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

This study has been completed.
Sponsor:
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01058733
First received: January 28, 2010
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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.

Condition Intervention
Diabetes Mellitus
 Other: Internet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Seoul St. Mary's Hospital College of Medicine The Catholic University of Korea, Seoul, Korea

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: October 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: clinical decision-supporting system

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058733

Locations
Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Principal Investigator: Kun-Ho Yoon Seoul St. Mary's Hospital, Seoul, Korea
  More Information

Publications:

Responsible Party: Kun-Ho Yoon, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01058733     History of Changes
Other Study ID Numbers: SARS-Project
Study First Received: January 28, 2010
Last Updated: January 28, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
semi-automatic response system (SARS)
Diabetes Mellitus
Internet
ubiquitous health care system

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013