Glucotrack, a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, announced that it is expanding its glucose monitoring technology to include measuring glucose in the epidural space. A continuous glucose monitoring system that takes readings in the spinal epidural space may be integrated with existing treatments for patients with Painful Diabetic Neuropathy (PDN).

PDN is a progressive neurological disorder that affects approximately one-fifth of the more than 38 million Americans with with diabetes, equating to more than 7 million individuals.1,2 Its symptoms include pain and numbness in the feet, legs, and hands which can significantly impact patients’ quality of life and functional ability.3 Recently, Spinal Cord Stimulation (SCS) technology has been indicated as a treatment option providing significant long-term pain relief to these patients.4 A spinal cord stimulator is an implanted device, with electrodes placed in the epidural space, that sends low levels of electricity directly into the spinal cord to relieve pain.5 Glucotrack’s sensor has the potential to be integrated with existing SCS devices to measure epidural glucose in patients with PDN who are undergoing SCS treatment. Combining SCS and continuous glucose monitoring (CGM) could provide several possible advantages, such as simplifying device management for those patients.

Glucotrack has successfully completed preclinical animal testing in an acute setting. Building on the success of the acute studies, the Company has now initiated a long-term animal study to assess sustained epidural glucose monitoring performance. This is the second application of Glucotrack’s technology for implantable continuous glucose monitoring, in addition to its development of a long-term Continuous Blood Glucose Monitoring (CBGM) system.

The preclinical testing compared the Glucotrack sensor against blood glucose and a commercially available subcutaneous CGM in an acute large animal model while varying blood glucose levels for several hours. The results demonstrated the Glucotrack epidural glucose values closely tracked both the blood glucose and subcutaneous CGM values. The study was completed with no adverse effect on the animals. A second acute study successfully confirmed the repeatability of these results.

“We have always been committed to developing a portfolio of innovative glucose monitoring technologies to offer patients with diabetes more choice; today’s announcement underscores this commitment.” said Paul V. Goode, PhD, CEO of Glucotrack. “We are excited to pioneer the epidural glucose monitoring space which we believe holds meaningful strategic potential. By making disease management more intuitive and less intrusive, Glucotrack is looking beyond traditional approaches to improve the quality of life for millions of people with diabetes.”