DiabetesNCT01914302
The Characterization of Blood Volumes of Commercially Available Lancing Devices
An observational study of Diabetes, run by Facet Technologies at 1 site in United States.
Trial summary
Characterize expressed blood volume ≥1μL across representative, commercially available lancing device systems using finger sticks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Delica Lancing Device, Flash Lancing Device and Easy Touch Lancing Device
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jul 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with diabetes
Who may be able to join
- Must be diagnosed with type 1 or type 2 diabetes for one (1) or more year(s).
- Must be currently self-monitoring blood glucose levels for at least 6 months.
- Must self-test at least 2 times daily.
- Must be between the ages of 18 and 75 to participate.
- Subjects must be able to perform all tasks required in this protocol.
- Subjects must be willing to complete all study procedures.
- Subjects must be able to speak, read and understand English and understand the Informed Consent document.
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 pain relievers within 24 hours.
- 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 Case Report Form if Subject is excluded).
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- Subjects working for Facet, LifeScan Inc., or a competitive company.
- Subjects with missing digits.
- Subjects who are pregnant or nursing.
- Subjects on chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lancing Device Blood Volume Study
Characterize expressed blood volume ≥1μL across representative, commercially available lancing device systems using finger sticks.
Read the detailed description
Primary Objective:
- Characterize expressed blood volume ≥1μL across representative, commercially available lancing device systems using finger sticks.
Secondary Objectives: the following characterizations will be performed in the data analysis within each device and across each device:
- Correlation of Subject pain response to blood volume collected;
- Proportion of Subjects that produce sufficient blood to fill a 1µl test strip;
- Proportion of Subjects that generate ≥1µl blood volume;
- Proportion of Subjects who generate multiple- times the blood volume needed to fill a 1µl test strip
- Proportion of Subjects who generate multiple- times ≥1µl of blood volume
- Proportion of Subjects that produce on average (≥1µl) of blood volume on 1st attempt
- Proportion of Subjects that produce on average (≥1µl) of blood volume on their first and second lancing attempt
- Conditions
- Diabetes
- Being tested
- Delica Lancing Device, Flash Lancing Device, Easy Touch Lancing Device, Glucoject Lancing Device, Microlet Lancing Device
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delica Lancing DeviceDevice
Characterize Blood Volume and Pain under normal use circumstances
Flash Lancing DeviceDevice
Characterize Blood Volume and Pain under normal use circumstances
Easy Touch Lancing DeviceDevice
Characterize Blood Volume and Pain under normal use circumstances
Glucoject Lancing DeviceDevice
Characterize Blood Volume and Pain under normal use circumstances
Microlet Lancing DeviceDevice
Characterize Blood Volume and Pain under normal use circumstances
Multiclix Lancing DeviceDevice
Characterize Blood Volume and Pain under normal use circumstances
Fastclix Lancing DeviceDevice
Characterize Blood Volume and Pain under normal use circumstances
Reli-On Lancing DeviceDevice
Characterize Blood Volume and Pain under normal use circumstances
| Study group | Role | What they receive |
|---|---|---|
| Delica Lancing Device | Subjects in this group either use the Delica lancing device or a meter that requires 1.0 microliters of blood Receives: Device: Delica Lancing Device | |
| Freestyle Flash Lancing Device | Subjects in this group either use the Flash lancing device or a meter that requires 0.3/0.6 microliters of blood Receives: Device: Flash Lancing Device | |
| Easy Touch Lancing Device | Subjects in this group either use the Easy Touch lancing device or a meter that requires 0.3/0.6 microliters of blood Receives: Device: Easy Touch Lancing Device | |
| Glucoject Lancing Device | Subjects in this group either use the Glucoject lancing device or a meter that requires 0.3/0.6 microliters of blood Receives: Device: Glucoject Lancing Device | |
| Microlet Lancing Device | Subjects in this group either use the Microlet lancing device or a meter that requires 0.3/0.6 microliters of blood Receives: Device: Microlet Lancing Device | |
| Multiclix Lancing Device | Subjects in this group either use the Multiclix lancing device or a meter that requires 0.3/0.6 microliters of blood Receives: Device: Multiclix Lancing Device | |
| Fastclix Lancing Device | Subjects in this group either use the Fastclix lancing device or a meter that requires 0.3/0.6 microliters of blood Receives: Device: Fastclix Lancing Device | |
| Reli-On Lancing Device | Subjects in this group either use the Reli-On lancing device or a meter that requires 0.3/0.6 microliters of blood Receives: Device: Reli-On Lancing Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Volumes measured in microliters
Study subject lances assigned finger and acquires blood drop; at that time the study facilitator gathers blood in pipette and measures on scale
Measured: between 1 and 10 days after first visit
Secondary outcomes (1)
Pain rating measure on a 0-20 Gracely Scale
Subjects were asked to rate pain on Gracely scale after each lancing even on the finger
Measured: between 1 and 10 days after first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2013
- Study completionJul 2013
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Facet Technologies
- Sponsor type
- University, hospital or other
- Collaborators
- LifeScan
- Responsible party
- Sponsor
- Investigators
- Barry Ginsberg, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914302
- Sponsor's protocol ID
- FT6000682013
- Status last verified
- Aug 2013
- First submitted
- 31 Jul 2013
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lancing Device Blood Volume Study
- ClinicalTrials.gov ID
- NCT01914302
- Acronym / sponsor ID
- FT6000682013
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Facet TechnologiesUniversity, hospital or other
- Collaborators
- LifeScan
- Study start
- Jul 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Aug 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.
Characterize expressed blood volume ≥1μL across representative, commercially available lancing device systems using finger sticks.
Detailed description
Primary Objective:
- Characterize expressed blood volume ≥1μL across representative, commercially available lancing device systems using finger sticks.
Secondary Objectives: the following characterizations will be performed in the data analysis within each device and across each device:
- Correlation of Subject pain response to blood volume collected;
- Proportion of Subjects that produce sufficient blood to fill a 1µl test strip;
- Proportion of Subjects that generate ≥1µl blood volume;
- Proportion of Subjects who generate multiple- times the blood volume needed to fill a 1µl test strip
- Proportion of Subjects who generate multiple- times ≥1µl of blood volume
- Proportion of Subjects that produce on average (≥1µl) of blood volume on 1st attempt
- Proportion of Subjects that produce on average (≥1µl) of blood volume on their first and second lancing attempt
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Delica Lancing Device | – | Device: Delica Lancing DeviceSubjects in this group either use the Delica lancing device or a meter that requires 1.0 microliters of blood |
| Freestyle Flash Lancing Device | – | Device: Flash Lancing DeviceSubjects in this group either use the Flash lancing device or a meter that requires 0.3/0.6 microliters of blood |
| Easy Touch Lancing Device | – | Device: Easy Touch Lancing DeviceSubjects in this group either use the Easy Touch lancing device or a meter that requires 0.3/0.6 microliters of blood |
| Glucoject Lancing Device | – | Device: Glucoject Lancing DeviceSubjects in this group either use the Glucoject lancing device or a meter that requires 0.3/0.6 microliters of blood |
| Microlet Lancing Device | – | Device: Microlet Lancing DeviceSubjects in this group either use the Microlet lancing device or a meter that requires 0.3/0.6 microliters of blood |
| Multiclix Lancing Device | – | Device: Multiclix Lancing DeviceSubjects in this group either use the Multiclix lancing device or a meter that requires 0.3/0.6 microliters of blood |
| Fastclix Lancing Device | – | Device: Fastclix Lancing DeviceSubjects in this group either use the Fastclix lancing device or a meter that requires 0.3/0.6 microliters of blood |
| Reli-On Lancing Device | – | Device: Reli-On Lancing DeviceSubjects in this group either use the Reli-On lancing device or a meter that requires 0.3/0.6 microliters of blood |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with diabetes
Key inclusion criteria (7 listed)
- Must be diagnosed with type 1 or type 2 diabetes for one (1) or more year(s).
- Must be currently self-monitoring blood glucose levels for at least 6 months.
- Must self-test at least 2 times daily.
- Must be between the ages of 18 and 75 to participate.
- Subjects must be able to perform all tasks required in this protocol.
Key exclusion criteria (10 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 pain relievers within 24 hours.
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delica Lancing DeviceCharacterize Blood Volume and Pain under normal use circumstances | Device | Delica Lancing Device |
| Flash Lancing DeviceCharacterize Blood Volume and Pain under normal use circumstances | Device | Freestyle Flash Lancing Device |
| Easy Touch Lancing DeviceCharacterize Blood Volume and Pain under normal use circumstances | Device | Easy Touch Lancing Device |
| Glucoject Lancing DeviceCharacterize Blood Volume and Pain under normal use circumstances | Device | Glucoject Lancing Device |
| Microlet Lancing DeviceCharacterize Blood Volume and Pain under normal use circumstances | Device | Microlet Lancing Device |
| Multiclix Lancing DeviceCharacterize Blood Volume and Pain under normal use circumstances | Device | Multiclix Lancing Device |
| Fastclix Lancing DeviceCharacterize Blood Volume and Pain under normal use circumstances | Device | Fastclix Lancing Device |
| Reli-On Lancing DeviceCharacterize Blood Volume and Pain under normal use circumstances | Device | Reli-On Lancing Device |
Primary outcome
Blood Volumes measured in microliters
Time frame: between 1 and 10 days after first visit
Study subject lances assigned finger and acquires blood drop; at that time the study facilitator gathers blood in pipette and measures on scale
1 secondary outcome
Pain rating measure on a 0-20 Gracely Scale
Time frame: between 1 and 10 days after first visit
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 2 Aug 2013.
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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.
Barry Ginsberg, MD principal investigator
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 Diabetes, run by Facet Technologies at 1 site 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 10 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 2 Aug 2013. 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 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 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 Volumes measured in microliters (time frame: between 1 and 10 days after first visit). 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 2 Aug 2013.