DiabetesNCT03368209
Noninvasive Glucose Measurements - Database and Calibration Compilation
A study testing WM3.4 in people with Diabetes, run by RSP Systems A/S at 1 site in Denmark.
Trial summary
This study collected spectral raman data from diabetic patients. Data was paired with validated capillary references as well as CGM/FGM readings. Data was used to develop models for glucose prediction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- WM3.4
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Dec 2015to 7 May 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with and without diabetes including pregnant women
Who cannot join
- Subject under 18 years of age
- Subjects not able to understand provided information
- Subjects without measuring sites
- Subjects with rash or wound on measuring sites
- Subjects with stained fingers, such a oil or nicotine
- Subjects not capable of holding arm/hand steadily on probe
- Subjects with thrombosis in arm/hand
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology M, Odense University Hospital
Odense, 5000
About this study
This study collected spectral raman data from diabetic patients. Data was paired with validated capillary references as well as CGM/FGM readings. Data was used to develop models for glucose prediction.
Read the detailed description
This trial constitutes three subprotocols: "The OUH protocol", "The Home 1 protocol" and "The Home 2 protocol" The investigation was initiated to collect spectral raman data paired with validated blood references. In the OUH protocol, capillary blood was analysed by ABL 800 Flex blood gas analyzer by Radiometer. In the Home 1 protocol, references were obtained by the finger pricking procedure from HemoCue (Radiometer). In the Home 2 protocol, HemoCue measurements were conducted along with continuous monitoring using Dexcom G4/G5 device (Dexcom) or FreeStyle Libre (Abbott) The data was collected from diabetic patients and Optical Coherence Tomography (OCT) readings were obtained from all subjects.
- Conditions
- Diabetes
- Being tested
- WM3.4
- 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.
WM3.4Device
Investigational Medical Device collecting spectral raman data from tissue.
| Study group | Role | What they receive |
|---|---|---|
| OUH protocol | Experimental | The protocol constituted two outpatient visits in the clinic within one week. Each visit had a duration of approximately 2,5 hours. Prior to study, optical screenings were conducted:
* Optical Coherence Tomography (OCT)
* Optical screening on measuring site with WM3.4.
Subjects were measured by the following scheme: ABL measurement, two optical measurements on WM3.4 #1 followed by two optical measurements on WM3.4 #2. Receives: Device: WM3.4 |
| Home 1 protocol | Experimental | Optical screening (OCT and device) was conducted at baseline visit in the Department of Endocrinology M at Odense University Hospital.
WM3.4 was subsequently delivered to subject's home and the subject measured 30 days in a 60 days period of time. HemoCue was used for reference. Receives: Device: WM3.4 |
| Home 2 protocol | Experimental | Optical screening (OCT and device) was conducted at baseline visit in the Department of Endocrinology M at Odense University Hospital.
WM3.4 was subsequently delivered to subject's home and the subject measured 30 days in a 60 days period of time. HemoCue and CGM/FGM was used for reference. Receives: Device: WM3.4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calibration models for device predictive purposes
Spectral raman data paired with validated references used to develop predictive algorithms with glucose prediction capablities. The preformance was validated using the consensus error grid.
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 posted11 Dec 2017
- Study start4 Dec 2015
- Primary completion7 May 2017
- Study completion7 May 2017
Why it stopped: Failed to recruit sufficient subjects
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
- Parallel groups
- Model description
- Open, non-randomized comparison study between device and blood references with diabetic patients
- Masking
- None (open label)
- Enrolment
- 62 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, Principal investigator, Odense University Hospital, Dpt. of Endocrinology M
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368209
- Sponsor's protocol ID
- RSP-07
- Status last verified
- Oct 2020
- First submitted
- 22 Nov 2017
- 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
- Noninvasive Glucose Measurements - Database and Calibration Compilation
- ClinicalTrials.gov ID
- NCT03368209
- Acronym / sponsor ID
- RSP-07
- Conditions
- Diabetes
- Keywords
- Non-invasive glucose monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failed to recruit sufficient subjects
- Enrolment
- 62 participants (actual)
- Lead sponsor
- RSP Systems A/SIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2015 (actual)
- Primary completion
- 7 May 2017 (actual)
- Study completion
- 7 May 2017 (actual)
- First posted
- 11 Dec 2017 (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 study collected spectral raman data from diabetic patients. Data was paired with validated capillary references as well as CGM/FGM readings. Data was used to develop models for glucose prediction.
Detailed description
This trial constitutes three subprotocols: "The OUH protocol", "The Home 1 protocol" and "The Home 2 protocol" The investigation was initiated to collect spectral raman data paired with validated blood references. In the OUH protocol, capillary blood was analysed by ABL 800 Flex blood gas analyzer by Radiometer. In the Home 1 protocol, references were obtained by the finger pricking procedure from HemoCue (Radiometer). In the Home 2 protocol, HemoCue measurements were conducted along with continuous monitoring using Dexcom G4/G5 device (Dexcom) or FreeStyle Libre (Abbott) The data was collected from diabetic patients and Optical Coherence Tomography (OCT) readings were obtained from all subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open, non-randomized comparison study between device and blood references with diabetic patients
| Arm | Type | Receives |
|---|---|---|
| OUH protocol | Experimental | Device: WM3.4The protocol constituted two outpatient visits in the clinic within one week. Each visit had a duration of approximately 2,5 hours. Prior to study, optical screenings were conducted: * Optical Coherence Tomography (OCT) * Optical screening on measuring site with WM3.4. Subjects were measured by the following scheme: ABL measurement, two optical measurements on WM3.4 #1 followed by two optical measurements on WM3.4 #2. |
| Home 1 protocol | Experimental | Device: WM3.4Optical screening (OCT and device) was conducted at baseline visit in the Department of Endocrinology M at Odense University Hospital. WM3.4 was subsequently delivered to subject's home and the subject measured 30 days in a 60 days period of time. HemoCue was used for reference. |
| Home 2 protocol | Experimental | Device: WM3.4Optical screening (OCT and device) was conducted at baseline visit in the Department of Endocrinology M at Odense University Hospital. WM3.4 was subsequently delivered to subject's home and the subject measured 30 days in a 60 days period of time. HemoCue and CGM/FGM was used for reference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with and without diabetes including pregnant women
Key exclusion criteria (7 listed)
- Subject under 18 years of age
- Subjects not able to understand provided information
- Subjects without measuring sites
- Subjects with rash or wound on measuring sites
- Subjects with stained fingers, such a oil or nicotine
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 |
|---|---|---|
| WM3.4Investigational Medical Device collecting spectral raman data from tissue. | Device | Home 1 protocol, Home 2 protocol, OUH protocol |
Primary outcome
Calibration models for device predictive purposes
Time frame: 6 months
Spectral raman data paired with validated references used to develop predictive algorithms with glucose prediction capablities. The preformance was validated using the consensus error grid.
Results and safety
The study was stopped early (reason given: Failed to recruit sufficient subjects). Results are not available in the source record.
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.
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 WM3.4 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 1 inclusion and 7 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: stopped early, 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 was stopped early (reason given: Failed to recruit sufficient subjects). Results are not available in the source record.
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?
Calibration models for device predictive purposes (time frame: 6 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 8 Oct 2020; AzTrials last refreshed its copy on 28 Oct 2026.