Diabetes MellitusVAARANCT05771090
First Clinical Evaluation of a Novel Glucose Non-invasive Sensor Technology in Patients With Type 1 Diabetes
A study testing Sokru device in people with Diabetes Mellitus, run by DCB Research AG at 1 site in Switzerland.
Trial summary
The primary aim of this clinical study is to find signal characteristics of VOCs detected by Sokru device during fasting, insulin injection and after glucose intake and to find the association with blood glucose variation in variant states of glycemia and hypoglycemia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Sokru device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2023to 16 Jun 2023
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent
- T1D with MDI or CSII therapy >1 year
- Age 18 - 50 (inclusive)
- Caucasian ethnicity
- BMI between 18.5 and 24.9 kg/m2 (inclusive)
- Usage of a continuous glucose monitoring (CGM)
Who cannot join
- Pregnancy or breastfeeding
- History of cardiovascular diseases
- Diabetes-related comorbidities
- HbA1c >9 %
- Epilepsy
- Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome
- Known sensitivity to Latex
- Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM) Inselspital, Universitätsspital
Bern, 3010
About this study
Official title: First Clinical Evaluation of a Novel Glucose Non-invasive Sensor Technology in Patients With Type 1 Diabetes: a Single-arm Pilot Study
The primary aim of this clinical study is to find signal characteristics of VOCs detected by Sokru device during fasting, insulin injection and after glucose intake and to find the association with blood glucose variation in variant states of glycemia and hypoglycemia.
- Conditions
- Diabetes Mellitus
- Being tested
- Sokru device
- Keywords
- Volatile Organic Compounds, Hypoglycaemia
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sokru deviceDevice
Different induced glycaemic states in people living with diabetes (PwD).
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Participants in the study arm will undergo the study procedure which are different induced glycaemic states. Receives: Device: Sokru device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of volatile organic compound (VOC) signals measured by the Sokru device
The primary outcome are changes in VOC signals measured by the Sokru at low glucose levels (below 3.0 -3.9 mmol/L) or during the time when the blood glucose level is decreasing (from 10 and 3.9 mmol/L).
Measured: During the study procedure (approximately 5 hours)
Secondary outcomes (5)
Volatile Organic Compound Signals
VOC signals measured by the Sokru device at different blood glucose levels
Measured: During the study procedure (approximately 5 hours)
Blood glucose concentration
Blood glucose levels are measured with the continuous glucose measurement system and in the venous blood at the time of the appearance of VOC signal peaks or drops
Measured: During the study procedure (approximately 5 hours)
Time of onset of subjective symptoms of hypoglycemia
Self-reported onset of subjective symptoms of hypoglycemia
Measured: During the study procedure (approximately 5 hours)
Heart rate
Heart rate is measured with a Mindray device
Measured: During the study procedure (approximately 5 hours)
Oxygen saturation
Oxygen saturation is measured with a Mindray device
Measured: During the study procedure (approximately 5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Apr 2023
- Primary completion16 Jun 2023
- Study completion16 Jun 2023
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
- Model description
- Sokru device, prototype
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- DCB Research AG
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor
- Investigators
- Derek Brandt, Study chair, DCB Research AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771090
- Sponsor's protocol ID
- VAARA study
- Acronym
- VAARA
- Status last verified
- Jun 2023
- First submitted
- 28 Feb 2023
- Last updated
- 29 Jun 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 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Clinical Evaluation of a Novel Glucose Non-invasive Sensor Technology in Patients With Type 1 Diabetes: a Single-arm Pilot Study
- ClinicalTrials.gov ID
- NCT05771090
- Acronym / sponsor ID
- VAARA / VAARA study
- Conditions
- Diabetes Mellitus
- Keywords
- Volatile Organic Compounds, Hypoglycaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- DCB Research AGUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 16 Mar 2023 (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 primary aim of this clinical study is to find signal characteristics of VOCs detected by Sokru device during fasting, insulin injection and after glucose intake and to find the association with blood glucose variation in variant states of glycemia and hypoglycemia.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sokru device, prototype
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Device: Sokru deviceParticipants in the study arm will undergo the study procedure which are different induced glycaemic states. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent
- T1D with MDI or CSII therapy >1 year
- Age 18 - 50 (inclusive)
- Caucasian ethnicity
- BMI between 18.5 and 24.9 kg/m2 (inclusive)
Key exclusion criteria (8 listed)
- Pregnancy or breastfeeding
- History of cardiovascular diseases
- Diabetes-related comorbidities
- HbA1c >9 %
- Epilepsy
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 |
|---|---|---|
| Sokru deviceDifferent induced glycaemic states in people living with diabetes (PwD). | Device | Study arm |
Primary outcome
Characteristics of volatile organic compound (VOC) signals measured by the Sokru device
Time frame: During the study procedure (approximately 5 hours)
The primary outcome are changes in VOC signals measured by the Sokru at low glucose levels (below 3.0 -3.9 mmol/L) or during the time when the blood glucose level is decreasing (from 10 and 3.9 mmol/L).
5 secondary outcomes
Volatile Organic Compound Signals
Time frame: During the study procedure (approximately 5 hours)
Blood glucose concentration
Time frame: During the study procedure (approximately 5 hours)
Time of onset of subjective symptoms of hypoglycemia
Time frame: During the study procedure (approximately 5 hours)
Heart rate
Time frame: During the study procedure (approximately 5 hours)
Oxygen saturation
Time frame: During the study procedure (approximately 5 hours)
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 29 Jun 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.
Derek Brandt study chair
DCB Research AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sokru device in people with Diabetes Mellitus, run by DCB Research AG at 1 site in Switzerland.
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 8 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 29 Jun 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 Switzerland. 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?
Characteristics of volatile organic compound (VOC) signals measured by the Sokru device (time frame: During the study procedure (approximately 5 hours)). 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 29 Jun 2023.