NCT01934842

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
Last Updated

November 25, 2014

Status Verified

August 1, 2013

Enrollment Period

Same day

First QC Date

August 30, 2013

Last Update Submit

November 24, 2014

Conditions

DiabetesAnemia

Outcome Measures

Primary Outcomes (1)

  • Non Inferiority of Analyte Levels

    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.

    Day 1

Study Arms (2)

TAP20-C

EXPERIMENTAL

TAP20-C

Device: TAP20-C

SAFE-T-FILL

ACTIVE COMPARATOR

SAFE-T-FILL

Device: SAFE-T-FILL

Interventions

TAP20-CDEVICE
TAP20-C
SAFE-T-FILLDEVICE
SAFE-T-FILL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Subject Group
  • Male and female volunteers 18 years of age or older.
  • Voluntary written consent to participate in this study.
  • 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.
  • Voluntary written consent to participate in this study.

You may not qualify if:

  • Subjects who are pregnant or nursing mothers by self-report.
  • Subjects who have eaten or consumed sugar-containing drinks in the 2 hours before blood sample collection begins.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seventh Sense Biosytems

Cambridge, Massachusetts, 02141, United States

Location

MeSH Terms

Conditions

Diabetes MellitusAnemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHematologic DiseasesHemic and Lymphatic Diseases
0

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

August 30, 2013

First Posted

September 4, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

November 25, 2014

Record last verified: 2013-08

Locations

US(1)