Interim data analysis of the first in-human study shows that Lifecare’s sensor is able to monitor glucose variations. Conducting clinical trials on humans is a significant step towards Lifecare’s goal of contributing to helping people with diabetes to live a normal life.
The purpose of the first study is to optimize signal reading from the company’s groundbreaking sensor technology for continuous glucose monitoring for people with diabetes. The glucose sensor for the clinical trials is produced at the company’s development department in Reutlingen, Germany, and the studies are conducted at the company’s clinical department in Mainz, Germany.
Lifecare aims to offer continuous glucose monitoring with a sensor that is significantly smaller and has a function time that is 12 times longer than existing needle-type glucose sensors. The sensor “Sencell” has the size of a grain of rice. It will be the first solution for continuous glucose monitoring that can be fully placed under the skin, without a fixed device on the outside of the body. Lifecare’s solution is expected to be significantly less expensive than existing glucose monitoring systems.
As we have underlined in previous communication performing a clinical study with a novel technology and device never before used by humans is a complex operation. The primary purpose of the ongoing study is to provide proof-of-concept confirmation for glucose measurement in humans.
The data points collected from the early readout in the study show that our sensor is able to follow glucose variations in humans. Consequently, we will continue the pilot study based on these encouraging data.
Lifecare Chief Scientific Officer, Professor Andreas Pfützner states: “Our sensor measures glucose in the human interstitial fluid in the subcutaneous tissue. We have shown a sensitivity that is in line with that of widely used Continuous Glucose Monitoring systems, which act as a reference measurement in the study. We have confirmed the functionality that we observed in the animal trials, and we are going to provide further information once we have more comprehensive data from this ongoing trial”.
Lifecare Chief Executive Officer Joacim Holter comments: “This is a major achievement in our development and an important preparation to further improve the device specifications considering the planned clinical studies for CE approval.”