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

S

Seventh Sense Biosystems

Status

Withdrawn

Conditions

Anemia
Diabetes

Treatments

Device: SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
Device: TAP20-C

Study type

Interventional

Funder types

Industry

Identifiers

NCT01786408
13-P001

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 2 patient groups

TAP20-C
Experimental group
Description:
Single Use Integrated Capillary Blood Collection System
Treatment:
Device: TAP20-C
SAFE-T-FILL CAPILLARY SYSTEM
Active Comparator group
Description:
Single Use Capillary Blood Collection System
Treatment:
Device: SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems