Impact on CGM on Hypoglycaemia in Type 1 Diabetes
Research type
Research Study
Full title
Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data
IRAS ID
186760
Contact name
Nick Oliver
Contact email
Sponsor organisation
Imperial College
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Good glucose control in type 1 diabetes is associated with a reduced risk of diabetes complications and self-monitoring of glucose levels is an important component of achieving and maintaining glucose control. Continuous glucose monitoring (CGM) improves overall glucose control in all age groups when used continuously, and reduces the incidence of low blood glucose (hypoglycaemia) in people with good glucose control.
Hypoglycaemia is one of the commonest metabolic complications of type 1 diabetes and, if it occurs frequently, people can become less aware of it. This reduced aware of hypoglycaemia has significant risks including seizures, coma and even death, and has an impact on people's ability to drive and function.
The Abbott Libre intermittent glucose monitoring system provides up to 8 hours of retrospective continuous glucose monitoring data to users when the monitor is waved in proximity with the sensor. In contrast to real-time CGM the Libre system sensor is used for 14 days and is non-adjunctive (does not require calibration to capillary blood glucose).
This clinical study proposes to assess the impact of Libre on frequency, duration and severity of hypoglycaemia, compared with the Dexcom G5 real-time CGM and will focus on people with impaired awareness of hypoglycaemia.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/1679
Date of REC Opinion
28 Oct 2015
REC opinion
Further Information Favourable Opinion