Study Enabling the Collection of Clinical Data Necessary for the Second Phase of Development of the Glycemic Measurement Device by Analysis of Exhaled Air
BOYDSENSE DATA
1 other identifier
interventional
235
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Oct 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2024
CompletedFirst Posted
Study publicly available on registry
September 26, 2024
CompletedStudy Start
First participant enrolled
October 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
October 24, 2024
October 1, 2024
1.6 years
September 23, 2024
October 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurements of volatile organic compounds
Measurements of volatile organic compounds in participants' breath, measured by the Module In Box device.
19 months
Study Arms (1)
Patient with type 2 diabetes or non-diabetic patient treated in the Diabetology departments
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Ongoing respiratory infection.
- Pregnancy or breastfeeding.
- Patient under guardianship, curatorship or safeguard of justice.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Fontaine Salée Hospital
Salies-du-Salat, France, 31 260, France
Rangueil Hospital
Toulouse, France, 31059, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Gourdy, MD
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2024
First Posted
September 26, 2024
Study Start
October 11, 2024
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
October 24, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share