Type1diabetesNCT03530644
Comparative Study Between Two Models of a Non-invasive Glucose Monitoring Device
A study testing WM3.4NR and P0.1 in people with Type1diabetes, run by RSP Systems A/S at 1 site in Denmark.
Trial summary
This clinical study has been launched to compare the performances of two models of a non-invasive glucose monitoring device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1diabetes
- What is being tested?
- WM3.4NR and P0.1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Aug 2018to 14 Dec 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 type 1 patients
- Insulin pump users
- 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
- Subjects 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
- 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
- Subjects currently enrolled in another study
Trial locations and contacts
1 site in 1 country.
About this study
This clinical study has been launched to compare the performances of two models of a non-invasive glucose monitoring device.
Read the detailed description
Subjects will be optical screened at baseline visit. Study comprises two in-clinic visits. Subjects will arrive in a fasting state and and oral glucose bolus will be administered.
Subjects will during each of two study days be subjected to optical readings on two different device prototypes. During each of the study days, FGM readings, capillary blood samples and arterialized venous blood samples will be collected.
- Conditions
- Type1diabetes
- Being tested
- WM3.4NR, P0.1
- Keywords
- Non-invasive glucose monitoring
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.
P0.1Device
The investigational medical device will collect spectral Raman data from tissue.
| Study group | Role | What they receive |
|---|---|---|
| RSP-14 | Experimental | Comparative study of two Investigational Medical Devices (WM3.4NR and P0.1)
Optical data will be obtained from T1D over a dynamic glycemic range. Data will be paired with references. Receives: Device: WM3.4NR; Device: P0.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation and validation of prediction models
Two in-clinic visits each of a duration of 7-8 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM readings. In parallel, optical glucose data from two different prototypes of the investigational medical device will be collected.
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 from the two devices will be validated on independent data sets using MARD, ISUP and Consensus Error Grid endpoint measures.
Measured: 4 months
Performance evaluation
Validated calibration models will be compared with MARD, ISUP and Consensus Error Grid endpoint measures.
Measured: 4 months
Secondary outcomes (1)
Safety by paucity of adverse events
To evaluate safety of devices in a descriptive manner by the paucity of adverse events. Adverse events will be recorded during study.
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 posted21 May 2018
- Study start28 Aug 2018
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies 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
- 3 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
- NCT03530644
- Sponsor's protocol ID
- RSP-14
- Status last verified
- Dec 2018
- First submitted
- 11 Apr 2018
- Last updated
- 19 Dec 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 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Two Models of a Non-invasive Glucose Monitoring Device
- ClinicalTrials.gov ID
- NCT03530644
- Acronym / sponsor ID
- RSP-14
- Conditions
- Type1diabetes
- Keywords
- Non-invasive glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- RSP Systems A/SIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 21 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 compare the performances of two models of a non-invasive glucose monitoring device.
Detailed description
Subjects will be optical screened at baseline visit. Study comprises two in-clinic visits. Subjects will arrive in a fasting state and and oral glucose bolus will be administered.
Subjects will during each of two study days be subjected to optical readings on two different device prototypes. During each of the study days, FGM readings, capillary blood samples and arterialized venous blood samples 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 |
|---|---|---|
| RSP-14 | Experimental | Device: WM3.4NR, Device: P0.1Comparative study of two Investigational Medical Devices (WM3.4NR and P0.1) Optical data will be obtained from T1D over a dynamic glycemic range. Data will be paired with references. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects 18 years of age or older
- Diabetic type 1 patients
- Insulin pump users
- 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 |
|---|---|---|
| WM3.4NRThe investigational medical device will collect spectral Raman data from tissue. | Device | RSP-14 |
| P0.1The investigational medical device will collect spectral Raman data from tissue. | Device | RSP-14 |
Primary outcome
Generation and validation of prediction models
Time frame: 4 months
Two in-clinic visits each of a duration of 7-8 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM readings. In parallel, optical glucose data from two different prototypes of the investigational medical device will be collected. 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 from the two devices will be validated on independent data sets using MARD, ISUP and Consensus Error Grid endpoint measures.
Performance evaluation
Time frame: 4 months
Validated calibration models will be compared with MARD, ISUP and Consensus Error Grid endpoint measures.
1 secondary outcome
Safety by paucity of adverse events
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 19 Dec 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, 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 WM3.4NR and P0.1 in people with Type1diabetes, 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 4 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 19 Dec 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 prediction models (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 19 Dec 2018.