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 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 monitoring system in own home with maintaining usual routines. Subjects will either collect data for 5 days during a 10 days period or collect data for 90 days during a 40 days period or collect data for 90 days during 6 months period.
Interventions
DEVICEP0.2
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 patients (all types) * Skin phototype 1-4
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Generation of predictive algorithms for determining blood glucose levels | 3 years | Collected spectral raman data will found the development of predictive algorithms for glucose determination. |
| Validation of predictive algorithms for determining blood glucose levels | 3 years | Performance of predictive models will be evaluated using the consensus error grid. |
Countries
Denmark
Contacts
Primary ContactStefan Ovesen Banke, MSc
Outcome results
None listed