Clinical trial NCT01914302: The Characterization of Blood Volumes of Commercially Available Lancing Devices
Official title: Lancing Device Blood Volume Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Facet Technologies
Sponsor class: OTHER
Collaborators: name: LifeScan
First posted: 2013-08-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: People with diabetes

Brief summary: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Blood Volumes measured in microliters
timeFrame: between 1 and 10 days after first visit
Secondary outcomes:
measure: Pain rating measure on a 0-20 Gracely Scale
timeFrame: between 1 and 10 days after first visit
Other outcomes:
Locations:
city: Kennesaw
country: United States
facility: Facet Technologies
state: Georgia
Study officials:
name: Barry Ginsberg, MD
role: PRINCIPAL_INVESTIGATOR
References: