Clinical trial NCT04518813: A Study of a Non-invasive Glucose Measuring Device in Out-patient Settings
Official title: An Explorative Study of a Novel Non-invasive Glucose Measuring Device in Out-patient Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Non-invasive glucose monitoring
Raman spectroscopy
Lead sponsor: RSP Systems A/S
Sponsor class: INDUSTRY
First posted: 2020-08-19
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: Determination of number of calibration days
timeFrame: 2 years
measure: Safety evaluation of the Investigational Medical Device by reporting of adverse events
timeFrame: 2 years
Secondary outcomes:
measure: Device function
timeFrame: 2 years
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Study officials:
References: