Diabetes MellitusNCT03519841
Performance Study of a Non-invasive Glucose Monitoring Device Prototype
A study testing P0.1 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?
- P0.1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Apr 2018to 8 Oct 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), insulin requiring
- Skin phototype 1-4
Who cannot join
- For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
- For female participants: Breastfeeding
- Subjects not able to understand and read Danish
- In Investigator's opinion, subject is not able to follow instructions as specified in the protocol
- Rejection by optical screenings
- Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
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- Diagnosed with reduced circulation
- Extensive skin changes, tattoos or diseases on probe application site
- Known allergy to medical grade alcohol
- Known allergy to adhesives, applicable to subjects in RSP-13-01
- Systemic or topical administration of glucocorticoids for the past 7 days
- Subjects undergoing dialysis treatment
- Medical history or any condition that may, in the opinion of the Investigator, compromise the subject's ability to participate
- Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff.
- Participants currently enrolled in another study
Trial locations and contacts
1 site in 1 country.
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
Protocol consists of two parts:
Part A) Subjects will collect spectral Raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributed within 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.
Part B) Subjects will perform four daily measuring sessions in which optical Raman readings are paired with capillary Blood Glucose comparator. Measuring sessions are performed in subjects' own home while maintaining usual diabetes management routines. Subjects will collect data for 30 days during a 60 days' period.
- Conditions
- Diabetes Mellitus
- Being tested
- P0.1
- 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.
P0.1Device
Investigational Medical Device collecting spectral Raman data from tissue.
| Study group | Role | What they receive |
|---|---|---|
| RSP-13-01 | Experimental | Experimental: IMD data collection Subjects will intensively collect spectral Raman data on P0.1 in a home-based setting for 5 days. Data will be paired with reference measurements. Receives: Device: P0.1 |
| RSP-13-02 | Experimental | Experimental: IMD data collection Subjects will collect spectral Raman data on P0.1 during four measuring sessions a day for 30 days distributed over a time period of 60 days. Each timepoint is conducted in duplicate. Spectral data will be compared to standard BG measurements. Receives: Device: P0.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation and validation of predictive models by ISUP and MARD measures
Optical glucose data will be collected together with paired reference values (BGM and FGM, Protocol 1 and BGM, Subprotocol 2).
For subprotocol 1, measurements will be collected every 15 minutes for 10 hours a day for 5 days distributed over a period of 10 days.
For subprotocol 2, four daily measurements will be collected while subject is maintaining normal routines. Data will be collected for 30 days distributed over a period of 60 days.
Optical glucose readings will be masked to the subjects.
Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using MARD and ISUP measures.
Measured: 6 months
Secondary outcomes (1)
Safety evaluation: paucity of adverse events
Safety will be evaluated in a descriptive manner by the paucity of adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start13 Apr 2018
- Primary completion8 Oct 2018
- Study completion8 Oct 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized interventional study comparing device and blood reference measurements in diabetic patients
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 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, PhD, Principal investigator, Steno Diabetes Center Odense, DenmarkVibe Vestergaard, Nurse, Principal investigator, Steno Diabetes Center Odense, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519841
- Sponsor's protocol ID
- RSP-13
- Status last verified
- Oct 2020
- First submitted
- 11 Apr 2018
- Last updated
- 8 Oct 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 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Study of a Non-invasive Glucose Monitoring Device Prototype
- ClinicalTrials.gov ID
- NCT03519841
- Acronym / sponsor ID
- RSP-13
- Conditions
- Diabetes Mellitus
- Keywords
- Non-invasive glucose monitoring, Raman spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- RSP Systems A/SIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 9 May 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 clinical study has been launched to collect spectral Raman data paired with validated glucose reference values in private homes of subjects.
Detailed description
Protocol consists of two parts:
Part A) Subjects will collect spectral Raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributed within 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.
Part B) Subjects will perform four daily measuring sessions in which optical Raman readings are paired with capillary Blood Glucose comparator. Measuring sessions are performed in subjects' own home while maintaining usual diabetes management routines. Subjects will collect data for 30 days during a 60 days' period.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Non-randomized interventional study comparing device and blood reference measurements in diabetic patients
| Arm | Type | Receives |
|---|---|---|
| RSP-13-01 | Experimental | Device: P0.1Experimental: IMD data collection Subjects will intensively collect spectral Raman data on P0.1 in a home-based setting for 5 days. Data will be paired with reference measurements. |
| RSP-13-02 | Experimental | Device: P0.1Experimental: IMD data collection Subjects will collect spectral Raman data on P0.1 during four measuring sessions a day for 30 days distributed over a time period of 60 days. Each timepoint is conducted in duplicate. Spectral data will be compared to standard BG measurements. |
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 and female subjects 18 years of age or older
- Diabetic patients (all types), insulin requiring
- Skin phototype 1-4
Key exclusion criteria (15 listed)
- For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
- For female participants: Breastfeeding
- Subjects not able to understand and read Danish
- In Investigator's opinion, subject is not able to follow instructions as specified in the protocol
- Rejection by optical screenings
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 |
|---|---|---|
| P0.1Investigational Medical Device collecting spectral Raman data from tissue. | Device | RSP-13-01, RSP-13-02 |
Primary outcome
Generation and validation of predictive models by ISUP and MARD measures
Time frame: 6 months
Optical glucose data will be collected together with paired reference values (BGM and FGM, Protocol 1 and BGM, Subprotocol 2). For subprotocol 1, measurements will be collected every 15 minutes for 10 hours a day for 5 days distributed over a period of 10 days. For subprotocol 2, four daily measurements will be collected while subject is maintaining normal routines. Data will be collected for 30 days distributed over a period of 60 days. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using MARD and ISUP measures.
1 secondary outcome
Safety evaluation: paucity of adverse events
Time frame: 6 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 8 Oct 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.
Jan Erik Henriksen, MD, PhD principal investigator
Steno Diabetes Center Odense, Denmark
Vibe Vestergaard, Nurse principal investigator
Steno Diabetes Center Odense, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P0.1 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 3 inclusion and 15 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 8 Oct 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?
Generation and validation of predictive models by ISUP and MARD measures (time frame: 6 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 8 Oct 2020.