Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care (Smart-DM)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by LG Electronics Inc..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
LG Electronics Inc.
Information provided by:
LG Electronics Inc.
ClinicalTrials.gov Identifier:
NCT01345435
First received: April 28, 2011
Last updated: April 29, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes |
Procedure: Telemonitoring group Procedure: Telemonitoring & Telemedicine Other: Usual Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by LG Electronics Inc.:
Primary Outcome Measures:
- Changes in Hemoglobin A1c [ Time Frame: 0 and 24 weeks ] [ Designated as safety issue: No ]
Changes in Hemoglobin A1c from baseline to 24 weeks visit.
Reduce Hemoglobin A1c after study
Secondary Outcome Measures:
- Changes in FBS (Fasting blood sugar) [ Time Frame: 0 and 24 weeks ] [ Designated as safety issue: No ]
Changes in FBS (Fasting blood sugar) from baseline to 24 weeks visit
Maintains FBS within the normal range
- Changes in lipid profile [ Time Frame: 0 and 24 weeks ] [ Designated as safety issue: No ]
Changes in lipid profile from baseline to 24 weeks visit
Maintains normal lipid profile
- Percentage of subjects who achieved goal Hemoglobin A1c [ Time Frame: 0 and 24 weeks ] [ Designated as safety issue: No ]Goal Hemoglobin A1c <7%
- Changes in body mass index (BMI) [ Time Frame: 0 and 24 weeks ] [ Designated as safety issue: No ]
Reduction of body mass index
- BMI=Body weight (kg)/Height2(m)
- SMBG(Self-monitoring of blood glucose) compliance [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
- Changes in body weight [ Time Frame: 0 and 24 weeks ] [ Designated as safety issue: No ]Reduce body weight from baseline to 24 weeks visit
- Assessment of patients' satisfaction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Assessment of subjects' satisfaction, Only remote monitoring group and remote visit + remote monitoring group are applicable
- Medication compliance [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
- 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%
| Estimated Enrollment: | 492 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
Experimental: Telemonitoring group
|
Procedure: 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
Other Name: Smartcare System : Telemonitoring
|
Experimental: Telemonitoring & Telemedicine group
|
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.
Other Name: Smartcare System : Telemonitoring & Telemedicine
|
No Intervention: Control group
|
Other: Usual Care
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 Name: Self blood glucose measurement
|
Detailed Description:
- 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
Eligibility| Ages Eligible for Study: | 20 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345435
Contacts
| Contact: Jeongweon Park | 82-10-2357-0538 | Jeongweon.Park@lge.com |
| Contact: Youngdon Hwang | 82-10-7575-0406 | youngdon.hwang@lge.com |
Locations
| Korea, Republic of | |
| Kyungpook National University Hospital | Recruiting |
| Daegu, Korea, Republic of | |
| Contact: In Kyu Lee, M.D. 82-53-420-6728 | |
| Yeungnam University Medical Center | Recruiting |
| Daegu, Korea, Republic of | |
| Contact: Kyu Chang Won, M.D. 82-53-620-3846 | |
| Yonsei University Health System | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Bong Su Cha, M.D 82-2-2228-1962 | |
| Gangnam Severance Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Chol Woo Ahn, M.D. 82-2-2019-3339 | |
Sponsors and Collaborators
LG Electronics Inc.
Investigators
| Principal Investigator: | In Kyu Lee, M.D. | Kyungpook National University |
More Information
No publications provided
| Responsible Party: | Youngdon Hwang/Chief Research Engineer, LG Electronics Inc. |
| ClinicalTrials.gov Identifier: | NCT01345435 History of Changes |
| Other Study ID Numbers: | Smartcare-DM |
| Study First Received: | April 28, 2011 |
| Last Updated: | April 29, 2011 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by LG Electronics Inc.:
|
telemonitoring usual care telemedicine telehealth |
home care Health Care Quality Access Evaluation |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013