The Characterization of Blood Volumes of Commercially Available Lancing Devices
NCT ID: NCT01914302
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
64 participants
OBSERVATIONAL
2013-07-31
2013-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
• 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Delica Lancing Device
Subjects in this group either use the Delica lancing device or a meter that requires 1.0 microliters of blood
Delica Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
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
Flash Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
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
Easy Touch Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
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
Glucoject Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
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
Microlet Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
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
Multiclix Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
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
Fastclix Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
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
Reli-On Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Delica Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
Flash Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
Easy Touch Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
Glucoject Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
Microlet Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
Multiclix Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
Fastclix Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
Reli-On Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
* Subjects working for Facet, LifeScan Inc., or a competitive company.
* Subjects with missing digits.
* Subjects who are pregnant or nursing.
* Subjects on chemotherapy.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LifeScan
INDUSTRY
Facet Technologies
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Barry Ginsberg, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Facet Technologies
Kennesaw, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FT6000682013
Identifier Type: -
Identifier Source: org_study_id