Database and Calibration of a Non-invasive Glucose Monitoring Device
Not Applicable
Completed
- Conditions
- Diabetes
- Registration Number
- NCT03362528
- Lead Sponsor
- RSP Systems A/S
- 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 2-4 daily optical raman readings paired with capillary Blood Glucose comparator in own home with maintaining usual routines. Subjects will either collect data for 30 days during a 60 days period or collect data for 90 days during 6 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Male and female subjects 18 years of age or older
- Diabetic (all types) patients
Exclusion Criteria
- 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
- Rejection by prescreening optical measurements
- Known allergy to medical grade alcohol used to disinfect skin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Generation and validation of predictive algorithms for determining blood glucose levels 7 months Collected spectral raman data will found the development of predictive algorithms for glucose determination. Performance of predictive models will be evaluated using the consensus error grid
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Endocrinology M
🇩🇰Odense, Denmark
Department of Endocrinology M🇩🇰Odense, Denmark