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Glucose Monitor Accuracy Investigation (Ⅰ)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00877461
First Posted: April 7, 2009
Last Update Posted: April 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
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.

Condition
Healthy

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).
  Eligibility

Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • volunteers with diabetes and non-diabetes

Exclusion Criteria:

  • hypertension,fever,AIDS,hemophilia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877461


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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
ClinicalTrials.gov Identifier: NCT00877461     History of Changes
Other Study ID Numbers: 9461700317
First Submitted: April 6, 2009
First Posted: April 7, 2009
Last Update Posted: April 8, 2009
Last Verified: April 2009