Glucose Monitor Accuracy Investigation (Ⅰ)

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National Taiwan University

Status

Completed

Conditions

Healthy

Study type

Observational

Funder types

Other

Identifiers

NCT00877461
9461700317

Details and patient eligibility

About

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.

Full 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).

Enrollment

308 patients

Sex

All

Ages

15 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • volunteers with diabetes and non-diabetes

Exclusion criteria

  • hypertension,fever,AIDS,hemophilia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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