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Glucose Monitor Accuracy Investigation (Ⅱ)

This study has been completed.
Information provided by:
National Taiwan University Hospital Identifier:
First received: April 6, 2009
Last updated: April 7, 2009
Last verified: April 2009
According to Section 7.3 and Section 7.4, ISO 15197(2003), it adopts the whole blood of fingertips as samples to evaluate the accuracy of portable BGM.


Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Glucose Monitor Accuracy Investigation (Ⅱ)

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • glucose [ Time Frame: 10 min ]

Enrollment: 319
Study Start Date: April 2006
Study Completion Date: December 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Detailed Description:
The clinical medical technologists collected blood samples from 319 volunteers including 90 diabetics and 229 healthy people. The range of the blood glucose concentration was from 30.2mg/dL to 577.5mg/dL. The result of clinic evaluation shows that the accuracy of BGM matches the requirement of ISO15197(2003).

Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The glucose concentrations of volunteer shall be distributed as specified in ISO15197 Table 3

Inclusion Criteria:

  • volunteers with diabetes and non-diabets

Exclusion Criteria:

  • hypertension,fever,AIDS,hemophilia
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Please refer to this study by its identifier: NCT00876590

National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Study Director: Feng-Huei Lin, PhD Biomedical Engineering Department of National Taiwan University Hospital
  More Information

Responsible Party: Feng-Huei Lin, Biomedical Engineering Department of National Taiwan University Hospital Identifier: NCT00876590     History of Changes
Other Study ID Numbers: 9461701248
Study First Received: April 6, 2009
Last Updated: April 7, 2009 processed this record on May 25, 2017