NCT02767336

Brief Summary

Clinical Evaluation including System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
174

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

4 active sites

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

April 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

1 month

First QC Date

May 6, 2016

Last Update Submit

September 12, 2016

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (5)

  • User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument.

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

    Up to 1 hour

  • System Accuracy (SA) evaluation measured by blood glucose level(mg/dl) of BGMSs 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 questionnaire.

    Assessment of how the patient uses the BGMS.

    Up to 15 minutes

  • Instructions for Use Evaluation questionnaire.

    Questionnaires to assess the effectiveness of the instructions for use.

    Up to 6 days.

  • Marketing Claims Evaluation questionnaire.

    Assess Lay User Acceptance of the Bloom BGMS in support of marketing claims.

    Up to 6 days.

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

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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.
  • For subjects participating in the In Vivo Glucose adjustment procedure age range is 18 - 45.

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 (4)

BioKinetic Europe Ltd

Belfast, Antrim, BT2 7BA, United Kingdom

Location

Diabetes Centre, Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

NHS Lothian

Edinburgh, EH16 4SA, United Kingdom

Location

Highland Diabetes Institute

Inverness, IV2 3JH, 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 Scotland Ltd

    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

May 6, 2016

First Posted

May 10, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 14, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(4)