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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • Georgia
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Delica Lancing Device
Subjects in this group either use the Delica lancing device or a meter that requires 1.0 microliters of blood
Device: 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
Device: 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
Device: 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
Device: 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
Device: 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
Device: 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
Device: 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
Device: Reli-On Lancing Device
Characterize Blood Volume and Pain under normal use circumstances

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Facet Technologies

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
LifeScan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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