Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, smart-care, U-health care
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: Treatment satisfaction (DTSQ, Diabetes Treatment Satisfaction Questionnaire): To see if there's any change in treatment satisfaction scores compared Visit 2 (baseline) within each group and between the two groups.
Interventions
OTHERSMARTCARE service
U-Healthcare service
Sponsors
SK Telecom Consortium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes 2. At least 1 year after being diagnosed with Type 2 diabetes 3. 7.0% ≤ HbA1c ≤ 10.0% 4. Agreed to participate voluntarily in the study
Exclusion criteria
1. Severe chronic disease 2. Diabetes mellitus complications 3. Severe renal disease; Serum creatinin \> 1.5(men), \> 1.4 (women) 4. Severe liver disease or AST, ALT ≥ 2.5 x ULN 5. Known not to be taking medication reliably 3 months before the screening visit 6. Insulin pump user 7. Being registered for other clinical research or are planning to participate in other clinical researches during this study 8. Pregnant woman 9. Illiterate 10. Being assessed irrelevant by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| change in QOL(Quality of life) | 0 to 12 months | Change in QOL(Quality of life) at Visit 6 from baseline. |
| Treatment satisfaction(DTSQ, Diabetes Treatment Satisfaction Questionnaire) | 0 to 12 months | change in Treatment satisfaction(DTSQ, Diabetes Treatment Satisfaction Questionnaire) at Visit 6 from baseline. |
| Changes in lipid profile at Visit 4 and 6 from baseline. | 0 to 12 months | Changes in lipid profile at visit 4 and 6 from baseline. Reduction of lipid profile |
| Change in Hemoglobin A1C at visit 3,4,6 from baseline | 0 to 12 months | Change in Hemoglobin A1C at Visit3,4,6 from baseline. Reduce Hemoglobin A1c after study |
| Changes in Waist Circumference(WC) | 0 to 12 months | Changes in Waist Circumference(WC) at each visit(visit 3,4,5,6) from baseline during 12 months. Reduction of Waist Circumference(WC) |
| Changes in Blood Pressure | 0 to 12 months | Changes in Blood Pressure at each visit(visit 3,4,5,6) from baseline during 12 months. Changes in mean Blood Pressure |
| Changes in body weight | 0 to 12 months | Changes in body weight at each visit(visit 3,4,5,6) from baseline during 12 months. Reduction of body weight |
Countries
South Korea
Outcome results
None listed