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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

April 28, 2011
April 29, 2011
January 2011
December 2011   (final data collection date for primary outcome measure)
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

Same as current
Complete list of historical versions of study NCT01345435 on ClinicalTrials.gov Archive Site
  • 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%
Same as current
Not Provided
Not Provided
 
Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care
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

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Type 2 Diabetes
  • 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
  • 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
  • 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
  • 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
    Intervention: Procedure: Telemonitoring group
  • 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
    Intervention: Procedure: Telemonitoring & Telemedicine
  • No Intervention: Control group
    • Blood glucose meter and body composition analyzer will be provided
    • Self-monitoring Blood Glucose (SMBG)
    Intervention: Other: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
492
March 2013
December 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years to 60 Years
No
Contact: Jeongweon Park 82-10-2357-0538 Jeongweon.Park@lge.com
Contact: Youngdon Hwang 82-10-7575-0406 youngdon.hwang@lge.com
Korea, Republic of
 
NCT01345435
Smartcare-DM
Yes
Youngdon Hwang/Chief Research Engineer, LG Electronics Inc.
LG Electronics Inc.
Not Provided
Principal Investigator: In Kyu Lee, M.D. Kyungpook National University
LG Electronics Inc.
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP