Diabetes MellitusNCT04518813
A Study of a Non-invasive Glucose Measuring Device in Out-patient Settings
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
- 173 participants
- Where
- 1 siteGermany
- Study dates
- 24 Sep 2020to 23 Apr 2022
- 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 and female subjects minimum 18 years of age
- Individuals diagnosed with any type of insulin-dependent diabetes mellitus ≥ 1 year
- Willing to perform up to 12 finger-pricks during each day of out-patient measurements
- Signed informed consent
- For women of childbearing potential: Willing and able to practice FDA approved birth control during the duration of the investigation
- Subject has a 2.4 GHz wireless internet connection at home (standard in normal routers) to be used in the study
Who cannot join
- For female subjects: Pregnancy or breastfeeding
- Skin phototype VI categorized by Fitzpatrick scale measured on thenar
- 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 protocol
- Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease)
- Extensive skin changes, tattoos or diseases on right thenar (measurement site)
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- Reduced circulation in right hand evaluated by Allen's test
- Known allergy to medical grade alcohol
- Hemodialysis
- Systemic or topical administration of glucocorticoids at the right hand for the past 7 days or during the study period expected
- Any disorder, which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol
- Severe diabetes-related complications such as advanced autonomic neuropathy, kidney disease, foot ulcers, legal blindness, or symptomatic cardiovascular disease as evidenced by a history of cardiovascular episode(s)
- 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
- Subjects who have participated in the study IDT-1904-RO/RSP-21 or RSP-19.
- Incapacity for consent
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 Study of a Novel Non-invasive Glucose Measuring Device in Out-patient Settings
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 glucose monitoring, 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-24 | Experimental | Subjects will perform calibrations on the IMD (Prototype 0.5) for 41 days over a 60 day period. Receives: Device: Prototype 0.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of number of calibration days
The number of calibration days needed for reaching a well-performing glucose predictive calibration model will be determined. The clinical performance of the reduced calibration model will be based on the data from the validation part by studying linear regression, Inter Subject Unified Performance value and Consensus Error Grid.
Measured: 2 years
Safety evaluation of the Investigational Medical Device by reporting of adverse events
Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical investigation
Measured: 2 years
Secondary outcomes (1)
Device function
Device function will be evaluated in regard to durability and reliability. This is evaluated by reported device deficiencies during the study in the terms of subject diaries
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start24 Sep 2020
- Primary completion23 Apr 2022
- Study completion23 Apr 2022
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 173 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
- NCT04518813
- Sponsor's protocol ID
- RSP-24
- Status last verified
- Nov 2023
- First submitted
- 13 Aug 2020
- Last updated
- 18 Nov 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative Study of a Novel Non-invasive Glucose Measuring Device in Out-patient Settings
- ClinicalTrials.gov ID
- NCT04518813
- Acronym / sponsor ID
- RSP-24
- Conditions
- Diabetes Mellitus
- Keywords
- Non-invasive glucose monitoring, Raman spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- RSP Systems A/SIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 23 Apr 2022 (actual)
- Study completion
- 23 Apr 2022 (actual)
- First posted
- 19 Aug 2020 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RSP-24 | Experimental | Device: Prototype 0.5Subjects will perform calibrations on the IMD (Prototype 0.5) for 41 days over a 60 day period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female subjects minimum 18 years of age
- Individuals diagnosed with any type of insulin-dependent diabetes mellitus ≥ 1 year
- Willing to perform up to 12 finger-pricks during each day of out-patient measurements
- Signed informed consent
- For women of childbearing potential: Willing and able to practice FDA approved birth control during the duration of the investigation
Key exclusion criteria (16 listed)
- For female subjects: Pregnancy or breastfeeding
- Skin phototype VI categorized by Fitzpatrick scale measured on thenar
- 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 protocol
- Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease)
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-24 |
Primary outcome
Determination of number of calibration days
Time frame: 2 years
The number of calibration days needed for reaching a well-performing glucose predictive calibration model will be determined. The clinical performance of the reduced calibration model will be based on the data from the validation part by studying linear regression, Inter Subject Unified Performance value and Consensus Error Grid.
Safety evaluation of the Investigational Medical Device by reporting of adverse events
Time frame: 2 years
Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical investigation
1 secondary outcome
Device function
Time frame: 2 years
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 18 Nov 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 6 inclusion and 16 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 18 Nov 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?
Determination of number of calibration days (time frame: 2 years). The study lists 2 primary outcomes in all. 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 18 Nov 2023.