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

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: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Procedure: Telemonitoring group; Procedure: Telemonitoring & Telemedicine; Other: SMBG

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: Interventional
• Enrollment (Actual): 417
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Changes in Hemoglobin A1c	Changes in Hemoglobin A1c from baseline to 24 weeks visit. Reduce Hemoglobin A1c after study	0 and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in FBS (Fasting blood sugar)	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	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	Goal Hemoglobin A1c <7%	0 and 24 weeks
Changes in body mass index (BMI)	Reduction of body mass index - BMI=Body weight (kg)/Height2(m)	0 and 24 weeks
SMBG(Self-monitoring of blood glucose) compliance	measurement of Self-monitoring of blood glucose	up to 24 weeks
Changes in body weight	Reduce body weight from baseline to 24 weeks visit	0 and 24 weeks
Assessment of patients' satisfaction	Assessment of subjects' satisfaction, Only remote monitoring group and remote visit + remote monitoring group are applicable	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%	up to 24 weeks

Collaborators and Investigators

• Sponsor: CHANGHEE LEE
• Collaborators: Purdue University; LG Electronics Inc.
• Investigators: Principal Investigator: In Kyu Lee, M.D., Kyungpook National University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: April 28, 2011
• First Submitted That Met QC Criteria: April 29, 2011
• First Posted (ESTIMATE): May 2, 2011

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 1, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Health Care Quality; Access; Evaluation; telemedicine; home care; telemonitoring; telehealth; usual care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Smartcare-DM