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

Diabetes Clinical Trial

Official title:

A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick Using the SAFE-T-FILL Capillary Blood Collection System

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01934842
• Other study ID #: 13-P005
• Status: Withdrawn
• Phase: N/A
• First received: August 30, 2013
• Last updated: November 24, 2014
• Start date: September 2013
• Est. completion date: September 2013

Study information

• Verified date: August 2013
• Source: Seventh Sense Biosystems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anemia
• Diabetes

Intervention

Device:
• TAP20-C

• SAFE-T-FILL

Locations

Country	Name	City	State
United States	Seventh Sense Biosytems	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Seventh Sense Biosystems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non Inferiority of Analyte Levels	The study will compare the concentrations of glucose, hemoglobin and hemoglobin A1c in blood samples collected with the two different blood collection methods in a single 2 1/2 hour session.	Day 1	No