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

Not Applicable

Withdrawn

• Conditions: Diabetes; Anemia
• Interventions: Device: SAFE-T-FILL; Device: TAP20-C

• Registration Number: NCT01934842
• 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 finger tip. The blood collected from the forearm and from the fingertip will then be analyzed for glucose, hemoglobin and hemoglobin A1c.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-08
• Study First Submitted: 2013-08-30
• Study Start: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Study First Submitted QC: 2013-09-03
• Study First Posted: 2013-09-04
• 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• Status: WITHDRAWN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.
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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SAFE-T-FILL	SAFE-T-FILL	SAFE-T-FILL
TAP20-C	TAP20-C	TAP20-C

Primary Outcome Measures

Name	Time	Method
Non Inferiority of Analyte Levels	Day 1	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.

Trial Locations

Locations (1)

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