The Characterization of Blood Volumes of Commercially Available Lancing Devices

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

Detailed Description
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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

Official Title
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Lancing Device Blood Volume Study

Conditions
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Diabetes

Intervention / Treatment
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* Device: Delica Lancing Device
* Device: Flash Lancing Device
* Device: Easy Touch Lancing Device
* Device: Glucoject Lancing Device
* Device: Microlet Lancing Device
* Device: Multiclix Lancing Device
* Device: Fastclix Lancing Device
* Device: Reli-On Lancing Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Delica Lancing Device<br>Subjects in this group either use the Delica lancing device or a meter that requires 1.0 microliters of blood | Device: Delica Lancing Device<br>* Characterize Blood Volume and Pain under normal use circumstances<br>|
| Freestyle Flash Lancing Device<br>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<br>* Characterize Blood Volume and Pain under normal use circumstances<br>|
| Easy Touch Lancing Device<br>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<br>* Characterize Blood Volume and Pain under normal use circumstances<br>|
| Glucoject Lancing Device<br>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<br>* Characterize Blood Volume and Pain under normal use circumstances<br>|
| Microlet Lancing Device<br>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<br>* Characterize Blood Volume and Pain under normal use circumstances<br>|
| Multiclix Lancing Device<br>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<br>* Characterize Blood Volume and Pain under normal use circumstances<br>|
| Fastclix Lancing Device<br>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<br>* Characterize Blood Volume and Pain under normal use circumstances<br>|
| Reli-On Lancing Device<br>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<br>* Characterize Blood Volume and Pain under normal use circumstances<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |