Database and Calibration of a Non-invasive Glucose Monitoring Device

Database and Calibration of a Non-invasive Glucose Monitoring Device

This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.

Subjects will collect 2-4 daily optical raman readings paired with capillary Blood Glucose comparator in own home with maintaining usual routines. Subjects will either collect data for 30 days during a 60 days period or collect data for 90 days during 6 months.

Inclusion Criteria:

• Male and female subjects 18 years of age or older
• Diabetic (all types) patients

Exclusion Criteria:

• Pregnant women
• Subjects not able to understand and read Danish
• In investigator's opinion, subject is not able to follow instructions as specified in the protocol
• Subjects not able to hold hand/arm steadily
• Extensive skin changes, tattoos or diseases on probe application site
• Rejection by prescreening optical measurements
• Known allergy to medical grade alcohol used to disinfect skin