Glucose Monitor Accuracy Investigation (Ⅱ)

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00876590
First received: April 6, 2009
Last updated: April 7, 2009
Last verified: April 2009
  Purpose

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
Healthy

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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • glucose [ Time Frame: 10 min ] [ Designated as safety issue: Yes ]

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).

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 6, 2009
Last Updated: April 7, 2009
Health Authority: Taiwan: Department of Health

ClinicalTrials.gov processed this record on August 27, 2014