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

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Other: Exhaled air analysis

• Registration Number: NCT06614101
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-23
• Study First Posted: 2024-09-26
• Status Verified: 2024-10
• Study Start: 2024-10-11
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-24
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 235

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with type 2 diabetes or non-diabetic patient treated in the Diabetology departments	Exhaled air analysis	-

Primary Outcome Measures

Name	Time	Method
Measurements of volatile organic compounds	19 months	Measurements of volatile organic compounds in participants' breath, measured by the Module In Box device.

Trial Locations

Locations (2)

Fontaine Salée Hospital; 🇫🇷 Salies-du-Salat, France

Rangueil Hospital; 🇫🇷 Toulouse, France