Glucose Monitor Accuracy Investigation (Ⅰ)

This study has been completed.

First Received: April 6, 2009 Last Updated: April 7, 2009 History of Changes

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00877461

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, 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 ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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-diabetes

Exclusion Criteria:

hypertension,fever,AIDS,hemophilia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Biomedical Engineering Department of National Taiwan University Hospital ( Feng-Huei Lin )
Study ID Numbers:	9461700317
Study First Received:	April 6, 2009
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00877461 History of Changes
Health Authority:	Taiwan: Department of Health

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009