The Effect of Online Based Mentoring Program on the Blood Glucose and Satisfaction Score in Type 1 Diabetes Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01157611
First received: July 5, 2010
Last updated: July 26, 2011
Last verified: July 2011
  Purpose

Purpose:

To evaluate the effects of online based mentoring program on the blood glucose and satisfaction score in type 1 diabetes patients. Peer group mentoring will be as effective as guidance by the doctors.

Methods:

80 type 1 patients will be randomly divided into two groups (e.g. mentoring program group and control group). All patients will receive routine check up and blood test for ordinary type 1 patients. In addition, program group patients should register their SMBG, exercise, food intake and insulin dose on the website designed for this study and receive advices of mentors from peer group. Every patient will submit questionnaire on the first day of the study and the last day(after 12 weeks) of the study.


Condition Intervention
Type 1 Diabetes
Behavioral: Mentoring program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Online Based Mentoring Program on the Blood Glucose and Satisfaction Score in Type 1 Diabetes Patients

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • change of the blood glucose [ Time Frame: week 0 (baseline), 6, 12 ] [ Designated as safety issue: No ]
    HbA1c, Fructosamine


Secondary Outcome Measures:
  • satisfaction score [ Time Frame: week 0 (baseline), 6, 12 ] [ Designated as safety issue: No ]
    incidence of hypoglycemia, numbers of daily SMBG, DTSQs, DTSQc, ADDQoL


Estimated Enrollment: 80
Study Start Date: July 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mentoring program group
type 1 diabetes patients participating in online base mentoring program
Behavioral: Mentoring program
mentoring program group patients should register their SMBG, exercise, food intake and insulin dose on the website designed for this study and receive advices of mentors from peer group.
Other Name: online based mentoring program
No Intervention: Control group
type 1 diabetes patients receiving regular clinic visits

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18, more than 6 month after the diagnosis of type 1 diabetes
  • HbA1c > 8% despite of multiple insulin injection or insulin pump
  • who are capable of using the internet

Exclusion Criteria:

  • pregnant women
  • who cannot use the internet
  • those who does not want to participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157611

Contacts
Contact: Jae Hyeon Kim, M.D., Ph. D. 82-2-3410-1580 jaehyeonmd.kim@samsung.com
Contact: Sunghwan Suh, M.D. 82-2-3410-1885 sunghwan.suh@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Jae Hyeon Kim, M.D.,Ph. D    82-2-3410-1580    jaehyeonmd.kim@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Study Director: Jae Hyeon Kim, M.D., Ph. D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Jae Hyeon Kim, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01157611     History of Changes
Other Study ID Numbers: 2010-05-065
Study First Received: July 5, 2010
Last Updated: July 26, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
online based mentoring program,
type 1 diabetes,
blood glucose,
satisfaction score

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 01, 2014