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Glucose Monitor Accuracy Investigation (Ⅱ)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00876590
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
April 6, 2009
April 7, 2009
April 8, 2009
April 2006
October 2006   (Final data collection date for primary outcome measure)
glucose [ Time Frame: 10 min ]
Same as current
Complete list of historical versions of study NCT00876590 on ClinicalTrials.gov Archive Site
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Glucose Monitor Accuracy Investigation (Ⅱ)
Glucose Monitor Accuracy Investigation (Ⅱ)
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.
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).
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample
The glucose concentrations of volunteer shall be distributed as specified in ISO15197 Table 3
Healthy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
319
December 2006
October 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • volunteers with diabetes and non-diabets

Exclusion Criteria:

  • hypertension,fever,AIDS,hemophilia
Sexes Eligible for Study: All
15 Years to 70 Years   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00876590
9461701248
Yes
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Feng-Huei Lin, Biomedical Engineering Department of National Taiwan University Hospital
National Taiwan University Hospital
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Study Director: Feng-Huei Lin, PhD Biomedical Engineering Department of National Taiwan University Hospital
National Taiwan University Hospital
April 2009