A Pilot Study of Self Management Using Application for Chronic Disease Care in Real siTuation (SMART) - DM
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Inje University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- fasting serum glucose and HbA1c
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the effectiveness of smartphone application for management of type 2 diabetes mellitus (DM).
Type 2 DM is an almost incurable chronic disease and continuous management is important for long-term prognosis. However, patient's compliance to conventional medical intervention is generally unsatisfactory and many patients feel difficult to access to the detail medical advice for type 2 DM.
Thus, the investigators developed a smartphone application for giving programed medical intervention to patients according to patients data; blood pressure, fasting blood sugar, body weight, calorie intake,exercise amount, etc.
Investigators
Jongha Park
Study principal investigator
Inje University
Eligibility Criteria
Inclusion Criteria
- •Type 2 DM using oral hypoglycemic agent
- •6.5% \< HbA1c \< 10%
- •systolic blood pressure \> 130 mmHg or diastolic blood pressure \> 80 mmHg
- •BMI over 23.0
- •20 \< age \< 70
- •smartphone user (android OS based)
Exclusion Criteria
- •Serum fasting glucose \> 250 mg/L or post prandial 2 hour serum glucose \> 350 mg/L
- •systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg
- •Diabetes mellitus patient using insulin
- •severe chronic diabetic complications (diabetic foot ulcer, severe diabetic retinopathy, diabetic nephropathy with severe proteinuria)
- •congestive heart failure (NYHA III-IV or left ventricular ejection fraction \< 30%)
- •Aspartate aminotransferase (AST) or alanine transaminase (ALT) over 3 times of upper normal limit
- •Serum creatinine \> 1.5 mg/dL
- •refusal to participate in the study
- •drug addiction or alcohol addiction
- •major psychiatric illness
Outcomes
Primary Outcomes
fasting serum glucose and HbA1c
Time Frame: 3months after enrollemnt (day 0-day 90)
we will check the fasting serum glucose and HbA1C at the day of enrollment (day0)and those at 3months after enrollment (day 90)
Secondary Outcomes
- Lipid profile(3months after enrollment (day 0-90))
- body weight and BMI(3months after enrollemnt (day 0-day 90))