Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device

RSP Systems

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: WM3.4NR

Study type: Interventional

Funder types: Industry

Identifiers

NCT03352518

RSP-12-02

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 spectral raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributes with in a timeframe of ten days. A Flash Glucose Monitor will be used as a comparator. In addition to this, four daily capillary Blood Glucose readings will be collected.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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
• Known allergy to medical grade alcohol used to disinfect skin

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

IMD data collection

Experimental group

Description:

Subjects will intensively collect spectral raman data in a home-based setting for 5 days using WM3.4NR and comparators.

Treatment:

Device: WM3.4NR