Diabetes Clinical Trial
Official title:
Lancing Device Blood Volume Study
Characterize expressed blood volume ≥1μL across representative, commercially available lancing device systems using finger sticks.
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
;
Observational Model: Case-Only, Time Perspective: Cross-Sectional
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