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

NCT ID: NCT01934842

Last Updated: 2014-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Anemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TAP20-C

TAP20-C

Group Type EXPERIMENTAL

TAP20-C

Intervention Type DEVICE

SAFE-T-FILL

SAFE-T-FILL

Group Type ACTIVE_COMPARATOR

SAFE-T-FILL

Intervention Type DEVICE

Interventions

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TAP20-C

Intervention Type DEVICE

SAFE-T-FILL

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seventh Sense Biosystems

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seventh Sense Biosytems

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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13-P005

Identifier Type: -

Identifier Source: org_study_id