Clinical Study to Collect Data for Developing a Breath Analysis Device to Measure Blood Sugar Levels in Adults with Type 2 Diabetes or at Risk

What this Trial Is About

Researchers are exploring a new way to measure blood glucose levels by analyzing volatile organic compounds in the breath. This study builds on earlier work by ALPHA-MOS and BOYDSense that showed the potential of this non-invasive technology in people with type 2 diabetes. The goal is to collect more clinical data to improve the algorithm that estimates blood glucose from breath samples, since the characteristics of human exhaled air are difficult to simulate. Participants will have their breath analyzed using the Module In a Box prototypes, which measure volatile organic compounds. At the same time, capillary blood glucose levels will be measured using a calibrated glucose meter as part of routine care. This study includes both people with type 2 diabetes and non-diabetic individuals at risk due to overweight or obesity. The breath test devices will indicate if the measurement is valid but will not display blood glucose estimates. During the 19-month study, participants will provide breath samples and undergo blood glucose testing during routine visits. Researchers will compare the breath compound measurements with blood glucose readings to refine the technology. No masking or randomization is involved. The study is sponsored by the University Hospital, Toulouse, and aims to support development of a new, non-invasive glucose monitoring method.

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