Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care (Smart-DM)

CHANGHEE LEE

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Procedure: Telemonitoring & Telemedicine; Procedure: Telemonitoring group; Other: SMBG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01345435

Smartcare-DM

Details and patient eligibility

About

A multi-center, randomized, parallel, interventional, open label trial to compare Hemoglobin A1C-lowering effect of conventional treatment and Smart Care Service in patients with type 2 diabetes.

Full description

1. Objectives : To evaluate superiority in the Hemoglobin A1C -lowering effect of Smart Care Service compared to the conventional treatment in patients with type 2 diabetes.

2. Test and control group

   • Control group : The subject group who is receiving any conventional treatment (hospital visit).

   • Test groups

     • Conventional treatment + remote monitoring group: The subject group who is receiving the health care services using conventional treatment (hospital visit) and remote monitoring.
     • Remote visit + remote monitoring group: The subject group who is receiving remote visit and remote monitoring using videotelephony

3. Target Subject: Type II diabetes patients

Enrollment: 417 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. More than 20 years of age and under 60 years of age
2. Patients who are able to receive outpatient treatment with type II diabetes mellitus.
3. If the patients require using insulin, patients who are using basal insulin or premixed insulin less than 2 times a day are eligible.
4. Patients with HbA1c above 7% and less than 11% (7%≤HbA1c≤11%).
5. Patients who are able to understand the purpose of this trial and to read and write.
6. Patients who are able to use the Smart Care PC for this study.
7. Patients who have wired/wireless internet access at home.
8. Patients who participate voluntarily and sign the informed consent.

Exclusion criteria

1. Patients with type I diabetes mellitus
2. Patients who are using Bolus insulin (short-acting insulin) or insulin pump.
3. Patients who take medicines which can significantly affect glycemic control.
4. Patients with acute illness, untreated other disease or diabetic complications required additional treatment.
5. Patients currently being hospitalized or planning to hospitalize during the study period.
6. Patients who have severe renal disease (above 1.5 times the upper limit of normal serum creatinine levels).
7. Pregnant or lactating women.
8. Patients with any severe liver disease including cirrhosis (AST or ALT: above 3 times the upper limit of normal).
9. Patients with uncontrolled chronic lung disease.
10. Patients with known history of alcoholism, mental illness, or drug dependency.
11. Patients who have cognitive disorder or psychiatric problems
12. Patients who have participated in other clinical trial within 12 weeks prior to screening visit.
13. Any clinically significant medical condition including neurologic disease, gastrointestinal disease or malignant tumor, etc., which may affect the test results, or any other medical condition which in the opinion of the investigator makes the patients unsuitable for participation in the trial.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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417 participants in 3 patient groups

Telemonitoring group

Experimental group

Description:

* A Smart Care PC, blood glucose meter and body composition analyzer will be provided * transmitting the results to the Smart Care Server via Smart Care PC * At Smart care Center,care manager will provide remote blood glucose monitoring and individual diabetes case management

Treatment:

Procedure: Telemonitoring group

Telemonitoring & Telemedicine group

Experimental group

Description:

* A Smart Care PC, blood glucose meter and body composition analyzer will be provided * transmitting the results to the Smart Care Server via Smart Care PC * At Smart care Center,care manager will provide remote blood glucose monitoring and individual diabetes case management * taking telemedicine through video telephone instead of visiting hospital

Treatment:

Procedure: Telemonitoring & Telemedicine

Control group

Other group

Description:

* Blood glucose meter and body composition analyzer will be provided * Self-monitoring Blood Glucose (SMBG)

Treatment:

Other: SMBG