Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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 Target Subject: Type II diabetes patients

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Procedure: Telemonitoring group
* Procedure: Telemonitoring & Telemedicine
* Other: SMBG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 20 years of age and under 60 years of age Patients who are able to receive outpatient treatment with type II diabetes mellitus. If the patients require using insulin, patients who are using basal insulin or premixed insulin less than 2 times a day are eligible. Patients with HbA1c above 7% and less than 11% (7%≤HbA1c≤11%). Patients who are able to understand the purpose of this trial and to read and write. Patients who are able to use the Smart Care PC for this study. Patients who have wired/wireless internet access at home. Patients who participate voluntarily and sign the informed consent. Exclusion Criteria: Patients with type I diabetes mellitus Patients who are using Bolus insulin (short-acting insulin) or insulin pump. Patients who take medicines which can significantly affect glycemic control. Patients with acute illness, untreated other disease or diabetic complications required additional treatment. Patients currently being hospitalized or planning to hospitalize during the study period. Patients who have severe renal disease (above 1.5 times the upper limit of normal serum creatinine levels). Pregnant or lactating women. Patients with any severe liver disease including cirrhosis (AST or ALT: above 3 times the upper limit of normal). Patients with uncontrolled chronic lung disease. Patients with known history of alcoholism, mental illness, or drug dependency. Patients who have cognitive disorder or psychiatric problems Patients who have participated in other clinical trial within 12 weeks prior to screening visit. 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemonitoring group<br>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 | Procedure: Telemonitoring group<br>* 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<br>* Other names: Smartcare System : Telemonitoring;|
| Experimental: Telemonitoring & Telemedicine group<br>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 | Procedure: Telemonitoring & Telemedicine<br>* 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.<br>* Other names: Smartcare System : Telemonitoring & Telemedicine;|
| Other: Control group<br>Blood glucose meter and body composition analyzer will be provided Self-monitoring Blood Glucose (SMBG) | Other: SMBG<br>* 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).<br>* Other names: Self blood glucose measurement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 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% | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemonitoring, usual care, telemedicine, telehealth, home care, Health Care Quality, Access, Evaluation