Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care
Smart-DM
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 other identifier
interventional
417
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Jan 2011
Typical duration for not_applicable type-2-diabetes
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 28, 2011
CompletedFirst Posted
Study publicly available on registry
May 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFebruary 5, 2020
February 1, 2020
2.2 years
April 28, 2011
February 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Hemoglobin A1c
Changes in Hemoglobin A1c from baseline to 24 weeks visit. Reduce Hemoglobin A1c after study
0 and 24 weeks
Secondary Outcomes (8)
Changes in FBS (Fasting blood sugar)
0 and 24 weeks
Changes in lipid profile
0 and 24 weeks
Percentage of subjects who achieved goal Hemoglobin A1c
0 and 24 weeks
Changes in body mass index (BMI)
0 and 24 weeks
SMBG(Self-monitoring of blood glucose) compliance
up to 24 weeks
- +3 more secondary outcomes
Study Arms (3)
Telemonitoring group
EXPERIMENTAL* 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
Telemonitoring & Telemedicine group
EXPERIMENTAL* 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
Control group
OTHER* Blood glucose meter and body composition analyzer will be provided * Self-monitoring Blood Glucose (SMBG)
Interventions
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
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.
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHANGHEE LEElead
- LG Electronics Inc.collaborator
- Purdue Universitycollaborator
Study Sites (4)
Kyungpook National University Hospital
Daegu, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Yonsei University Health System
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
In Kyu Lee, M.D.
Kyungpook National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief Research Engineer
Study Record Dates
First Submitted
April 28, 2011
First Posted
May 2, 2011
Study Start
January 1, 2011
Primary Completion
April 1, 2013
Study Completion
December 1, 2013
Last Updated
February 5, 2020
Record last verified: 2020-02