Status:
COMPLETED
Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device
Lead Sponsor:
RSP Systems A/S
Conditions:
Diabetes Mellitus
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 spectral raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributes with in a timeframe of ten days. A Flash Glucose Monitor will b...
Eligibility Criteria
Inclusion
- Male and female subjects 18 years of age or older
- Diabetic patients (all types)
Exclusion
- Pregnant women
- Subjects not able to understand and read Danish
- In investigator's opinion, subject is not able to follow instructions as specified in the protocol
- Subjects not able to hold hand/arm steadily
- Extensive skin changes, tattoos or diseases on probe application site
- Known allergy to medical grade alcohol used to disinfect skin
Key Trial Info
Start Date :
December 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03352518
Start Date
December 28 2017
End Date
April 17 2018
Last Update
October 15 2018
Active Locations (1)
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1
Department of Endocrinology M, Odense University Hospital
Odense, Denmark, 5000