Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device

RSP Systems

Status

Withdrawn

Conditions

Diabetes Mellitus

Treatments

Device: Prototype 0.5

Study type

Interventional

Funder types

Industry

Identifiers

NCT04031300

RSP-20

Details and patient eligibility

About

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

Full description

Participants will be enrolled at six different sites in four different countries. All participants will undergo identical procedures, which include four steps: Baseline visit (1 day), calibration period (25 days), validation period (23 days) and a close-out visit (1 day) with a total duration of 50 days.

The calibration period consists of 23 home-based days and two in-clinic days. At the two in-clinic days, measurement sessions are performed every 30 minutes. A measurement session consists of two reference measurements (Contour Next One) and three measurements on the Investigational Medical Device. The glucose level of the participants is manipulated by administration of a glucose rich drink. At home-based days, the subject must perform four measurement sessions a day. During the validation period, participants perform up to four home-based measurement sessions a day.

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
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 the local language
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)
Subject diagnosed with cardiovascular diseases
Reduced circulation in right hand evaluated by Allen's test
Subjects receiving anticoagulants, active cancer treatment, tetracyclines and other medication/topical agents increasing photosensitivity
Radiotherapy for the past six months
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