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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SK Telecom Consortium
ClinicalTrials.gov Identifier:
NCT01505036
First received: July 19, 2011
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Diabetes Mellitus
 Other: SMARTCARE service

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by SK Telecom Consortium:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Change in Hemoglobin A1C at visit 3,4,6 from baseline [ Time Frame: 0 to 12 months ] [ Designated as safety issue: No ]
    Change in Hemoglobin A1C at Visit3,4,6 from baseline. Reduce Hemoglobin A1c after study

  • change in QOL(Quality of life) [ Time Frame: 0 to 12 months ] [ Designated as safety issue: No ]
    Change in QOL(Quality of life) at Visit 6 from baseline.

  • Treatment satisfaction(DTSQ, Diabetes Treatment Satisfaction Questionnaire) [ Time Frame: 0 to 12 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 0 to 12 months ] [ Designated as safety issue: No ]
    Changes in lipid profile at visit 4 and 6 from baseline. Reduction of lipid profile

  • Changes in body weight [ Time Frame: 0 to 12 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 0 to 12 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 0 to 12 months ] [ Designated as safety issue: No ]

    Changes in Blood Pressure at each visit(visit 3,4,5,6) from baseline during 12 months.

    Changes in mean Blood Pressure



Enrollment: 554
Study Start Date: December 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SMARTCARE service
U-Health service
 Other: SMARTCARE service
U-Healthcare service
Other Name: U-Healthcare
No Intervention: Usual care
Usual care

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505036

Locations
Korea, Republic of
Medicrostar
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: SK Telecom Consortium
ClinicalTrials.gov Identifier: NCT01505036     History of Changes
Other Study ID Numbers: SMARTCARE_DM
Study First Received: July 19, 2011
Last Updated: February 5, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by SK Telecom Consortium:
Diabetes Mellitus
smart-care
U-health care

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013