Diabetes MellitusNCT04060693
Device Accuracy of Non-invasive Glucose Measurements in Ethnic Skin
A study testing P0.5 in people with Diabetes Mellitus, run by RSP Systems A/S at 1 site in United Kingdom.
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?
- P0.5
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Dec 2019to 10 Dec 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
- Between 18 and 40 years of age.
- Have a diagnosis of diabetes mellitus.
- Distribution of skin phototype: 50-70 % of enrolled subjects phototype IV, 20-40 % of enrolled subjects phototype III, 5-15 % of enrolled subjects phototype II, 5-15 % of enrolled subjects phototype I.
- Be willing to perform a minimum of 8 finger sticks per day during the study.
- Be willing to perform a minimum of 8 optical measurements per day during the study.
- Be 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 during the study execution (applicable to female subjects only).
- Subjects not able to understand and read English.
- 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).
- Diagnosed with cardiovascular diseases.
- Reduced circulation in right hand evaluated by Allen's test.
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- 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 probe application site (thenar) that could interfere with the accuracy of the interstitial glucose measurements.
- Known allergy to medical grade alcohol used to clean the skin.
- Systemic or topical administration of glucocorticoids for the past 7 days and under investigation.
- Subjects undergoing dialysis treatment.
- Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff.
- Medical history or any condition that may, in the opinion of the investigator, compromise subject's ability to participate.
- Subjects currently enrolled in another study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Rare Disease ITM, Heritage Building (Queen Elizabeth Hospital Birmingham)
Birmingham, Edgbaston, B15 2TH
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
The subjects enrolled in this protocol will dedicate 30 days of home-based measurement, scheduled within a 40 days' time frame. For reference measurements, subjects will be equipped with a blood glucose meter (Contour Next One, Ascenia). Optical measurements are collected with the investigational medical device. Each day of measurements consists of four sessions each comprising two capillary blood glucose measurement with a blood glucose meter and two investigational medical device measurements.
- Conditions
- Diabetes Mellitus
- Being tested
- P0.5
- Keywords
- Non-invasive glucose monitoring
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P0.5Device
Investigational Medical Device collecting spectral raman data from tissue.
| Study group | Role | What they receive |
|---|---|---|
| Protocol 1 | Experimental | The subjects enrolled in this protocol will dedicate 30 days of home-based measurement, scheduled within a 40 days' time frame. 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 within 3 minutes after the BG measurement using the thenar of the right hand of the subject. Receives: Device: P0.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement accuracy of IMD
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: 8 months
Secondary outcomes (1)
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: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start10 Dec 2019
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
Why it stopped: Miscommunication with the CRO that was hired to help with the regulatory submission process
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
- Model description
- Open, non-randomized comparison study between device and blood references with diabetic patients.
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060693
- Sponsor's protocol ID
- RSP 18
- Status last verified
- Nov 2023
- First submitted
- 12 Oct 2018
- Last updated
- 18 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Device Accuracy of Non-invasive Glucose Measurements in Ethnic Skin
- ClinicalTrials.gov ID
- NCT04060693
- Acronym / sponsor ID
- RSP 18
- Conditions
- Diabetes Mellitus
- Keywords
- Non-invasive glucose monitoring
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Miscommunication with the CRO that was hired to help with the regulatory submission process
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RSP Systems A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 19 Aug 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
The subjects enrolled in this protocol will dedicate 30 days of home-based measurement, scheduled within a 40 days' time frame. For reference measurements, subjects will be equipped with a blood glucose meter (Contour Next One, Ascenia). Optical measurements are collected with the investigational medical device. Each day of measurements consists of four sessions each comprising two capillary blood glucose measurement with a blood glucose meter and two investigational medical device measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open, non-randomized comparison study between device and blood references with diabetic patients.
| Arm | Type | Receives |
|---|---|---|
| Protocol 1 | Experimental | Device: P0.5The subjects enrolled in this protocol will dedicate 30 days of home-based measurement, scheduled within a 40 days' time frame. 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 within 3 minutes after the BG measurement using the thenar of the right hand of the subject. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between 18 and 40 years of age.
- Have a diagnosis of diabetes mellitus.
- Distribution of skin phototype: 50-70 % of enrolled subjects phototype IV, 20-40 % of enrolled subjects phototype III, 5-15 % of enrolled subjects phototype II, 5-15 % of enrolled subjects phototype I.
- Be willing to perform a minimum of 8 finger sticks per day during the study.
- Be willing to perform a minimum of 8 optical measurements per day during the study.
Key exclusion criteria (15 listed)
- Breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control during the study execution (applicable to female subjects only).
- Subjects not able to understand and read English.
- 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).
- Diagnosed with cardiovascular diseases.
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 |
|---|---|---|
| P0.5Investigational Medical Device collecting spectral raman data from tissue. | Device | Protocol 1 |
Primary outcome
Measurement accuracy of IMD
Time frame: 8 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).
1 secondary outcome
Safety evaluation: paucity of adverse events
Time frame: 8 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 18 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P0.5 in people with Diabetes Mellitus, run by RSP Systems A/S at 1 site in United Kingdom.
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 6 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: withdrawn, as of the sponsor's last update on 18 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 1 site in 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 of IMD (time frame: 8 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 18 Nov 2023.