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In vivo evaluation of an electroenzymatic glucose sensor implanted in subcutaneous tissue
K W Johnson1, J J Mastrototaro, D C Howey
1Medical Devices and Diagnostics Division, Lilly Laboratory for Clinical Research, Eli Lilly & Co., Indianapolis, IN 46285.
Biosensors & Bioelectronics
|January 1, 1992
Summary
Flexible, implantable electroenzymatic glucose sensors were mass-produced using cleanroom techniques. In human subjects, these sensors demonstrated excellent correlation with traditional glucose monitoring methods.
Area of Science:
- Biomedical Engineering
- Sensor Technology
- Materials Science
Background:
- Subcutaneous glucose monitoring is crucial for diabetes management.
- Existing continuous glucose monitors face challenges in long-term stability and biocompatibility.
- Mass-producible, implantable sensors are needed for improved patient outcomes.
Purpose of the Study:
- To develop and evaluate a novel flexible, electroenzymatic glucose sensor for subcutaneous implantation.
- To assess the in vitro and in vivo performance of the developed glucose sensor.
- To validate the sensor's accuracy against established glucose measurement techniques.
Main Methods:
- Utilized cleanroom processing techniques for mass production of flexible electroenzymatic glucose sensors.
- Conducted in vitro characterization to assess sensor performance.
- Performed initial in vivo studies in rabbits and subsequent studies in normal human subjects with subcutaneous sensor implantation.
Main Results:
- In vitro studies confirmed acceptable sensor performance.
- Subcutaneous implantation in rabbits provided initial in vivo data.
- Human subject studies demonstrated an excellent correlation between sensor glucose readings and commercial analyzer results from capillary finger sticks.
Conclusions:
- Mass-produced, flexible electroenzymatic glucose sensors are viable for subcutaneous implantation.
- The developed sensor shows high accuracy and excellent correlation with conventional glucose monitoring in humans.
- This technology holds promise for improved diabetes management through reliable continuous glucose sensing.