- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02362607
Integrated Diabetes Management Protocol Using Smartphone
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Smartphones and digital healthcare is expected to provide better diabetes care. The investigators aim to assess whether using integrated diabetes management protocol using smartphone would increase glucose control among diabetes patients.
Smartphone apps for food diary, activity monitor, blood glucose will be used for three months.
Blood glucose control and patient satisfaction will be assessed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Chungcheongbuk-Do
-
Cheongju, Chungcheongbuk-Do, Korea, Republic of, 361-711
- Chungbuk National University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Type 2 diabetes, type 1 diabetes, gestational diabetes
Exclusion Criteria:
- Medications which interfere glucose control
- Cancer
- Chronic kidney injury
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Integrated Diabetes Management Protocol
Smartphone apps for food diary, activity monitor, blood glucose will be used for three months.
|
|
|
Active Comparator: Standard Diabetes Management Protocol
Subjects will receive standard diabetes management protocol with standard education and standard blood glucose measurement devices.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Glucose Control Status Measured by HbA1c
Time Frame: After three months
|
Blood test results for HbA1c after three months.
|
After three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Satisfaction Measured by Questionnaire
Time Frame: After three months
|
Summary of Diabetes Self-Care Activities Measure (SDSCA) Questionnaire (Toobert et al., 2000)
|
After three months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-06-006
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