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

Seventh Sense Biosystems

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Diabetes Anemia

Interventions

TAP20-CDEVICE

SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEMDEVICE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 \-

Locations (1)

Seventh Sense BIosystems

Cambridge, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 1

Data from ClinicalTrials.gov

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