A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick

NCT ID: NCT02045758

Last Updated: 2014-09-03

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-09-30

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 fingertip.

Detailed Description

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Conditions

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Diabetes

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

Fingerstick

Fingerstick

Group Type ACTIVE_COMPARATOR

Fingerstick

Intervention Type DEVICE

Interventions

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Fingerstick

Intervention Type DEVICE

TAP20-C

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

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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 with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested.
3. Subjects with a missing index or middle finger on either hand or a missing forearm
4. 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 Biosystems

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Central Contacts

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Howard Bernstein, MD, Phd

Role: CONTACT

617-547-7246

Other Identifiers

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14-P002

Identifier Type: -

Identifier Source: org_study_id

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