Type 2 DiabetesEvoNCT06621030
Evaluation of Correlations Between Volatile Organic Compounds and Venous Blood Glucose in Subjects With Type 2 Diabetes
A study testing MIB Breath Analyzer in people with Type 2 Diabetes, run by BOYDSENSE.
Trial summary
The goal of this study is to evaluate correlations between VOCs in the breath and venous blood glucose values in various glycaemic states in people living with Type 2 Diabetes. VOCs are measured with a gold-standard GC-IMS device and a prototype of a novel breath analyzer. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- MIB Breath Analyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 30 Mar 2025
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- T2D treated with one or more oral anti-diabetic drugs (incl GLP-1 and/or GIP)
- 10 years since T2D diagnosis
- HbA1c ≤8% (HbA1c based on last measurement by treating physician but not older than 120 days)
- Willingness to undergo study procedures
- Age 45 -70 years (inclusive)
Who cannot join
- Pregnancy and/or lactation period
- Currently on chronic or occasional treatment with pulmonary drugs
- Insulin dependency
- Smoking (last cigarette within the last six months)
- BMI above 30 kg/m²
- Lp(a) above 125 nmol/l
Show all 14Show fewer
- LDL not in the individual target range of an earlier cholesterol goal according ESC guideline 2021 (LDL based on last measurement by treating physician but not older than 30 days)
- Irregular 12-lead ECG or increased carotid plaque burden based on a three-point sonography. Both examinations are performed and evaluated according to the investigator's judgment.
- History of, or manifested, cardiovascular diseases
- Medical history of epilepsy or other neurological disease associated with seizure events
- Known sensitivity to medical grade adhesives
- Comorbidities that are suspected to alter the VOC spectra
- Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
- Not able to understand, write or read German
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Correlations Between Volatile Organic Compounds (VOCs) Spectra Measured With GC-IMS and MOx-sensors and Venous Blood Glucose in Subjects With Type 2 Diabetes
The goal of this study is to evaluate correlations between VOCs in the breath and venous blood glucose values in various glycaemic states in people living with Type 2 Diabetes. VOCs are measured with a gold-standard GC-IMS device and a prototype of a novel breath analyzer. Participants will be exposed to different blood glucose levels at different rates of change by administering glucose solution and insulin and by a meal challenge.
Read the detailed description
The research project aims to expand the understanding of correlations between VOCs in the breath and venous blood glucose levels in non-insulin-dependent people with Type 2 Diabetes. To better understand correlations, the subjects are exposed to hyperglycaemic, euglycaemic and hyposglcycaemic states at different rates of change by applying a hand clamp procedure, and the VOCs are compared after a standardized meal and the same excursion by applying a hand clamp procedure. Inter- and intraparticipant variability as well as the timing of changes in the VOC spectra compared to changes in the glucose values are of interest. Secondarily, the feasibility of estimating glycaemic states with a prototype of a novel breath analyzer is being investigated.
- Conditions
- Type 2 Diabetes
- Being tested
- MIB Breath Analyzer
- Keywords
- Volatile Organic Compounds, Gas Chromatography - Ion Mobility Spectrometry, Rates of change of glucose values, Breath-analysis, Hyperglycaemia, Hypoglycaemia, Glucose excursions
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIB Breath AnalyzerDevice
Going through visit-specific blood glucose excursions by the administration of glucose and insulin (clamp), monitoring physiological processes, and measuring reference blood glucose values and VOC measurements in the breath using a GC IMS and the MIBs (investigational devices). Going through visit-specific blood glucose excursions by consuming a standardized meal, monitoring physiological processes, and measuring reference blood glucose values and VOC measurements in the breath using a GC-IMS and the MIBs (investigational devices) Imitating the glucose excursion from the meal excursion by infusing glucose and insulin (clamp), monitoring physiological processes, and measuring reference blood glucose values and VOC measurements in the breath using a GC-IMS and the MIBs (investigational devices).
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Exposure to various glycaemic states at different rates of change by administering glucose solution, insulin, or a standardized meal. Receives: Device: MIB Breath Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
VOC spectra
Primary outcome focuses on VOC spectra (measured with the GC-IMS) across varying intravenous blood glucose levels
Measured: 6-8 hour study visit
Secondary outcomes (5)
Inter-Participant VOC Variability
Evaluation of VOC spectral differences measured with the GC-IMS among participants under identical glycemic states.
Measured: 6-8 hour study visit
Intra-Participant VOC Variability
Comparison of VOC spectral differences measured with the GC-IMS within the same participant across different glycemic states.
Measured: 6-8 hour study visit
MIB VOC Spectra Analysis
Investigation of VOC spectra (measured with the MIB) in diverse intravenously measured glycemic states.
Measured: 6-8 hour study visit
VOC Spectra Response Time
Assessment of the delay in VOC spectral shifts relative to changes in venous glucose from fluctuating to stable states at different change rates.
Measured: 6-8 hour study visit
Comparison of meal vs clamp induced VOC changes
Analysis of VOC spectral differences between natural post-meal glucose increases and clamp-induced glucose elevations measured with the GC-IMS.
Measured: 6-8 hour study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention consists of inducing different glycaemic states in people with diabetes.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BOYDSENSE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Insel Gruppe AG, University Hospital Bern, DCB Research AG
- Responsible party
- Sponsor
- Investigators
- Frank Flacke, Dr, Study chair, BOYDSense SASMarkus Laimer, Prof, Principal investigator, Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621030
- Sponsor's protocol ID
- Evo Study
- Acronym
- Evo
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 1 Oct 2024
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Correlations Between Volatile Organic Compounds (VOCs) Spectra Measured With GC-IMS and MOx-sensors and Venous Blood Glucose in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06621030
- Acronym / sponsor ID
- Evo / Evo Study
- Conditions
- Type 2 Diabetes
- Keywords
- Volatile Organic Compounds, Gas Chromatography - Ion Mobility Spectrometry, Rates of change of glucose values, Breath-analysis, Hyperglycaemia, Hypoglycaemia, Glucose excursions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- BOYDSENSEIndustry (pharma, biotech, devices)
- Collaborators
- Insel Gruppe AG, University Hospital Bern, DCB Research AG
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 1 Oct 2024 (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 goal of this study is to evaluate correlations between VOCs in the breath and venous blood glucose values in various glycaemic states in people living with Type 2 Diabetes. VOCs are measured with a gold-standard GC-IMS device and a prototype of a novel breath analyzer. Participants will be exposed to different blood glucose levels at different rates of change by administering glucose solution and insulin and by a meal challenge.
Detailed description
The research project aims to expand the understanding of correlations between VOCs in the breath and venous blood glucose levels in non-insulin-dependent people with Type 2 Diabetes. To better understand correlations, the subjects are exposed to hyperglycaemic, euglycaemic and hyposglcycaemic states at different rates of change by applying a hand clamp procedure, and the VOCs are compared after a standardized meal and the same excursion by applying a hand clamp procedure. Inter- and intraparticipant variability as well as the timing of changes in the VOC spectra compared to changes in the glucose values are of interest. Secondarily, the feasibility of estimating glycaemic states with a prototype of a novel breath analyzer is being investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention consists of inducing different glycaemic states in people with diabetes.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: MIB Breath AnalyzerExposure to various glycaemic states at different rates of change by administering glucose solution, insulin, or a standardized meal. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed written informed consent
- T2D treated with one or more oral anti-diabetic drugs (incl GLP-1 and/or GIP)
- 10 years since T2D diagnosis
- HbA1c ≤8% (HbA1c based on last measurement by treating physician but not older than 120 days)
- Willingness to undergo study procedures
Key exclusion criteria (14 listed)
- Pregnancy and/or lactation period
- Currently on chronic or occasional treatment with pulmonary drugs
- Insulin dependency
- Smoking (last cigarette within the last six months)
- BMI above 30 kg/m²
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 |
|---|---|---|
| MIB Breath AnalyzerGoing through visit-specific blood glucose excursions by the administration of glucose and insulin (clamp), monitoring physiological processes, and measuring reference blood glucose values and VOC measurements in the breath using a GC IMS and the MIBs (investigational devices). Going through visit-specific blood glucose excursions by consuming a standardized meal, monitoring physiological processes, and measuring reference blood glucose values and VOC measurements in the breath using a GC-IMS and the MIBs (investigational devices) Imitating the glucose excursion from the meal excursion by infusing glucose and insulin (clamp), monitoring physiological processes, and measuring reference blood glucose values and VOC measurements in the breath using a GC-IMS and the MIBs (investigational devices). | Device | Single Arm |
Primary outcome
VOC spectra
Time frame: 6-8 hour study visit
Primary outcome focuses on VOC spectra (measured with the GC-IMS) across varying intravenous blood glucose levels
5 secondary outcomes
Inter-Participant VOC Variability
Time frame: 6-8 hour study visit
Intra-Participant VOC Variability
Time frame: 6-8 hour study visit
MIB VOC Spectra Analysis
Time frame: 6-8 hour study visit
VOC Spectra Response Time
Time frame: 6-8 hour study visit
Comparison of meal vs clamp induced VOC changes
Time frame: 6-8 hour study visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 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.
Frank Flacke, Dr study chair
BOYDSense SAS
Markus Laimer, Prof principal investigator
Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM)
Questions about this trial
What is this clinical trial studying?
A study testing MIB Breath Analyzer in people with Type 2 Diabetes, run by BOYDSENSE.
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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefanie Hossmann, MSc (041794217376, stefanie.hossmann@dcberne.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VOC spectra (time frame: 6-8 hour study visit). 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 1 Oct 2024.