Evaluation of NIBGM: Study 3
Research type
Research Study
Full title
Evaluation of Non-Invasive Blood Glucose Monitor (NIBGM) Sensor: Study 3
IRAS ID
172414
Contact name
Stephen Luzio
Contact email
Sponsor organisation
Cardiff University
Duration of Study in the UK
0 years, 2 months, 31 days
Research summary
Patients should make regular measurements of their blood glucose. This usually involves withdrawing a blood sample via an invasive finger-prick procedure, which because it is painful and inconvenient, results in reduced patient compliance and less effective glycaemic control, or by other invasive methods, such as continuous glucose monitoring systems (CGMS), with associated risk of infection.
A new glucose monitoring system (NIBGM System) is being designed in which associated electromagnetic (EM) fields penetrate the body to a depth of 5 -10 mm (depending on location), so that blood vessels beneath the surface of the skin can be accessed. In practice a subject will wear the sensor, attached to the skin with an adhesive dressing. Electromagnetic waves generated by the sensor will result in a signal, from which the concentration of blood glucose may be calculated. Blood glucose levels can therefore be determined without the need for the extraction of blood by invasive procedures.
Proof of concept data has been obtained from previous clinical studies. The results obtained so far have shown that the data acquired from prototype NIBGM Sensor systems correlate with changing glucose levels in blood and are insensitive to changes in body/sensor temperature, blood pressure, pulse, perspiration and blood salinity.
Based on the experimental data obtained from the previous studies the sensor has been further designed to incorporate the sensor head and microwave electronics into a wireless device which can be placed on the skin of the subject and which will communicate wirelessly with a computer to measure blood glucose concentrations.
The intention of this study (NIBGM3) therefore is to validate the accuracy of the wireless NIBGM Sensor against an accepted reference method (glucose oxidase laboratory analyser) using a wide range of blood glucose levels obtained from persons with and without diabetes and with different degrees of obesity.
REC name
Wales REC 6
REC reference
15/WA/0146
Date of REC Opinion
2 Jun 2015
REC opinion
Further Information Favourable Opinion