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Glucose Monitor Accuracy Investigation (Ⅱ)

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ClinicalTrials.gov Identifier: NCT00876590
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : April 8, 2009
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief Summary:
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.

Condition or disease
Healthy

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).

Study Type : Observational
Actual Enrollment : 319 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Glucose Monitor Accuracy Investigation (Ⅱ)
Study Start Date : April 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : December 2006



Primary Outcome Measures :
  1. glucose [ Time Frame: 10 min ]


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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
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-diabets

Exclusion Criteria:

  • hypertension,fever,AIDS,hemophilia

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): NCT00876590


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

Responsible Party: Feng-Huei Lin, Biomedical Engineering Department of National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00876590     History of Changes
Other Study ID Numbers: 9461701248
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: April 8, 2009
Last Verified: April 2009