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

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ClinicalTrials.gov Identifier: NCT01041144
Recruitment Status : Completed
First Posted : December 31, 2009
Last Update Posted : December 31, 2009
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Collaborator:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Type 2 Diabetes Lifestyle Intervention Glucose Control Internet Communication Behavioral: lifestyle counseling

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Primary Purpose: Supportive Care

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Lifestyle counseling Behavioral: lifestyle counseling
supporting diabetes patients using Internet communication


Outcome Measures

Primary Outcome Measures :
  1. HbA1c

Secondary Outcome Measures :
  1. PP2hr Lipid profile

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT01041144     History of Changes
Other Study ID Numbers: Seoul R&D Project
First Posted: December 31, 2009    Key Record Dates
Last Update Posted: December 31, 2009
Last Verified: June 2005

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