Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Blood sugar measurement
exhaled air
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

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.

Primary outcomes:
measure: Measurements of volatile organic compounds
timeFrame: 19 months
Secondary outcomes:
Other outcomes:
Locations:
city: Salies-du-Salat
country: France
facility: Fontaine Salée Hospital
city: Toulouse
country: France
facility: Rangueil Hospital
Study officials:
affiliation: CHU Toulouse
name: Pierre Gourdy, MD
role: PRINCIPAL_INVESTIGATOR
References: