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

Not Applicable

• Conditions: Diabetes
• Interventions: Device: TAP20-C; Device: Fingerstick

• Registration Number: NCT02045758
• Lead Sponsor: Seventh Sense Biosystems

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-27
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-02
• Last Update Posted: 2014-09-03
• Study Start: 2014-12
• Primary Completion: 2015-06
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAP20-C	TAP20-C	TAP20-C
Fingerstick	Fingerstick	Fingerstick

Primary Outcome Measures

Name	Time	Method
Non-Inferiority of Analyte Levels	Day 1	The study will compare the concentrations of various analytes in blood samples collected by both collection methods in a single 2 hour session.

Trial Locations

Locations (1)

Seventh Sense Biosystems; 🇺🇸 Cambridge, Massachusetts, United States