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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 235 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
OTHER	Exhaled air analysis	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.

Timeline

• Start date: 2024-10-11
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2024-09-26
• Last updated: 2024-10-24

Locations

2 sites across 1 country: France