Type 2 DiabetesBOYDSENSE DATANCT06614101
Study Enabling the Collection of Clinical Data Necessary for the Second Phase of Development of the Glycemic Measurement Device by Analysis of Exhaled Air
A study testing Exhaled air analysis in people with Type 2 Diabetes, run by University Hospital, Toulouse at 2 sites in France.
Trial summary
A pilot study carried out by the company ALPHA-MOS in 2017-19 showed that the analysis of volatile organic compounds contained in exhaled air could reliably predict blood glucose levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Exhaled air analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Oct 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient living with type 2 diabete or non-diabetic individuals characterized by overweight/obesity (Body Mass Index >= 25Kg/m²) , admitted in the two departments of the Toulouse University Hospital (Diabetology, Metabolic Diseases and Nutrition as well as Endocrinology, Metabolic Diseases and Nutrition).
- Aged 18 years or more.
- Ability to sign informed consent.
- Affiliation to a social security scheme.
Who cannot join
- Ongoing respiratory infection.
- Pregnancy or breastfeeding.
- Patient under guardianship, curatorship or safeguard of justice.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Fontaine Salée Hospital
Salies-du-Salat, France, 31 260
Pierre Gourdy, MD, 0561323218 ext. +33, gourdy.p@chu-toulouse.fr
Laurent Cazals, MD, 0561323361 ext. +33, cazals.l@chu-toulouse.fr
- Recruiting
Rangueil Hospital
Toulouse, France, 31059
Pierre Gourdy, MD, 0561323218 ext. +33, gourdy.p@chu-toulouse.fr
Laurent Cazals, 0561323361 ext. +33, cazals.l@chu-toulouse.fr
About this study
A pilot study carried out by the company ALPHA-MOS in 2017-19 showed that the analysis of volatile organic compounds contained in exhaled air could reliably predict blood glucose levels. Subsequently, the company BOYDSense, a subsidiary of ALPHA-MOS, produced the Module In a Box prototypes of portable, non-invasive volatile organic compounds analyzers that could be equipped with an on-board algorithm estimating blood glucose levels. The Toulouse University Hospital conducted the BOYDSENSE-GM study in 2021-2023, in partnership with BOYDSense, aiming to develop the first algorithm for calculating blood glucose levels based on the analysis of the breath of 100 patients living with type 2 diabetes and to carry out a first performance test of the Module In a Box prototype in 30 additional subjects with type 2 diabetes. These recent results confirmed the potential of this innovative blood glucose measurement technology and gave the first indications about the next developments needed to improve its performances. The characteristics of the air exhaled by a human are impossible to simulate. Therefore, further development of the glucose calculation algorithm requires the production of additional clinical data, supporting the carrying out of the present study.
Read the detailed description
The BOYDSense-DATA+ study consists of measuring the concentrations of volatile organic compounds at the same time as capillary blood glucose measurements carried out as part of routine care of patients with type 2 diabetes and non-diabetic individuals at risk of type 2 diabetes. The volatile organic compounds measurements will be done using the Module In a Box prototypes previously used in the BOYDSENSE-GM study. The reference blood glucose levels will be capillary blood glucose values, measured with a properly calibrated blood glucose meter validated for hospital use.
- Conditions
- Type 2 Diabetes
- Being tested
- Exhaled air analysis
- Keywords
- Blood sugar measurement, exhaled air
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exhaled air analysisOther
The patient takes two breaths into two different Module In a Box devices (one measurement per device) which will give two measurements of the volatile organic compounds in the exhaled air. No estimate of blood glucose by breath will be displayed: the Module In Boxes will be set to only display the indication valid measurement/invalid measurement.
| Study group | Role | What they receive |
|---|---|---|
| Patient with type 2 diabetes or non-diabetic patient treated in the Diabetology departments | Experimental | Not described Receives: Other: Exhaled air analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of volatile organic compounds
Measurements of volatile organic compounds in participants' breath, measured by the Module In Box device.
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start11 Oct 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (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.
- More trials run by University Hospital, ToulouseThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Gourdy, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614101
- Sponsor's protocol ID
- RC31/24/0046
- Acronym
- BOYDSENSE DATA
- Status last verified
- May 2026
- First submitted
- 23 Sep 2024
- Last updated
- 1 Jun 2026
- 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 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Enabling the Collection of Clinical Data Necessary for the Second Phase of Development of the Glycemic Measurement Device by Analysis of Exhaled Air
- ClinicalTrials.gov ID
- NCT06614101
- Acronym / sponsor ID
- BOYDSENSE DATA / RC31/24/0046
- Conditions
- Type 2 Diabetes
- Keywords
- Blood sugar measurement, exhaled air
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 26 Sep 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.
A pilot study carried out by the company ALPHA-MOS in 2017-19 showed that the analysis of volatile organic compounds contained in exhaled air could reliably predict blood glucose levels. Subsequently, the company BOYDSense, a subsidiary of ALPHA-MOS, produced the Module In a Box prototypes of portable, non-invasive volatile organic compounds analyzers that could be equipped with an on-board algorithm estimating blood glucose levels. The Toulouse University Hospital conducted the BOYDSENSE-GM study in 2021-2023, in partnership with BOYDSense, aiming to develop the first algorithm for calculating blood glucose levels based on the analysis of the breath of 100 patients living with type 2 diabetes and to carry out a first performance test of the Module In a Box prototype in 30 additional subjects with type 2 diabetes. These recent results confirmed the potential of this innovative blood glucose measurement technology and gave the first indications about the next developments needed to improve its performances. The characteristics of the air exhaled by a human are impossible to simulate. Therefore, further development of the glucose calculation algorithm requires the production of additional clinical data, supporting the carrying out of the present study.
Detailed description
The BOYDSense-DATA+ study consists of measuring the concentrations of volatile organic compounds at the same time as capillary blood glucose measurements carried out as part of routine care of patients with type 2 diabetes and non-diabetic individuals at risk of type 2 diabetes. The volatile organic compounds measurements will be done using the Module In a Box prototypes previously used in the BOYDSENSE-GM study. The reference blood glucose levels will be capillary blood glucose values, measured with a properly calibrated blood glucose meter validated for hospital use.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with type 2 diabetes or non-diabetic patient treated in the Diabetology departments | Experimental | Other: Exhaled air analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient living with type 2 diabete or non-diabetic individuals characterized by overweight/obesity (Body Mass Index >= 25Kg/m²) , admitted in the two departments of the Toulouse University Hospital (Diabetology, Metabolic Diseases and Nutrition as well as Endocrinology, Metabolic Diseases and Nutrition).
- Aged 18 years or more.
- Ability to sign informed consent.
- Affiliation to a social security scheme.
Key exclusion criteria (3 listed)
- Ongoing respiratory infection.
- Pregnancy or breastfeeding.
- Patient under guardianship, curatorship or safeguard of justice.
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 |
|---|---|---|
| Exhaled air analysisThe patient takes two breaths into two different Module In a Box devices (one measurement per device) which will give two measurements of the volatile organic compounds in the exhaled air. No estimate of blood glucose by breath will be displayed: the Module In Boxes will be set to only display the indication valid measurement/invalid measurement. | Other | Patient with type 2 diabetes or non-diabetic patient treated in the Diabetology departments |
Primary outcome
Measurements of volatile organic compounds
Time frame: 19 months
Measurements of volatile organic compounds in participants' breath, measured by the Module In Box device.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- 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.
Pierre Gourdy, MD principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exhaled air analysis in people with Type 2 Diabetes, run by University Hospital, Toulouse at 2 sites in France.
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 3 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: looking for participants now, as of the sponsor's last update on 1 Jun 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Gourdy, MD (0561323740 ext. +33, gourdy.p@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurements of volatile organic compounds (time frame: 19 months). 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 Jun 2026.