TheraSense buoyed by continuos glucose monitor:
This article was originally published in Clinica
Executive Summary
TheraSense reports that a pivotal trial of its real-time, continuous glucose monitoring system has produced data to support the product's accuracy and efficacy. The results come from the first 30 participants to complete the trial, says the Alameda, California firm, which plans to submit a premarket approval application for the sensor to the US FDA in the second half of 2003. Patients wore the sensors for consecutive three-day periods over 21 days, generating over 3,500 confirmatory capillary blood glucose measurements. These data were compared with capillary finger-stick samples in a Clarke Grid analysis. Some 96.5% of the paired results fell into Clarke Grid regions A and B.