Diabetes MellitusNCT03352518
Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device
A study testing WM3.4NR in people with Diabetes Mellitus, run by RSP Systems A/S at 1 site in Denmark.
Trial summary
This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects. 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?
- WM3.4NR
- 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
- 28 Dec 2017to 17 Apr 2018
- 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 or older
- Diabetic patients (all types)
Who cannot join
- Pregnant women
- Subjects not able to understand and read Danish
- In investigator's opinion, subject is not able to follow instructions as specified in the protocol
- Subjects not able to hold hand/arm steadily
- Extensive skin changes, tattoos or diseases on probe application site
- Known allergy to medical grade alcohol used to disinfect skin
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology M, Odense University Hospital
Odense, 5000
About this study
This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.
Read the detailed description
Subjects will collect spectral raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributes with in a timeframe of ten days. A Flash Glucose Monitor will be used as a comparator. In addition to this, four daily capillary Blood Glucose readings will be collected.
- Conditions
- Diabetes Mellitus
- Being tested
- WM3.4NR
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WM3.4NRDevice
The investigational medical device will collect spectral raman data from tissue.
| Study group | Role | What they receive |
|---|---|---|
| IMD data collection | Experimental | Subjects will intensively collect spectral raman data in a home-based setting for 5 days using WM3.4NR and comparators. Receives: Device: WM3.4NR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation and validation of predictive calibration models
The collected data will generate individual calibration models capable of predicting tissue glucose concentrations. An evaluation of the models by the consensus error grid will be performed.
Measured: 3 months
Secondary outcomes (1)
Safety assessment of the intervention by the paucity of adverse events
The number of subjects experiencing device-related adverse events will be recorded.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start28 Dec 2017
- Primary completion13 Apr 2018
- Study completion17 Apr 2018
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
- Jan Erik Henriksen, MD, Principal investigator, University Hospital Odense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352518
- Sponsor's protocol ID
- RSP-12-02
- Status last verified
- Nov 2017
- First submitted
- 13 Nov 2017
- Last updated
- 15 Oct 2018
- 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 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device
- ClinicalTrials.gov ID
- NCT03352518
- Acronym / sponsor ID
- RSP-12-02
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- RSP Systems A/SIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 24 Nov 2017 (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 clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.
Detailed description
Subjects will collect spectral raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributes with in a timeframe of ten days. A Flash Glucose Monitor will be used as a comparator. In addition to this, four daily capillary Blood Glucose readings will be collected.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMD data collection | Experimental | Device: WM3.4NRSubjects will intensively collect spectral raman data in a home-based setting for 5 days using WM3.4NR and comparators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female subjects 18 years of age or older
- Diabetic patients (all types)
Key exclusion criteria (6 listed)
- Pregnant women
- Subjects not able to understand and read Danish
- In investigator's opinion, subject is not able to follow instructions as specified in the protocol
- Subjects not able to hold hand/arm steadily
- Extensive skin changes, tattoos or diseases on probe application site
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 |
|---|---|---|
| WM3.4NRThe investigational medical device will collect spectral raman data from tissue. | Device | IMD data collection |
Primary outcome
Generation and validation of predictive calibration models
Time frame: 3 months
The collected data will generate individual calibration models capable of predicting tissue glucose concentrations. An evaluation of the models by the consensus error grid will be performed.
1 secondary outcome
Safety assessment of the intervention by the paucity of adverse events
Time frame: 3 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 15 Oct 2018.
- 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.
Jan Erik Henriksen, MD principal investigator
University Hospital Odense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WM3.4NR 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 2 inclusion and 6 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 15 Oct 2018. 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?
Generation and validation of predictive calibration models (time frame: 3 months). 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 15 Oct 2018.