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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
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 5, 2010
Last Updated
November 16, 2015
Sponsor
Samsung Medical Center
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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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