Status:
COMPLETED
Lancet Blood Volume Comparison Study
Lead Sponsor:
Facet Technologies
Conditions:
Diabetes
Eligibility:
All Genders
18-85 years
Brief Summary
The primary objective of the study examines the success rate of various OneTouch Delica lancet sizes across depth settings of the OneTouch Delica lancing device. The sample size is based on 30 subject...
Eligibility Criteria
Inclusion
- Must have been diagnosed with type 1 or type 2 diabetes for at least 1 year
- Must be doing Blood Glucose Monitoring, at least twice daily for at least 6 months
- Subjects must be between 18 and 85 years of age.
- 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
- 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 prescription medications for neuropathy.
- 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.
- Subjects with poor circulation to the hands as judged by a refill time of more than 5 seconds
Key Trial Info
Start Date :
February 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT01916096
Start Date
February 1 2012
End Date
February 1 2012
Last Update
August 5 2013
Active Locations (1)
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1
Facet Technologies
Kennesaw, Georgia, United States, 30144