Study of a Non-invasive Glucose Measuring Device

RSP Systems

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Prototype 0.5

Study type: Interventional

Funder types: Industry

Identifiers

NCT05851469

RSP-26

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subject ≥18 years.
2. Subject with type 2 diabetes.
3. Signed informed consent form (ICF).

Exclusion criteria

1. Individual treated with intensified insulin treatment.
2. Sodium, Potassium. Creatinine, eGFR, and ALAT (more than three times the upper limit of normal range).
3. Clinically relevant anaemia or thrombocytopenia.
4. Infection with hepatitis B, C or HIV (if subject participates in subprotocol 1).
5. Intake of anticoagulant medication (with the exception of acetylsalicylic acid, ASS 100).
6. For female subjects: Pregnancy or breastfeeding or lack of a negative pregnancy test (except in case of menopause, sterilization, or hysterectomy).
7. Subjects not able to understand and read local language.
8. Cognitive impairment, or in investigator's opinion, subject is not able to follow instructions provided and as specified in the clinical investigation plan (CIP).
9. Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease).
10. Skin changes, tattoos, or diseases on right thenar (measurement site).
11. Reduced circulation in right hand evaluated by Allen's test.
12. Known allergy to medical grade alcohol.
13. Haemodialysis.
14. Topical administration of glucocorticoids at the right hand for the past 7 days or during the study period.
15. Any disorder, which in the investigator's opinion, might jeopardise subject's safety or compliance with the CIP.
16. 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.
17. Dependency from the sponsor or the clinical investigator (e.g., co-workers of the sponsor, the study site, and/ or their families).
18. Subjects currently participating in another study.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

RSP-26-01

Experimental group

Treatment:

Device: Prototype 0.5

RSP-26-02

Experimental group

Treatment:

Device: Prototype 0.5