Study of a Non-invasive Glucose Measuring Device
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
1 other identifier
interventional
50
1 country
1
Brief Summary
This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started May 2023
Shorter than P25 for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedStudy Start
First participant enrolled
May 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2023
CompletedAugust 14, 2023
August 1, 2023
2 months
March 31, 2023
August 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Adverse events
4 days
Study Arms (2)
RSP-26-01
EXPERIMENTALRSP-26-02
EXPERIMENTALInterventions
Investigational Medical Device collecting Raman data from tissue
Eligibility Criteria
You may qualify if:
- Male or female subject ≥18 years.
- Subject with type 2 diabetes.
- Signed informed consent form (ICF).
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RSP Systems A/Slead
Study Sites (1)
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, 89081, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2023
First Posted
May 9, 2023
Study Start
May 31, 2023
Primary Completion
July 27, 2023
Study Completion
July 27, 2023
Last Updated
August 14, 2023
Record last verified: 2023-08