
PDA
Internet
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013