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

February 5, 2013 updated by: SK Telecom Consortium

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 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.
0 to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin A1C at visit 3,4,6 from baseline
Time Frame: 0 to 12 months
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)
Time Frame: 0 to 12 months
Change in QOL(Quality of life) at Visit 6 from baseline.
0 to 12 months
Treatment satisfaction(DTSQ, Diabetes Treatment Satisfaction Questionnaire)
Time Frame: 0 to 12 months
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.
Time Frame: 0 to 12 months
Changes in lipid profile at visit 4 and 6 from baseline. Reduction of lipid profile
0 to 12 months
Changes in body weight
Time Frame: 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
0 to 12 months
Changes in Waist Circumference(WC)
Time Frame: 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)
0 to 12 months
Changes in Blood Pressure
Time Frame: 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
0 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMARTCARE_DM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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