Diabetes MellitusNCT03782649
Performance Evaluation of a Novel Non-invasive Glucometer, Calibrated Against Validated Interstitial Glucose References
A study testing Working Model 3.4NR in people with Diabetes Mellitus, run by RSP Systems A/S at 1 site in Sweden.
Trial summary
This clinical study has been launched to collect spectral Raman data on the Investigational Medical Device (IMD) compared with reference methods in terms of interstitial fluid samples and capillary and venous references. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Working Model 3.4NR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 29 Nov 2018to 19 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects 18-70 years old
- Patients diagnosed with type 1 or type 2 diabetes (T1D or T2D) (insulin requiring T2D patients)
- Diabetes management strategy: lifestyle regimen + insulin ± oral hypoglycemic agents
- 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
- > 10 cigarettes pr. day
- Participants not able to understand and read Swedish
- In investigator's opinion, participant is not able to follow instructions as specified in the protocol
- Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
- Diagnosed with reduced circulation
Show all 18Show fewer
- Extensive skin changes, tattoos or diseases on probe application site
- Rejection by screening optical measurements
- Known allergy to medical grade alcohol
- Known allergy to adhesives
- Systemic or topical administration of glucocorticoids for the past 7 days
- Participants undergoing dialysis treatment
- Anti-coagulation or anti-platelet therapy
- Use of beta-blockers
- Medical conditions causing bleeding tendency
- 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. Such conditions include but are not limited to HIV and Hepatitis B or C.
- Participants currently enrolled in another study
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Gothia Forum för Klinisk Forskning, Sahlgrenska Universitetssjukhuset
Gothenburg
About this study
This clinical study has been launched to collect spectral Raman data on the Investigational Medical Device (IMD) compared with reference methods in terms of interstitial fluid samples and capillary and venous references.
Read the detailed description
Subjects will visit the clinic for a baseline visit and two in-clinic visits. On in-clinic days, subjects will attend the clinic in a fasting state. They will have inserted a Dexcom and Freestyle Libre and a microdialysis catheter. At time = 0, subjects will be administered a glucose rich drink and every 6. minut measurements will be performed. These include a measurement on the IMD, microdialysate, FreeStyle Libre and Dexcom readings. Every 18. minut a venous blood sample will be included and every 36. minut a capillary blood sample will be collected. This continues until time = 180 minutes.
- Conditions
- Diabetes Mellitus
- Being tested
- Working Model 3.4NR
- 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.
Working Model 3.4NRDevice
Investigational Medical Device collecting spectral Raman data from tissue
| Study group | Role | What they receive |
|---|---|---|
| RSP-08 | Experimental | All subjects undergo the same procedures. Subjects will be subjected to measurements on the IMD (Working Model 3.4NR), FreeStyle Libre, Dexcom, microdialysis, venous and capillary blood collection. Receives: Device: Working Model 3.4NR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation and validation of prediction models - MARD
Two in-clinic visits each of a duration of 5-6 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 and CGM readings and microdialysis. In parallel, optical glucose data from 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 will be validated on independent data sets using Mean Absolute Relative Difference (MARD) endpoint measure.
Measured: One year
Generation and validation of prediction models - ISUP
Two in-clinic visits each of a duration of 5-6 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 and CGM readings and microdialysis. In parallel, optical glucose data from 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 will be validated on independent data sets using Inter Subject Unified Performance (ISUP) measure.
Measured: One year
Generation and validation of prediction models - Consensus Error Grid
Two in-clinic visits each of a duration of 5-6 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 and CGM readings and microdialysis. In parallel, optical glucose data from 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 will be validated on independent data sets using Consensus Error Grid Analysis
Measured: One year
Secondary outcomes (2)
Evaluation of dynamics between arterial and venous glucose profiles in relation to interstitial glucose levels
Two in-clinic visits each of a duration of 5-6 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 and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected.
Optical glucose readings will be masked to the subjects.
A modeling-based evaluation of the dynamics between blood glucose and tissue glucose will be conducted and serve as a secondary endpoint of the study.
Measured: One year
Safety evaluation: paucity of adverse events
Safety will be evaluated in a descriptive manner by the paucity of adverse events
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start29 Nov 2018
- Primary completion19 Jun 2019
- Study completion19 Jun 2019
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- RSP Systems A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per-Anders Jansson, MD, Principal investigator, Sahlgrenska Universitetssjukhuset, Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782649
- Sponsor's protocol ID
- RSP-08
- Status last verified
- Dec 2019
- First submitted
- 3 Dec 2018
- Last updated
- 12 Dec 2019
- 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 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of a Novel Non-invasive Glucometer, Calibrated Against Validated Interstitial Glucose References
- ClinicalTrials.gov ID
- NCT03782649
- Acronym / sponsor ID
- RSP-08
- Conditions
- Diabetes Mellitus
- Keywords
- Non-invasive glucose monitoring, Raman spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- RSP Systems A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 20 Dec 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 collect spectral Raman data on the Investigational Medical Device (IMD) compared with reference methods in terms of interstitial fluid samples and capillary and venous references.
Detailed description
Subjects will visit the clinic for a baseline visit and two in-clinic visits. On in-clinic days, subjects will attend the clinic in a fasting state. They will have inserted a Dexcom and Freestyle Libre and a microdialysis catheter. At time = 0, subjects will be administered a glucose rich drink and every 6. minut measurements will be performed. These include a measurement on the IMD, microdialysate, FreeStyle Libre and Dexcom readings. Every 18. minut a venous blood sample will be included and every 36. minut a capillary blood sample will be collected. This continues until time = 180 minutes.
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-08 | Experimental | Device: Working Model 3.4NRAll subjects undergo the same procedures. Subjects will be subjected to measurements on the IMD (Working Model 3.4NR), FreeStyle Libre, Dexcom, microdialysis, venous and capillary blood collection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects 18-70 years old
- Patients diagnosed with type 1 or type 2 diabetes (T1D or T2D) (insulin requiring T2D patients)
- Diabetes management strategy: lifestyle regimen + insulin ± oral hypoglycemic agents
- Skin phototype 1-4
Key exclusion criteria (18 listed)
- For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
- > 10 cigarettes pr. day
- Participants not able to understand and read Swedish
- In investigator's opinion, participant is not able to follow instructions as specified in the protocol
- Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
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 |
|---|---|---|
| Working Model 3.4NRInvestigational Medical Device collecting spectral Raman data from tissue | Device | RSP-08 |
Primary outcome
Generation and validation of prediction models - MARD
Time frame: One year
Two in-clinic visits each of a duration of 5-6 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 and CGM readings and microdialysis. In parallel, optical glucose data from 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 will be validated on independent data sets using Mean Absolute Relative Difference (MARD) endpoint measure.
Generation and validation of prediction models - ISUP
Time frame: One year
Two in-clinic visits each of a duration of 5-6 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 and CGM readings and microdialysis. In parallel, optical glucose data from 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 will be validated on independent data sets using Inter Subject Unified Performance (ISUP) measure.
Generation and validation of prediction models - Consensus Error Grid
Time frame: One year
Two in-clinic visits each of a duration of 5-6 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 and CGM readings and microdialysis. In parallel, optical glucose data from 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 will be validated on independent data sets using Consensus Error Grid Analysis
2 secondary outcomes
Evaluation of dynamics between arterial and venous glucose profiles in relation to interstitial glucose levels
Time frame: One year
Safety evaluation: paucity of adverse events
Time frame: One year
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 12 Dec 2019.
- 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.
Per-Anders Jansson, MD principal investigator
Sahlgrenska Universitetssjukhuset, Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Working Model 3.4NR in people with Diabetes Mellitus, run by RSP Systems A/S at 1 site in Sweden.
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 18 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 12 Dec 2019. 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 Sweden. 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 - MARD (time frame: One year). The study lists 3 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 12 Dec 2019.