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| Name | Class |
|---|---|
| LG Electronics Inc. | INDUSTRY |
| Purdue University | OTHER |
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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.
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.
Test and control group
Control group : The subject group who is receiving any conventional treatment (hospital visit).
Test groups
Target Subject: Type II diabetes patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemonitoring group | Experimental |
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| Telemonitoring & Telemedicine group | Experimental |
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| Control group | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitoring group | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Hemoglobin A1c | Changes in Hemoglobin A1c from baseline to 24 weeks visit. Reduce Hemoglobin A1c after study | 0 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in FBS (Fasting blood sugar) | Changes in FBS (Fasting blood sugar) from baseline to 24 weeks visit Maintains FBS within the normal range | 0 and 24 weeks |
| Changes in lipid profile | Changes in lipid profile from baseline to 24 weeks visit Maintains normal lipid profile |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In Kyu Lee, M.D. | Kyungpook National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Daegu | South Korea | ||||
| Yeungnam University Medical Center |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Telemonitoring & Telemedicine | 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. |
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| SMBG | 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). |
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| 0 and 24 weeks |
| Percentage of subjects who achieved goal Hemoglobin A1c | Goal Hemoglobin A1c <7% | 0 and 24 weeks |
| Changes in body mass index (BMI) | Reduction of body mass index - BMI=Body weight (kg)/Height2(m) | 0 and 24 weeks |
| SMBG(Self-monitoring of blood glucose) compliance | measurement of Self-monitoring of blood glucose | up to 24 weeks |
| Changes in body weight | Reduce body weight from baseline to 24 weeks visit | 0 and 24 weeks |
| Assessment of patients' satisfaction | Assessment of subjects' satisfaction, Only remote monitoring group and remote visit + remote monitoring group are applicable | 24 weeks |
| Medication compliance |
| up to 24 weeks |
| Daegu |
| South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Yonsei University Health System | Seoul | South Korea |
| D004700 | Endocrine System Diseases |