Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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
    

Intervention name(s): Telemonitoring group; Telemonitoring & Telemedicine; SMBG
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): 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; 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.; 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).
Other intervention name(s): Smartcare System : Telemonitoring; Smartcare System : Telemonitoring & Telemedicine; Self blood glucose measurement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: telemonitoring; usual care; telemedicine; telehealth; home care; Health Care Quality; Access; Evaluation