DiabetesPhase 1NCT01913145
Comparison Study of Lay Person Finger Stick Versus Blood Draw
A Phase 1 study testing A1c, Self-collection, Blood sample in people with Diabetes, run by Home Access Health Corporation at 2 sites in United States.
Trial summary
This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- A1c, Self-collection, Blood sample
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Oct 2012
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to understand and follow verbal and written instructions in English
- Demonstrate a willingness to participate by providing a written informed consent
- Aged between 18 to 80 years of age with no obvious signs of illness (e.g. fever, vomiting)
- Diabetics who were diagnosed 6 months ago or longer are preferred. However, non-diabetics will be accepted into the study.
Who cannot join
- Withdrawn informed consent
- Mental or physical impairment which would preclude participation
- Any condition which, in the opinion of the Principle Investigator or site or study coordinator, makes the participant unsuitable for this study. This includes but is not limited to any mental or physical impairment, which would preclude provision of adequate and knowledgeable consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
L-MARC
Louisville, Kentucky, 40213
Mills-Peninsula Health Services
San Mateo, California, 94401
About this study
Official title: Usability and HbA1c Method Comparison Study Using Lay Person Micro-Blood Specimens
This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein).
Read the detailed description
This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein). The information and data obtained will be used to finish development of a convenience kit that allows doctors to provide their patients a method to have their blood tested for clinical laboratory tests in the convenience of their home without having to visit the doctor's office or clinic.
- Conditions
- Diabetes
- Being tested
- A1c, Self-collection, Blood sample
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A1c, Self-collection, Blood sampleDevice
Also called HomeAccess A1c Kit
This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein).
| Study group | Role | What they receive |
|---|---|---|
| A1c, Self-collection, Blood sample | Experimental | Can a lay-persons safely and effectively self-collect a capillary blood sample of sufficient adequacy for A1c ("HbA1c") testing in a clinical laboratory Receives: Device: A1c, Self-collection, Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability and HbA1c Method Comparison Study Using Lay-Person Micro-Blood Specimens
To establish that when using capillary blood collected in the Home Access Collection Cassette, lay-users can obtain HbA1c results equivalent to results from professionally-collected samples
Measured: Outpoint measured within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startMay 2012
- Primary completionOct 2012
- Study completionOct 2012
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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Home Access Health Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Klonoff, MD, Principal investigator, Mills-Peninsula Health Services Dorothy L. and James E. Frank Diabetes Research Institute 100 South San Mateo Drive San Mateo, California 94401Harold E. Bayes, MD, Principal investigator, L-MARC, 3288 Illinois Ave., Louisville, KY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913145
- Sponsor's protocol ID
- 040412
- Status last verified
- Apr 2014
- First submitted
- 21 Mar 2013
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability and HbA1c Method Comparison Study Using Lay Person Micro-Blood Specimens
- ClinicalTrials.gov ID
- NCT01913145
- Acronym / sponsor ID
- 040412
- Conditions
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Home Access Health CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 31 Jul 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.
This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein).
Detailed description
This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein). The information and data obtained will be used to finish development of a convenience kit that allows doctors to provide their patients a method to have their blood tested for clinical laboratory tests in the convenience of their home without having to visit the doctor's office or clinic.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A1c, Self-collection, Blood sample | Experimental | Device: A1c, Self-collection, Blood sampleCan a lay-persons safely and effectively self-collect a capillary blood sample of sufficient adequacy for A1c ("HbA1c") testing in a clinical laboratory |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to understand and follow verbal and written instructions in English
- Demonstrate a willingness to participate by providing a written informed consent
- Aged between 18 to 80 years of age with no obvious signs of illness (e.g. fever, vomiting)
- Diabetics who were diagnosed 6 months ago or longer are preferred. However, non-diabetics will be accepted into the study.
Key exclusion criteria (3 listed)
- Withdrawn informed consent
- Mental or physical impairment which would preclude participation
- Any condition which, in the opinion of the Principle Investigator or site or study coordinator, makes the participant unsuitable for this study. This includes but is not limited to any mental or physical impairment, which would preclude provision of adequate and knowledgeable consent.
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 |
|---|---|---|
| A1c, Self-collection, Blood sampleAlso: HomeAccess A1c KitThis is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein). | Device | A1c, Self-collection, Blood sample |
Primary outcome
Usability and HbA1c Method Comparison Study Using Lay-Person Micro-Blood Specimens
Time frame: Outpoint measured within 3 months
To establish that when using capillary blood collected in the Home Access Collection Cassette, lay-users can obtain HbA1c results equivalent to results from professionally-collected samples
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 21 Apr 2014.
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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.
David Klonoff, MD principal investigator
Mills-Peninsula Health Services Dorothy L. and James E. Frank Diabetes Research Institute 100 South San Mateo Drive San Mateo, California 94401
Harold E. Bayes, MD principal investigator
L-MARC, 3288 Illinois Ave., Louisville, KY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing A1c, Self-collection, Blood sample in people with Diabetes, run by Home Access Health Corporation at 2 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 4 inclusion and 3 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Usability and HbA1c Method Comparison Study Using Lay-Person Micro-Blood Specimens (time frame: Outpoint measured within 3 months). 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 21 Apr 2014.