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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01157611
First Posted: July 7, 2010
Last Update Posted: November 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jae Hyeon Kim, Samsung Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (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 Jae Hyeon Kim, Samsung Medical Center:

Primary Outcome Measures:
  • change of the blood glucose [ Time Frame: week 0 (baseline), 6, 12 ]
    HbA1c, Fructosamine


Secondary Outcome Measures:
  • satisfaction score [ Time Frame: week 0 (baseline), 6, 12 ]
    incidence of hypoglycemia, numbers of daily SMBG, DTSQs, DTSQc, ADDQoL


Enrollment: 57
Study Start Date: July 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (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

Detailed Description:
Subjects with T1DM on intensive insulin therapy and with hemoglobin A1c (HbA1c) ≥8.0% were randomized to mentored (glucometer transmission with feedback from mentors) or control (glucometer transmission without feedback) groups and were examined for 12 weeks. Five mentors were interviewed and selected, of which two were T1DM patients themselves and three were parents with at least one child diagnosed with T1DM since more than 5 years ago.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01157611


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Study Director: Jae Hyeon Kim, M.D., Ph. D. Samsung Medical Center
  More Information

Responsible Party: Jae Hyeon Kim, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01157611     History of Changes
Other Study ID Numbers: 2010-05-065
First Submitted: July 5, 2010
First Posted: July 7, 2010
Last Update Posted: November 17, 2015
Last Verified: November 2015

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

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


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