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

NCT ID: NCT01786408

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WITHDRAWN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

2013-03-31

Study Completion Date

2013-03-31

Brief Summary

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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.

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

Single Use Integrated Capillary Blood Collection System

Group Type EXPERIMENTAL

TAP20-C

Intervention Type DEVICE

SAFE-T-FILL CAPILLARY SYSTEM

Single Use Capillary Blood Collection System

Group Type ACTIVE_COMPARATOR

SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM

Intervention Type DEVICE

Interventions

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TAP20-C

Intervention Type DEVICE

SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM

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

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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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 BIosystems

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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13-P001

Identifier Type: -

Identifier Source: org_study_id