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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Internet

Other

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

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

Acronym: SARS

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Jan 29, 2010
Registry last updated: Jan 29, 2010

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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Completed