DiabetesNCT04021251
Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes
A study testing P0.2 in people with Diabetes, 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
- What is being tested?
- P0.2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Dec 2018to Aug 2021
- 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)
- 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
- Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
- Diagnosed with reduced circulation
Show all 14Show fewer
- 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-16-01
- Systemic or topical administration of glucocorticoids for the past 7 days and under investigation
- Participants 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.
Denmark1 site, 1 recruiting
- Recruiting
Department of Endocrinology M
Odense, 5000
Jan Erik Henriksen, MD, +45 65411811, Jan.Erik.Henriksen@rsyd.dk
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 either 8 or 44 daily optical raman readings paired with either 8 capillary Blood Glucose comparator or 8 capillary Blood Glucose comparator plus 44 readings using a flash glucose monitoring system in own home with maintaining usual routines. Subjects will either collect data for 5 days during a 10 days period or collect data for 90 days during a 40 days period or collect data for 90 days during 6 months period.
- Conditions
- Diabetes
- Being tested
- P0.2
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P0.2Device
Investigational Medical Device collecting spectral raman data from tissue.
| Study group | Role | What they receive |
|---|---|---|
| Short term collection of IMD data | Experimental | Subjects will collect spectral raman data on P0.2 for minimum 10 hours per day with a maximum of 15 minutes between each measurement for 5 days distributed over a time period of 10 days. Spectral data will be compared to standard BG and/or FGM measurements. Receives: Device: P0.2 |
| Medium term collection of IMD data | Experimental | Subjects will collect spectral raman data on P0.2 for four times a day for 30 days distributed over a time period of 40 days. Spectral data will be compared to standard BG measurements. Receives: Device: P0.2 |
| Long term collection of IMD data | Experimental | Subjects will collect spectral raman data on P0.2 for four times a day for 90 days distributed over a time period of 6 months. Spectral data will be compared to standard BG measurements. Receives: Device: P0.2 |
| Medium term collection of IMD data, increased # of sessions | Experimental | Subjects will collect spectral raman data on P0.2 four times a day for 30 days distributed over a time period of 40 days. Spectral data will be compared to standard BG measurements. The number of optical sessions performed each time measurements are done are increased compared to the investigation's second arm. Receives: Device: P0.2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation of predictive algorithms for determining blood glucose levels
Collected spectral raman data will found the development of predictive algorithms for glucose determination.
Measured: 3 years
Validation of predictive algorithms for determining blood glucose levels
Performance of predictive models will be evaluated using the consensus error grid.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start20 Dec 2018
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
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, Odense University Hospital, Dpt. of Endocrinology M
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021251
- Sponsor's protocol ID
- RSP-16
- Status last verified
- Aug 2020
- First submitted
- 20 Dec 2018
- Last updated
- 17 Aug 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 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes
- ClinicalTrials.gov ID
- NCT04021251
- Acronym / sponsor ID
- RSP-16
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- RSP Systems A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 16 Jul 2019 (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 either 8 or 44 daily optical raman readings paired with either 8 capillary Blood Glucose comparator or 8 capillary Blood Glucose comparator plus 44 readings using a flash glucose monitoring system in own home with maintaining usual routines. Subjects will either collect data for 5 days during a 10 days period or collect data for 90 days during a 40 days period or collect data for 90 days during 6 months period.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Short term collection of IMD data | Experimental | Device: P0.2Subjects will collect spectral raman data on P0.2 for minimum 10 hours per day with a maximum of 15 minutes between each measurement for 5 days distributed over a time period of 10 days. Spectral data will be compared to standard BG and/or FGM measurements. |
| Medium term collection of IMD data | Experimental | Device: P0.2Subjects will collect spectral raman data on P0.2 for four times a day for 30 days distributed over a time period of 40 days. Spectral data will be compared to standard BG measurements. |
| Long term collection of IMD data | Experimental | Device: P0.2Subjects will collect spectral raman data on P0.2 for four times a day for 90 days distributed over a time period of 6 months. Spectral data will be compared to standard BG measurements. |
| Medium term collection of IMD data, increased # of sessions | Experimental | Device: P0.2Subjects will collect spectral raman data on P0.2 four times a day for 30 days distributed over a time period of 40 days. Spectral data will be compared to standard BG measurements. The number of optical sessions performed each time measurements are done are increased compared to the investigation's second arm. |
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)
- Skin phototype 1-4
Key exclusion criteria (14 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
- Participants not able to hold hand/arm steadily (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 |
|---|---|---|
| P0.2Investigational Medical Device collecting spectral raman data from tissue. | Device | Long term collection of IMD data, Medium term collection of IMD data, Medium term collection of IMD data, increased # of sessions, Short term collection of IMD data |
Primary outcome
Generation of predictive algorithms for determining blood glucose levels
Time frame: 3 years
Collected spectral raman data will found the development of predictive algorithms for glucose determination.
Validation of predictive algorithms for determining blood glucose levels
Time frame: 3 years
Performance of predictive models will be evaluated using the consensus error grid.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 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 principal investigator
Odense University Hospital, Dpt. of Endocrinology M
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P0.2 in people with Diabetes, 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 14 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: status not confirmed, as of the sponsor's last update on 17 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Ovesen Banke, MSc (+45 71 99 79 77, stefan@rspsystems.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generation of predictive algorithms for determining blood glucose levels (time frame: 3 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 17 Aug 2020.