A Study to Compare Analyte Levels in Blood Samples Collec... | NCT02045758

Studies
A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick

NCT02045758

Sponsor

Seventh Sense Biosystems

Status

Unknown status

Last Update Posted

Sep 3, 2014Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Diabetes

Interventions

Fingerstick
TAP20-C

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Jun 2015Estimated

Completion Date

Sep 2015Estimated

First Submitted Date

Jan 22, 2014

First Submission Date that Met QC Criteria

Jan 22, 2014

First Posted Date

Jan 27, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2014

Last Update Posted Date

Sep 3, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will compare blood collection from the forearm using an investigational device TAP20-C to blood collection from the fingertip.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TAP20-C	Experimental	TAP20-C	Device: TAP20-C
Fingerstick	Active Comparator	Fingerstick	Device: Fingerstick

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fingerstick	Device		Fingerstick
TAP20-C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Non-Inferiority of Analyte Levels	The study will compare the concentrations of various analytes in blood samples collected by both collection methods in a single 2 hour session.	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Subjects who are pregnant or nursing mothers by self-report.
Subjects with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested.
Subjects with a missing index or middle finger on either hand or a missing forearm
Subjects who have known allergies to titanium.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Howard Bernstein, MD, Phd	Contact	617-547-7246		hbernstein@7sbio.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seventh Sense Biosystems		Cambridge	Massachusetts	02141	United States

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided