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Status unknownNCT02045758Updated Sep 3, 2014

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

An interventional study of Fingerstick and TAP20-C in Diabetes, sponsored by Seventh Sense Biosystems. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-03.

Sponsored by Seventh Sense Biosystems · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Sep 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetes
03

In context

Lead sponsor

Seventh Sense Biosystems is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    TAP20-C

    TAP20-C

    Device: TAP20-C

  • Active comparator
    Fingerstick

    Fingerstick

    Device: Fingerstick

Interventions

  • DeviceFingerstick
  • DeviceTAP20-C
06

What researchers measure

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.

    Time frame: Day 1

07

Study locations

1 site
  • Seventh Sense Biosystems
    Cambridge, Massachusetts 02141, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02045758
Lead sponsor
Seventh Sense Biosystems
Responsible party
Sponsor
First posted
Jan 27, 2014
Start date
Dec 2014
Primary completion
Jun 2015 (estimated)
Completion
Sep 2015 (estimated)
Last update
Sep 3, 2014

Study contacts

Howard Bernstein, MD, Phd
Contact
hbernstein@7sbio.com
617-547-7246

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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