Lifecare’s Sencell Continuous Glucose Monitoring (CGM) sensor has reached an operational lifetime of more than 24 weeks (172 days), with a sensor chemistry shelf life of almost 27 weeks (187 days).
This achievement confirms the Sencell CGM technology potential and validates Lifecares expectation of a minimum 6-month sensor longevity. The longevity results were achieved by the use of a sensor that was first implanted and tested clinically in human (in vivo), and then explanted and transferred to continued testing in vitro.
CEO Joacim Holter
This innovative approach allows Lifecare to demonstrate the longevity of the Sencell sensor in a more realistic and relevant environment, as well as to document a solid sensor robustness. The experiment also confirms the stability of the chemistry used in the sensor and demonstrates that the technology has a superior longevity compared to existing needle based CGM sensors.
In May 2023, Lifecare finalized the first Clinical Development Study confirming proof of concept in humans and an encouraging sensitivity compared to commercially available glucose sensors.
Based on study data analysis, Lifecare disclosed the study results in June 2023 at the American Diabetes Conference in San Diego, including a mean absolute relative difference (MARD) of 9,6%. The MARD value positions the Sencell technology with an accuracy that is acceptable for therapeutic (medical) decisions, such as insulin dose adjustments. Furthermore, the study results include a consensus error grid analysis that confirms that all the 261 data points collected in the study were within zones A (90.3%) and B (9.7%), meaning that the study results meet regulatory requirements for Continuous Glucose Monitoring systems.
-With our prototype sensors, we have shown a clinical accuracy to base medical decisions and we have concluded data readings within regulatory acceptable ranges. As we now also can confirm a sensor longevity of 6 months in vitro, we are even closer to disrupt the market with our superior technology. We have initiated important preparations for production and the whole Lifecare organization focuses on quality measures to provide our long-term and accurate Continuous Glucose Monitoring system for people with diabetes, says Joacim Holter, CEO of Lifecare.