Study Enabling the Collection of Clinical Data Necessary for the Second Phase of Development of the Glycemic Measurement Device by Analysis of Exhaled Air

Recruiting · NCT06614101 · Interventional (participants receive a specific treatment)

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Interventions studied

Exhaled air analysis

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

2 locations listed.

Fontaine Salée Hospital - Salies-du-Salat, France, France
Rangueil Hospital - Toulouse, France, France

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →