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

Diabetes Mellitus Clinical Trial

— SMARTCARE_DM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505036
• Other study ID #: SMARTCARE_DM
• Status: Completed
• Phase: N/A
• First received: July 19, 2011
• Last updated: February 5, 2013
• Start date: December 2010
• Est. completion date: September 2012

Study information

• Verified date: February 2013
• Source: SK Telecom Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

SMARTCARE-diabetes management system' to evaluate the long-term effects on patients with diabetes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• SMARTCARE service
U-Healthcare service

Locations

Country	Name	City	State
Korea, Republic of	Medicrostar	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SK Telecom Consortium

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	0 to 12 months	No
Secondary	Change in Hemoglobin A1C at visit 3,4,6 from baseline	Change in Hemoglobin A1C at Visit3,4,6 from baseline. Reduce Hemoglobin A1c after study	0 to 12 months	No
Secondary	change in QOL(Quality of life)	Change in QOL(Quality of life) at Visit 6 from baseline.	0 to 12 months	No
Secondary	Treatment satisfaction(DTSQ, Diabetes Treatment Satisfaction Questionnaire)	change in Treatment satisfaction(DTSQ, Diabetes Treatment Satisfaction Questionnaire) at Visit 6 from baseline.	0 to 12 months	No
Secondary	Changes in lipid profile at Visit 4 and 6 from baseline.	Changes in lipid profile at visit 4 and 6 from baseline. Reduction of lipid profile	0 to 12 months	No
Secondary	Changes in body weight	Changes in body weight at each visit(visit 3,4,5,6) from baseline during 12 months. Reduction of body weight	0 to 12 months	No
Secondary	Changes in Waist Circumference(WC)	Changes in Waist Circumference(WC) at each visit(visit 3,4,5,6) from baseline during 12 months.; Reduction of Waist Circumference(WC)	0 to 12 months	No
Secondary	Changes in Blood Pressure	Changes in Blood Pressure at each visit(visit 3,4,5,6) from baseline during 12 months.; Changes in mean Blood Pressure	0 to 12 months	No