GluSense is developing GlydeTM CGM – a truly long-term implantable continuous glucose sensor. Glyde implant measures glucose values under the skin and will directly transmit information to the mobile app, without the need for a wearable device on the skin. The implant is designed for >2 years of operations.
Glucose sensing in Glyde CGM is done using an optical fluorescence measurement. A proprietary fluorescent protein (‘biosensor’) inside the Glyde implant is changing its fluorescence properties upon selectively binding to glucose. The optical measurement, performed by the implant, quantifies this fluorescence, enabling accurate glucose measurement.
The main challenge in developing an implantable sensor is maintaining long term functionality. As in all sensing technologies, the active material, in our case, the biosensor, decays over time. GluSense breakthrough technology allows for constantly replenishing the biosensor in-situ using modified live cells, safely encapsulated inside the device.
GluSense patented, innovative technology is unique in its potential for truly long term operation.
Glucose detection is based on a proprietary fluorescent Biosensor protein having two fluorophore groups and a glucose binding domain. Utilizing the Fluorescent Resonant Energy Transfer (FRET) effect, this biosensor changes its fluorescent emission upon selectively binding a glucose molecule. As the binding is reversible, the percentage of biosensor molecules which are found at the bound state at a given moment is determined by the glucose concentration in the medium. Utilizing the FRET effect, two fluorescent signals are detected in every measurement event, where one signal is glucose-sensitive and the other is glucose-insensitive. By taking the ratio between the two fluorescent signals a robust measurement is obtained, which is insensitive to changes in biosensor concentration or exact measurement conditions. The patent-pending Biosensor was optimized by GluSense for best response in the full physiological range of glucose values with special emphasis on the low glucose values, which are most important in order to prevent hypoglycemia.
Maintaining sensor functionality for the long term is challenging using any sensing technology, as the active material, enzyme or fluorescent molecule, decays in the body over just a few weeks. GluSense’s innovative technology utilizes engineered live human cells to continuously replenish the Biosensor in-situ, verifying that fresh biosensor is always available. A tiny amount of the cells are encapsulated inside a compartment of the implant, effectively separated from the body by a selective membrane which allows only small molecules, e.g. glucose and Oxygen, to diffuse in and out. The membrane thus protects the cells from the immune system of the patient which would otherwise destroy the cells.
Glyde CGM is composed of a miniature implant and an external wearable device. The implant does not contain a battery and is energized in real time by the wearable device using RF. The optical measurement is performed by the combined operation of the implant and the wearable device and is repeated every several seconds. The raw data is analyzed by the wearable device using advanced algorithms, translated to glucose levels and update on the wearable’s display every several minutes. Glucose data will be sent to a smartphone application for additional display, charting and cloud upload.
The first generation of Glyde CGM includes a miniature implant, injected under the skin, and an external wearable device that reads glucose data from the implant. Calibrated glucose values are displayed on the wearable device and transmitted to a smartphone application. The system has been validated in pre-clinical studies and will soon start clinical trials.
Optical measurement is done by the combined operation of the implant and the wearable device.
Glyde CGM is now ready for First-in-Human Clinical studies, which are about to start soon.
Frequently Asked Questions
Q: Where can I buy this product?
A: The product is not ready for market yet. We are doing are best to develop and qualify it as fast as possible, but it will take several more years.
Q: Can I join a clinical study?
A: We are not yet there, but soon. We will let you know as soon as we are there.
Q: What about product safety?
A: Everything we do during the development stage is focused on product safety. Before release to market the product will comply to all criteria of the relevant regulatory authorities.
Q: How will the sensor be implanted?
A: The sensor will be injected under the skin by a doctor, under local anesthesia.
Q: Where in the body will the sensor be implanted?
A: Several options are possible. Most locations used for CGM sensors are relevant.