Afon Technology Clinical Proof-of-Concept Study

Afon Technology are pleased to share the published paper “Noninvasive Continuous Glucose Monitoring With a Novel Wearable Dial Resonating Sensor: A Clinical Proof-of-Concept Study”. This was published in the Journal of Diabetes Science and Technology in April 2023.

Included below is the abstract and the full paper can be read in PDF form above.

Noninvasive Continuous Glucose Monitoring With a Novel Wearable Dial Resonating Sensor: A Clinical Proof-of-Concept Study

Authors

Consuelo Handy BSc, Mohamed Sabih Chaudhry PhD, Muhammad Rafaqat Ali Qureshi PhD, Bradley Love PhD, John Shillingford PhD, Leona Plum-Mörschel PhD, and Eric Zijlstra,PhD.

Abstract

Background

A noninvasive, wearable continuous glucose monitor would be a major advancement in Diabetes therapy. This trial investigated a novel noninvasive glucose monitor which analyzes spectral variations in radio frequency/microwave signals reflected from the wrist.

Methods

A single-arm, open-label, experimental study compared glucose values from a prototype investigational device with laboratory glucose measurements from venous blood samples (Super GL Glucose Analyzer, Dr. Müller Gerätebau GmbH) at varying levels of glycemia. The study included 29 male participants with type 1 Diabetes (age range = 19-56 years).

The study comprised three stages with the following aims:

  1. demonstrate initial proof-of-principle
  2. test an improved device design
  3. test performance on two consecutive days without device recalibration.

The co-primary endpoints in all trial stages were median and mean absolute relative difference (ARD) calculated across all data points.

Results

In stage 1, the median and mean ARDs were 30% and 46%, respectively. Stage 2 produced marked performance improvements with a median and mean ARD of 22% and 28%, respectively. Stage 3 showed that, without recalibration, the device performed as well as the initial prototype (stage 1) with a median and mean ARD of 35% and 44%, respectively.

Conclusion

This proof-of-concept study shows that a novel noninvasive continuous glucose monitor was capable of detecting glucose levels. Furthermore, the ARD results are comparable to first models of commercially available minimally invasive products without the need to insert a needle. The prototype has been further developed and is being tested in subsequent studies.

Keywords

blood glucose self-monitoring, Diabetes mellitus, microwaves, noninvasive, radio frequency, wearable electronic devices