As the DTM returns as a face-to-face meeting after three years of virtual set-up, Lifecare is pleased to be present at the conference to present a poster presentation on October 16th with the title “Continuous Glucose Monitoring with an Osmotic-Pressure Based Continuous Glucose Sensor – Human Pilot Study Results and Next Development Steps”.

The results from Lifecare’s clinical study LFC-SEN-001 has previously been presented at the American Diabetes Association Scientific Sessions (ADA) in San Diego, CA, USA, in June 2023, and with additional data at the virtual DTM 2023. At the upcoming event Lifecare will in addition present ongoing and upcoming development steps in the longevity study LFC-SEN-002.

The clinical study data presented at the ADA 2023 and DTM 2023 included the technology proof-of-concept in human tissue, as well as confirmation that Lifecare’s CGM system Sencell has a solid clinical accuracy. The initial data from Lifecare’s ongoing longevity study LFC-SEN-002 has confirmed a 12-week operational sensor lifetime in live tissue, without any unexpected tissue reactions.

From the clinical study data, Lifecare calculated a Mean Absolute Relative Difference (MARD) value of 9,6%. In context, regulatory authorities expect a MARD below 10% to acknowledge CGMs 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%.

The Sencell MARD calculated in 2023 indicates accuracy comparable with commercially available CGM systems.

On October 10th, 2024, Lifecare announce that the company’s next human study protocol has been internally concluded, with the aim to progress the clinical sensor development towards regulatory approval.