NCT05851469CompletedNot Applicable
An Explorative, Non-randomized, Open-label, In-clinic Study, Investigating the Performance of a Novel Non-invasive Glucose Monitoring Device Using a New Guided Calibration Model
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- RSP Systems A/S
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Clinical performance
Study Overview
Brief Summary
This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female subject ≥18 years.
- •Subject with type 2 diabetes.
- •Signed informed consent form (ICF).
Exclusion Criteria
- •Individual treated with intensified insulin treatment.
- •Sodium, Potassium. Creatinine, eGFR, and ALAT (more than three times the upper limit of normal range).
- •Clinically relevant anaemia or thrombocytopenia.
- •Infection with hepatitis B, C or HIV (if subject participates in subprotocol 1).
- •Intake of anticoagulant medication (with the exception of acetylsalicylic acid, ASS 100).
- •For female subjects: Pregnancy or breastfeeding or lack of a negative pregnancy test (except in case of menopause, sterilization, or hysterectomy).
- •Subjects not able to understand and read local language.
- •Cognitive impairment, or in investigator's opinion, subject is not able to follow instructions provided and as specified in the clinical investigation plan (CIP).
- •Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease).
- •Skin changes, tattoos, or diseases on right thenar (measurement site).
- •Reduced circulation in right hand evaluated by Allen's test.
- •Known allergy to medical grade alcohol.
- •Haemodialysis.
- •Topical administration of glucocorticoids at the right hand for the past 7 days or during the study period.
- •Any disorder, which in the investigator's opinion, might jeopardise subject's safety or compliance with the CIP.
- •Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g., mental, or visual incapacity, language barriers, alcohol or drug abuse.
- •Dependency from the sponsor or the clinical investigator (e.g., co-workers of the sponsor, the study site, and/ or their families).
- •Subjects currently participating in another study.
Arms & Interventions
RSP-26-01
Experimental
Intervention: Prototype 0.5 (Device)
RSP-26-02
Experimental
Intervention: Prototype 0.5 (Device)
Outcomes
Primary Outcomes
Clinical performance
Time Frame: 2 days
Repeated measurements of blood sugar, to cover the diurnal variation, with the non-invasive examination device, and compare the result with blood drawn capillary and venous
Secondary Outcomes
- Adverse events(4 days)
Investigators
Study Sites (1)
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