Type 2 DiabetesSmart-DMNCT01345435
Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care
A study testing Telemonitoring group, Telemonitoring & Telemedicine and SMBG in people with Type 2 Diabetes, run by CHANGHEE LEE at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Telemonitoring group, Telemonitoring & Telemedicine and SMBG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 417 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Jan 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 13Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Kyungpook National University Hospital
Daegu
Yeungnam University Medical Center
Daegu
Gangnam Severance Hospital
Seoul
Yonsei University Health System
Seoul
About this study
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
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.
Read the 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
- Conditions
- Type 2 Diabetes
- Being tested
- Telemonitoring group, Telemonitoring & Telemedicine, SMBG
- Keywords
- telemonitoring, usual care, telemedicine, telehealth, home care, Health Care Quality, Access, Evaluation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring groupProcedure or surgery
Also called Smartcare System : Telemonitoring
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
Telemonitoring & TelemedicineProcedure or surgery
Also called Smartcare System : 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.
SMBGOther
Also called Self blood glucose measurement
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Telemonitoring group |
| 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 Receives: Procedure: Telemonitoring & Telemedicine |
| Control group | Other | * Blood glucose meter and body composition analyzer will be provided
* Self-monitoring Blood Glucose (SMBG) Receives: Other: SMBG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Hemoglobin A1c
Changes in Hemoglobin A1c from baseline to 24 weeks visit.
Reduce Hemoglobin A1c after study
Measured: 0 and 24 weeks
Secondary outcomes (8)
Changes in FBS (Fasting blood sugar)
Changes in FBS (Fasting blood sugar) from baseline to 24 weeks visit
Maintains FBS within the normal range
Measured: 0 and 24 weeks
Changes in lipid profile
Changes in lipid profile from baseline to 24 weeks visit
Maintains normal lipid profile
Measured: 0 and 24 weeks
Percentage of subjects who achieved goal Hemoglobin A1c
Goal Hemoglobin A1c <7%
Measured: 0 and 24 weeks
Changes in body mass index (BMI)
Reduction of body mass index
- BMI=Body weight (kg)/Height2(m)
Measured: 0 and 24 weeks
SMBG(Self-monitoring of blood glucose) compliance
measurement of Self-monitoring of blood glucose
Measured: up to 24 weeks
Changes in body weight
Reduce body weight from baseline to 24 weeks visit
Measured: 0 and 24 weeks
Assessment of patients' satisfaction
Assessment of subjects' satisfaction, Only remote monitoring group and remote visit + remote monitoring group are applicable
Measured: 24 weeks
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%
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHANGHEE LEE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LG Electronics Inc., Purdue University
- Responsible party
- Sponsor-investigator, CHANGHEE LEE, LG Electronics Inc.
- Investigators
- In Kyu Lee, M.D., Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345435
- Sponsor's protocol ID
- Smartcare-DM
- Acronym
- Smart-DM
- Status last verified
- Feb 2020
- First submitted
- 28 Apr 2011
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01345435
- Acronym / sponsor ID
- Smart-DM / Smartcare-DM
- Conditions
- Type 2 Diabetes
- Keywords
- telemonitoring, usual care, telemedicine, telehealth, home care, Health Care Quality, Access, Evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- CHANGHEE LEEIndustry (pharma, biotech, devices)
- Collaborators
- LG Electronics Inc., Purdue University
- Study start
- Jan 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring group | Experimental | Procedure: 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 |
| Telemonitoring & Telemedicine group | Experimental | Procedure: Telemonitoring & Telemedicine* 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 | Other: SMBG* Blood glucose meter and body composition analyzer will be provided * Self-monitoring Blood Glucose (SMBG) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemonitoring groupAlso: Smartcare System : TelemonitoringThe 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 | Procedure or surgery | Telemonitoring group |
| Telemonitoring & TelemedicineAlso: Smartcare System : Telemonitoring & TelemedicineThe 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. | Procedure or surgery | Telemonitoring & Telemedicine group |
| SMBGAlso: Self blood glucose measurementThe 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 | Control group |
Primary outcome
Changes in Hemoglobin A1c
Time frame: 0 and 24 weeks
Changes in Hemoglobin A1c from baseline to 24 weeks visit. Reduce Hemoglobin A1c after study
8 secondary outcomes
Changes in FBS (Fasting blood sugar)
Time frame: 0 and 24 weeks
Changes in lipid profile
Time frame: 0 and 24 weeks
Percentage of subjects who achieved goal Hemoglobin A1c
Time frame: 0 and 24 weeks
Changes in body mass index (BMI)
Time frame: 0 and 24 weeks
SMBG(Self-monitoring of blood glucose) compliance
Time frame: up to 24 weeks
Changes in body weight
Time frame: 0 and 24 weeks
Assessment of patients' satisfaction
Time frame: 24 weeks
Medication compliance
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In Kyu Lee, M.D. principal investigator
Kyungpook National University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring group, Telemonitoring & Telemedicine and SMBG in people with Type 2 Diabetes, run by CHANGHEE LEE at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Hemoglobin A1c (time frame: 0 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.