Glucose Monitor Accuracy Investigation (Ⅰ)

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