Glucose Monitor Accuracy Investigation (Ⅰ)
This study has been completed.
Sponsor:
National Taiwan University Hospital
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00877461
First received: April 6, 2009
Last updated: April 7, 2009
Last verified: April 2009
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Purpose
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.
| Condition |
|---|
|
Healthy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Glucose Monitor Accuracy Investigation (Ⅰ) |
Resource links provided by NLM:
Further study details as provided by National Taiwan University Hospital:
Primary Outcome Measures:
- glucose [ Time Frame: 10 min ] [ Designated as safety issue: Yes ]
| Enrollment: | 308 |
| 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).
Eligibility| Ages Eligible for Study: | 15 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
The glucose concentrations of volunteer shall be distributed as specified in ISO15197 Table 3
Criteria
Inclusion Criteria:
- volunteers with diabetes and non-diabetes
Exclusion Criteria:
- hypertension,fever,AIDS,hemophilia
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877461
Locations
| Taiwan | |
| National Taiwan University Hospital | |
| Taipei, Taiwan | |
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
| Study Director: | Feng-Huei Lin, PhD | Biomedical Engineering Department of National Taiwan University Hospital |
More Information
No publications provided
| Responsible Party: | Feng-Huei Lin, Biomedical Engineering Department of National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00877461 History of Changes |
| Other Study ID Numbers: | 9461700317 |
| Study First Received: | April 6, 2009 |
| Last Updated: | April 7, 2009 |
| Health Authority: | Taiwan: Department of Health |
ClinicalTrials.gov processed this record on May 19, 2013