Diabetes MellitusNCT04031300
Performance and Safety Evaluation 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 6 sites in 4 countries.
Trial summary
This pivotal multicenter 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
- 0 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 1 Jun 2019to 1 Jun 2019
- 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
- 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 the local language
- 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)
Show all 14Show fewer
- Subject diagnosed with cardiovascular diseases
- Reduced circulation in right hand evaluated by Allen's test
- Subjects receiving anticoagulants, active cancer treatment, tetracyclines and other medication/topical agents increasing photosensitivity
- Radiotherapy for the past six months
- 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
6 sites in 4 countries.
6 sites in 4 countries
Denmark2 sites
Steno Diabetes Center Copenhagen (SDCC)
Gentofte Municipality, 2820
Steno Diabetes Center Odense (SDCO)
Odense C, 5000
Sweden2 sites
Sahlgrenske University Hospital (SUH)
Gothenburg, 413 45
Department of Medicine, Uddevalla Hospital (UVH)
Uddevalla, 451 53
Germany1 site
Institut für Diabetes-Technologie Forschungs- und Entwicklungs-gesellschaft mbH an der Universität Ulm (IDT)
Ulm, 89081
About this study
This pivotal multicenter study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.
Read the detailed description
Participants will be enrolled at six different sites in four different countries. All participants will undergo identical procedures, which include four steps: Baseline visit (1 day), calibration period (25 days), validation period (23 days) and a close-out visit (1 day) with a total duration of 50 days.
The calibration period consists of 23 home-based days and two in-clinic days. At the two in-clinic days, measurement sessions are performed every 30 minutes. A measurement session consists of two reference measurements (Contour Next One) and three measurements on the Investigational Medical Device. The glucose level of the participants is manipulated by administration of a glucose rich drink. At home-based days, the subject must perform four measurement sessions a day. During the validation period, participants perform up to four home-based measurement sessions a day.
- 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
Also called P0.5
Investigational Medical Device collecting spectral Raman data non-invasively from tissue
| Study group | Role | What they receive |
|---|---|---|
| RSP-20 | Experimental | Subjects will perform daily measurements on the IMD (Prototype 0.5) in addition to capillary reference measurements for 48 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
Accuracy of measurements performed on the IMD will be evaluated by data from subjects. Data will be analyzed by Mean Absolute Relative Difference (MARD).
Measured: 6 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: 6 months
Secondary outcomes (2)
Device deficiencies
Description of device deficiencies will be listed. Deficiencies will be reported during the clinical study.
Measured: Up to 6 months
Device usability
The use of the device will be evaluated by means of questionnaires. The subjects are asked if they encountered any problems during measurements, and if so, to elaborate the problems encountered.
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 posted24 Jul 2019
- Study start1 Jun 2019 (estimated)
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Why it stopped: The study was withdrawn due to change in project strategy (new intended use)
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RSP Systems A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kirsten Nørgaard, MD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031300
- Sponsor's protocol ID
- RSP-20
- Status last verified
- Nov 2023
- First submitted
- 26 Mar 2019
- Last updated
- 21 Nov 2023
- 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 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device
- ClinicalTrials.gov ID
- NCT04031300
- Acronym / sponsor ID
- RSP-20
- Conditions
- Diabetes Mellitus
- Keywords
- Non-invasive glucose monitoring, Raman spectroscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to change in project strategy (new intended use)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RSP Systems A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 24 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 pivotal multicenter study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.
Detailed description
Participants will be enrolled at six different sites in four different countries. All participants will undergo identical procedures, which include four steps: Baseline visit (1 day), calibration period (25 days), validation period (23 days) and a close-out visit (1 day) with a total duration of 50 days.
The calibration period consists of 23 home-based days and two in-clinic days. At the two in-clinic days, measurement sessions are performed every 30 minutes. A measurement session consists of two reference measurements (Contour Next One) and three measurements on the Investigational Medical Device. The glucose level of the participants is manipulated by administration of a glucose rich drink. At home-based days, the subject must perform four measurement sessions a day. During the validation period, participants perform up to four home-based measurement sessions a day.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RSP-20 | Experimental | Device: Prototype 0.5Subjects will perform daily measurements on the IMD (Prototype 0.5) in addition to capillary reference measurements for 48 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects ≥18 years of age
- Diagnosed with diabetes, all types except gestational diabetes
- 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
Key exclusion criteria (14 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 the local language
- 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 0.5Also: P0.5Investigational Medical Device collecting spectral Raman data non-invasively from tissue | Device | RSP-20 |
Primary outcome
Measurement accuracy
Time frame: 6 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).
Safety evaluation: paucity of adverse events
Time frame: 6 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 deficiencies
Time frame: Up to 6 months
Device usability
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- 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.
Kirsten Nørgaard, MD principal investigator
Steno Diabetes Center Copenhagen
6 sites in 4 countries: 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 6 sites in 4 countries.
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 5 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: withdrawn, as of the sponsor's last update on 21 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 6 sites in Denmark, Sweden, Germany, United Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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 (time frame: 6 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 21 Nov 2023.