Status:
COMPLETED
Study of a Novel Non-invasive Glucose Monitoring Device
Lead Sponsor:
RSP Systems A/S
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
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 interm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03782441
Start Date
November 5 2019
End Date
December 1 2020
Last Update
December 3 2020
Active Locations (1)
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1
Steno Diabetes Center Aarhus
Aarhus, Denmark