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Completed

NCT Number: NCT01505036

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medicrostar

Seoul, 137-701, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes
  • At least 1 year after being diagnosed with Type 2 diabetes
  • 7.0% ≤ HbA1c ≤ 10.0%
  • Agreed to participate voluntarily in the study

Exclusion criteria

  • Severe chronic disease
  • Diabetes mellitus complications
  • Severe renal disease; Serum creatinin > 1.5(men), > 1.4 (women)
  • Severe liver disease or AST, ALT ≥ 2.5 x ULN
  • Known not to be taking medication reliably 3 months before the screening visit
  • Insulin pump user
  • Being registered for other clinical research or are planning to participate in other clinical researches during this study
  • Pregnant woman
  • Illiterate
  • Being assessed irrelevant by the investigator

Treatment and study plan

SMARTCARE service

Other

U-Healthcare service

Other names: U-Healthcare

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. change in QOL(Quality of life)

    Time frame: 0 to 12 months

    Change in QOL(Quality of life) at Visit 6 from baseline.

  3. 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.

  4. 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

  5. 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

  6. 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)

  7. 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

Sponsors and collaborators

Lead sponsor

SK Telecom Consortium

Other

Registry information

Official study title

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

Acronym: SMARTCARE_DM

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 6, 2012
Registry last updated
Feb 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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