Glucose Monitor Accuracy Investigation (Ⅰ)

NCT ID: NCT00877461

Last Updated: 2009-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

308 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Healthy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* volunteers with diabetes and non-diabetes

Exclusion Criteria

* hypertension,fever,AIDS,hemophilia
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Biomedical Engineering Department of National Taiwan University Hospital

Principal Investigators

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Feng-Huei Lin, PhD

Role: STUDY_DIRECTOR

Biomedical Engineering Department of National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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9461700317

Identifier Type: -

Identifier Source: org_study_id

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