Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care

NCT ID: NCT01345435

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 417 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-12-31

Brief Summary

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.

Detailed 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

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Telemonitoring group

• 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

Group Type: EXPERIMENTAL

Telemonitoring group

Intervention Type: PROCEDURE

The Telemonitoring group will be provided blood glucose meter, body composition analyzer, and remote monitoring PC. They should visit the site once per every 2 months (8 weeks), and measure their blood glucose using a provided blood glucose monitor twice a day during study period (once after first morning urination and once before going to bed). After measurement of blood glucose and body composition, the subjects should make transmit measured information through Smart Care PC into a centralized server of Smart Care Center. At Smart care Center, care manager will provide remote blood glucose monitoring and individual diabetes case management

Telemonitoring & Telemedicine group

• 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

Group Type: EXPERIMENTAL

Telemonitoring & Telemedicine

Intervention Type: PROCEDURE

The Telemonitoring \& Telemedicine group will be provided blood glucose meter, body composition analyzer, and remote monitoring PC. They should measure their blood glucose using a provided blood glucose monitor twice a day during the study period. After measurement of blood glucose and body composition, the subjects should make transmit measured information through Smart Care PC into a centralized server of Smart Care Center. At Smart care Center, care manager will provide remote blood glucose monitoring and individual diabetes case management. A remote medical doctor should provide medical consultation to the subjects through videotelephony using the remote monitoring PC and then issue electronic prescriptions.

Control group

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

Group Type: OTHER

SMBG

Intervention Type: OTHER

The subjects who are assigned in the control group will be provided blood glucose Monitor. The subjects who are assigned in the control group should perform the same blood glucose measurement same as the test group during the study, and measured results should be recorded in a diary of self blood glucose measurement. In addition, the subjects should visit the site once per every two months (8 weeks).

Interventions

Telemonitoring group

The Telemonitoring group will be provided blood glucose meter, body composition analyzer, and remote monitoring PC. They should visit the site once per every 2 months (8 weeks), and measure their blood glucose using a provided blood glucose monitor twice a day during study period (once after first morning urination and once before going to bed). After measurement of blood glucose and body composition, the subjects should make transmit measured information through Smart Care PC into a centralized server of Smart Care Center. At Smart care Center, care manager will provide remote blood glucose monitoring and individual diabetes case management

Intervention Type: PROCEDURE

Telemonitoring & Telemedicine

The Telemonitoring \& Telemedicine group will be provided blood glucose meter, body composition analyzer, and remote monitoring PC. They should measure their blood glucose using a provided blood glucose monitor twice a day during the study period. After measurement of blood glucose and body composition, the subjects should make transmit measured information through Smart Care PC into a centralized server of Smart Care Center. At Smart care Center, care manager will provide remote blood glucose monitoring and individual diabetes case management. A remote medical doctor should provide medical consultation to the subjects through videotelephony using the remote monitoring PC and then issue electronic prescriptions.

Intervention Type: PROCEDURE

SMBG

The subjects who are assigned in the control group will be provided blood glucose Monitor. The subjects who are assigned in the control group should perform the same blood glucose measurement same as the test group during the study, and measured results should be recorded in a diary of self blood glucose measurement. In addition, the subjects should visit the site once per every two months (8 weeks).

Intervention Type: OTHER

Other Intervention Names

Smartcare System : Telemonitoring; Smartcare System : Telemonitoring & Telemedicine; Self blood glucose measurement

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LG Electronics Inc.

INDUSTRY

Sponsor Role: collaborator

Purdue University

OTHER

Sponsor Role: collaborator

CHANGHEE LEE

INDUSTRY

Sponsor Role: lead

Responsible Party

CHANGHEE LEE

Chief Research Engineer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

In Kyu Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Locations

Kyungpook National University Hospital

Daegu, , South Korea

Yeungnam University Medical Center

Daegu, , South Korea

Gangnam Severance Hospital

Seoul, , South Korea

Yonsei University Health System

Seoul, , South Korea

Countries

South Korea

Other Identifiers

Smartcare-DM

Identifier Type: -

Identifier Source: org_study_id