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

SK Telecom Consortium554 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

554

Conditions

Diabetes Mellitus

Interventions

SMARTCARE serviceOTHER

U-Healthcare service

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Medicrostar

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 0 to 12 months

Secondary Outcomes

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

Time frame: 0 to 12 months

change in QOL(Quality of life)

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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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)

Data from ClinicalTrials.gov

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