Database and Calibration of a Non-invasive Glucose Monitoring Device

RSP Systems

Status: Completed

Conditions: Diabetes

Treatments: Device: WM3.4NR

Study type: Interventional

Funder types: Industry

Identifiers

NCT03362528

RSP-10

Details and patient eligibility

About

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

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Short term collection of IMD data

Experimental group

Description:

Subjects will collect spectral raman data on WM3.4NR four times a day for 30 days distributed over a time period of 60 days. Each timepoints are conducted in duplicate. Spectral data will be compared to standard BG measurements.

Treatment:

Device: WM3.4NR

Long term collection of IMD data

Experimental group

Description:

Subjects will collect spectral raman data on WM3.4NR four times a day for the initial 30 days, distributed over a time period of 60 days. Subjects will for the remaining 60 days of measurements, distributed over 120 days collect spectral data twice a day. Each timepoints are conducted in duplicate. Spectral data will be compared to standard BG measurements.

Treatment:

Device: WM3.4NR