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| Name | Class |
|---|---|
| LifeScan | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delica Lancing Device | Subjects in this group either use the Delica lancing device or a meter that requires 1.0 microliters of blood |
| |
| Freestyle Flash Lancing Device | Subjects in this group either use the Flash lancing device or a meter that requires 0.3/0.6 microliters of blood |
| |
| Easy Touch Lancing Device | Subjects in this group either use the Easy Touch lancing device or a meter that requires 0.3/0.6 microliters of blood |
| |
| Glucoject Lancing Device | Subjects in this group either use the Glucoject lancing device or a meter that requires 0.3/0.6 microliters of blood |
| |
| Microlet Lancing Device | Subjects in this group either use the Microlet lancing device or a meter that requires 0.3/0.6 microliters of blood |
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| Multiclix Lancing Device |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delica Lancing Device | Device | Characterize Blood Volume and Pain under normal use circumstances |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Volumes measured in microliters | Study subject lances assigned finger and acquires blood drop; at that time the study facilitator gathers blood in pipette and measures on scale | between 1 and 10 days after first visit |
| Measure | Description | Time Frame |
|---|---|---|
| Pain rating measure on a 0-20 Gracely Scale | Subjects were asked to rate pain on Gracely scale after each lancing even on the finger | between 1 and 10 days after first visit |
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Inclusion Criteria:
Exclusion Criteria:
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People with diabetes
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| Name | Affiliation | Role |
|---|---|---|
| Barry Ginsberg, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facet Technologies | Kennesaw | Georgia | 30144 | United States |
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Subjects in this group either use the Multiclix lancing device or a meter that requires 0.3/0.6 microliters of blood |
|
| Fastclix Lancing Device | Subjects in this group either use the Fastclix lancing device or a meter that requires 0.3/0.6 microliters of blood |
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| Reli-On Lancing Device | Subjects in this group either use the Reli-On lancing device or a meter that requires 0.3/0.6 microliters of blood |
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| Flash Lancing Device | Device | Characterize Blood Volume and Pain under normal use circumstances |
|
| Easy Touch Lancing Device | Device | Characterize Blood Volume and Pain under normal use circumstances |
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| Glucoject Lancing Device | Device | Characterize Blood Volume and Pain under normal use circumstances |
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| Microlet Lancing Device | Device | Characterize Blood Volume and Pain under normal use circumstances |
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| Multiclix Lancing Device | Device | Characterize Blood Volume and Pain under normal use circumstances |
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| Fastclix Lancing Device | Device | Characterize Blood Volume and Pain under normal use circumstances |
|
| Reli-On Lancing Device | Device | Characterize Blood Volume and Pain under normal use circumstances |
|
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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