Clinical Validation on Healthy Humans of a Portable Non-invasive Continuous Glucose Monitor Based on Transdermal...

Area of Science:

• Biomedical Engineering
• Spectroscopy
• Medical Devices

Background:

• Accurate and painless glucose monitoring is crucial for diabetes management.
• Existing continuous glucose monitoring (CGM) methods often involve invasive procedures.
• There is a need for compact, portable, and non-invasive glucose monitoring solutions.

Purpose of the Study:

• To develop and evaluate a non-invasive continuous glucose monitoring (CGM) device using transdermal band-pass Raman (BPR) spectroscopy.
• To assess the device's accuracy and performance compared to existing glucose monitoring methods.

Main Methods:

• Developed a compact, portable, non-invasive CGM device utilizing transdermal band-pass Raman (BPR) spectroscopy.
• The BPR-CGM device targets specific Raman bands of glucose in interstitial fluid for concentration measurement.
• Employed intra-spectrum referencing to compensate for background variations, enhancing accuracy and reducing component bulk.

Main Results:

• A clinical study with six participants demonstrated that the BPR-CGM closely matched reference blood glucose values during an oral glucose tolerance test.
• The device achieved a mean absolute relative difference of 11.34 ± 1.96%, comparable to invasive needle-based CGM sensors.
• All readings were within clinically acceptable zones A and B of the Parkes error grid, with no observed adverse skin reactions.

Conclusions:

• The BPR-CGM technology demonstrates clinical-grade accuracy, rivaling invasive glucose monitoring systems.
• This non-invasive approach paves the way for wearable, needle-free, and miniaturized glucose monitoring solutions.
• The study highlights the potential of BPR spectroscopy for accessible and comfortable diabetes management.