Glucose Monitor Accuracy Investigation (Ⅰ)
Completed
- Conditions
- Healthy
- Registration Number
- NCT00877461
- Lead Sponsor
- National Taiwan University Hospital
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 308
Inclusion Criteria
- volunteers with diabetes and non-diabetes
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Exclusion Criteria
- hypertension,fever,AIDS,hemophilia
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method glucose 10 min
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan