Clinical trial NCT03519841: Performance Study of a Non-invasive Glucose Monitoring Device Prototype
Official title: Performance Study of a Non-invasive Glucose Monitoring Device Prototype
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: 2018-05-09
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-randomized interventional study comparing device and blood reference measurements in diabetic patients
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This clinical study has been launched to collect spectral Raman data paired with validated glucose reference values in private homes of subjects.

Detailed description: Protocol consists of two parts:

Part A) Subjects will collect spectral Raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributed within a timeframe of ten days. A Flash Glucose Monitor will be used as a comparator. In addition to this, four daily capillary Blood Glucose readings will be collected.

Part B) Subjects will perform four daily measuring sessions in which optical Raman readings are paired with capillary Blood Glucose comparator. Measuring sessions are performed in subjects' own home while maintaining usual diabetes management routines. Subjects will collect data for 30 days during a 60 days' period.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects 18 years of age or older
* Diabetic patients (all types), insulin requiring
* Skin phototype 1-4

Exclusion Criteria:

* For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
* For female participants: Breastfeeding
* Subjects not able to understand and read Danish
* In Investigator's opinion, subject is not able to follow instructions as specified in the protocol
* Rejection by optical screenings
* Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
* Diagnosed with reduced circulation
* Extensive skin changes, tattoos or diseases on probe application site
* Known allergy to medical grade alcohol
* Known allergy to adhesives, applicable to subjects in RSP-13-01
* Systemic or topical administration of glucocorticoids for the past 7 days
* Subjects undergoing dialysis treatment
* Medical history or any condition that may, in the opinion of the Investigator, compromise the subject's ability to participate
* Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff.
* Participants currently enrolled in another study

Primary outcomes:
measure: Generation and validation of predictive models by ISUP and MARD measures
timeFrame: 6 months
Secondary outcomes:
measure: Safety evaluation: paucity of adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Steno Diabetes Center Odense
Study officials:
affiliation: Steno Diabetes Center Odense, Denmark
name: Jan Erik Henriksen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Steno Diabetes Center Odense, Denmark
name: Vibe Vestergaard, Nurse
role: PRINCIPAL_INVESTIGATOR
References: