Diabetes Mellitus, Type 2BOYDSENSENCT05207020
Development and Validation of the Blood Glucose Measurement Device by Air Analysis Expired
A study testing Glycemia estimated by exhaled air analyzer, Questionnaire and Veinous glycemia in people with Diabetes Mellitus, Type 2, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This clinical study aims to finalize the algorithm and assess the performance of the BOYDSense® breath glucose monitoring system prototype in patients living with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Glycemia estimated by exhaled air analyzer, Questionnaire and Veinous glycemia
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to 9 Feb 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes diagnosed for at least 3 months.
- Acceptance of constraints related to participation in the study.
- Acceptance to participate in the constitution of a plasma library.
- Ability to sign informed consent.
- Affiliation to a social security scheme.
Who cannot join
- Ongoing prandial insulin therapy
- Treated bacterial or viral respiratory infection in the 2 weeks preceding the meal test.
- Surgical intervention under general anesthesia in the last 12 weeks.
- Asthmatic subjects with bronchospasm or under chronic inhaled therapy.
- Ongoing COVID-19 (PCR +) or contact case in the isolation period.
- Pregnancy or breast-feeding.
- Participation in another clinical study or exclusion period from another research protocol.
- Patient under guardianship, curatorship or legal protection.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Diabétologie, maladies métaboliques et nutrition, CHU Toulouse, 1 avenue Jean Pouilhes, TSA 50032
Toulouse, 31059
About this study
Official title: Study Allowing the Collection of Clinical and Biological Data Necessary for Development and Validation of the Blood Glucose Measurement Device by Air Analysis Expired Developed by the Company BOYDSense
This clinical study aims to finalize the algorithm and assess the performance of the BOYDSense® breath glucose monitoring system prototype in patients living with type 2 diabetes.
Read the detailed description
Self-monitoring of blood glucose (SMBG) is prescribed to patients living with diabetes according to their type of diabetes, their clinical profile and their personalized needs such as therapeutic adjustments, detection of an asymptomatic hyperglycaemic drift, prevention of hypoglycaemia, or adaptation of the therapeutic strategy to the evolution of the pathology. Most of the people living with type2 diabetes mellitus (T2DM) use an invasive finger prick SMBG glucometer. A pilot study conducted by the BOYDSense mother company Alpha-MOS showed that the analysis of volatile organic compounds (VOC) in exhaled air could reliably predict blood glucose. The development of a breath glucose-monitoring device, by its non-invasive nature, should be an alternative to existing systems by making it possible to avoid capillary samples. Investigators could expect a better quality of life and a better compliance with SMBG in the majority of patients with T2DM. The objectives of our study are to improve the BOYDSense®glucose algorithm based on the VOC analysis of exhaled air; then to assess the performance of the BOYDSense® prototype with the finalized algorithm.
This study aims to gather, in patients with T2DM, successive blood and capillary reference glucose values during a meal test, and to compare them to glucose levels estimated by the BOYDSense® prototype.
All the enrolled patients will undergo a 3 hours standardized meal test with seven glucose measurement endpoints at T0, 30 min, 1hour 1H30, 2H, 2H30 and 3H post meal. Blood glucose will be measured with three different techniques: venous blood glucose measured with a COBAS 8000 automatic analyzer, SMBG measured with a commercial glucometer and blood glucose value estimated from exhaled air using the BOYDSense® prototype.
The study duration will be 4H for each enrolled patient. After the meal test being completed, the end of study procedure includes a 30 min observational period dedicated to the completion of the patients'questionnaire.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Glycemia estimated by exhaled air analyzer, Questionnaire, Veinous glycemia, Capillary glycemia, constitution biological collection
- Keywords
- Type 2 diabetes mellitus, self monitoring of blood glucose,, breath glucose monitoring system
- 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.
Glycemia estimated by exhaled air analyzerDevice
Measurement of volatile compounds in the air exhaled by the volunteer on 3 different MIBs (3 breaths in total) at 7 times: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal
QuestionnaireBehavioural
The questionnaire focuses on the methods and feelings of the blood glucose self-monitoring that he is currently carrying out, a first feedback on user experience on the operation of the prototype and the collection of his expectations for a future commercial device
Veinous glycemiaBiological
Measurement of the veinous glycemia at 7 times: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal
Capillary glycemiaBiological
7-step capillary glycemia measurement: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal
constitution biological collectionBiological
Sampling for storage of serum at 7 times: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal
Blood sampleBiological
Single blood sample before mealtimes for HbA1C molecular analysis
Test mealOther
taking a test meal before the various blood sugar measurements
| Study group | Role | What they receive |
|---|---|---|
| Blood sugar levels estimated by analysis of exhaled air | Experimental | Not described Receives: Device: Glycemia estimated by exhaled air analyzer; Behavioral: Questionnaire; Biological: Veinous glycemia; Biological: Capillary glycemia; Biological: constitution biological collection; Biological: Blood sample; Other: Test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect glucose values
Collect successive fasting blood glucose values in patients with type 2 diabetes
Measured: 1 day
Collect glucose values
Collect successive blood glucose values after taking a test meal, in patients with type 2 diabetes
Measured: 1day
Collect glucose values (fasting)
Measurement of blood glucose by the exhaled air analyzer from volatile compounds in exhaled air (fasting)
Measured: 1 day
Collect glucose values (after a test meal)
Measurement of blood glucose by the exhaled air analyzer from volatile compounds in exhaled air (after taking a test meal))
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Dec 2021
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group with a device
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre GOURDY, MD, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207020
- Sponsor's protocol ID
- RC31/21/0305
- Acronym
- BOYDSENSE
- Status last verified
- Feb 2023
- First submitted
- 30 Nov 2021
- Last updated
- 13 Feb 2023
- 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 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Allowing the Collection of Clinical and Biological Data Necessary for Development and Validation of the Blood Glucose Measurement Device by Air Analysis Expired Developed by the Company BOYDSense
- ClinicalTrials.gov ID
- NCT05207020
- Acronym / sponsor ID
- BOYDSENSE / RC31/21/0305
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes mellitus, self monitoring of blood glucose,, breath glucose monitoring system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 26 Jan 2022 (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.
This clinical study aims to finalize the algorithm and assess the performance of the BOYDSense® breath glucose monitoring system prototype in patients living with type 2 diabetes.
Detailed description
Self-monitoring of blood glucose (SMBG) is prescribed to patients living with diabetes according to their type of diabetes, their clinical profile and their personalized needs such as therapeutic adjustments, detection of an asymptomatic hyperglycaemic drift, prevention of hypoglycaemia, or adaptation of the therapeutic strategy to the evolution of the pathology. Most of the people living with type2 diabetes mellitus (T2DM) use an invasive finger prick SMBG glucometer. A pilot study conducted by the BOYDSense mother company Alpha-MOS showed that the analysis of volatile organic compounds (VOC) in exhaled air could reliably predict blood glucose. The development of a breath glucose-monitoring device, by its non-invasive nature, should be an alternative to existing systems by making it possible to avoid capillary samples. Investigators could expect a better quality of life and a better compliance with SMBG in the majority of patients with T2DM. The objectives of our study are to improve the BOYDSense®glucose algorithm based on the VOC analysis of exhaled air; then to assess the performance of the BOYDSense® prototype with the finalized algorithm.
This study aims to gather, in patients with T2DM, successive blood and capillary reference glucose values during a meal test, and to compare them to glucose levels estimated by the BOYDSense® prototype.
All the enrolled patients will undergo a 3 hours standardized meal test with seven glucose measurement endpoints at T0, 30 min, 1hour 1H30, 2H, 2H30 and 3H post meal. Blood glucose will be measured with three different techniques: venous blood glucose measured with a COBAS 8000 automatic analyzer, SMBG measured with a commercial glucometer and blood glucose value estimated from exhaled air using the BOYDSense® prototype.
The study duration will be 4H for each enrolled patient. After the meal test being completed, the end of study procedure includes a 30 min observational period dedicated to the completion of the patients'questionnaire.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group with a device
| Arm | Type | Receives |
|---|---|---|
| Blood sugar levels estimated by analysis of exhaled air | Experimental | Device: Glycemia estimated by exhaled air analyzer, Behavioral: Questionnaire, Biological: Veinous glycemia, Biological: Capillary glycemia, Biological: constitution biological collection, Biological: Blood sample, Other: Test meal |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes diagnosed for at least 3 months.
- Acceptance of constraints related to participation in the study.
- Acceptance to participate in the constitution of a plasma library.
- Ability to sign informed consent.
- Affiliation to a social security scheme.
Key exclusion criteria (8 listed)
- Ongoing prandial insulin therapy
- Treated bacterial or viral respiratory infection in the 2 weeks preceding the meal test.
- Surgical intervention under general anesthesia in the last 12 weeks.
- Asthmatic subjects with bronchospasm or under chronic inhaled therapy.
- Ongoing COVID-19 (PCR +) or contact case in the isolation period.
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 |
|---|---|---|
| Glycemia estimated by exhaled air analyzerMeasurement of volatile compounds in the air exhaled by the volunteer on 3 different MIBs (3 breaths in total) at 7 times: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal | Device | Blood sugar levels estimated by analysis of exhaled air |
| QuestionnaireThe questionnaire focuses on the methods and feelings of the blood glucose self-monitoring that he is currently carrying out, a first feedback on user experience on the operation of the prototype and the collection of his expectations for a future commercial device | Behavioural | Blood sugar levels estimated by analysis of exhaled air |
| Veinous glycemiaMeasurement of the veinous glycemia at 7 times: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal | Biological | Blood sugar levels estimated by analysis of exhaled air |
| Capillary glycemia7-step capillary glycemia measurement: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal | Biological | Blood sugar levels estimated by analysis of exhaled air |
| constitution biological collectionSampling for storage of serum at 7 times: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal | Biological | Blood sugar levels estimated by analysis of exhaled air |
| Blood sampleSingle blood sample before mealtimes for HbA1C molecular analysis | Biological | Blood sugar levels estimated by analysis of exhaled air |
| Test mealtaking a test meal before the various blood sugar measurements | Other | Blood sugar levels estimated by analysis of exhaled air |
Primary outcome
Collect glucose values
Time frame: 1 day
Collect successive fasting blood glucose values in patients with type 2 diabetes
Collect glucose values
Time frame: 1day
Collect successive blood glucose values after taking a test meal, in patients with type 2 diabetes
Collect glucose values (fasting)
Time frame: 1 day
Measurement of blood glucose by the exhaled air analyzer from volatile compounds in exhaled air (fasting)
Collect glucose values (after a test meal)
Time frame: 1 day
Measurement of blood glucose by the exhaled air analyzer from volatile compounds in exhaled air (after taking a test meal))
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 13 Feb 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.
Pierre GOURDY, MD, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycemia estimated by exhaled air analyzer, Questionnaire and Veinous glycemia in people with Diabetes Mellitus, Type 2, run by University Hospital, Toulouse at 1 site 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 5 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 13 Feb 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 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?
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?
Collect glucose values (time frame: 1 day). The study lists 4 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 13 Feb 2023.