Glucose Monitor Accuracy Investigation (Ⅱ)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00876590

Enrollment

319

Registered

2009-04-07

Start date

2006-04-30

Completion date

2006-12-31

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 as samples to evaluate the accuracy of portable BGM.

Detailed 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).

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-diabets

Exclusion criteria

* hypertension,fever,AIDS,hemophilia

Design outcomes

Primary

Measure	Time frame
glucose	10 min

Countries

Taiwan

Outcome results