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Glucose Monitor Accuracy Investigation (Ⅰ)

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 and vein 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 (Ⅰ)

Further study details as provided by National Taiwan University Hospital:

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

Enrollment: 308
Study Start Date: May 2005
Study Completion Date: December 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Detailed Description:
The clinical medical technologists collected blood samples from 308 volunteers including 87 diabetics and 221 healthy people. The range of the blood glucose concentration was from 41.2mg/dL to 521mg/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-diabetes

Exclusion Criteria:

  • hypertension,fever,AIDS,hemophilia
  Contacts and Locations
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Please refer to this study by its identifier: NCT00877461

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: NCT00877461     History of Changes
Other Study ID Numbers: 9461700317
Study First Received: April 6, 2009
Last Updated: April 7, 2009 processed this record on March 28, 2017