Status:
COMPLETED
The Characterization of Blood Volumes of Commercially Available Lancing Devices
Lead Sponsor:
Facet Technologies
Collaborating Sponsors:
LifeScan
Conditions:
Diabetes
Eligibility:
All Genders
18-75 years
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 characteri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01914302
Start Date
July 1 2013
End Date
July 1 2013
Last Update
August 2 2013
Active Locations (1)
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1
Facet Technologies
Kennesaw, Georgia, United States, 30144