Study of a Non-invasive Glucose Measuring Device

Study Overview
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Brief Summary
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This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.

Official Title
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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
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Diabetes Mellitus

Intervention / Treatment
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* Device: Prototype 0.5


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RSP-26-01<br> | Device: Prototype 0.5<br>* Investigational Medical Device collecting Raman data from tissue<br>|
| Experimental: RSP-26-02<br> | Device: Prototype 0.5<br>* Investigational Medical Device collecting Raman data from tissue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance | 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 | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Frequency of adverse reactions related and non-related to the investigational device | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-invasive, Blood sugar, Raman spectroscopy