A Study to Compare Analyte Levels 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:2/7/2015
Start Date:September 2013
End Date:February 2014

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Trial Summary
Trial Overview
Inclusion Criteria

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 compare blood collection from the forearm using an investigational device,
TAP20-C to blood collection from the finger tip. The blood collected from the forearm and
from the fingertip will then be analyzed for glucose, hemoglobin and hemoglobin A1c.


Inclusion Criteria:

Healthy Subject Group

1. Male and female volunteers 18 years of age or older.

2. Voluntary written consent to participate in this study.

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.

3. Voluntary written consent to participate in this study.

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.
We found this trial at
1
site
Seventh Sense Biosytems
Cambridge, Massachusetts 02141
?
mi
from
Cambridge, MA
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