Glucose Monitor Accuracy Investigation (Ⅰ)

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.

Completed

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Key information

Conditions

Healthy

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

volunteers with diabetes and non-diabetes

Exclusion criteria

hypertension,fever,AIDS,hemophilia

Treatment and study plan

Primary outcomes

glucose

Time frame: 10 min

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start: 2005
Primary completion: 2005
Study completion: 2005
First posted: Apr 7, 2009
Registry last updated: Apr 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed