A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate

Withdrawn before enrolling · Not applicable

Conditions studied: Diabetes, Anemia

In brief

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.

Key facts

Study ID

NCT01934842

Run by

Seventh Sense Biosystems

People needed

0

Starts

2013-09-01

Expected to finish

2013-09-01

Last updated by the study team

2014-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy Subject Group
• Male and female volunteers 18 years of age or older.
• Voluntary written consent to participate in this study.
• Diabetic Subject Group
• Male and female volunteers 18 years of age or older.
• Have been diagnosed with Type 1 or Type 2 diabetes mellitus by self-report.
• Voluntary written consent to participate in this study.

You may not qualify if…

• Subjects who are pregnant or nursing mothers by self-report.
• Subjects who have eaten or consumed sugar-containing drinks in the 2 hours before blood sample collection begins.
• Subjects with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested.
• Subjects with a missing index or middle finger on either hand or a missing forearm
• Subjects who have known allergies to titanium.

Where it is running

• Seventh Sense Biosytems — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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