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

Seventh Sense Biosystems

Status: Unknown

Conditions: Diabetes

Treatments: Device: Fingerstick; Device: TAP20-C

Study type: Interventional

Funder types: Industry

Identifiers

NCT02045758

14-P002

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 fingertip.

Enrollment: 120 estimated patients

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
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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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

TAP20-C

Experimental group

Description:

TAP20-C

Treatment:

Device: TAP20-C

Fingerstick

Active Comparator group

Description:

Fingerstick

Treatment:

Device: Fingerstick