Diabetes MellitusVAARABreathNCT05933616
Analysis of Volatile Organic Compounds in Patients With Type 1 Diabetes in Induced Hypoglycaemia With a Breath Analyser
A study testing Device: Sokru device in people with Diabetes Mellitus and Metabolic Disease, run by University of Bern at 1 site in Switzerland.
Trial summary
The breath analysis (BreathSpec® device) data of all participants that were included into the VAARA study (NCT05771090) will be analysed, this includes data from up to 40 breath samples from each of the 10 participants who underwent 2 insulin-induced hypoglycaemic episodes during two visits. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Diabetes Mellitus, Metabolic Disease, Glucose Metabolism Disorders
- What is being tested?
- Device: 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
- 20 Apr 2023to 31 Jul 2024
- 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.
- Type 1 Diabetes with Multiple daily insulin injection (MDI) or Continuous subcutaneous insulin infusion therapy (CSII) >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 lactation period
- History of cardiovascular diseases
- Diabetes-related comorbidities
- HbA1c >9 %
- Epilepsy
- Smoking (last cigarette within past 6 months)
Show all 9Show fewer
- 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.
About this study
The breath analysis (BreathSpec® device) data of all participants that were included into the VAARA study (NCT05771090) will be analysed, this includes data from up to 40 breath samples from each of the 10 participants who underwent 2 insulin-induced hypoglycaemic episodes during two visits. The primary objective is to find a possible association between volatile organic compounds (VOCs) measured by the BreathSpec® device and blood glucose. For this we will use descriptive statistics, correlation coefficients, as well as a Principal Component Analysis and a partial least squares discriminant analysis. Furthermore, the time lag between hypoglycaemia onset and change in VOCs will be quantified.
- Conditions
- Diabetes Mellitus, Metabolic Disease, Glucose Metabolism Disorders, Endocrine System Diseases
- Being tested
- Device: Sokru device
- Keywords
- Volatile Organic Compounds, Hypoglycaemia
- Medical subject headings
- Diabetes Mellitus, Metabolic Diseases, Glucose Metabolism Disorders, Endocrine System Diseases, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: 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: Device: Sokru device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes VOC Patterns over time as gallery plots
Difference in gallery plots (3D visualization of retention index, drift time, ion current) from selected VOC peaks over time.
Measured: During the study procedure (approximately 5 hours)
Changes VOC Patterns over time as boxplots
Difference in box plots from selected VOC peaks over time.
Measured: During the study procedure (approximately 5 hours)
Correlation between blood glucose and patterns
Signals will be classified into euglycemic (between 4 and 10 mmol/l), hypoglycaemic (smaller than 4 mmol/l) and hyperglycaemic (above 10 mmol/l) phases or stable and changing phases. A principal component analysis (PCA) of the data will be performed to identify which VOCs are characteristic for certain glucose levels. A partial least squares discriminant analysis (PLS-DA) will be used to further identify important features of the VOC fingerprints.
Measured: During the study procedure (approximately 5 hours)
Secondary outcomes (2)
Time lag
The time lag between hypoglycaemia onset and change in VOCs will be calculated-
Measured: During the study procedure (approximately 5 hours)
Association between the onset of change in glucose, vital signs and VOC spectra
Associations between changes in VOCs and perceived hypoglycaemic symptoms, heart rate, ECG, and oxygen saturation will be evaluated using correlation coefficients and mixed effects models.
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 posted6 Jul 2023
- Study start20 Apr 2023
- Primary completion16 Jun 2023
- Study completion31 Jul 2024
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.
- More trials run by University of BernThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- DCB Research AG, Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor
- Investigators
- Witthauer Lilian, Prof.Dr., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933616
- Sponsor's protocol ID
- VAARABreath
- Acronym
- VAARABreath
- Status last verified
- Aug 2024
- First submitted
- 26 Jun 2023
- Last updated
- 16 Aug 2024
- Results posted
- 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 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Volatile Organic Compounds in Patients With Type 1 Diabetes in Induced Hypoglycaemia With a Breath Analyser
- ClinicalTrials.gov ID
- NCT05933616
- Acronym / sponsor ID
- VAARABreath / VAARABreath
- Conditions
- Diabetes Mellitus, Metabolic Disease, Glucose Metabolism Disorders, Endocrine System Diseases
- Keywords
- Volatile Organic Compounds, Hypoglycaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- DCB Research AG, Insel Gruppe AG, University Hospital Bern
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 6 Jul 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 breath analysis (BreathSpec® device) data of all participants that were included into the VAARA study (NCT05771090) will be analysed, this includes data from up to 40 breath samples from each of the 10 participants who underwent 2 insulin-induced hypoglycaemic episodes during two visits. The primary objective is to find a possible association between volatile organic compounds (VOCs) measured by the BreathSpec® device and blood glucose. For this we will use descriptive statistics, correlation coefficients, as well as a Principal Component Analysis and a partial least squares discriminant analysis. Furthermore, the time lag between hypoglycaemia onset and change in VOCs will be quantified.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Device: 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.
- Type 1 Diabetes with Multiple daily insulin injection (MDI) or Continuous subcutaneous insulin infusion therapy (CSII) >1 year
- Age 18 - 50 (inclusive)
- Caucasian ethnicity
- BMI between 18.5 and 24.9 kg/m2 (inclusive)
Key exclusion criteria (9 listed)
- Pregnancy or lactation period
- 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 |
|---|---|---|
| Device: Sokru deviceDifferent induced glycaemic states in people living with diabetes (PwD). | Device | Study Arm |
Primary outcome
Changes VOC Patterns over time as gallery plots
Time frame: During the study procedure (approximately 5 hours)
Difference in gallery plots (3D visualization of retention index, drift time, ion current) from selected VOC peaks over time.
Changes VOC Patterns over time as boxplots
Time frame: During the study procedure (approximately 5 hours)
Difference in box plots from selected VOC peaks over time.
Correlation between blood glucose and patterns
Time frame: During the study procedure (approximately 5 hours)
Signals will be classified into euglycemic (between 4 and 10 mmol/l), hypoglycaemic (smaller than 4 mmol/l) and hyperglycaemic (above 10 mmol/l) phases or stable and changing phases. A principal component analysis (PCA) of the data will be performed to identify which VOCs are characteristic for certain glucose levels. A partial least squares discriminant analysis (PLS-DA) will be used to further identify important features of the VOC fingerprints.
2 secondary outcomes
Time lag
Time frame: During the study procedure (approximately 5 hours)
Association between the onset of change in glucose, vital signs and VOC spectra
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 16 Aug 2024.
- 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.
Witthauer Lilian, Prof.Dr. principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Sokru device in people with Diabetes Mellitus and Metabolic Disease, run by University of Bern 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 9 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 16 Aug 2024. 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?
Changes VOC Patterns over time as gallery plots (time frame: During the study procedure (approximately 5 hours)). 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 16 Aug 2024.