Semi-automatic Response System(SARS)in Type 2 Diabetes (SARS)

January 28, 2010 updated by: The Catholic University of Korea

Seoul St. Mary's Hospital College of Medicine The Catholic University of Korea, Seoul, Korea

Background

  • Various kinds of interactive online communication systems have been introduced for long-term diabetes management, and their importance in managing patients is increasing. The investigators investigated the amount of physician time needed to maintain such a system, and the investigators developed software to maximise the cost effectiveness.

Methods

  • The investigators conducted a prospective, randomised, controlled trial to investigate the efficacy and safety of a semi-automatic response system (SARS) for online glucose monitoring over a 24-week period of patients with type 2 diabetes. In the SARS group, the "SARS" software filtered the recorded self-monitoring of blood glucose data automatically to reduce the physicians' time, and the physicians managed patients regularly but only manually in the control (manual) group. The investigators measured the time spent by the physicians for online management and compared the HbA1c levels at enrolment and follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • 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

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

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • men or women aged 20-70 years with type 2 diabetes
  • lasting more than one year who had used the online communication system for diabetes management at the web site https://www.bi odang.com for more than six months
  • baseline HbA1c level was 6-10%
  • Patients who able and willing to complete glucose-monitoring diaries on a web chart as instructed.

Exclusion Criteria:

  • patients who required intensive insulin therapy (multiple insulin injections or insulin pump therapy) or who were unwilling to use self-monitoring of blood glucose (SMBG)
  • acute metabolic complications of diabetes (e.g., diabetic ketoacidosis, hyperosmolar non-ketotic hyperglycaemia, lactic acidosis)
  • serum creatinine concentration >2.0 mg/dl at screening
  • active liver disease or ALT or AST activities >2.5 times the upper limit of normal
  • acute illness, chronic infection, heart failure of NYHA Class III or IV
  • recent myocardial infarction or stroke during the past six months
  • pregnancy or GDM, or any other factor likely to limit protocol compliance or reporting of adverse events

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Internet
New clinical decision-supporting system for glucose monitoring, SARS, which could identify glucose data recorded by patients and make some optimal decisions.The SARS engine assigned subjects to one of three levels according to the glucose control status and glucose control method.
Other: Internet
new clinical decision-supporting system for glucose monitoring, SARS, which could identify glucose data recorded by patients and make some optimal decisions.The SARS engine assigned subjects to one of three levels according to the glucose control status and glucose control method.
Other Names:
  • clinical decision-supporting system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
physicians' labour time and frequency of contact with the online communication system required for reviewing the patients' information and sending recommendations
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

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

Sponsor

The Catholic University of Korea

Investigators

  • Principal Investigator: Kun-Ho Yoon, Seoul St. Mary's hospital, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2006

Primary Completion (ACTUAL)

May 1, 2007

Study Completion (ACTUAL)

May 1, 2007

Study Registration Dates

First Submitted

January 28, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (ESTIMATE)

January 29, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2010

Last Update Submitted That Met QC Criteria

January 28, 2010

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SARS-Project

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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