Back to resultsEffects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care (Smart-DM)
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Telemonitoring group
Telemonitoring & Telemedicine
SMBG
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes focused on measuring telemonitoring, usual care, telemedicine, telehealth, home care, Health Care Quality, Access, Evaluation
Eligibility 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.
Sites / Locations
- Kyungpook National University Hospital
- Yeungnam University Medical Center
- Gangnam Severance Hospital
- Yonsei University Health System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Telemonitoring group
Telemonitoring & Telemedicine group
Control group
Arm Description
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
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
Blood glucose meter and body composition analyzer will be provided Self-monitoring Blood Glucose (SMBG)
Outcomes
Primary Outcome Measures
Changes in Hemoglobin A1c
Changes in Hemoglobin A1c from baseline to 24 weeks visit.
Reduce Hemoglobin A1c after study
Secondary Outcome Measures
Changes in FBS (Fasting blood sugar)
Changes in FBS (Fasting blood sugar) from baseline to 24 weeks visit
Maintains FBS within the normal range
Changes in lipid profile
Changes in lipid profile from baseline to 24 weeks visit
Maintains normal lipid profile
Percentage of subjects who achieved goal Hemoglobin A1c
Goal Hemoglobin A1c <7%
Changes in body mass index (BMI)
Reduction of body mass index
- BMI=Body weight (kg)/Height2(m)
SMBG(Self-monitoring of blood glucose) compliance
measurement of Self-monitoring of blood glucose
Changes in body weight
Reduce body weight from baseline to 24 weeks visit
Assessment of patients' satisfaction
Assessment of subjects' satisfaction, Only remote monitoring group and remote visit + remote monitoring group are applicable
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%
Full Information
NCT ID
NCT01345435
First Posted
April 28, 2011
Last Updated
February 1, 2020
Sponsor
CHANGHEE LEE
Collaborators
LG Electronics Inc., Purdue University
1. Study Identification
Unique Protocol Identification Number
NCT01345435
Brief Title
Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care
Acronym
Smart-DM
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CHANGHEE LEE
Collaborators
LG Electronics Inc., Purdue University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
telemonitoring, usual care, telemedicine, telehealth, home care, Health Care Quality, Access, Evaluation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
417 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telemonitoring group
Arm Type
Experimental
Arm Description
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
Arm Title
Telemonitoring & Telemedicine group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Other
Arm Description
Blood glucose meter and body composition analyzer will be provided
Self-monitoring Blood Glucose (SMBG)
Intervention Type
Procedure
Intervention Name(s)
Telemonitoring group
Other Intervention Name(s)
Smartcare System : Telemonitoring
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Telemonitoring & Telemedicine
Other Intervention Name(s)
Smartcare System : Telemonitoring & Telemedicine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
SMBG
Other Intervention Name(s)
Self blood glucose measurement
Intervention Description
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).
Primary Outcome Measure Information:
Title
Changes in Hemoglobin A1c
Description
Changes in Hemoglobin A1c from baseline to 24 weeks visit.
Reduce Hemoglobin A1c after study
Time Frame
0 and 24 weeks
Secondary Outcome Measure Information:
Title
Changes in FBS (Fasting blood sugar)
Description
Changes in FBS (Fasting blood sugar) from baseline to 24 weeks visit
Maintains FBS within the normal range
Time Frame
0 and 24 weeks
Title
Changes in lipid profile
Description
Changes in lipid profile from baseline to 24 weeks visit
Maintains normal lipid profile
Time Frame
0 and 24 weeks
Title
Percentage of subjects who achieved goal Hemoglobin A1c
Description
Goal Hemoglobin A1c <7%
Time Frame
0 and 24 weeks
Title
Changes in body mass index (BMI)
Description
Reduction of body mass index
- BMI=Body weight (kg)/Height2(m)
Time Frame
0 and 24 weeks
Title
SMBG(Self-monitoring of blood glucose) compliance
Description
measurement of Self-monitoring of blood glucose
Time Frame
up to 24 weeks
Title
Changes in body weight
Description
Reduce body weight from baseline to 24 weeks visit
Time Frame
0 and 24 weeks
Title
Assessment of patients' satisfaction
Description
Assessment of subjects' satisfaction, Only remote monitoring group and remote visit + remote monitoring group are applicable
Time Frame
24 weeks
Title
Medication compliance
Description
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%
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In Kyu Lee, M.D.
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Health System
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care
We'll reach out to this number within 24 hrs