Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes
- Conditions
- Diabetes
- Registration Number
- NCT04021251
- 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
- Male and female subjects 18 years of age or older
- Diabetic patients (all types)
- Skin phototype 1-4
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Validation of predictive algorithms for determining blood glucose levels 3 years Performance of predictive models will be evaluated using the consensus error grid.
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.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Department of Endocrinology M
🇩🇰Odense, Denmark
Department of Endocrinology M🇩🇰Odense, DenmarkJan Erik Henriksen, MDContact+45 65411811Jan.Erik.Henriksen@rsyd.dk