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CompletedNCT01058733SARSUpdated Jan 29, 2010

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

An interventional study of Internet in Diabetes Mellitus, sponsored by The Catholic University of Korea. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-01-29.

Sponsored by The Catholic University of Korea · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
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Study 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.
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Conditions studied

  • Diabetes Mellitus

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Keywords

  • semi-automatic response system (SARS)
  • Diabetes Mellitus
  • Internet
  • ubiquitous health care system
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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 79 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

The Catholic University of Korea is the lead sponsor of 150 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
79 participants (actual)

Study arms

  • 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

Interventions

  • OtherInternet

    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.

    Also known as: clinical decision-supporting system

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What researchers measure

Primary outcomes

  1. 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

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Study locations

1 site
  • Seoul St. Mary's Hospital
    Seoul, 137-701, Korea, Republic of
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References and documents

Publications

  • Kwon HS, Cho JH, Kim HS, Song BR, Ko SH, Lee JM, Kim SR, Chang SA, Kim HS, Cha BY, Lee KW, Son HY, Lee JH, Lee WC, Yoon KH. Establishment of blood glucose monitoring system using the internet. Diabetes Care. 2004 Feb;27(2):478-83. doi: 10.2337/diacare.27.2.478. PubMed 14747232 ↗
  • Yoon KH, Lee JH, Kim JW, Cho JH, Choi YH, Ko SH, Zimmet P, Son HY. Epidemic obesity and type 2 diabetes in Asia. Lancet. 2006 Nov 11;368(9548):1681-8. doi: 10.1016/S0140-6736(06)69703-1. PubMed 17098087 ↗
  • Kwon HS, Cho JH, Kim HS, Lee JH, Song BR, Oh JA, Han JH, Kim HS, Cha BY, Lee KW, Son HY, Kang SK, Lee WC, Yoon KH. Development of web-based diabetic patient management system using short message service (SMS). Diabetes Res Clin Pract. 2004 Dec;66 Suppl 1:S133-7. doi: 10.1016/j.diabres.2003.10.028. PubMed 15563964 ↗
  • Cho JH, Chang SA, Kwon HS, Choi YH, Ko SH, Moon SD, Yoo SJ, Song KH, Son HS, Kim HS, Lee WC, Cha BY, Son HY, Yoon KH. Long-term effect of the Internet-based glucose monitoring system on HbA1c reduction and glucose stability: a 30-month follow-up study for diabetes management with a ubiquitous medical care system. Diabetes Care. 2006 Dec;29(12):2625-31. doi: 10.2337/dc05-2371. PubMed 17130195 ↗
  • Cho JH, Lee HC, Lim DJ, Kwon HS, Yoon KH. Mobile communication using a mobile phone with a glucometer for glucose control in Type 2 patients with diabetes: as effective as an Internet-based glucose monitoring system. J Telemed Telecare. 2009;15(2):77-82. doi: 10.1258/jtt.2008.080412. PubMed 19246607 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01058733
Lead sponsor
The Catholic University of Korea
First posted
Jan 29, 2010
Start date
Oct 2006
Primary completion
May 2007
Completion
May 2007
Last update
Jan 29, 2010

Study contacts

Kun-Ho Yoon
principal investigator · Seoul St. Mary's Hospital, Seoul, Korea

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2007. You cannot join it, but the record below documents what was studied.

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