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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Glucose Monitor Accuracy Investigation (Ⅰ)|
- glucose [ Time Frame: 10 min ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2005|
|Study Completion Date:||December 2005|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877461
|National Taiwan University Hospital|
|Study Director:||Feng-Huei Lin, PhD||Biomedical Engineering Department of National Taiwan University Hospital|