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

Not Applicable

Withdrawn

• Conditions: Anemia; Diabetes
• Interventions: Device: SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM; Device: TAP20-C

• Registration Number: NCT01786408
• Lead Sponsor: Seventh Sense Biosystems

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-04
• Study First Submitted QC: 2013-02-05
• Study First Posted: 2013-02-08
• Study Start: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-05
• Last Update Submitted: 2014-11-24
• Last Update Posted: 2014-11-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SAFE-T-FILL CAPILLARY SYSTEM	SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM	Single Use Capillary Blood Collection System
TAP20-C	TAP20-C	Single Use Integrated Capillary Blood Collection System

Primary Outcome Measures

Name	Time	Method
Non-Inferiority of Analyte Levels	Day 1	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.

Trial Locations

Locations (1)

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