NCT02718703

Brief Summary

Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of a new Blood Glucose Monitoring System.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable diabetes-mellitus

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 1, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

28 days

First QC Date

March 1, 2016

Last Update Submit

September 12, 2016

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

  • User Performance (UP) evaluation - blood glucose level: BGMS vs reference instrument.

    UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by subject and HCP ( HealthCare Professional)

    Up to 1 hour

  • System Accuracy (SA) evaluation - blood glucose level: BGMS vs reference instrument.

    Accuracy verification of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only.

    Up to 1 hour

  • System Use Evaluation - HCP ( HealthCare Professional) questionnaire

    Assessing use of BGMS and supporting material by subject.

    Up to 1 hour

Study Arms (1)

Blood Glucose monitoring System (BGMS)

EXPERIMENTAL

Intervention: Blood Glucose monitoring System (BGMS) Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI)

Device: Blood Glucose Monitoring System.

Interventions

Blood Glucose Monitoring System.DEVICE

In vitro diagnostic medical device

Blood Glucose monitoring System (BGMS)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Able to voluntarily provide written informed consent to participate in the study.
  • User Performance Accuracy Testing Only: Self-Monitoring - Subject is currently performing unassisted self-monitoring of blood glucose.

You may not qualify if:

  • Female subjects who are pregnant or lactating.
  • Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
  • User Performance Accuracy Testing Only -Prior involvement with the investigational BGMS being used in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BioKinetic Europe Ltd

Belfast, Antrim, BT2 7BA, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Lorna Stewart

    LifeScan

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 1, 2016

First Posted

March 24, 2016

Study Start

February 1, 2015

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

September 14, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)