Diabetes mellitus affects about 250 million people world- wide. Self-monitoring of blood sugar levels is a key aspect of managing this condition. The sole method used to date has been an invasive process of applying a drop of blood to a sensor strip on a blood sugar monitoring device, which many patients fi nd painful. This often leads to limited compliance and is counterproductive to encouraging a cooperative attitude to patient management of the condition.
EyeSense GmbH, at its Bavarian location in Großostheim, has developed a hydro gel implant – containing fluorophores – as the carrier system, which is implanted under the conjunctiva of the eye. The benefit of this location as a monitoring point is its excellent implant tolerance and the fact that the mini sensor is surrounded by conjunctival fluid, which facilitates blood sugar analysis. Depending on the concentration of glucose, fluorescent light of different intensity is emitted by the biochemical implant sensor, which is optically and non-invasively detected and eva- luated via a small photometer held in front of the eye without actually touching it
As part of a Löhn Award-winning transfer project, laboratory experiments were initially carried out by the IVCRC Steinbeis Research Center at the University Eye Clinic in Heidelberg to determine the optimal monitoring position between the sensor and photometer. At the same time, the implant was checked by EyeSense for compatibility with frequently applied local medica- tions. As part of a Phase II study, clinical evaluation then began in August 2008 under the auspices of the IVCRC. The process was then successively improved by means of a regular exchange of information between all involved. The IVCRC Steinbeis Research Center initiated the development of an injector for optimal insertion of the implant. At the same time, EyeSense worked on reducing the size of the implant and rounding off the edges. The fi ndings of the first study cohorts are very promising. They indi- cate a good correlation between the readings of the mini sensor and the reference method and also point to a high level of tole- rance for the implants. The future goals of the collaborative venture are further evaluation and development of the implant, with the aim of producing a reliable and sustainable method of sub-conjunctival blood sugar monitoring and bringing it to market.
Prof. Dr. med. Gerd Auffarth
Steinbeis Research Centre International Vision Correction Research Centre (IVCRC) (Heidelberg)