Status:
UNKNOWN
Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes
Lead Sponsor:
RSP Systems A/S
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
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
Subjects will collect either 8 or 44 daily optical raman readings paired with either 8 capillary Blood Glucose comparator or 8 capillary Blood Glucose comparator plus 44 readings using a flash glucose...
Eligibility Criteria
Inclusion
- Male and female subjects 18 years of age or older
- Diabetic patients (all types)
- Skin phototype 1-4
Exclusion
- 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
- 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-16-01
- Systemic or topical administration of glucocorticoids for the past 7 days and under investigation
- Participants 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
Key Trial Info
Start Date :
December 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04021251
Start Date
December 20 2018
End Date
August 1 2021
Last Update
August 17 2020
Active Locations (1)
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1
Department of Endocrinology M
Odense, Denmark, 5000