Clinical evaluation of a transcutaneous interrogated fluorescence lifetime-based microsensor for continuous glucose...

Area of Science:

• Biomedical Engineering
• Medical Devices
• Sensor Technology

Background:

• Continuous glucose monitoring (CGM) is crucial for diabetes management worldwide.
• Key sensor parameters include accuracy, precision, durability, invasiveness, lag time, and drift.
• Existing systems face limitations that newer technologies aim to address.

Purpose of the Study:

• To describe a novel online, minimally invasive, biodegradable microsensor for optical, transcutaneous glucose interrogation.
• To evaluate the functionality, precision, and durability of this new sensor system.

Main Methods:

• In vitro and in vivo studies were conducted.
• Animal models (pigs) and human subjects with type 1 diabetes were used.
• Venous blood samples served as the reference, with single-point calibration per experiment.

Main Results:

• The microsensor demonstrated excellent stability over 14-day in vitro trials and up to 70-hour in vivo trials.
• In type 1 diabetic patients, the median relative absolute difference was 11.4%, with 97.7% of values in the A+B zone of error grid analysis.
• No sensor drift was observed in any trial, indicating high reliability.

Conclusions:

• The study indicates the potential for developing a stable and precise minimally invasive glucose reader.
• The developed microsensor offers continuous glucose monitoring capabilities for at least two weeks.
• This technology could significantly advance diabetes care through improved monitoring devices.