Diabetes
Conditions
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
Interventions
DEVICEFastclix Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
DEVICEDelica Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
DEVICEFlash Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
DEVICEEasy Touch Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
DEVICEGlucoject Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
DEVICEMicrolet Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
DEVICEMulticlix Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
DEVICEReli-On Lancing Device
Characterize Blood Volume and Pain under normal use circumstances
Sponsors
LifeScan
Facet Technologies
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Volumes measured in microliters | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain rating measure on a 0-20 Gracely Scale | between 1 and 10 days after first visit | Subjects were asked to rate pain on Gracely scale after each lancing even on the finger |
Countries
United States
Outcome results
None listed