Study of a Non-invasive Glucose Measuring Device

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Prototype 0.5

• Registration Number: NCT05851469
• Lead Sponsor: RSP Systems A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-09
• Study Start: 2023-05-31
• Primary Completion: 2023-07-27
• Study Completion: 2023-07-27
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-10
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
RSP-26-01	Prototype 0.5	-
RSP-26-02	Prototype 0.5	-

Primary Outcome Measures

Name	Time	Method
Clinical performance	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 Outcome Measures

Name	Time	Method
Adverse events	4 days	Frequency of adverse reactions related and non-related to the investigational device

Trial Locations

Locations (1)

Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm; 🇩🇪 Ulm, Germany