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

S

Seventh Sense Biosystems

Status

Withdrawn

Conditions

Anemia
Diabetes

Treatments

Device: TAP20-C
Device: SAFE-T-FILL

Study type

Interventional

Funder types

Industry

Identifiers

NCT01934842
13-P005

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 2 patient groups

TAP20-C
Experimental group
Description:
TAP20-C
Treatment:
Device: TAP20-C
SAFE-T-FILL
Active Comparator group
Description:
SAFE-T-FILL
Treatment:
Device: SAFE-T-FILL

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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