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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
417
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.
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
Changes in Hemoglobin A1c
Changes in Hemoglobin A1c from baseline to 24 weeks visit. Reduce Hemoglobin A1c after study
Time frame: 0 and 24 weeks
Changes in FBS (Fasting blood sugar)
Changes in FBS (Fasting blood sugar) from baseline to 24 weeks visit Maintains FBS within the normal range
Time frame: 0 and 24 weeks
Changes in lipid profile
Changes in lipid profile from baseline to 24 weeks visit Maintains normal lipid profile
Time frame: 0 and 24 weeks
Percentage of subjects who achieved goal Hemoglobin A1c
Goal Hemoglobin A1c \<7%
Time frame: 0 and 24 weeks
Changes in body mass index (BMI)
Reduction of body mass index \- BMI=Body weight (kg)/Height2(m)
Time frame: 0 and 24 weeks
SMBG(Self-monitoring of blood glucose) compliance
measurement of Self-monitoring of blood glucose
Time frame: up to 24 weeks
Changes in body weight
Reduce body weight from baseline to 24 weeks visit
Time frame: 0 and 24 weeks
Assessment of patients' satisfaction
Assessment of subjects' satisfaction, Only remote monitoring group and remote visit + remote monitoring group are applicable
Time frame: 24 weeks
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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).
Medication compliance
* Patients diary will be recorded and medication compliance will be calculated by calculating the number of days administered Insulin or Oral Hypoglycemic Agents during the study * Drugs compliance = the number of days administered antihypertensive drugs / participated period in this study \* 100%
Time frame: up to 24 weeks