DiabetesNCT01829061
Reproducibility and Method Comparison Studies of the Quo-Test™ A1C System and the Quo-Lab A1C Test and CLIA Waiver Study of the Quo-Test™ A1C System
An observational study of Diabetes, run by Quotient Diagnostics Limited at 3 sites in United States.
Trial summary
The Quo-Test A1C Analyzer and Reagent Test System (Quo-Test A1C System) are intended for the in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained from fingerstick or venous samples for point-of-care testing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- How many people
- 360 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2013to Apr 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: From site's patient database
Who may be able to join
- Aged 18 years or over
- Able to read English
- Read, understood and signed the Informed Consent Form
- Agrees to participate and does not withdraw\
- Either healthy (without diabetes) or has Type 1 or Type 2 diabetes
- Exlcusion Criteria:
- Declines participation or withdraws before study completion
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ridgeview Research
Chaska, Minnesota, 55318
University of Missouri
Columbia, Missouri, 65212
AMCR Institute
Escondido, California, 92026
About this study
Official title: Reproducibility and Method Comparison of the Quo-Test™ A1C System and the Quo-Lab A1C Test and CLIA Waiver of the Quo-Test™ A1C System
The Quo-Test A1C Analyzer and Reagent Test System (Quo-Test A1C System) are intended for the in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained from fingerstick or venous samples for point-of-care testing. The Quo-Test A1C System is indicated in the management and treatment of diabetes and for monitoring long term glycemic control by diabetics. It is for multiple patient use. Only auto-disabling, single use lancing devices should be used with this system.
- Conditions
- Diabetes
- Keywords
- Type I Diabetes, Type II Diabetes, HbA1C
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No Treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective is to conduct reproducibility testing using duplicates of each of 3 levels of HbA1C
The objective is to conduct a method comparison between both the Quo-Test and Quo-Lab investigational devices and the reference method [Tosoh G8 (K071132)]. The reference method also serves as the predicate for the premarket notifications for both investigational devices. Both capillary and venous samples will be tested on the Quo-Test A1C System and Quo-Lab A1C Test, while only venous samples will be tested on the reference method.
Measured: 10 Days
Secondary outcomes (1)
Obtain CLIA Waiver Status for the Quo-Test
Measured: 10 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionApr 2014
Why it stopped: Data for Study Devices vs. Predicate not within allowable ranges.
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
- Observational
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quotient Diagnostics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Bailey, MD, Principal investigator, AMCR InstituteStephanie Svoboda, PharmD, Principal investigator, Ridgeview ResearchMichael Gardner, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829061
- Sponsor's protocol ID
- QDL Clinical Studies
- Status last verified
- Nov 2013
- First submitted
- 1 Apr 2013
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility and Method Comparison of the Quo-Test™ A1C System and the Quo-Lab A1C Test and CLIA Waiver of the Quo-Test™ A1C System
- ClinicalTrials.gov ID
- NCT01829061
- Acronym / sponsor ID
- QDL Clinical Studies
- Conditions
- Diabetes
- Keywords
- Type I Diabetes, Type II Diabetes, HbA1C
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Data for Study Devices vs. Predicate not within allowable ranges.
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Quotient Diagnostics LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Apr 2013 (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.
The Quo-Test A1C Analyzer and Reagent Test System (Quo-Test A1C System) are intended for the in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained from fingerstick or venous samples for point-of-care testing. The Quo-Test A1C System is indicated in the management and treatment of diabetes and for monitoring long term glycemic control by diabetics. It is for multiple patient use. Only auto-disabling, single use lancing devices should be used with this system.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Treatment | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- From site's patient database
Key inclusion criteria (7 listed)
- Aged 18 years or over
- Able to read English
- Read, understood and signed the Informed Consent Form
- Agrees to participate and does not withdraw\
- Either healthy (without diabetes) or has Type 1 or Type 2 diabetes
Key exclusion criteria (0 listed)
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
The objective is to conduct reproducibility testing using duplicates of each of 3 levels of HbA1C
Time frame: 10 Days
The objective is to conduct a method comparison between both the Quo-Test and Quo-Lab investigational devices and the reference method [Tosoh G8 (K071132)]. The reference method also serves as the predicate for the premarket notifications for both investigational devices. Both capillary and venous samples will be tested on the Quo-Test A1C System and Quo-Lab A1C Test, while only venous samples will be tested on the reference method.
1 secondary outcome
Obtain CLIA Waiver Status for the Quo-Test
Time frame: 10 Days
Results and safety
The study was stopped early (reason given: Data for Study Devices vs. Predicate not within allowable ranges.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
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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.
Tim Bailey, MD principal investigator
AMCR Institute
Stephanie Svoboda, PharmD principal investigator
Ridgeview Research
Michael Gardner, MD principal investigator
University of Missouri-Columbia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Quotient Diagnostics Limited at 3 sites in United States.
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 7 inclusion and 0 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: stopped early, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 was stopped early (reason given: Data for Study Devices vs. Predicate not within allowable ranges.). Results are not available in the source record.
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?
The objective is to conduct reproducibility testing using duplicates of each of 3 levels of HbA1C (time frame: 10 Days). 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 29 Mar 2016.