MEDICAL DEVICES
blood could be observed through the resonance shifts in the super high-frequency microwave spectrum. In the tests conducted where the only variable was the glucose concentration, it was shown that the glucose in whole blood could be observed by way of a resonance shift observed in a given microwave spectral range. A prototype of a non-invasive blood glucose
measurement system has, therefore, evolved. The dial resonating sensor (DRS) that comprise a power-feed structure and a ring or number of rings, has been developed and tested both in vitro and in vivo. The antennae has been designed to be placed on the volunteer’s wrist to monitor the blood sugar non-invasively. This proof of concept trial has been completed as part of a programme for development of a prototype antennae. Analysis of the antennae signals and development of an algorithm for the assessment of blood glucose will enable the development of a non-invasive blood glucose monitor.
True potential The Afon device, studied under both hyper and hypoglycaemic conditions during clinical trials, showed promise of providing a truly non-invasive method for blood glucose measurement.
76 | Outsourcing in Clinical Trials Handbook
Sixteen white male subjects – mean±SD age 31.5±9.38 years, BMI 25.9±2.92kg/m2, diabetes duration 12.6±9.34 years – participated. Data from one subject could not be analysed as the subject didn’t appear for his repeat visit due to personal reasons. Paired, non-invasive glucose monitoring- reference blood glucose values were obtained (n=3593). Predictive MARD, using individual models from the data from first clamp to predict data obtained at the second clamp, was approximately 22.2±9% with a range of 12–34%. Correlation analysis revealed a strong relation between SuperGL and Afon device values. Error grid analysis shows that 48.9%, 47.1% and 4.0% of Afon device and SuperGL pairs are located in none, slight and moderate regions respectively, while no data were allocated in the severe to extreme, as shown in the graph on the previous page. The Afon device is also designed to be physically connected to a smartwatch. It is clear from this work that the microwave
system has its advantages, in that the signal penetration is deep enough to reach tissues containing significant glucose and is sensitive to small changes in glucose concentrations. Although much work still needs to be done, this
microwave technology has the potential to offer a truly non-invasive, continuous glucose monitor and blood glucose measurement system. ●
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