A Study to Compare Analytes 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Clinical Trial Details — Status: Withdrawn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: NCT01786408
• Other study ID #: 13-P001
• Status: Withdrawn
• Phase: N/A
• First received: February 4, 2013
• Last updated: November 24, 2014
• Start date: March 2013
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: Seventh Sense Biosystems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will involve an investigational device, the Seventh Sense Biosystems TAP20-C. The TAP20-C device collects small amounts of blood from the forearm which can then be used for blood testing. The study will also involve collecting blood by fingerstick which is a common way of collecting blood. The SAFE-T-FILL Capillary Blood Collection system and the Terumo Capiject 1.5 mm Blade Safety Lancet will be used for this. The study will compare the concentrations of glucose, hemoglobin, and HbA1C in blood samples collected with the two different blood collection methods. Additional information will be collected about how the TAP20-C device performs.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2013
• Est. primary completion date: March 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

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

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 CAPILLARY BLOOD COLLECTION SYSTEM

Locations

Country	Name	City	State
United States	Seventh Sense BIosystems	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 HbA1C in blood samples collected with the two different blood collection methods in a single two hour session.	Day 1	No