Actively Recruiting
Study Enabling the Collection of Clinical Data Necessary for the Second Phase of Development of the Glycemic Measurement Device by Analysis of Exhaled Air
Led by University Hospital, Toulouse · Updated on 2024-10-24
235
Participants Needed
2
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study Enabling the Collection of Clinical Data Necessary for the Second Phase of Development of the Glycemic Measurement Device by Analysis of Exhaled Air
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient living with type 2 diabetes or non-diabetic individuals with overweight or obesity (BMI ≥ 25 Kg/m²), admitted to Toulouse University Hospital departments of Diabetology, Metabolic Diseases and Nutrition or Endocrinology, Metabolic Diseases and Nutrition
- Aged 18 years or older
- Able to sign informed consent
- Affiliated to a social security scheme
You will not qualify if you...
- Ongoing respiratory infection
- Pregnancy or breastfeeding
- Under guardianship, curatorship, or safeguard of justice
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Fontaine Salée Hospital
Salies-du-Salat, France, France, 31 260
Not Yet Recruiting
2
Rangueil Hospital
Toulouse, France, France, 31059
Actively Recruiting
Research Team
P
Pierre Gourdy, MD
CONTACT
L
Laurent Cazals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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