Study to Evaluate the Effect of the Smart Care-diabetes Management System on Subjects With Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT01505036
• Lead Sponsor: SK Telecom Consortium

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2012-01-03
• Study First Posted: 2012-01-06
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-05
• Last Update Posted: 2013-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 554

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Medicrostar; 🇰🇷 Seoul, Korea, Republic of