Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT05207020
Status:
COMPLETED
Last Update Posted:
2023-02-13
First Post:
2021-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development and Validation of the Blood Glucose Measurement Device by Air Analysis Expired
Sponsor:
University Hospital, Toulouse
Organization:
Study Overview
Official Title:
Study Allowing the Collection of Clinical and Biological Data Necessary for Development and Validation of the Blood Glucose Measurement Device by Air Analysis Expired Developed by the Company BOYDSense
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOYDSENSE
Brief Summary:
This clinical study aims to finalize the algorithm and assess the performance of the BOYDSense® breath glucose monitoring system prototype in patients living with type 2 diabetes.
Detailed Description:
Self-monitoring of blood glucose (SMBG) is prescribed to patients living with diabetes according to their type of diabetes, their clinical profile and their personalized needs such as therapeutic adjustments, detection of an asymptomatic hyperglycaemic drift, prevention of hypoglycaemia, or adaptation of the therapeutic strategy to the evolution of the pathology. Most of the people living with type2 diabetes mellitus (T2DM) use an invasive finger prick SMBG glucometer. A pilot study conducted by the BOYDSense mother company Alpha-MOS showed that the analysis of volatile organic compounds (VOC) in exhaled air could reliably predict blood glucose. The development of a breath glucose-monitoring device, by its non-invasive nature, should be an alternative to existing systems by making it possible to avoid capillary samples. Investigators could expect a better quality of life and a better compliance with SMBG in the majority of patients with T2DM. The objectives of our study are to improve the BOYDSense®glucose algorithm based on the VOC analysis of exhaled air; then to assess the performance of the BOYDSense® prototype with the finalized algorithm.
This study aims to gather, in patients with T2DM, successive blood and capillary reference glucose values during a meal test, and to compare them to glucose levels estimated by the BOYDSense® prototype.
All the enrolled patients will undergo a 3 hours standardized meal test with seven glucose measurement endpoints at T0, 30 min, 1hour 1H30, 2H, 2H30 and 3H post meal. Blood glucose will be measured with three different techniques: venous blood glucose measured with a COBAS 8000 automatic analyzer, SMBG measured with a commercial glucometer and blood glucose value estimated from exhaled air using the BOYDSense® prototype.
The study duration will be 4H for each enrolled patient. After the meal test being completed, the end of study procedure includes a 30 min observational period dedicated to the completion of the patients'questionnaire.
This study aims to gather, in patients with T2DM, successive blood and capillary reference glucose values during a meal test, and to compare them to glucose levels estimated by the BOYDSense® prototype.
All the enrolled patients will undergo a 3 hours standardized meal test with seven glucose measurement endpoints at T0, 30 min, 1hour 1H30, 2H, 2H30 and 3H post meal. Blood glucose will be measured with three different techniques: venous blood glucose measured with a COBAS 8000 automatic analyzer, SMBG measured with a commercial glucometer and blood glucose value estimated from exhaled air using the BOYDSense® prototype.
The study duration will be 4H for each enrolled patient. After the meal test being completed, the end of study procedure includes a 30 min observational period dedicated to the completion of the patients'questionnaire.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: