A Study of a Non-invasive Glucose Measuring Device in Out-patient Settings

RSP Systems

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Device: Prototype 0.5

Study type

Interventional

Funder types

Industry

Identifiers

NCT04518813

RSP-24

Details and patient eligibility

About

This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.

Enrollment

173 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female subjects minimum 18 years of age
Individuals diagnosed with any type of insulin-dependent diabetes mellitus ≥ 1 year
Willing to perform up to 12 finger-pricks during each day of out-patient measurements
Signed informed consent
For women of childbearing potential: Willing and able to practice FDA approved birth control during the duration of the investigation
Subject has a 2.4 GHz wireless internet connection at home (standard in normal routers) to be used in the study

Exclusion criteria

For female subjects: Pregnancy or breastfeeding
Skin phototype VI categorized by Fitzpatrick scale measured on thenar
Subjects not able to understand and read local language
Cognitive impairment, or 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)
Extensive skin changes, tattoos or diseases on right thenar (measurement site)
Reduced circulation in right hand evaluated by Allen's test
Known allergy to medical grade alcohol
Hemodialysis
Systemic or topical administration of glucocorticoids at the right hand for the past 7 days or during the study period expected
Any disorder, which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol
Severe diabetes-related complications such as advanced autonomic neuropathy, kidney disease, foot ulcers, legal blindness, or symptomatic cardiovascular disease as evidenced by a history of cardiovascular episode(s)
Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor, the study site, and/ or their families)
Subjects currently participating in another study
Subjects who have participated in the study IDT-1904-RO/RSP-21 or RSP-19.
Incapacity for consent