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

The Catholic University of Korea

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Other: Internet

Study type: Interventional

Funder types: Other

Identifiers

NCT01058733

SARS-Project

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 1 patient group

Internet

Other group

Description:

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.

Treatment:

Other: Internet