Diabetes MellitusNCT04126759
Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes
A study testing P0.3 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 and reference measurements to establish and validate a calibration model for the device during daily glycemic fluctuations and evaluate analytical performance of device in the hypoglycemic range. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- P0.3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2019to 31 Jan 2020
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female subjects between 18 and 40 years of age.
- Diagnosed with type 1 diabetes mellitus.
- Uses an insulin pen or pump.
- Hb1Ac > 55 mmol/mol at baseline visit.
- Skin phototype 1-4 according to Fitzpatrick skin tone scale.
- Willing to perform a minimum of 8 finger sticks per day during the study for the home-based study and approximately 16 finger sticks for the in-clinic study days.
- Willing to have a peripheral venous catheter inserted.
- Willing to provide written signed and dated informed consent.
Who cannot join
- Breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control according to approved contraceptives from NCA during the study execution (applicable to female subjects only).
- Subjects not able to understand and read Danish.
- Inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator.
- Subject is not able to hold hand/arm steadily (including tremors and Parkinson's Disease).
- Reduced circulation in hand. "Allen's test" is used for assessing hand circulation to evaluate occurrence of reduced blood.
- Extensive skin changes, tattoos or diseases on probe application site (thenar) that could interfere with the accuracy of the interstitial glucose measurements.
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- Known allergy to medical grade alcohol.
- Having active cancer treatment and/or use tetracyclines and other medication / topical agents known to increase photosensitivity in skin.
- 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.
- Diagnosed with cardiovascular diseases.
- Subjects currently enrolled in another study.
- Radiotherapy for the past six months.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Steno Diabetes Center Copenhagen (SDCC)
Gentofte Municipality, 2820
About this study
This clinical study has been launched to collect spectral Raman data and reference measurements to establish and validate a calibration model for the device during daily glycemic fluctuations and evaluate analytical performance of device in the hypoglycemic range. The study is a combined home-based and in-clinic study where subjects will attend the clinic two times.
- Conditions
- Diabetes Mellitus
- Being tested
- P0.3
- 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.
P0.3Device
Subjects will perform daily measurements on the IMD (Prototype 0.3) for 35 days.
| Study group | Role | What they receive |
|---|---|---|
| Protocol 1 | Experimental | The subjects enrolled in this protocol will dedicate 33 days of home-based measurement and two days for in-clinic measurements. For reference measurements, subjects will be equipped with a BG-meter (Contour Next One, Ascenia). Optical measurements are collected with the IMD. Each day of measurements consists of four sessions each comprising two capillary blood glucose measurement with a BG-meter and two IMD measurements. IMD measurements will be performed using the thenar of the right hand of the subject. Receives: Device: P0.3 |
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: 12 months
Validation of predictive algorithms for determining blood glucose levels
Performance of predictive models will be evaluated using the consensus error grid.Unified Performance (ISUP), Mean Absolute Relative Difference (MARD) and Consensus Error Grid (CEG) distribution.
Measured: 12 months
Secondary outcomes (2)
Risk/benefit analysis
Support of a favorable risk/benefit analysis based on reported Adverse Device Effects and Serious Adverse Device Effects.
Measured: 12 months
Number of encountered Device Deficiencies
Evaluation of Device Deficiencies with respect to identity, quality, durability or reliability, including malfunctions, use errors and inadequate labeling.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Jul 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- RSP Systems A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Steno Diabetes Center Copenhagen
- Responsible party
- Sponsor
- Investigators
- Kirsten Nørgaard, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126759
- Sponsor's protocol ID
- RSP-17
- Status last verified
- Oct 2020
- First submitted
- 15 Jul 2019
- 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
- Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04126759
- Acronym / sponsor ID
- RSP-17
- Conditions
- Diabetes Mellitus
- Keywords
- Non-invasive glucose monitoring, Raman spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- RSP Systems A/SIndustry (pharma, biotech, devices)
- Collaborators
- Steno Diabetes Center Copenhagen
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 15 Oct 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 and reference measurements to establish and validate a calibration model for the device during daily glycemic fluctuations and evaluate analytical performance of device in the hypoglycemic range. The study is a combined home-based and in-clinic study where subjects will attend the clinic two times.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Protocol 1 | Experimental | Device: P0.3The subjects enrolled in this protocol will dedicate 33 days of home-based measurement and two days for in-clinic measurements. For reference measurements, subjects will be equipped with a BG-meter (Contour Next One, Ascenia). Optical measurements are collected with the IMD. Each day of measurements consists of four sessions each comprising two capillary blood glucose measurement with a BG-meter and two IMD measurements. IMD measurements will be performed using the thenar of the right hand of the subject. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male and female subjects between 18 and 40 years of age.
- Diagnosed with type 1 diabetes mellitus.
- Uses an insulin pen or pump.
- Hb1Ac > 55 mmol/mol at baseline visit.
- Skin phototype 1-4 according to Fitzpatrick skin tone scale.
Key exclusion criteria (13 listed)
- Breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control according to approved contraceptives from NCA during the study execution (applicable to female subjects only).
- Subjects not able to understand and read Danish.
- Inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator.
- Subject is not able to hold hand/arm steadily (including tremors and Parkinson's Disease).
- Reduced circulation in hand. "Allen's test" is used for assessing hand circulation to evaluate occurrence of reduced blood.
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 |
|---|---|---|
| P0.3Subjects will perform daily measurements on the IMD (Prototype 0.3) for 35 days. | Device | Protocol 1 |
Primary outcome
Generation of predictive algorithms for determining blood glucose levels
Time frame: 12 months
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: 12 months
Performance of predictive models will be evaluated using the consensus error grid.Unified Performance (ISUP), Mean Absolute Relative Difference (MARD) and Consensus Error Grid (CEG) distribution.
2 secondary outcomes
Risk/benefit analysis
Time frame: 12 months
Number of encountered Device Deficiencies
Time frame: 12 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.
Kirsten Nørgaard principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P0.3 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 8 inclusion and 13 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 of predictive algorithms for determining blood glucose levels (time frame: 12 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 8 Oct 2020.