NCT06614101 Study Enabling the Collection of Clinical Data Necessary for the Second Phase of Development of the Glycemic Measurement Device by Analysis of Exhaled Air
| NCT ID | NCT06614101 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Toulouse |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 235 participants |
| Start Date | 2024-10-11 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 235 participants in total. It began in 2024-10-11 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Ongoing respiratory infection. * Pregnancy or breastfeeding. * Patient under guardianship, curatorship or safeguard of justice.
Contact & Investigator
Pierre Gourdy, MD
PRINCIPAL INVESTIGATOR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT06614101 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06614101 currently recruiting?
Yes, NCT06614101 is actively recruiting participants. Contact the research team at gourdy.p@chu-toulouse.fr for enrollment information.
Where is the NCT06614101 trial being conducted?
This trial is being conducted at Salies-du-Salat, France, Toulouse, France.
Who is sponsoring the NCT06614101 clinical trial?
NCT06614101 is sponsored by University Hospital, Toulouse. The principal investigator is Pierre Gourdy, MD at University Hospital, Toulouse. The trial plans to enroll 235 participants.
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