Clinical Results

Clinical feasibility study for a transdermal, continuously working fiber optic sensor

Introduction

Currently available Glucose Monitoring Systems (CGMS) have a short life time. In this study a new CGM system FiberSense is tested. It is based on a fluorescing biosensor at the tip of an optical fiber.

Method

The clinical trials were conducted over a 28 day period at the Diabetes Institute in St Joseph’s Hospital in Heidelberg, Germany. FiberSense was placed in the subcutaneous tissue in the abdomen or upper arm in both Type1 and Type 2 Diabetic patients. Data was collected in numerous monitoring phases. The patients were given glucose stimulation (orally administered glucose and delayed insulin administration). The FiberSense data were then compared with capillary blood glucose measurements (standard laboratory method) and with a commercially available CGM system with was implanted parallel to each other on the opposing abdominal side (for up to 7 days). The data collection phases also incorporated normal daily routines to give a true representation.

Results

During the 28 day period the FiberSense data remained within a range of error of 20% (Requirement of ISO 15197*) to the laboratory data. The FiberSense data was much more accurate than the commercially available CGM system.

Source: ISO 15197. In Vitro diagnostic test systems: requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. International Organization for Standardization, 2003.

In total the Mean Absolute Relative Deviation (MARD) lay between 8 and 9 percent depending on the sensor site. The corresponding statistic for the commercially available CGM System was 18 percent. 93 percent of the measurements were, compared with laboratory data, in the range of correct clinical treatment decisions (consensus error grid zone A and B*)

*source: Parkes et al., A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose, Diabetes Care 23: 1143-1148, 2000.

Conclusion

The FiberSense CGM system, with its fiber optic sensor, displays excellent precision over a time period of four weeks. This is a considerable improvement on currently available systems which monitor for maximally a week.

If you are interested in further information, we look forward to you contacting EyeSense.

Publications

The detailed study results have been presented at several international congresses and published in scientific journals

  1. Müller et al., Clinical Feasibility Study of a Percutaneous Optical Glucose Fiber Sensor, Nov 2012, DTM, San Francisco.
  2. Müller et al., Clinical Feasibility Study of a Percutaneous Optical Glucose Fiber Sensor, Feb 2013, ATTD, Barcelona.
  3. Müller et al., First Clinical Evaluation of a New Percutaneous Optical Fiber Glucose Sensor for Continuous Glucose Monitoring in Diabetes, J Diabetes Sci Technol, 2013; 7(1): 13-23.