Collecting clinical data for a new breath-based blood sugar measurement device
Study Enabling the Collection of Clinical Data Necessary for the Second Phase of Development of the Glycemic Measurement Device by Analysis of Exhaled Air
This study is testing a new device that measures blood sugar levels by analyzing breath to see if it can provide accurate results for people with type 2 diabetes and those at risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 235 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 2 sites (Salies-du-Salat, France and 1 other locations) |
| Trial ID | NCT06614101 on ClinicalTrials.gov |
What this trial studies
This study aims to gather clinical data necessary for the development of a non-invasive device that measures blood glucose levels through the analysis of volatile organic compounds in exhaled air. Participants, including those with type 2 diabetes and individuals at risk, will have their breath analyzed alongside traditional blood glucose measurements. The study will utilize prototypes of the Module In a Box, which were previously tested for their ability to estimate blood glucose levels. The goal is to refine the algorithm for accurate glucose level estimation based on breath analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with type 2 diabetes or non-diabetic individuals who are overweight or obese.
Not a fit: Patients with ongoing respiratory infections, those who are pregnant or breastfeeding, or individuals under legal guardianship may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a revolutionary non-invasive method for monitoring blood glucose levels in patients with type 2 diabetes.
How similar studies have performed: Previous studies have shown promising results in using breath analysis for glucose measurement, indicating potential for this innovative approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Salies-du-Salat, France and 1 other locations
- Fontaine Salée Hospital — Salies-du-Salat, France, France (Not_yet_recruiting)
- Rangueil Hospital — Toulouse, France, France (Recruiting)
Study contacts
- Principal investigator: Pierre Gourdy, MD — University Hospital, Toulouse
- Study coordinator: Pierre Gourdy, MD
- Email: gourdy.p@chu-toulouse.fr
- Phone: 0561323740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.