Clinical trial NCT01505036: Study to Evaluate the Effect of the Smart Care-diabetes Management System on Subjects With Diabetes
Official title: Randomized, Multi-center, Open-label, Parallel Group Study to Evaluate the Effect of the Smart Care-diabetes Management System on Subjects With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
smart-care
U-health care
Lead sponsor: SK Telecom Consortium
Sponsor class: OTHER
First posted: 2012-01-06
Enrollment: 554
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 0 to 12 months
Secondary outcomes:
measure: Change in Hemoglobin A1C at visit 3,4,6 from baseline
timeFrame: 0 to 12 months
measure: change in QOL(Quality of life)
timeFrame: 0 to 12 months
measure: Treatment satisfaction(DTSQ, Diabetes Treatment Satisfaction Questionnaire)
timeFrame: 0 to 12 months
measure: Changes in lipid profile at Visit 4 and 6 from baseline.
timeFrame: 0 to 12 months
measure: Changes in body weight
timeFrame: 0 to 12 months
measure: Changes in Waist Circumference(WC)
timeFrame: 0 to 12 months
measure: Changes in Blood Pressure
timeFrame: 0 to 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Medicrostar
Study officials:
affiliation: Seoul St. Mary's Hospital
name: kun-ho YOON, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Kanbuk Samsung Medical Center
name: sung-woo PARK, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Jung-yeol PARK, Professor
role: PRINCIPAL_INVESTIGATOR
References: