Diabetes MellitusNCT05851469
Study of a Non-invasive Glucose Measuring Device
A study testing Prototype 0.5 in people with Diabetes Mellitus, run by RSP Systems A/S at 1 site in Germany.
Trial summary
This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Prototype 0.5
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 31 May 2023to 27 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject ≥18 years.
- Subject with type 2 diabetes.
- Signed informed consent form (ICF).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, 89081
About this study
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
This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.
- Conditions
- Diabetes Mellitus
- Being tested
- Prototype 0.5
- Keywords
- Non-invasive, Blood sugar, Raman spectroscopy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototype 0.5Device
Investigational Medical Device collecting Raman data from tissue
| Study group | Role | What they receive |
|---|---|---|
| RSP-26-01 | Experimental | Not described Receives: Device: Prototype 0.5 |
| RSP-26-02 | Experimental | Not described Receives: Device: Prototype 0.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 days
Secondary outcomes (1)
Adverse events
Frequency of adverse reactions related and non-related to the investigational device
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start31 May 2023
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- RSP Systems A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851469
- Sponsor's protocol ID
- RSP-26
- Status last verified
- Aug 2023
- First submitted
- 31 Mar 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05851469
- Acronym / sponsor ID
- RSP-26
- Conditions
- Diabetes Mellitus
- Keywords
- Non-invasive, Blood sugar, Raman spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- RSP Systems A/SIndustry (pharma, biotech, devices)
- Study start
- 31 May 2023 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSP-26-01 | Experimental | Device: Prototype 0.5 |
| RSP-26-02 | Experimental | Device: Prototype 0.5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subject ≥18 years.
- Subject with type 2 diabetes.
- Signed informed consent form (ICF).
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prototype 0.5Investigational Medical Device collecting Raman data from tissue | Device | RSP-26-01, RSP-26-02 |
Primary outcome
Clinical performance
Time frame: 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
1 secondary outcome
Adverse events
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prototype 0.5 in people with Diabetes Mellitus, run by RSP Systems A/S at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023; AzTrials last refreshed its copy on 1 Nov 2026.