Status:
COMPLETED
Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose
Lead Sponsor:
Becton, Dickinson and Company
Conditions:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The procurement of blood for SMBG, usually via a finger stick, is considered by many patients to be the most painful portion of diabetes therapy. This has led to the marketing of smaller gauge lancets...
Eligibility Criteria
Inclusion
- Must currently be diagnosed with either Type I or Type II diabetes mellitus.
- Must currently be performing self monitoring of blood glucose
- Must be between 18-70 years of age (inclusive).
- Must be able to read and follow study instructions in English.
Exclusion
- Pregnant (self reported)
- History of poor blood circulation.
- Any skin condition on his or her fingers that prevents blood sampling.
- History of a bleeding disorder.
- Neuropathy or other condition affecting sensation in the hands.
- Self-reported blood borne infection (e.g., HIV, hepatitis B or C \[non A, non B\], syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, T lymphotropic virus Type 1, Creutzfeldt-Jakob disease).
- Currently participating in another study
- Employed by BD, J\&J, Roche or the Clinical Site.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00741390
Start Date
August 1 2008
End Date
September 1 2008
Last Update
March 10 2010
Active Locations (4)
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1
Thomas J. Stephens & Associates
Colorado Springs, Colorado, United States, 80915-3540
2
TKL Research, Inc.
Carlstadt, New Jersey, United States, 07072
3
TKL Research, Inc
Paramus, New Jersey, United States, 07652
4
TKL Research, Inc.
Ramsey, New Jersey, United States, 07446