NCT01041144

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2009

Completed
Last Updated

December 31, 2009

Status Verified

June 1, 2005

First QC Date

December 30, 2009

Last Update Submit

December 30, 2009

Conditions

Type 2 DiabetesLifestyle InterventionGlucose ControlInternet Communication

Keywords

DiabetesPDAInternetHbA1c

Outcome Measures

Primary Outcomes (1)

  • HbA1c

Secondary Outcomes (1)

  • PP2hr Lipid profile

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL
Behavioral: lifestyle counseling

Interventions

lifestyle counselingBEHAVIORAL

supporting diabetes patients using Internet communication

Lifestyle counseling

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, 137-041, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kun-Ho Yoon, Ph.D.

    Catholic Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 30, 2009

First Posted

December 31, 2009

Last Updated

December 31, 2009

Record last verified: 2005-06

Locations

KR(1)