NCT06614101Recruiting
Study Enabling the Collection of Clinical Data Necessary for the Second Phase of Development of the Glycemic Measurement Device by Analysis of Exhaled Air
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 235 (estimated)
- First submitted
- 23 Sept 2024
- Start date
- 11 Oct 2024
- Primary completion date
- 31 May 2027
- Lead sponsor
- University Hospital, Toulouse
- Diseases
- Type 2 diabetes
- NCT number
- NCT06614101
What you commit to
- Study type: Interventional
- Planned participants: 235
- From 11 Oct 2024 to the primary completion date, 31 May 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Ongoing respiratory infection.
Other
- Pregnancy or breastfeeding.
- Patient under guardianship, curatorship or safeguard of justice.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fontaine Salée Hospital Coordinator of this site? Confirm its status | Salies-du-Salat | France | Not yet recruiting |
| Rangueil hospital Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.