Diabete MellitusNCT03781232
Non-invasive Glucose Measurement With Raman Technology in Patients With Type 1 and Type 2 Diabetes
A study testing Prototype 0.3 in people with Diabete Mellitus and Medical Device, run by RSP Systems A/S at 2 sites in Germany.
Trial summary
The study was established to collect data and reference measurements in order to establish calibration models for the Prototype 0.3 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Mellitus, Medical Device
- What is being tested?
- Prototype 0.3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesGermany
- Study dates
- 22 Nov 2018to 5 Aug 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
- At least 18 years of age
- Have a diagnosis of type 1 or type 2 diabetes mellitus (for RSP-09-02, only patients with type 1 diabetes)
- Skin phototype 1-4
- Be willing to perform a minimum of 6 / 12 (31 during excursion days) finger sticks per day during the study
- Be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol
- Be willing to provide written signed and dated informed consent
Who cannot join
- Inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator, due to e.g. known psychiatric diagnoses, lack of cognitive ability, alcohol dependency, drug use, psychosocial overload
- Have known severe allergy to medical grade adhesive or isopropyl alcohol used to clean the skin
- Be breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control during the study execution (applicable to female subjects only)
- Unable to hold hand/arm steadily (including tremors and Parkinson's Disease)
- Severe diabetes related complications such as advanced autonomic neuropathy, kidney disease, foot ulcers, legal blindness, or symptomatic cardiovascular disease as evidenced by a history of cardiovascular episode(s)
- Systemic or topical administration of glucocorticoids for the past 7 days
Show all 14Show fewer
- Undergoing dialysis treatment
- Have extensive skin changes/diseases at the proposed measurement site (thenar) that could interfere with the accuracy of interstitial glucose measurements
- Have a concomitant medical condition which could interfere with the study devices (study arm 1: intake of acetaminophen study arm 2: intake of salicylic acid or higher doses of ascorbic acid)
- Unsuitable for participation due to any other cause as determined by the Investigator. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation e.g. with required documentation
- Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor, the study site, and/ or their families)
- Additional exclusion criteria for study arm 2:
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
- Hypoglycemia unawareness
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
m&i-Fachklinik Bad Heilbrunn - Zentrum für Diabetes und Stoffwechselerkrankungen
Bad Heilbrunn, 83670
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, 89081
About this study
Official title: Non-invasive Glucose Measurement With Raman Technology. Calibration of Newly Developed Devices in Patients With Type 1 and Type 2 Diabetes - Glucobrunn Study
The study was established to collect data and reference measurements in order to establish calibration models for the Prototype 0.3
Read the detailed description
Subjects are recruited at two different sites.
Site 1: In group 1 subjects will on their regular stay in the clinic perform four measurement sessions a day. A measurement session consist of a reference capillary blood sample and two measures on the IMD.
Site 2: The study in group 2 consists of 26 home-based measurements and two in-clinic days. During the home measurements, 6 measurement sessions will be performed by the subjects a day. A measurement session consists of two reference BGMs, two reference CGMs and two measurements on the device. On in-clinic visits, subjects will be administered high glucose breakfast and the following 6-7 hours, measurement sessions are performed every 15 minutes.
- Conditions
- Diabete Mellitus, Medical Device
- Being tested
- Prototype 0.3
- 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.
Prototype 0.3Device
Prototype 0.3 is a non-invasive glucose monitoring device using Raman spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| RSP-09-01 | Experimental | Enrolled subjects will perform 4 daily measurement session during their regular stay at the clinic. A measurement session consists of a reference capillary blood sample and two measurements on the Prototype 0.3. Receives: Device: Prototype 0.3 |
| RSP-09-02 | Experimental | Enrolled subjects will measure at home for 26 six days and visit the clinic two times. During home measurements, 6 measurement sessions will be performed by the subject a day. A measurement session consists of two BGMs, two CGMs and two measurements on the Prototype 0.3. On in-clinic visits the subject will be administered a high glucose breakfast and the following 6-7 hours, measurement sessions will be performed every 15 minutes. Receives: Device: Prototype 0.3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation and validation of predictive models by Inter Subject Unified Performance (ISUP).
Spectral Raman data will be collected together with paired reference measurements. Collected data will be used to generate calibration models capable of predicting tissue glucose levels.
Models will be validated on independent data sets using the ISUP measure.
Measured: 2 years
Generation and validation of predictive models by Mean Absolute Relative Difference (MARD) measures
Spectral Raman data will be collected together with paired reference measurements. Collected data will be used to generate calibration models capable of predicting tissue glucose levels.
Models will be validated on independent data sets using the MARD measure.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start22 Nov 2018
- Primary completion5 Aug 2019
- Study completion5 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- RSP Systems A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guido Freckmann, Dr., Principal investigator, Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781232
- Sponsor's protocol ID
- RSP-09
- Status last verified
- Dec 2019
- First submitted
- 21 Nov 2018
- Last updated
- 4 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 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Glucose Measurement With Raman Technology. Calibration of Newly Developed Devices in Patients With Type 1 and Type 2 Diabetes - Glucobrunn Study
- ClinicalTrials.gov ID
- NCT03781232
- Acronym / sponsor ID
- RSP-09
- Conditions
- Diabete Mellitus, Medical Device
- Keywords
- Non-invasive glucose monitoring, Raman spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- RSP Systems A/SIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 19 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.
The study was established to collect data and reference measurements in order to establish calibration models for the Prototype 0.3
Detailed description
Subjects are recruited at two different sites.
Site 1: In group 1 subjects will on their regular stay in the clinic perform four measurement sessions a day. A measurement session consist of a reference capillary blood sample and two measures on the IMD.
Site 2: The study in group 2 consists of 26 home-based measurements and two in-clinic days. During the home measurements, 6 measurement sessions will be performed by the subjects a day. A measurement session consists of two reference BGMs, two reference CGMs and two measurements on the device. On in-clinic visits, subjects will be administered high glucose breakfast and the following 6-7 hours, measurement sessions are performed every 15 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSP-09-01 | Experimental | Device: Prototype 0.3Enrolled subjects will perform 4 daily measurement session during their regular stay at the clinic. A measurement session consists of a reference capillary blood sample and two measurements on the Prototype 0.3. |
| RSP-09-02 | Experimental | Device: Prototype 0.3Enrolled subjects will measure at home for 26 six days and visit the clinic two times. During home measurements, 6 measurement sessions will be performed by the subject a day. A measurement session consists of two BGMs, two CGMs and two measurements on the Prototype 0.3. On in-clinic visits the subject will be administered a high glucose breakfast and the following 6-7 hours, measurement sessions will be performed every 15 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years of age
- Have a diagnosis of type 1 or type 2 diabetes mellitus (for RSP-09-02, only patients with type 1 diabetes)
- Skin phototype 1-4
- Be willing to perform a minimum of 6 / 12 (31 during excursion days) finger sticks per day during the study
- Be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol
Key exclusion criteria (14 listed)
- Inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator, due to e.g. known psychiatric diagnoses, lack of cognitive ability, alcohol dependency, drug use, psychosocial overload
- Have known severe allergy to medical grade adhesive or isopropyl alcohol used to clean the skin
- Be breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control during the study execution (applicable to female subjects only)
- Unable to hold hand/arm steadily (including tremors and Parkinson's Disease)
- Severe diabetes related complications such as advanced autonomic neuropathy, kidney disease, foot ulcers, legal blindness, or symptomatic cardiovascular disease as evidenced by a history of cardiovascular episode(s)
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 |
|---|---|---|
| Prototype 0.3Prototype 0.3 is a non-invasive glucose monitoring device using Raman spectroscopy | Device | RSP-09-01, RSP-09-02 |
Primary outcome
Generation and validation of predictive models by Inter Subject Unified Performance (ISUP).
Time frame: 2 years
Spectral Raman data will be collected together with paired reference measurements. Collected data will be used to generate calibration models capable of predicting tissue glucose levels. Models will be validated on independent data sets using the ISUP measure.
Generation and validation of predictive models by Mean Absolute Relative Difference (MARD) measures
Time frame: 2 years
Spectral Raman data will be collected together with paired reference measurements. Collected data will be used to generate calibration models capable of predicting tissue glucose levels. Models will be validated on independent data sets using the MARD measure.
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 4 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.
Guido Freckmann, Dr. principal investigator
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prototype 0.3 in people with Diabete Mellitus and Medical Device, run by RSP Systems A/S at 2 sites in Germany.
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 14 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 4 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 2 sites in Germany. 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 predictive models by Inter Subject Unified Performance (ISUP). (time frame: 2 years). 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 4 Dec 2019.