HealthyNCT00877461
Glucose Monitor Accuracy Investigation (Ⅰ)
An observational study of Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 308 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2005to Dec 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The glucose concentrations of volunteer shall be distributed as specified in ISO15197 Table 3
Who may be able to join
- volunteers with diabetes and non-diabetes
Who cannot join
- hypertension,fever,AIDS,hemophilia
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startMay 2005
- Primary completionNov 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Feng-Huei Lin, PhD, Study director, Biomedical Engineering Department of National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877461
- Sponsor's protocol ID
- 9461700317
- Status last verified
- Apr 2009
- First submitted
- 6 Apr 2009
- Last updated
- 8 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Monitor Accuracy Investigation (Ⅰ)
- ClinicalTrials.gov ID
- NCT00877461
- Acronym / sponsor ID
- 9461700317
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 7 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The glucose concentrations of volunteer shall be distributed as specified in ISO15197 Table 3
Key inclusion criteria (1 listed)
- volunteers with diabetes and non-diabetes
Key exclusion criteria (1 listed)
- hypertension,fever,AIDS,hemophilia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
glucose
Time frame: 10 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng-Huei Lin, PhD study director
Biomedical Engineering Department of National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glucose (time frame: 10 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2009.