Type 1 Diabetes Clinical Trial
Official title:
The Effect of Online Based Mentoring Program on the Blood Glucose and Satisfaction Score in Type 1 Diabetes Patients
Verified date | November 2015 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 57 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change of the blood glucose | HbA1c, Fructosamine | week 0 (baseline), 6, 12 | No |
Secondary | satisfaction score | incidence of hypoglycemia, numbers of daily SMBG, DTSQs, DTSQc, ADDQoL | week 0 (baseline), 6, 12 | No |
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