Study of a Non-invasive Glucose Measuring Device

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05851469
• Other study ID #: RSP-26
• Status: Completed
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: July 27, 2023

Study information

• Verified date: August 2023
• Source: RSP Systems A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 27, 2023
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Prototype 0.5
Investigational Medical Device collecting Raman data from tissue

Locations

Country	Name	City	State
Germany	Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
RSP Systems A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events	Frequency of adverse reactions related and non-related to the investigational device	4 days