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Completed

NCT Number: NCT01345435

Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyungpook National University Hospital, Daegu, South Korea

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About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemonitoring group

Procedure

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

Telemonitoring & Telemedicine

Procedure

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

SMBG

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Changes in lipid profile

    Time frame: 0 and 24 weeks

    Changes in lipid profile from baseline to 24 weeks visit

    Maintains normal lipid profile

  3. Percentage of subjects who achieved goal Hemoglobin A1c

    Time frame: 0 and 24 weeks

    Goal Hemoglobin A1c <7%

  4. Changes in body mass index (BMI)

    Time frame: 0 and 24 weeks

    Reduction of body mass index

    • BMI=Body weight (kg)/Height2(m)
  5. SMBG(Self-monitoring of blood glucose) compliance

    Time frame: up to 24 weeks

    measurement of Self-monitoring of blood glucose

  6. Changes in body weight

    Time frame: 0 and 24 weeks

    Reduce body weight from baseline to 24 weeks visit

  7. Assessment of patients' satisfaction

    Time frame: 24 weeks

    Assessment of subjects' satisfaction, Only remote monitoring group and remote visit + remote monitoring group are applicable

  8. 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%

Sponsors and collaborators

Lead sponsor

CHANGHEE LEE

Industry

Collaborators

  • LG Electronics Inc.
  • Purdue University

Registry information

Official study 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

Acronym: Smart-DM

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 2, 2011
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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