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

Randomized, Multi-center, Open-label, Parallel Group Study to Evaluate the Effect of the Smart Care-diabetes Management System on Subjects With Diabetes

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: SMARTCARE service

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 Type: Interventional
• Enrollment (Actual): 554
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 137-701
    • Medicrostar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Experimental: SMARTCARE service; U-Health service	Other: SMARTCARE service; U-Healthcare service; Other Names: U-Healthcare

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
change in QOL(Quality of life)	Change in QOL(Quality of life) at Visit 6 from baseline.	0 to 12 months
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
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
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
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
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

Collaborators and Investigators

• Sponsor: SK Telecom Consortium
• Investigators: Principal Investigator: kun-ho YOON, professor, Seoul St. Mary'S Hospital; Principal Investigator: sung-woo PARK, Professor, Kanbuk Samsung Medical Center; Principal Investigator: Jung-yeol PARK, Professor, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: July 19, 2011
• First Submitted That Met QC Criteria: January 3, 2012
• First Posted (Estimate): January 6, 2012

Study Record Updates

• Last Update Posted (Estimate): February 6, 2013
• Last Update Submitted That Met QC Criteria: February 5, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; smart-care; U-health care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: SMARTCARE_DM