Patient-Centered Smartphone-Based Diabetes Care

Early Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT02313363
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The investigators developed a patient-centered smartphone-based diabetes care system (PSDCS). This study was aimed to test the feasibility of the PSDCS.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-12
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-09
• Last Update Submitted: 2014-12-09
• Study First Posted: 2014-12-10
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• type 2 diabetes
• HbA1c levels ≥ 6.5%

Exclusion Criteria

• severe diabetic complication including severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy, chronic kidney disease stage 4-5, severe diabetic neuropathy, history of diabetic foot, history of angina pectoris, myocardial infarction, and cerebrovascular disease, and peripheral arterial disease
• type 1 diabetes
• insulin therapy other than insulin glargine
• subjects with insulin pump
• history of drug addiction
• history of psychotic disorder
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
change of HbA1c	baseline and the end of 12 week

Secondary Outcome Measures

Name	Time	Method
change of fasting plasma glucose	baseline and after 12 weeks (within 3 days)
change of lipid profile	baseline and after 12 weeks (within 3 days)
change of body weight	baseline and after 12 weeks (within 3 days)
change of the scores of Summary of Diabetes Self-Care Activities (SDSCA)	baseline and after 12 weeks (within 3 days)