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

SK Telecom Consortium

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Other: SMARTCARE service

Study type: Interventional

Funder types: Other

Identifiers

NCT01505036

SMARTCARE_DM

Details and patient eligibility

About

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

Full 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.

Enrollment: 554 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

554 participants in 2 patient groups

SMARTCARE service

Experimental group

Description:

U-Health service

Treatment:

Other: SMARTCARE service

Usual care

No Intervention group

Description:

Usual care