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Durability of the epidural approach for continuous glucose monitoring has now been confirmed for a 60-day period.
August 8, 2024
By: Michael Barbella
Managing Editor
Glucotrack Inc. is adding to the clinical evidence supporting the feasibility of its epidural continuous glucose monitoring technology. The company recently completed a 60-day long-term preclinical study of its Glucotrack sensor, implanted in trial subjects’ epidural space. Results indicate the sensor closely tracked glucose values from both a commercially available blood glucose monitor and a subcutaneous continuous glucose monitor (CGM) throughout the 60-day period. No abnormal clinical signs were observed throughout the study period, and no abnormal findings were observed in the spinal cord or surrounding tissues during post-explant analysis. Moreover, the sensor did not cause any delayed latent effects over the long-term period, which is particularly important as a complete healing process in animal studies with implanted devices may take several weeks. “With the successful completion of this long-term study, we are confident in the performance of our epidural sensor, and we are excited to be an innovator in epidural glucose monitoring. We are now exploring opportunities for continued development and application of our novel technology to benefit people living with diabetes,” Glucotrack CEO Paul V. Goode, Ph.D., said. Glucotrack previously announced interim performance and safety results from this long-term animal study assessing sustained epidural glucose monitoring performance. With this study completed, Glucotrack has added more clinical evidence proving the durability of the epidural approach for continuous glucose monitoring. Painful diabetic neuropathy (PDN) is a progressive neurological disorder that affects approximately one-fifth of the more than 38 million Americans with diabetes, equating to more than 7 million individuals.1,2 If approved, a continuous glucose monitoring system that takes readings in the epidural space may be integrated with existing treatments for these patients, simplifying their device and disease management, according to Glucotrack. Glucotrack Inc. designs, develops, and commercializes novel technologies for people with diabetes. The company is currently developing a long-term implantable continuous blood glucose monitoring system for diabetics. Glucotrack’s CBGM is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of more than two years, no on-body wearable component and with minimal calibration. References 1 Abbott CA, Malik RA, van Ross ER, Kulkarni J, Boulton AJ. Prevalence and characteristics of painful diabetic neuropathy in a large community-based diabetic population in the U.K. Diabetes Care 2011;34:2220–2224. 2 Centers for Disease Control and Prevention. (2022). National Diabetes Statistics Report website. https://www.cdc.gov/diabetes/data/statistics-report/index.html
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