Study of a Novel Non-invasive Glucose Monitoring Device

RSP Systems

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Device: Prototype 0.5

Study type

Interventional

Funder types

Industry

Identifiers

NCT03782441

RSP-19

Details and patient eligibility

About

This explorative clinical study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.

Full description

The Investigational Medical Device (IMD) for this investigation is the Prototype 0.5 (P0.5) developed and manufactured by RSP Systems (RSP). The device is intended for non-invasive interstitial intermittent glucose monitoring in persons (age 18 and older) with diabetes. The technology relies on the well-established capacities of Raman spectroscopy for directly detecting glucose subcutaneously. The Raman spectroscopy physical principle relies on the fact that when laser light of a given wavelength interferes with a molecule, a small fraction of the incident light will interact with the vibrational states of the molecule, causing the photons to lose a portion of their energy which will change the wavelength of the light. The scattered light will be collected by the optical probe head and analyzed with advanced algorithms to correlate the signal to glucose concentrations. Data collected from the IMD will be paired with validated glucose reference values collected by the finger sticking method.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female subjects ≥18 years of age
Diagnosed with diabetes, all types except gestational diabetes
HbA1c distribution > 60 mmol/mol at baseline visit
Skin phototype 1-4
Willing to perform a minimum of 8 finger sticks during each day of home-based measurements and 30 finger sticks at the two in-clinic study days
Subject has a wireless internet connection at home to be used in the study

Exclusion criteria

For female subjects: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
For female subjects: Breastfeeding
Subject currently participating in another study
Subject not able to understand and read Danish
In investigator's opinion, subject is not able to follow instructions provided and as specified in the protocol
Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease)
Reduced circulation in right hand evaluated by Allen's test
Extensive skin changes, tattoos or diseases on right hand thenar (probe application site)
Known allergy to medical grade alcohol used to clean the skin
Medical history or any condition that may, in the opinion of the investigator compromise the subject's ability to participate
Comorbidity or concomitant medical condition which, in the opinion of the Investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff