- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01914302
The Characterization of Blood Volumes of Commercially Available Lancing Devices
August 1, 2013 updated by: Facet Technologies
Lancing Device Blood Volume Study
Characterize expressed blood volume ≥1μL across representative, commercially available lancing device systems using finger sticks.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
64
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Georgia
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Kennesaw, Georgia, United States, 30144
- Facet Technologies
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
People with diabetes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- Subjects working for Facet, LifeScan Inc., or a competitive company.
- Subjects with missing digits.
- Subjects who are pregnant or nursing.
- Subjects on chemotherapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Delica Lancing Device
Subjects in this group either use the Delica lancing device or a meter that requires 1.0 microliters of blood
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
Characterize Blood Volume and Pain under normal use circumstances
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
between 1 and 10 days after first visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain rating measure on a 0-20 Gracely Scale
Time Frame: between 1 and 10 days after first visit
|
Subjects were asked to rate pain on Gracely scale after each lancing even on the finger
|
between 1 and 10 days after first visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Barry Ginsberg, MD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
July 31, 2013
First Submitted That Met QC Criteria
August 1, 2013
First Posted (Estimate)
August 2, 2013
Study Record Updates
Last Update Posted (Estimate)
August 2, 2013
Last Update Submitted That Met QC Criteria
August 1, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- FT6000682013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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