Diabetes
Conditions
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.
Interventions
DEVICEWM3.4NR
Investigational Medical Device collecting spectral raman data from tissue.
Sponsors
RSP Systems A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed