Clinical trial NCT03782441: Study of a Novel Non-invasive Glucose Monitoring Device
Official title: A Pilot Study of a Novel Non-invasive Glucose Monitoring Device
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: 2018-12-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement accuracy of IMD
timeFrame: 4 months
measure: Safety evaluation: paucity of adverse events
timeFrame: 4 months
Secondary outcomes:
measure: Device deficiency
timeFrame: 4 months
measure: Device usability
timeFrame: 4 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Steno Diabetes Center Aarhus
Study officials:
affiliation: Steno Diabetes Center, Aarhus University Hospital
name: Sanne Fisker
role: PRINCIPAL_INVESTIGATOR
References: