Diabetes Mellitus, Type 1NCT01740778
Lancing Device Comparison Study
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Facet Technologies.
Trial summary
To evaluate pain responses using the Aurora lancing device and Velvet 33g lancet compared to other common, commercially available lancing systems. Subjects will test the devices at a depth setting sufficient to provide enough blood volume to trigger the OneTouch® Ultra®Mini blood glucose meter using OneTouch® Ultra®… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Sep 2009
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Gender: Approximately 50% male, 50% female; Type Diabetes: 25% Type 1, 75% Type 2 Age: 18 or older
Who may be able to join
- Must have been diagnosed with type 1 or type 2 diabetes for at least 1 year Must be doing SMBG, at least twice daily for at least 6 months Must be 18 years of age and older Must have healthy fingers and hands Must be able to read instructions in English. Must be able to perform all tasks in the protocol.
Who cannot join
- Subjects with neuropathy or any other nerve damage in the hand or fingers (this will be discovered through the monofilament test)
- Subjects who are taking prescription anti-coagulants or more than one full aspirin per day during the past week or have clotting problems that may prolong bleeding (persons taking Plavix or a daily low dose aspirin will not be excluded but this will be recorded).
- Subjects taking prescription medications for neuropathy.
- Subjects with hemophilia or any other bleeding disorder.
- subjects with infection with a blood borne pathogen (e.g., HIV, hepatitis).
- Subjects having a condition such as a cognitive disorder, which in the opinion of the Investigator would put the person at risk or seriously compromise the integrity of the study (PI will sign CRF if subject is excluded).
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- Subjects with missing digits.
- Subjects who are pregnant or nursing.
- Subjects on chemotherapy.
About this study
To evaluate pain responses using the Aurora lancing device and Velvet 33g lancet compared to other common, commercially available lancing systems. Subjects will test the devices at a depth setting sufficient to provide enough blood volume to trigger the OneTouch® Ultra®Mini blood glucose meter using OneTouch® Ultra® blood glucose test strips from either the fingertip or alternate site testing.
Read the detailed description
A low-pain lancing is being developed code name Aurora) for use with a 33g proprietary lancet (code name Velvet). This study evaluates the pain associated with finger lancing using this device and compares that pain to other commercially available lancing devices and associated lancets.
All lancets used in the study are currently commercially available except the Facet 33g lancet, which is a prototype version of commercially available lancets.
The Roche Multiclix, Roche Softclix, One Touch Comfort and Bayer Microlet 2 lancing devices are all commercially available.
The Aurora Lancing Device is effective in obtaining a sufficient blood sample for performing an accurate blood glucose measurement; and the benefits of using the Aurora Lancing Device outweighs any residual risks associated with the product. Literature concerning blood glucose testing was researched by using popular medical databases such as pubmed.gov, diabeteshealth.com, clinicaltrial.gov and search terms lancing device, clinical study, blood volume and pain. Using other popular search engines such as Google was beneficial in helping to support claims concerning safety and efficacy. A commercial database company, NERAC was used as a part of the literature research effort. Our review, together with preliminary in-house bench testing, shows that the Aurora Lancing Device should be able to:
- Obtain enough blood volume for a meter reading that measures blood glucose levels;
- Is as safe as comparative lancing devices currently on the market;
- Produces no more pain than comparative lancing devices currently on the market using a 28 gauge needle; and
- Is representative of "current state of the art" The Aurora Lancing Device uses a 33 gauge, uniquely designed lancet developed under project Velvet. The blood lancet is designed so that it can only be used in the Aurora lancing device. The lancing device features multiple depth settings and includes alternate site test capability. The lancet guidance system is designed to maximize lancet control thereby increasing comfort and reducing pain perception. The Aurora lancing device is comparable to the Roche Softclix and other lancing devices already in commercial distribution. Like Aurora the Roche Softclix lancing device offers diabetics a unique lancet design and precise lancet motion. Roche Softclix uses a 28 gauge lancet and has eleven depth settings as well as alternative site test capability.
- Keywords
- Diabetes, Medical Device, Lancing
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus
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 |
|---|---|---|
| Study Group 1 | Aurora vs. Microlet 2 | |
| Study Group 2 | Aurora vs. SoftClix | |
| Study Group 3 | Aurora vs. One Touch Comfort | |
| Study Group 4 | Aurora vs. Multiclix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose Reading
During the first part of the study, subjects will test their lancing devices at a depth setting sufficient to provide enough blood volume to trigger the OneTouch® Ultra®Mini blood glucose meter using OneTouch® Ultra® blood glucose test strips.
The second part of the study will generate the pain data associated with the Alternate site testing (AST) will also be performed on the palm of the hand and the forearm with the Aurora device and Velvet 33g lancet.
Each lancing event, in the first portion of the study, is considered successful if at least 2 out of 3 lancing events are successful in producing enough blood to trigger the One Touch® Ultra®Mini blood glucose meter.
Measured: 1-1 hour visit during the study
Secondary outcomes (1)
Pain Scale Rating
The second part of the study will generate the pain data associated with the Aurora device and Velvet 33g lancet along with the study comparative device. During the second visit, alternate site testing (AST) will also be performed on the palm of the hand and the forearm with the Aurora device and Velvet 33g lancet.
The second portion of the study will compare and report the differences in pain between the device/lancet combinations. Pain will be assessed for each successful fingerstick per the visual analog scale (VAS).
Measured: 1- 1 hour visit during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startAug 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Facet Technologies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Kate Pynes, Facet Technologies
- Investigators
- Ashley Shemain, MBA, Principal investigator, SHEMAIN CONSULTING GROUP, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740778
- Sponsor's protocol ID
- FT-2009-Aurora
- Status last verified
- Nov 2012
- First submitted
- 26 Nov 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lancing Device Comparison Study
- ClinicalTrials.gov ID
- NCT01740778
- Acronym / sponsor ID
- FT-2009-Aurora
- Keywords
- Diabetes, Medical Device, Lancing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Facet TechnologiesUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 4 Dec 2012 (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.
To evaluate pain responses using the Aurora lancing device and Velvet 33g lancet compared to other common, commercially available lancing systems. Subjects will test the devices at a depth setting sufficient to provide enough blood volume to trigger the OneTouch® Ultra®Mini blood glucose meter using OneTouch® Ultra® blood glucose test strips from either the fingertip or alternate site testing.
Detailed description
A low-pain lancing is being developed code name Aurora) for use with a 33g proprietary lancet (code name Velvet). This study evaluates the pain associated with finger lancing using this device and compares that pain to other commercially available lancing devices and associated lancets.
All lancets used in the study are currently commercially available except the Facet 33g lancet, which is a prototype version of commercially available lancets.
The Roche Multiclix, Roche Softclix, One Touch Comfort and Bayer Microlet 2 lancing devices are all commercially available.
The Aurora Lancing Device is effective in obtaining a sufficient blood sample for performing an accurate blood glucose measurement; and the benefits of using the Aurora Lancing Device outweighs any residual risks associated with the product. Literature concerning blood glucose testing was researched by using popular medical databases such as pubmed.gov, diabeteshealth.com, clinicaltrial.gov and search terms lancing device, clinical study, blood volume and pain. Using other popular search engines such as Google was beneficial in helping to support claims concerning safety and efficacy. A commercial database company, NERAC was used as a part of the literature research effort. Our review, together with preliminary in-house bench testing, shows that the Aurora Lancing Device should be able to:
- Obtain enough blood volume for a meter reading that measures blood glucose levels;
- Is as safe as comparative lancing devices currently on the market;
- Produces no more pain than comparative lancing devices currently on the market using a 28 gauge needle; and
- Is representative of "current state of the art" The Aurora Lancing Device uses a 33 gauge, uniquely designed lancet developed under project Velvet. The blood lancet is designed so that it can only be used in the Aurora lancing device. The lancing device features multiple depth settings and includes alternate site test capability. The lancet guidance system is designed to maximize lancet control thereby increasing comfort and reducing pain perception. The Aurora lancing device is comparable to the Roche Softclix and other lancing devices already in commercial distribution. Like Aurora the Roche Softclix lancing device offers diabetics a unique lancet design and precise lancet motion. Roche Softclix uses a 28 gauge lancet and has eleven depth settings as well as alternative site test capability.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | – | –Aurora vs. Microlet 2 |
| Study Group 2 | – | –Aurora vs. SoftClix |
| Study Group 3 | – | –Aurora vs. One Touch Comfort |
| Study Group 4 | – | –Aurora vs. Multiclix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gender: Approximately 50% male, 50% female; Type Diabetes: 25% Type 1, 75% Type 2 Age: 18 or older
Key inclusion criteria (1 listed)
- Must have been diagnosed with type 1 or type 2 diabetes for at least 1 year Must be doing SMBG, at least twice daily for at least 6 months Must be 18 years of age and older Must have healthy fingers and hands Must be able to read instructions in English. Must be able to perform all tasks in the protocol.
Key exclusion criteria (9 listed)
- Subjects with neuropathy or any other nerve damage in the hand or fingers (this will be discovered through the monofilament test)
- Subjects who are taking prescription anti-coagulants or more than one full aspirin per day during the past week or have clotting problems that may prolong bleeding (persons taking Plavix or a daily low dose aspirin will not be excluded but this will be recorded).
- Subjects taking prescription medications for neuropathy.
- Subjects with hemophilia or any other bleeding disorder.
- subjects with infection with a blood borne pathogen (e.g., HIV, hepatitis).
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
Blood Glucose Reading
Time frame: 1-1 hour visit during the study
During the first part of the study, subjects will test their lancing devices at a depth setting sufficient to provide enough blood volume to trigger the OneTouch® Ultra®Mini blood glucose meter using OneTouch® Ultra® blood glucose test strips. The second part of the study will generate the pain data associated with the Alternate site testing (AST) will also be performed on the palm of the hand and the forearm with the Aurora device and Velvet 33g lancet. Each lancing event, in the first portion of the study, is considered successful if at least 2 out of 3 lancing events are successful in producing enough blood to trigger the One Touch® Ultra®Mini blood glucose meter.
1 secondary outcome
Pain Scale Rating
Time frame: 1- 1 hour visit during the study
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 4 Dec 2012.
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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.
Ashley Shemain, MBA principal investigator
SHEMAIN CONSULTING GROUP, LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Facet Technologies.
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 9 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 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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 Reading (time frame: 1-1 hour visit during the study). 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 4 Dec 2012.