Glucose Monitor Accuracy Investigation (Ⅱ)

National Taiwan University

Status: Completed

Conditions: Healthy

Study type: Observational

Funder types: Other

Identifiers

NCT00876590

9461701248

Details and patient eligibility

About

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.

Full 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).

Enrollment: 319 patients

Sex: All

Ages: 15 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• volunteers with diabetes and non-diabets

Exclusion criteria

• hypertension,fever,AIDS,hemophilia