Glucose Monitor Accuracy Investigation (Ⅰ)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00877461

Enrollment

308

Registered

2009-04-07

Start date

2005-05-31

Completion date

2005-12-31

Last updated

2009-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

15 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* volunteers with diabetes and non-diabetes

Exclusion criteria

* hypertension,fever,AIDS,hemophilia

Design outcomes

Primary

Measure	Time frame
glucose	10 min

Countries

Taiwan

Outcome results