The Effect of Online Based Mentoring Program on the Blood Glucose and Satisfaction Score in Type 1 Diabetes Patients
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mentoring program
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring online based mentoring program,, type 1 diabetes,, blood glucose,, satisfaction score
Eligibility 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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Mentoring program group
Control group
Arm Description
type 1 diabetes patients participating in online base mentoring program
type 1 diabetes patients receiving regular clinic visits
Outcomes
Primary Outcome Measures
change of the blood glucose
HbA1c, Fructosamine
Secondary Outcome Measures
satisfaction score
incidence of hypoglycemia, numbers of daily SMBG, DTSQs, DTSQc, ADDQoL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01157611
Brief Title
The Effect of Online Based Mentoring Program on the Blood Glucose and Satisfaction Score in Type 1 Diabetes Patients
Official Title
The Effect of Online Based Mentoring Program on the Blood Glucose and Satisfaction Score in Type 1 Diabetes Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
online based mentoring program,, type 1 diabetes,, blood glucose,, satisfaction score
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mentoring program group
Arm Type
Active Comparator
Arm Description
type 1 diabetes patients participating in online base mentoring program
Arm Title
Control group
Arm Type
No Intervention
Arm Description
type 1 diabetes patients receiving regular clinic visits
Intervention Type
Behavioral
Intervention Name(s)
Mentoring program
Other Intervention Name(s)
online based mentoring program
Intervention Description
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.
Primary Outcome Measure Information:
Title
change of the blood glucose
Description
HbA1c, Fructosamine
Time Frame
week 0 (baseline), 6, 12
Secondary Outcome Measure Information:
Title
satisfaction score
Description
incidence of hypoglycemia, numbers of daily SMBG, DTSQs, DTSQc, ADDQoL
Time Frame
week 0 (baseline), 6, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Hyeon Kim, M.D., Ph. D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Online Based Mentoring Program on the Blood Glucose and Satisfaction Score in Type 1 Diabetes Patients
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