NCT02606838

Brief Summary

The purpose of this study was to determine if untrained subjects with diabetes could perform basic tasks with the Styx lancing device to obtain adequate blood volume from fingerstick and palm lancings for Blood Glucose Meter testing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 12, 2017

Completed
Last Updated

May 12, 2017

Status Verified

December 1, 2016

Enrollment Period

1 month

First QC Date

November 13, 2015

Results QC Date

December 12, 2016

Last Update Submit

April 4, 2017

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 28 Gauge Lancets)

    Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain fingerstick capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.

    1 hour

Secondary Outcomes (4)

  • Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 28 Gauge Lancets)

    1 hour

  • Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 30 Gauge Lancets)

    1 hour

  • Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 30 Gauge Lancets)

    1 hour

  • Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device

    1 hour

Study Arms (1)

Persons with Diabetes

EXPERIMENTAL

Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.

Device: Styx Lancing Device

Interventions

Styx Lancing DeviceDEVICE

Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all.

Persons with Diabetes

Eligibility Criteria

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

You may qualify if:

  • Males and females, 18 years of age and older
  • People with type 1 or type 2 diabetes
  • People who regularly perform self-tests (at least once/day) with their own lancing device
  • Able to speak, read, and understand English
  • Willing to complete all study procedures

You may not qualify if:

  • Those with missing tips of the fingers indicated in the protocol or physically unable to lance the palm areas and all the fingers indicated in the protocol.
  • Hemophilia or any other bleeding disorder
  • Pregnancy
  • Physical, visual or neurological impairments that would make the person unable to perform testing
  • Persons who have used the Styx device in a previous clinical evaluation
  • Working for a competitive medical device company, or having an immediate family member who works for such a company
  • A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ascensia Diabetes Care

Mishawaka, Indiana, 46544, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Jane Wallace, Deputy Director for Global Clinical Affairs
Organization
Ascensia Diabetes Care
jane.wallace@ascensia.com
574-257-3063

Study Officials

  • Robert Morin, MD

    Ascensia Diabetes Care

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2015

First Posted

November 17, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 12, 2017

Results First Posted

May 12, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)