BLOOM System Accuracy & User Performance BGMS
Research type
Research Study
Full title
Project BLOOM Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation for a new Blood Glucose Monitoring System.
IRAS ID
196950
Contact name
Laura Ritchie
Contact email
Sponsor organisation
LifeScan Scotland ltd, a J&J Company
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 3 days
Research summary
This is an open label, non-randomised regulatory study to evaluate user performance ,system accuracy and system use evaluation of a new blood glucose monitoring system ( BGMS).
At least twenty male and female subjects aged 18 to 45 years who have Type 1 Diabetes Mellitus will be enrolled. These subjects will undergo in vivo glucose adjustment to achieve a stable glucose level. Once blood glucose level is within the target range, user performance and system accuracy assessments will be performed. Subjects will be monitored for up to 4 to 6 hours following the in vivo glucose adjustment procedure, after which a post-study medical will be performed before discharge from the unit.
If required based on recruitment needs, an additional subset of a minimum of 15 male and female subjects aged 18 and over, with Type 1 or Type 2 Diabetes Mellitus will be enrolled. These subjects will NOT take part in vivo glucose adjustment. They will come to the study unit and after informed consent and eligibility review will undergo user performance and / or system accuracy assessments based on their Glucose levels.
The study duration for individual subjects undergoing in vivo glucose adjustment will be up to approximately 24 hours (Day -1 to post study physical). For those subjects NOT undergoing in vivo glucose adjustment study duration will be up to 2 hours
REC name
West of Scotland REC 5
REC reference
16/WS/0012
Date of REC Opinion
4 Feb 2016
REC opinion
Further Information Favourable Opinion