Glucose Monitor Accuracy Investigation (Ⅱ)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Glucose Monitor Accuracy Investigation (Ⅱ)|
- glucose [ Time Frame: 10 min ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2006|
|Study Completion Date:||December 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876590
|National Taiwan University Hospital|
|Study Director:||Feng-Huei Lin, PhD||Biomedical Engineering Department of National Taiwan University Hospital|