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
Sponsor:
Information provided by:
LG Electronics Inc.
ClinicalTrials.gov Identifier:
NCT01345435
First received: April 28, 2011
Last updated: April 29, 2011
Last verified: April 2011
  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
  • 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
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
  • 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
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
  • Blood glucose meter and body composition analyzer will be provided
  • Self-monitoring Blood Glucose (SMBG)
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:
  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
  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. More than 20 years of age and under 60 years of age
  2. Patients who are able to receive outpatient treatment with type II diabetes mellitus.
  3. If the patients require using insulin, patients who are using basal insulin or premixed insulin less than 2 times a day are eligible.
  4. Patients with HbA1c above 7% and less than 11% (7%≤HbA1c≤11%).
  5. Patients who are able to understand the purpose of this trial and to read and write.
  6. Patients who are able to use the Smart Care PC for this study.
  7. Patients who have wired/wireless internet access at home.
  8. Patients who participate voluntarily and sign the informed consent.

Exclusion Criteria:

  1. Patients with type I diabetes mellitus
  2. Patients who are using Bolus insulin (short-acting insulin) or insulin pump.
  3. Patients who take medicines which can significantly affect glycemic control.
  4. Patients with acute illness, untreated other disease or diabetic complications required additional treatment.
  5. Patients currently being hospitalized or planning to hospitalize during the study period.
  6. Patients who have severe renal disease (above 1.5 times the upper limit of normal serum creatinine levels).
  7. Pregnant or lactating women.
  8. Patients with any severe liver disease including cirrhosis (AST or ALT: above 3 times the upper limit of normal).
  9. Patients with uncontrolled chronic lung disease.
  10. Patients with known history of alcoholism, mental illness, or drug dependency.
  11. Patients who have cognitive disorder or psychiatric problems
  12. Patients who have participated in other clinical trial within 12 weeks prior to screening visit.
  13. 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 April 17, 2014