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

NCT ID: NCT01505036

Last Updated: 2013-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

554 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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SMARTCARE service

U-Health service

Group Type EXPERIMENTAL

SMARTCARE service

Intervention Type OTHER

U-Healthcare service

Usual care

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SMARTCARE service

U-Healthcare service

Intervention Type OTHER

Other Intervention Names

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U-Healthcare

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SK Telecom Consortium

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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kun-ho YOON, professor

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

sung-woo PARK, Professor

Role: PRINCIPAL_INVESTIGATOR

Kanbuk Samsung Medical Center

Jung-yeol PARK, Professor

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Medicrostar

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SMARTCARE_DM

Identifier Type: -

Identifier Source: org_study_id

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