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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fontaine Salée Hospital, Salies-du-Salat, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exhaled air analysis

Other

The patient takes two breaths into two different Module In a Box devices (one measurement per device) which will give two measurements of the volatile organic compounds in the exhaled air. No estimate of blood glucose by breath will be displayed: the Module In Boxes will be set to only display the indication valid measurement/invalid measurement.

Primary outcomes

Measurements of volatile organic compounds

Time frame: 19 months

Measurements of volatile organic compounds in participants' breath, measured by the Module In Box device.

Study contacts

Contact information is provided by the study sponsor or research team.

Laurent Cazals

CONTACT

[email protected]

0561323361 ext. +33

Pierre Gourdy, MD

CONTACT

[email protected]

0561323740 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: BOYDSENSE DATA

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Sep 26, 2024
Registry last updated: Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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