Diabetes MellitusNCT03782441
Study of a Novel Non-invasive Glucose Monitoring Device
A study testing Prototype 0.5 in people with Diabetes Mellitus, run by RSP Systems A/S at 1 site in Denmark.
Trial summary
This explorative clinical study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients. 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
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Nov 2019to 1 Dec 2020
- 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 ≥18 years of age
- Diagnosed with diabetes, all types except gestational diabetes
- HbA1c distribution > 60 mmol/mol at baseline visit
- Skin phototype 1-4
- Willing to perform a minimum of 8 finger sticks during each day of home-based measurements and 30 finger sticks at the two in-clinic study days
- Subject has a wireless internet connection at home to be used in the study
Who cannot join
- For female subjects: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
- For female subjects: Breastfeeding
- Subject currently participating in another study
- Subject not able to understand and read Danish
- 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)
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- Reduced circulation in right hand evaluated by Allen's test
- Extensive skin changes, tattoos or diseases on right hand thenar (probe application site)
- Known allergy to medical grade alcohol used to clean the skin
- Medical history or any condition that may, in the opinion of the investigator compromise the subject's ability to participate
- Comorbidity or concomitant medical condition which, in the opinion of the Investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of a Novel Non-invasive Glucose Monitoring Device
This explorative clinical study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.
Read the detailed description
The Investigational Medical Device (IMD) for this investigation is the Prototype 0.5 (P0.5) developed and manufactured by RSP Systems (RSP). The device is intended for non-invasive interstitial intermittent glucose monitoring in persons (age 18 and older) with diabetes. The technology relies on the well-established capacities of Raman spectroscopy for directly detecting glucose subcutaneously. The Raman spectroscopy physical principle relies on the fact that when laser light of a given wavelength interferes with a molecule, a small fraction of the incident light will interact with the vibrational states of the molecule, causing the photons to lose a portion of their energy which will change the wavelength of the light. The scattered light will be collected by the optical probe head and analyzed with advanced algorithms to correlate the signal to glucose concentrations. Data collected from the IMD will be paired with validated glucose reference values collected by the finger sticking method.
- 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 spectral Raman data from tissue
| Study group | Role | What they receive |
|---|---|---|
| RSP-19 | Experimental | Subjects will perform daily measurements on the IMD (Prototype 0.5) for 42 days. Receives: Device: Prototype 0.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement accuracy of IMD
Accuracy of measurements performed on the IMD will be evaluated by data from subjects. Data will be analyzed by Mean Absolute Relative Difference (MARD) and Inter Subject Unified Performance (ISUP)
Measured: 4 months
Safety evaluation: paucity of adverse events
Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical study
Measured: 4 months
Secondary outcomes (2)
Device deficiency
Description of device deficiencies will be listed. Deficiencies will be reported during the clinical study.
Measured: 4 months
Device usability
The use of the device by the subjects will be evaluated by means of questionnaires
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start5 Nov 2019
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- RSP Systems A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sanne Fisker, Principal investigator, Steno Diabetes Center, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782441
- Sponsor's protocol ID
- RSP-19
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2018
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Novel Non-invasive Glucose Monitoring Device
- ClinicalTrials.gov ID
- NCT03782441
- Acronym / sponsor ID
- RSP-19
- Conditions
- Diabetes Mellitus
- Keywords
- Non-invasive glucose monitoring, Raman spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- RSP Systems A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 20 Dec 2018 (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 study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.
Detailed description
The Investigational Medical Device (IMD) for this investigation is the Prototype 0.5 (P0.5) developed and manufactured by RSP Systems (RSP). The device is intended for non-invasive interstitial intermittent glucose monitoring in persons (age 18 and older) with diabetes. The technology relies on the well-established capacities of Raman spectroscopy for directly detecting glucose subcutaneously. The Raman spectroscopy physical principle relies on the fact that when laser light of a given wavelength interferes with a molecule, a small fraction of the incident light will interact with the vibrational states of the molecule, causing the photons to lose a portion of their energy which will change the wavelength of the light. The scattered light will be collected by the optical probe head and analyzed with advanced algorithms to correlate the signal to glucose concentrations. Data collected from the IMD will be paired with validated glucose reference values collected by the finger sticking method.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RSP-19 | Experimental | Device: Prototype 0.5Subjects will perform daily measurements on the IMD (Prototype 0.5) for 42 days. |
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 ≥18 years of age
- Diagnosed with diabetes, all types except gestational diabetes
- HbA1c distribution > 60 mmol/mol at baseline visit
- Skin phototype 1-4
- Willing to perform a minimum of 8 finger sticks during each day of home-based measurements and 30 finger sticks at the two in-clinic study days
Key exclusion criteria (11 listed)
- For female subjects: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
- For female subjects: Breastfeeding
- Subject currently participating in another study
- Subject not able to understand and read Danish
- In investigator's opinion, subject is not able to follow instructions provided and as specified in the protocol
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 spectral Raman data from tissue | Device | RSP-19 |
Primary outcome
Measurement accuracy of IMD
Time frame: 4 months
Accuracy of measurements performed on the IMD will be evaluated by data from subjects. Data will be analyzed by Mean Absolute Relative Difference (MARD) and Inter Subject Unified Performance (ISUP)
Safety evaluation: paucity of adverse events
Time frame: 4 months
Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical study
2 secondary outcomes
Device deficiency
Time frame: 4 months
Device usability
Time frame: 4 months
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 3 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Sanne Fisker principal investigator
Steno Diabetes Center, Aarhus University Hospital
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 Denmark.
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 11 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 3 Dec 2020. 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 Denmark. 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?
Measurement accuracy of IMD (time frame: 4 months). 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 3 Dec 2020.