Project BLOOM Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation

NACompletedINTERVENTIONAL
Enrollment

174

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

May 31, 2016

Study Completion Date

May 31, 2016

Conditions
Diabetes Mellitus
Interventions
DEVICE

Blood Glucose Monitoring System.

In vitro diagnostic medical device

Trial Locations (4)

BT2 7BA

BioKinetic Europe Ltd, Belfast

B9 5SS

Diabetes Centre, Heartlands Hospital, Birmingham

EH16 4SA

NHS Lothian, Edinburgh

IV2 3JH

Highland Diabetes Institute, Inverness

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Bio-Kinetic Europe, Ltd.

INDUSTRY

lead

LifeScan

INDUSTRY