Diabetes Mellitus
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 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 be used as a comparator. In addition to this, four daily capillary Blood Glucose readings will be collected.
Interventions
DEVICEWM3.4NR
The investigational medical device will collect spectral raman data from tissue.
Sponsors
RSP Systems A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
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 patients (all types)
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 * Known allergy to medical grade alcohol used to disinfect skin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Generation and validation of predictive calibration models | 3 months | The collected data will generate individual calibration models capable of predicting tissue glucose concentrations. An evaluation of the models by the consensus error grid will be performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessment of the intervention by the paucity of adverse events | 3 months | The number of subjects experiencing device-related adverse events will be recorded. |
Countries
Denmark
Outcome results
None listed