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

Seventh Sense Biosystems

Status: Withdrawn

Conditions: Anemia; Diabetes

Treatments: Device: TAP20-C; Device: SAFE-T-FILL

Study type: Interventional

Funder types: Industry

Identifiers

NCT01934842

13-P005

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

TAP20-C

Experimental group

Description:

TAP20-C

Treatment:

Device: TAP20-C

SAFE-T-FILL

Active Comparator group

Description:

SAFE-T-FILL

Treatment:

Device: SAFE-T-FILL