Clinical Evidence for Use of a Noninvasive Biosensor for Tear Glucose as an Alternative to Painful Finger-Prick for Diabetes Management Utilizing a Biopolymer Coating

Abstract

Diabetes is a metabolic condition that is exponentially increasing worldwide. Current monitoring methods for diabetes are invasive, painful, and expensive. Herein, we present the first multipatient clinical trial that demonstrates clearly that tear fluid may be a valuable marker for systemic glucose measurements. The NovioSense Glucose Sensor, worn under the lower eye lid (inferior conjunctival fornix), is reported to continuously measure glucose levels in the basal tear fluid with good correlation to blood glucose values, showing clear clinical feasibility in both animals and humans. Furthermore, the polysaccharide coated device previously reported by our laboratory when worn, does not induce pain or irritation. In a phase II clinical trial, six patients with type 1 Diabetes Mellitus were enrolled and the capability of the device to measure glucose in the tear fluid was evaluated. The NovioSense Glucose Sensor gives a stable signal and the results correlate well to blood glucose values obtained from finger-prick measurements determined by consensus error grid analysis.

Radio-Frequency and Microwave Techniques for Non-Invasive Measurement of Blood Glucose Levels

“…Given these challenges, it may seem that dielectric spectroscopy is unsuitable for the task at hand. Indeed, with the decision to suspend activities into a smart contact lens for glucose monitoring by Verily (part of Alphabet, owner of Google) [85], the dream of non-invasive monitoring may seem unachievable (although the early work by Noviosense, which also works with tears and notably uses an enzyme-based approach to achieve selectivity, offers some hope [9,86]). Rather than concede this, we have suggested avenues for further exploration that may enable true non-invasive, continuous monitoring of blood glucose levels to be achieved.…”

Rücktitelbild: Droplet Precise Self‐Splitting on Patterned Adhesive Surfaces for Simultaneous Multidetection (Angew. Chem. 26/2020)

“…[33] The stains on the chip are the preloaded indicators.When a4.8 mL droplet containing metal ions over the concentration of the ppm scale was dripped on the chip,i tw as divided into five microdroplets and reacted with the indicators in the sensing zones.T he specific colors in these sensing zones indicate the existence of Ni 2+ ,C u 2+ ,o rC r 6+ ions and the acidity of the sample.T his strategy can be extended to the multianalyte detection of biosamples,s uch as tears,b lood, and urine. [34,35]…”

In-Vivo Microsystems: A Review

“…Glucose sensors have also been made for implantation in the eye and bladder [ 82 , 83 , 84 , 85 , 86 , 87 ]. This is a good measure of glucose in the body, but there is a delay in the change compared to blood.…”

“…This is a good measure of glucose in the body, but there is a delay in the change compared to blood. An example of a glucose sensor for the eye is given in Figure 18 [ 86 ]. This approach is less invasive than the implanted approach.…”