NCT01058733CompletedNot Applicable
Seoul St. Mary's Hospital College of Medicine The Catholic University of Korea, Seoul, Korea
The Catholic University of Korea2 sites in 1 country79 target enrollmentStarted: October 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 79
- Locations
- 2
- Primary Endpoint
- physicians' labour time and frequency of contact with the online communication system required for reviewing the patients' information and sending recommendations
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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