LifeScan Continuous Glucose Monitoring Studies
Research type
Research Study
Full title
LifeScan Continuous Glucose Monitoring Studies
IRAS ID
261851
Contact name
Barry Irvine
Contact email
Sponsor organisation
LifeScan
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
LifeScan designs and manufactures products to help people with diabetes monitor and manage their disease. We conduct extensive testing of our products in laboratories at LifeScan and conduct studies to determine how well our products perform with blood from people with diabetes recruited at hospital based clinical sites.
Continuous Glucose Monitors (CGMs) measure glucose levels every few minutes from interstitial fluid (not blood), providing a stream of information on glucose levels over 3 to 14 days depending on the respective CE Marked CGM. CGMs have now been around for many years and have been used routinely all over Europe and the UK.
The research question being addressed by this application relates to understanding the benefits and positive health outcomes of, primarily new CGMs that have recently been given a CE Mark and as such there is very limited clinical data available.
The research we intend to carry out could focus initially on creating more robust data on accuracy in different patient groups or under certain circumstances (e.g. during exercise) but the majority of the studies will be outcomes based looking at long term endpoints such as hypoglycemia reduction, improved time in-range or reducing glucose variability. Furthermore, creating more data in specific patient groups e.g. those with hypoglycemia unawareness or in older patients, will allow us to provide stronger UK based data for patient care and the value of CGM.
It is clear that immediately after CE Marking (demonstrating safety and commercial approval) most CGMs require far more investigation and therefore our application seeks to evaluate only approved CE Marked systems to determine real world value.
REC name
South East Scotland REC 02
REC reference
19/SS/0055
Date of REC Opinion
6 Jun 2019
REC opinion
Further Information Favourable Opinion