NCT01157611

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

3.1 years

First QC Date

July 5, 2010

Last Update Submit

November 16, 2015

Conditions

Keywords

online based mentoring program,type 1 diabetes,blood glucose,satisfaction score

Outcome Measures

Primary Outcomes (1)

  • change of the blood glucose

    HbA1c, Fructosamine

    week 0 (baseline), 6, 12

Secondary Outcomes (1)

  • satisfaction score

    week 0 (baseline), 6, 12

Study Arms (2)

Mentoring program group

ACTIVE COMPARATOR

type 1 diabetes patients participating in online base mentoring program

Behavioral: Mentoring program

Control group

NO INTERVENTION

type 1 diabetes patients receiving regular clinic visits

Interventions

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.

Also known as: online based mentoring program
Mentoring program group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnant women
  • who cannot use the internet
  • those who does not want to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jae Hyeon Kim, M.D., Ph. D.

    Samsung Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 5, 2010

First Posted

July 7, 2010

Study Start

July 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations