A Study to Compare Analytes in Blood Collected Using an Investigational Collection Device With a Commercial Predicate
| Status: | Completed |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2013 |
| Start Date: | March 2013 |
| End Date: | December 2013 |
A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick Using the SAFE-T-FILL Capillary Blood Collection System
This study will involve an investigational device, the Seventh Sense Biosystems TAP20-C. The
TAP20-C device collects small amounts of blood from the forearm which can then be used for
blood testing. The study will also involve collecting blood by fingerstick which is a common
way of collecting blood. The SAFE-T-FILL Capillary Blood Collection system and the Terumo
Capiject 1.5 mm Blade Safety Lancet will be used for this. The study will compare the
concentrations of glucose, hemoglobin, and HbA1C in blood samples collected with the two
different blood collection methods. Additional information will be collected about how the
TAP20-C device performs.
Inclusion Criteria:
Healthy Subject Group
1. Male and female volunteers 18 years of age or older
Diabetic Subject Group
1. Male and female volunteers 18 years of age or older
2. Have been diagnosed with Type 1 or Type 2 diabetes mellitus by self-report
Exclusion Criteria:
1.Subjects who are pregnant or nursing mothers by self report 2.Subjects who have eaten or
consumed sugar-containing drinks in the 2 hours before blood sample collection begins
3.Subjects with a history of skin disorders or who present with abnormal skin integrity or
atypical skin health within the areas to be tested 4.Subjects with a missing index or
middle finger on either hand or a missing forearm 5.Subjects who have known allergies to
titanium
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