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

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041144
• Other study ID #: Seoul R&D Project
• Status: Completed
• Phase: N/A
• First received: December 30, 2009
• Last updated: December 30, 2009

Study information

• Verified date: June 2005
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and WelfareKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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 Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Glucose Control
• Internet Communication
• Lifestyle Intervention
• Type 2 Diabetes

Intervention

Behavioral:
• lifestyle counseling
supporting diabetes patients using Internet communication

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
The Catholic University of Korea	Ministry for Health Welfare and Family Affairs

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c
Secondary	PP2hr Lipid profile