Data from Lifecare’s Clinical Development Study LFC-SEN-001 confirm that the Company’s Continuous Glucose Monitoring (CGM) system (Sencell) has a solid clinical accuracy: the mean average of absolute error (MARD) between Sencell and matched relative reference values was 9,6%.
In context, regulatory authorities expect a MARD below 10% to acknowledge CGM for therapeutic (medical) decisions such as insulin dose adjustments. In comparison, the MARD of glucose measurements in capillary blood (Blood Glucose Monitoring – BGM), representing the gold standard for patient self-monitoring of glucose, are in the range 5-10%.
CSO Professor Andreas Pfützner and CEO Joacim Holter
The Sencell MARD confirms previous communication from Lifecare that the system is at least as accurate as commercially available CGM systems, although the now calculated MARD of 9,6% significantly exceeds the anticipated outcome from this first-in-human study. At the current development stage, the sensor sensitivity and algorithm development provide accuracy far better than expected.
Lifecare will evaluate the scope of the planned upcoming study LFC-SEN-002. The purpose of the study is to investigate longevity and biocompatibility in live tissue. In light of the very encouraging outcomes of study LFS-SEN-001, Lifecare will consider adjusting the planned study to take advantage of technical and strategic synergies that can lead to a shorter time to market within the broad field of glucose monitoring.
“The Sencell MARD is impressively strong. Competing technologies were introduced to the market some 20 years ago with MARD values in the range 12,8-15%. The first CGM with a MARD of less than 10% became a reality in 2010. In this context it is a huge achievement to already on the pre-product stage confirm a MARD at 9,6%. This achievement stands on its own and is a solid signal that Lifecare’s technology has the potential to disrupt the market for CGM’s.”, Lifecare CEO, Joacim Holter states.
“Study LFS-SEN-001 has provided very encouraging data, confirming the technology’s maturity already in the first-in human testing. Considering that the sensors from the study also have shown a continued longevity in laboratory experiments for more than 12 weeks and still ongoing, the technology potential is huge. Our fantastic development team will continue to improve both the technology and algorithms, and I am confident that the MARD of Sencell will further improve and consequently challenge existing CGM technologies, not only on size and longevity, but most important on accuracy.”, Lifecare CSO Professor Andreas Pfützner states.
For media inquiries or more information, please contact: Asle Wingsternes, Head of Communications and Public Affairs at Lifecare, telephone +47 41 61 42 52, firstname.lastname@example.org