Randomized, Multi-center, Open-label, Parallel Group Study to Evaluate the Effect of the Smart Care-diabetes Management System on Subjects With Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 554
- Locations
- 2
- Primary Endpoint
- Rate of patients who attain,Hemoglobin A1C ≤ 7.0% and Blood pressure ≤ 130/80 and LDL-Cholesterol ≤ 100 or LDL-Cholesterol ≤ 70, all at 12 months.
Study Overview
Brief Summary
SMARTCARE-diabetes management system' to evaluate the long-term effects on patients with diabetes.
Detailed Description
Primary Outcome Measure: To see if there's any change in HbA1C at Visit 6 (12M) compared Visit 2 (baseline) within each group and between the two groups.
All statistical analysis will progress through the SAS (Version 9.1). statistical test's significance level is 0.05. The principle is two-sided test.
Secondary Outcome Measures :
To see if there's any change in HbA1C at each Visit (Visit 3 - Visit 6) compared Visit 2 (baseline) within each group and between the two groups.
Add a Secondary Outcome Measure:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 diabetes
- •At least 1 year after being diagnosed with Type 2 diabetes
- •7.0% ≤ HbA1c ≤ 10.0%
- •Agreed to participate voluntarily in the study
Exclusion Criteria
- •Severe chronic disease
- •Diabetes mellitus complications
- •Severe renal disease; Serum creatinin > 1.5(men), > 1.4 (women)
- •Severe liver disease or AST, ALT ≥ 2.5 x ULN
- •Known not to be taking medication reliably 3 months before the screening visit
- •Insulin pump user
- •Being registered for other clinical research or are planning to participate in other clinical researches during this study
- •Pregnant woman
- •Being assessed irrelevant by the investigator
Outcomes
Primary Outcomes
Rate of patients who attain,Hemoglobin A1C ≤ 7.0% and Blood pressure ≤ 130/80 and LDL-Cholesterol ≤ 100 or LDL-Cholesterol ≤ 70, all at 12 months.
Time Frame: 0 to 12 months
Rate of patients who attain, Hemoglobin A1C ≤ 7.0% and Blood pressure ≤ 130/80 and and LDL-Cholesterol ≤ 100 or LDL-Cholesterol ≤ 70, all at 12 months.
Secondary Outcomes
- Change in Hemoglobin A1C at visit 3,4,6 from baseline(0 to 12 months)
- change in QOL(Quality of life)(0 to 12 months)
- Treatment satisfaction(DTSQ, Diabetes Treatment Satisfaction Questionnaire)(0 to 12 months)
- Changes in lipid profile at Visit 4 and 6 from baseline.(0 to 12 months)
- Changes in body weight(0 to 12 months)
- Changes in Waist Circumference(WC)(0 to 12 months)
- Changes in Blood Pressure(0 to 12 months)