DiabetesNCT01268345
AST Clinical Investigation
A study testing blood glucose monitor in people with Diabetes, run by Andon Medical Co.,Ltd at 1 site in China.
Trial summary
Blood glucose monitoring system are tested in the alternative site to validate the accuracy of the blood glucose. Read more about this study
- Who is it for?
- Ages 21 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- blood glucose monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Dec 2010
- Phase
- Interventional
- 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 21 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- people ( disbetes people)with at least 8 hours of limosis
Who cannot join
- After meal(when doing the test)
- take Hypoglycemic Drugs(when doing the test)
- with insulin(when doing the test)
- after strenuous exercise(when doing the test)
- Pregnant women
- neonates
- patients in a hyperglycemic-hyperosmolur state, with or without ketosis.
- patients who are dehydrated, hypertensive, hypotensive or in shock.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Hexi Ruijing metabolism hospital
Tianjin, Tianjin Municipality
About this study
Blood glucose monitoring system are tested in the alternative site to validate the accuracy of the blood glucose.
- Conditions
- Diabetes
- Being tested
- blood glucose monitor
- Keywords
- blood glucose
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood glucose monitorDevice
Also called Andon blood glucose monitor
Blood glucose monitor is used to monitor the blood glucose level of the human-being
blood glucose monitorDevice
Also called Lifescan blood glucose monitor
Blood glucose monitor is used to monitor the blood glucose level of the human-being.
| Study group | Role | What they receive |
|---|---|---|
| Andon | Experimental | Andon blood glucose test strips with test meter Receives: Device: blood glucose monitor |
| Lifescan | Active comparator | Not described Receives: Device: blood glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose value
Measured: 5 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andon Medical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268345
- Sponsor's protocol ID
- AndonMedical2
- Status last verified
- Dec 2010
- First submitted
- 29 Dec 2010
- Last updated
- 30 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AST Clinical Investigation
- ClinicalTrials.gov ID
- NCT01268345
- Acronym / sponsor ID
- AndonMedical2
- Conditions
- Diabetes
- Keywords
- blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Andon Medical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Dec 2010 (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.
Blood glucose monitoring system are tested in the alternative site to validate the accuracy of the blood glucose.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Andon | Experimental | Device: blood glucose monitorAndon blood glucose test strips with test meter |
| Lifescan | Active comparator | Device: blood glucose monitor |
Who may qualify
- Ages
- 21 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- people ( disbetes people)with at least 8 hours of limosis
Key exclusion criteria (8 listed)
- After meal(when doing the test)
- take Hypoglycemic Drugs(when doing the test)
- with insulin(when doing the test)
- after strenuous exercise(when doing the test)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood glucose monitorAlso: Andon blood glucose monitorBlood glucose monitor is used to monitor the blood glucose level of the human-being | Device | Andon |
| blood glucose monitorAlso: Lifescan blood glucose monitorBlood glucose monitor is used to monitor the blood glucose level of the human-being. | Device | Lifescan |
Primary outcome
blood glucose value
Time frame: 5 seconds
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 30 Dec 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood glucose monitor in people with Diabetes, run by Andon Medical Co.,Ltd at 1 site in China.
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 8 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 30 Dec 2010. 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 China. 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?
blood glucose value (time frame: 5 seconds). 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 30 Dec 2010.