Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care (Smart-DM)

February 1, 2020 updated by: CHANGHEE LEE

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
417

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Kyungpook National University Hospital
      • Daegu, Korea, Republic of
        • Yeungnam University Medical Center
      • Seoul, Korea, Republic of
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of
        • Yonsei University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Smartcare System : Telemonitoring & Telemedicine
OTHER: Control group
  • Blood glucose meter and body composition analyzer will be provided
  • Self-monitoring Blood Glucose (SMBG)
Other: SMBG
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 Names:
  • Self blood glucose measurement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
0 and 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in FBS (Fasting blood sugar)
Time Frame: 0 and 24 weeks

Changes in FBS (Fasting blood sugar) from baseline to 24 weeks visit

Maintains FBS within the normal range
0 and 24 weeks
Changes in lipid profile
Time Frame: 0 and 24 weeks

Changes in lipid profile from baseline to 24 weeks visit

Maintains normal lipid profile
0 and 24 weeks
Percentage of subjects who achieved goal Hemoglobin A1c
Time Frame: 0 and 24 weeks
Goal Hemoglobin A1c <7%
0 and 24 weeks
Changes in body mass index (BMI)
Time Frame: 0 and 24 weeks

Reduction of body mass index

- BMI=Body weight (kg)/Height2(m)
0 and 24 weeks
SMBG(Self-monitoring of blood glucose) compliance
Time Frame: up to 24 weeks
measurement of Self-monitoring of blood glucose
up to 24 weeks
Changes in body weight
Time Frame: 0 and 24 weeks
Reduce body weight from baseline to 24 weeks visit
0 and 24 weeks
Assessment of patients' satisfaction
Time Frame: 24 weeks
Assessment of subjects' satisfaction, Only remote monitoring group and remote visit + remote monitoring group are applicable
24 weeks
Medication compliance
Time Frame: up to 24 weeks
  • 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%
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CHANGHEE LEE

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Purdue University
LG Electronics Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: In Kyu Lee, M.D., Kyungpook National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Smartcare-DM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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