A Study to Compare Analytes in Blood Collected Using an Investigational Collection Device With a Commercial Predicate
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
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Started Mar 2013
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2013
CompletedFirst Posted
Study publicly available on registry
February 8, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedNovember 25, 2014
May 1, 2013
Same day
February 4, 2013
November 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
TAP20-C
EXPERIMENTALSingle Use Integrated Capillary Blood Collection System
SAFE-T-FILL CAPILLARY SYSTEM
ACTIVE COMPARATORSingle Use Capillary Blood Collection System
Interventions
Eligibility Criteria
You may qualify if:
- Healthy Subject Group
- \. Male and female volunteers 18 years of age or older
- Diabetic Subject Group
- Male and female volunteers 18 years of age or older
- Have been diagnosed with Type 1 or Type 2 diabetes mellitus by self-report
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seventh Sense BIosystems
Cambridge, Massachusetts, 02141, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2013
First Posted
February 8, 2013
Study Start
March 1, 2013
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
November 25, 2014
Record last verified: 2013-05