Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614101
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief 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
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOYDSENSE DATA
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None