NCT02045758

Brief Summary

This study will compare blood collection from the forearm using an investigational device TAP20-C to blood collection from the fingertip.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 3, 2014

Status Verified

September 1, 2014

Enrollment Period

6 months

First QC Date

January 22, 2014

Last Update Submit

September 2, 2014

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Non-Inferiority of Analyte Levels

    The study will compare the concentrations of various analytes in blood samples collected by both collection methods in a single 2 hour session.

    Day 1

Study Arms (2)

TAP20-C

EXPERIMENTAL

TAP20-C

Device: TAP20-C

Fingerstick

ACTIVE COMPARATOR

Fingerstick

Device: Fingerstick

Interventions

FingerstickDEVICE
Fingerstick
TAP20-CDEVICE
TAP20-C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seventh Sense Biosystems

Cambridge, Massachusetts, 02141, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Howard Bernstein, MD, Phd

CONTACT

617-547-7246hbernstein@7sbio.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 27, 2014

Study Start

December 1, 2014

Primary Completion

June 1, 2015

Study Completion

September 1, 2015

Last Updated

September 3, 2014

Record last verified: 2014-09

Locations

US(1)