The Characterization of Blood Volumes of Commercially Available Lancing Devices

Diabetes Clinical Trial

Official title:

Lancing Device Blood Volume Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914302
• Other study ID #: FT6000682013
• Status: Completed
• Phase: N/A
• First received: July 31, 2013
• Last updated: August 1, 2013
• Start date: July 2013
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Facet Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Characterize expressed blood volume ≥1μL across representative, commercially available lancing device systems using finger sticks.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Facet Technologies	Kennesaw	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Facet Technologies	LifeScan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	between 1 and 10 days after first visit	No
Secondary	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	between 1 and 10 days after first visit	No